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hinokunio.bsky.social
だいたいびーえる創作においては大きいからって文句が多いかというと多分そうではないと思う……ファンタジーだからね、受けが再起不能になるのはnotFor meですが
September 22, 2026 at 7:46 AM
green8686.bsky.social
私は主人公の哀しみに支配されたし、べべさんは主人公のために怒ってくれるかもしれない。けど、正直オススメはしない。品質の問題ではなく、NOTfor我々
September 16, 2026 at 2:14 PM
naveed360.bsky.social
Persistent myths about past conflicts add to the problem, esp the notion that the US military failed notfor it should not have started a war or because its goals were unattainable, but because it did not pursue the right tactics or commit enough resources. www.foreignaffairs.com/united-state...
August 13, 2026 at 8:19 AM
pdubpolitics.bsky.social
To all the Michganders it is Election Day and I believe it is paramount that you vote for Abdul El Sayed in the primary today to help get Corporate PAC money out of politics and also to fight against the aiding of the genocide in Gaza. Vote for Abdul El Sayed and NOTfor Haley Stevens.
August 4, 2026 at 7:51 PM
expat123.bsky.social
Healthcare for me but notfor thee.
June 30, 2026 at 7:27 PM
epsteinweb.bsky.social
Parts 1-3/3 — EFTA01197798.jpg
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EFTA01197789 | EFTA01197798 neighborhood from small businesses to jewelry and handbag stores targeting wealthy tourists. "Canton Road is °famous street in Hong Kong, but it's notfor Hong Kong people anymore," she said. If you come here on a holiday, you never hear Cantonese, everyone's speaking Mandarin." Needless to say, mainland shoppers passing through Tsim Sha Tsui didn't feel especially welcome. "It's not safe here,"said Men, a 25-year-old woman from Wuxi who had come to Ilong Kong for the national holiday. If known about this before, I would have canceled my trip."(In fact, Beijing suspended tour ptroups to Hong Kong this week.) She added that protests like this would never happen back home. "Everybody there wants peace,"she said. "Wejust pay attention to our own affairs." A young woman named Liu, who also declined to give her full name, said Hong !Congers should be grateful that mainlanders are supporting their economy. "Idon't think they should complain,"she said. 'During the more than hundred years ofBritish occupation, they didn't do this."Most of the mainlanders don't want to talk at all. It'sjust a small conflict,"one woman said without stopping. It'll be resolved soon." Under British rule, the Hong Kong Chinese felt that they enjoyed a superior quality of life than their counterparts on the Mainland and for the most part this is true for the average Chinese person living in Hong Kong. Except that due to the sheer size of the new middle class of more than 250,000 million people living on the Mainland, the privilege/entitled lives could be easily erased if they lose their special status which was guaranteed in a deal when the UK handed Hong Kong back to China in 1997. Under the principle of "one country, two systems," Ilong Kong was afforded economic and political freedoms outside the traditional socialist rule of the People's Republic of China. This system is supposed to remain in place until 2047, yet what is to happen after that time has never been officially stated. Herein lies the underlying reason for the Occupy Central protests. And ultimately, in spite of whatever the protesters do, eventually this special status that I long Kong currently enjoys will end. Ebola virus disease The diagnosis of the first Ebola patient on U.S. soil last week may have put people in a panic, fearing the exotic virus more than mundane germs - such as influenza that pose a far greater threat to the average American. The Ebola outbreak in West Africa - the largest in the go-year history of the virus - has infected 7,178 and killed 3,338, according to the World Health Organization and that there could be another ig,000 (*Ace's that have gone unreported. Still, because Ebola is rare and relatively difficult to transmit, it kills far fewer people than diseases of which Americans are no longer afraid, such as measles and influenza, says Peter Hotez, dean of the National School of Tropical Medicine and professor at Baylor College of Medicine in I louston. "It's important to keep these things in perspective," says Lisa Maragakis, associate hospital epidemiologist at the Johns Hopkins Hospital in Baltimore. She compared Americans' fear of Ebola to the fear of flying. Though many people are afraid to fly, Maragakis points out that far more people are killed in cars. But it is difficult to believe this when the headlines in the national and international media is saying: Ebola Nightmare: I lospitals Become Morgues.... Sweeps Into New Regions Of Africa Not Prepared To Combat... Patients Lie Amongst Bodies, Human Excrement... 'A Lot Of Babies Are Dying Here'... Aid Efforts Failing... 'Not At All Under Control'... As deadly diseases go, Ebola isn't nearly as contagious as tuberculosis, which can be spread through the air. And it isn't as deadly as HIV/AIDS. So far this year, during the worst Ebola outbreak in history, the virus has killed about 3000 people in West Africa. That puts it on par with other deadly, yet preventable ailments. Diarrhea -- a preventable and treatable condition -- kills about 1.5 million children each year -- more than malaria, AIDS and measles combined, according to global health organizations. The !I'M' swine flu pandemic killed more than 284,000 people in 2009 and 2020, according to the Centers for Disease Control and Prevention. Yet Ebola's deadliness and the danger it poses to civil society in affected countries have made this epidemic a problem of global proportions: In September, the United Nations announced that it is establishing an "Ebola Crisis Center," withM. Secretary-General Ban Ki-moon issuing an "international rescue call." And after an in-person briefing in mid-September from the staff at the Centers for Disease Control and Prevention in Atlanta, President Barack Obama announced a "major increase in the U.S. response to the Ebola outbreak in West Africa and that the United States are sending troops, material to build field hospitals, additional health care workers, community care kits and badly needed medical supplies. Since the Ebola outbreak began in February, around 300,000 people have died from malaria, while tuberculosis has likely claimed over 600,000 lives. Ebola might have our attention, but it's not even close to being the biggest problem in Africa right now. Even Lassa fever, which shares many of the terrifying symptoms of Ebola (including bleeding from the eyelids), kills many more than Ebola - and frequently finds its way to the US. Here is the skinny EFTA01197798
May 13, 2026 at 4:12 AM
epsteinweb.bsky.social
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EFTA01195155 | EFTA01195179 Pakistan, Tanzania, Ethiopia, and Kenya, those ten countries together account for 8o percent of the world's total "extreme poor." GDP, Coyle writers in her book, is a "made-up entity"-a product of the 1940s "designedfor the twentieth-century economy ofphysical mass production, notfor the modern economy of rapid innovation and intangible, increasingly digital, services." The good news is that the Nigerian government now has a better system for measuring its economy. The bad news? Knowing Nigeria has a 85m-billion economy doesn't reveal a whole lot about the welfare of its citizens. The change is noteworthy for, in the words of finance minister Ngozi Okonjo-Iweala, the "psychological impact" it will have on foreign investors. They will pay greater attention to Nigeria now that its economy casts a larger shadow than South Africa's and display new confidence that will potentially be rewarded with lucrative gains, especially at a time when value-laden sectors such as power are opening up in unprecedented ways. Business will also boom for hotel owners, travel agents, airlines, and events planners as the number of Nigeria-focused trips and investment conferences (already a booming industry since 2013) swell. Scammers might even be expected to cash in as well. ("Good Day dear friend, I am Lamido Sanusi, governor of the central bank of the newly rebased west African nation of Nigeria...") The one class of people who have nothing to gain will be ordinary Nigerians: the market woman in Ibadan, the itinerant shoe cleaner in Lagos, the motorcycle taxi rider in Makurdi, the cattle merchant in Potiskum, the shoe maker in Aba, the newspaper vendor in Abuja; the sprawling class of `bottom millions' condemned by their country to extreme poverty). The $1,200 by which Nigeria's per-capita income has suddenly risen will not somehow magically appear in their pockets. For this crowd the news is the sort of sleight of mouth that they've since grown to expect from the government. In the aftermath of protests against the removal of fuel subsidies in 2012, President Jonathan announced, in a public broadcast, the creation of 370,000 jobs. Just like that, because everyone knows jobs are created when well-meaning presidential words mix with faith in the hearts of job-hungry citizens. But for me the two big problems with Nigeria are the lack of transparency and rule of law, where there is neither. I first traveled to Nigeria four decades ago, it was still suffering from the aftermath of the Biafran War, and as far as I am concerned it is still a mess. With an estimated population of 174.5 million, land mass twice the size of the state of California and being the 8th largest exporter of crude oil, if Nigeria could ever get its act together, there is a possibility for it to become a true economic power beyond it regional power base. But until it institutes government policies that directed ground up, with full transparency and rule of law it will still be a long way from achieving South Africa's incredible success of more than quadrupling the size of its Middle Class in first ten years after majority rule in 1994 and doubling it again since 2004. We have to stop judging a county's success by economic numbers and instead concentrate on how to raise those condemned to extreme poverty at the bottom. And until Africa does this, it will still be the Dark Continent to me and other humanitarians who believe the greatest thing that we can do is champion policies and efforts that support the must unfortunate. c:!Inline image 10 The Austin City Limits Music Festival There is a new demographic shift in America as Millennials (people bornfrom the early 19805 to the early 2000$) are increasingly deciding not to cast their roots in New York and Los Angeles, and instead are moving to somewhere less expensive, less massive, less hectic, and—again for good measure—less expensive. Many of these people are now moving from Los Angeles to Charlotte, from EFTA01195179
May 13, 2026 at 2:34 AM
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EFTA01133557 | EFTA01133583 society should make sure that every citizen has adequate healthcare, if not the best healthcare possible. If every major country in Western Europe, several the countries in Central & South America, Israel, Singapore, Australia, Japan, Morocco, Iceland and Canada can, then why can't we? Maybe this embarrassing statistic helps change this ugliness. ****** Among the many problems in the U.S., one of the biggest is hunger, now diplomatically referred to as, "food insecurity." Almost 5o million Americans who live on the edge of poverty, endure food insecurity, often skipping meals and rationing food. Many are the "working poor", who shop for grocery bargains, cooking budget-stretching stews, spaghetti and limiting their families to one meal a day. They buy discounts meats and canned vegetables, cheaper than fresh. Many are single parent families, resulting in an estimated 15 million children going to bed every night hungry. And although this sounds like vignettes in a poor Third World country, we are describing people who are trying to survive day-to-day in the richest country on the planet. When Congress officially returns to Washington next week, the diets of families like those described above will be caught up in a debate over deficit reduction. Republicans, alarmed by a rise in food stamp enrollment, are pushing to revamp and scale down the program. Democrats are resisting the cuts. No matter what Congress decides, benefits will be reduced in November, when a provision in the 2009 stimulus bill expires. Yet as lawmakers cast the fight in terms of spending, nonpartisan budget analysts and hunger relief advocates warn of a spike in "food insecurity" among poor Americans. Surrounded by corn and soybean farms — including one owned by the local Republican congressman, Representative Stephen Pincher — Dyersburg, about 75 miles north of Memphis, provides an eyeopening view into Washington's food stamp debate. Mr. Fincher, who was elected in 2010 on a Tea Party wave and collected nearly $3.5 million in farm subsidies from the government from 1999 to 2012, recently voted for a farm bill that omitted food stamps. "The role of citizens, of Christianity, of humanity, is to take care of each other, notfor Washington to stealfrom those in the country and give to others in the country," Mr. Pincher, whose office did not respond to interview requests, said after his vote in May. In response to a Democrat who invoked the Bible during the food stamp debate EFTA01133583 Epstein Web iOS app on the App Store.
May 10, 2026 at 12:19 PM
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EFTA00721040 | EFTA00721043 No species has deliberately designed its own extinction but through industrial agriculture we are. It is in the design of industrial agriculture because it first's creed is to place profits over product and as a result it is destroying the base of farming, ecological systems, as well as not being a productive and efficient use of resources. Industrial agriculture uses 10 units of energy to produce 1 unit of food, whereas ecological systems use 1 unit of food to produce 2 units of food. The mainstay of food security is and should be small farms and urban gardens. Food can only be cared for on a small scale. Food can only be cared for in decentralized systems. The centralized system of production and with that centralizing, the centralized system of distribution by its very necessity means waste. There is no waste in living systems. There is no waste in ecological farming systems. There is no waste in local food systems. I grow many crops all of them are used, some for the soil, some for the cow. In India nothing gets wasted because the cow is always waiting. Or the earthworms are waiting. It only becomes waste when aid sent long distances and stored in centralized systems as in the large store houses/silos in the Punjab. Or if it is taken by Walmart. Because Walmart will throwaway half because the apples aren't exactly the right size. A South African told me that overnight they had to change the trees, variety of their apples because Walmart changed the size of their trucks. And as you know that 'flavor savor"was designed for transport not for eating as so much food is now. Breeding today is for trucks not for human beings. How long can it sit on a truck? Then it has to be the identical size. That is why they didn't like the round tomatoes and Berkeley had a whole study on tomatoes for packaging and transport. Farmers should grow as much diverse crops possible and people should eat as much diverse foods as they can. And when told that organic is too costly Dr. Vandana Shiva says "notfor thefarmer who grew it as they have thefirst right to organicfood." And when you measure, not the mono culture which is yield, the yield per acre, which is repeatedly talked about because the yield is a single commodity that leaves the farm. So the grain of wheat is measured as yield but not the straw that should stay on the farm. The corn is measured as yield, but not the straw of corn. So what should be recycled to the farm is treated as waste and isn't allowed to return to the soil. As a result the mono culture is harvested by combine harvesters, which leave a huge stalk which they farmers have to burn. As a result a bio-diverse farm produces more across the board. Also when you have diverse farming at least one of the crops will thrive/survive nature's challenges. Whereas, when you have only one crop with external input and the perfect requirement of water, two little rain, too much means disaster for everything. Also in the end what matters is now how much we eat but the nutritional content in the food that we eat. And our food has been systemically de-nutritionaified because of the application of nitrogen phosphate potassium and no other micro-nutrients and trace elements are going into the soil, our plants are deprived, our food is deprived and therefore we are deprived of potassium, magnesium, phosphorus, iron and zinc. We forget that our plants need zinc, soils need zinc and humans need zinc. Our current system is wiping out nutrition. First by wiping out biodiversity. Then by depleting the soil, plants and foods of their nutrients. And the focus of yield, yield, yield of single commodities, is creating huge deficiencies. If there are no greens in the fields, and pesticides like Round-Up kills everything green, our kids will have vitamin deficiencies. So the obvious solution is grow the greens again. We know the different foods that will provide the needed nutrients. We have to change our current farming system. We have to work for greater biodiversity to produce more food and nutrition using up less of the earth's resources — a smaller foot print and a higher EFTA00721043
May 5, 2026 at 5:14 PM
epsteinweb.bsky.social
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EFTA00691949 | EFTA00691954 MARSHALL GANZ: There were three questions posed by a 1st century Jerusalem scholar Rabbi Hillel, when asked "How do we, how do we understand what we are to do in the world?" And he responded with three questions. The first one to ask yourself, "If I am notfor myself who will befor me?" It's not a selfish question, but it is a self-regarding question. Sort of saying, "Ask yourself what you're about, what you value, what you have to contribute, what..." But then the second question is, "If I am for myself alone, what am I?" But it, which is, it's to even be a who and not a what is to recognize that we are in the world in relationship with others and that our capacity to realize our own objectives is inextricably wrapped up with the capacity of others to realize theirs. And finally, "If not now, when?" The time for action is always now, because it's often only through action that we can learn what we need to learn in order to be able to act effectively in the ways that we intend. And the fact that they're questions is also really important to me, because it suggests that this work, this work of organizing, leadership is not about knowing, it's about learning. And it's about asking and it's about understanding that it is about dealing with the uncertain. It is about probing the unknown. It's not about control. It's about, it's about learning through purposeful experience. And so that's kind of, I think, what I've tried to, as I look back, what I've tried to learn, to teach, to do, to practice is how to be that kind of a learner and teacher. There was a cliché that management consultants coined years ago, "thinking outside the box." These words suns up much of what is wonderful about Marshall Ganz. He is a non-liner thinker who understands structure and realizes that our real strength is that instead of me, his mantra is we . He is someone who seeks the greater good, even if it necessitates conflict before compromise. Because if you are not willing for fight for something, you deserve whatever you are given. In Ganz's world, we should to see beyond monetary value, status quo, fame or convenience. Example, great films are based are not on box office success and great music is not the result of record sales or how many people download an iTune selection. Greatness is the shared experience that we can offer to others, even if we are not famous or rich, as long as we do it for the greater good for everyone and without prejudice As such, I urge everyone to download and watch Bill Moyers' interview with Marshall Ganz, as he is a inspiration and a guide for everyone who is willing to look beyond their own needs, desires or special interest in search of the greater good. On its second showing I strongly recommend that everyone see — The Untold History of the United States, a to hour (to episodes) documentary series on Showtime, directed and narrated by Oliver Stone. Co-written and co-produced by American University history professor Peter Kuznick — who collaborated with Stone on a same-titled, 784-page tie-in book — Untold History is part of a tradition of alternative cultural criticism, journalism, and history. Its chapters echo Ida Tarbell, Upton Sinclair, John Reid, Noam Chomsky, Howard Zinn, Norman Mailer, I.F. Stone, Michael Moore and Jim Burns. With one reviewer calling it ominous, seductive, verbose, apocalypse-left in its politics, filled with scurrilous factoids about men who have monuments named after them, I found it as a refreshing look at United States during the last 8o years, especially when history is always re-written by the winners.... The most recent installment, episode 6, OLIVER STONE'S UNTOLD HISTORY OF THE US: JFK chronicled JFK and the Bay of Pigs; on the brink of total war during Cuban Missile Crisis; early Vietnam; JFK's attempts at peace with Khrushchev; JFK assassinated. As a result, I took another look at the Presidency of JFK, which I would like to share below. President John Kennedy, harboring doubts about another land war in Asia as a student of history who as a young Congressman that visited Viet Nam in 1951 during the debacle of the Korean War he advised the Truman Administration against "aiding the French Colonist and later spoke broadly of needing to win the support ofArabs, Africans and Asians who hated the White Man who bled them, beat them, exploited them and ruled them while pointing out the contradiction of supporting the French empire in Africa and Asia, while opposing Soviet moves in Hungry and Poland." However EFTA00691954
May 5, 2026 at 9:23 AM
epsteinweb.bsky.social
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EFTA00315128 | EFTA00315161 J. CRAIG VENTER J. Craig Venter, Ph.D., is regarded as one of the leading scientists of the zest century for his numerous invaluable influenzae, using his new whole genome shotgun technique. In 1998, Dr. Venter founded Celera Genomics contributions to genomic research. He is Founder, Chairman, to sequence the human genome using new tools and and President of the J. Craig Venter Institute (JCVI), a notfor-profit, research organization with approximately 300 techniques he and his team developed. This research culminated with the February zoo]. publication of the human scientists and staff dedicated to human, microbial, plant, genome in the journal, Science. He and his team at Celera synthetic and environmental genomic research, and the exploration of social and ethical issues in genomics. also sequenced the fruit fly, mouse and rat genomes. Dr. Venter and his team at JCVI continue to blaze Dr. Venter is also Founder and CEO of Synthetic new trails in genomics. They have sequenced and analyzed Genomics Inc (Sal), a privately held company dedicated to commercializing genomic-driven solutions to address hundreds of genomes, and have published numerous important papers covering such areas as environmental global needs such as new sources of energy, new food and genomics, the first complete diploid human genome, and the nutritional products, and next generation vaccines. Dr. Venter began his formal education after a tour groundbreaking advance in creating the first self-replicating bacterial cell constructed entirely with synthetic DNA. of duty as a Navy Corpsman in Vietnam from 1967 to 1968. Dr. Venter is one of the most frequently cited After earning both a Bachelor's degree in Biochemistry and a Ph.D. in Physiology and Pharmacology from the University of scientists, and the author of more than 250 research articles. He is also the recipient of numerous honorary degrees, California at San Diego, he was appointed professor at the State public honors, and scientific awards, including the wog University of New York at Buffalo and the Roswell Park Cancer Institute. In 1984, he moved to the National Institutes of United States National Medal of Science, the zooz Gairdner Foundation International Award, the zoos Paul Ehrlich and Health campus where he developed Expressed Sequence Tags Ludwig Darmstaedter Prize and the King Faisal International or ESTs, a revolutionary new strategy for rapid gene discovery. In 1992 Dr. Venter founded The Institute for Genomic Award for Science. Dr. Venter is a member of numerous prestigious scientific organizations including the National Research (TIGR, now part of JCVI), a not-for-profit research Academy of Sciences, the American Academy of Arts and institute, where in 1995 he and his team decoded the genome of the first free-living organism, the bacterium Haemophilus Sciences, and the American Society for Microbiology. EFTA00315161
April 27, 2026 at 6:16 AM
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EFTA00224444 | EFTA00224518 A0442 (Rev 01109) Anne wanes (Page 2) This second page contains personal identifiers provided for law-enforcement use only and therefore should not be filed in court with the executed warrant unless under seal. (Notfor Public Disclosure) Name of defendant/offender: Known aliases: Last known residence: Prior addresses to which defendant/offender may still have ties: Last known employment: Last known telephone numbers: Place of birth: Date of birth: Social Security number: Height: Sex: Weight: Female Race: White Eyes: Hair: Scars. tattoos, other distinguishing marks: History of violence, weapons, drug use: Known family, friends, and other associates !name. relation, address, phone number): FBI number: Complete description of auto: Investigative agency and address: Federal Bureau of Investigation, West Palm Beach, FL Name and telephone numbers (office and cell) of pretrial services or probation officer rilapplicable): Date of last contact with pretrial services or probation officer lifopplkable): Case No. 08-80736-CV-MARRA P-011775 EFTA00224518 Epstein Web iOS app on the App Store.
April 24, 2026 at 7:29 PM
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EFTA00224444 | EFTA00224515 A0442 (Rev 01.4/9) Arrest Wemini (Page 2) This second page contains personal identifiers provided for law-enforcement use only and therefore should not be filed in court with the executed warrant unless under seal. (Notfor Public Disclosure) Name of defendant/offender Last known residence: Prior addresses to which defendant/offender may still have ties: Last known employment: Last known telephone numbers: Place of birth: Date of birth: Social Security number. Height: sex: Female Weight: Race: Flair: Eyes: White Scars, tattoos, other distinguishing marks: History of violence, weapons, drug use: Known family, friends, and other associates frame. relation. address. phone number): FBI number: Complete description of auto: Investigative agency and address: Federal Bureau of Investigation. West Palm Beach, FL Name and telephone numbers (office and cell) of pretrial services or probation officer (Jappircable): Date of last contact with pretrial services or probation officer ft/applicable): Case No. 08-80736-CV-MARRA P-011772 EFTA00224515
April 24, 2026 at 7:29 PM
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EFTA00224444 | EFTA00224512 AO 442 (Rev 01/09) Arrest Warrant (Past 2) This second page contains personal identifiers provided for law-enforcement use only and therefore should not be filed in court with the executed warrant unless under seal. (Notfor Public Disclosure) Name of defendant/offender: Known aliases: Last known residence: Prior addresses to which defendant/offender may still have ties: Last known employment: Last known telephone numbers: Place of birth: Date of birth: Social Security number: Weight: Height: Sex: Female Race: White Eyes: Hair: Scars. tattoos. other distinguishing marks: History of violence, weapons, drug use: Known family, friends, and other associates mom& relation. address. phone number): FBI number: Complete description of auto: Investigative agency and address: Federal Bureau of Investigation, West Palm Beach. FL Name and telephone numbers (office and cell) of pretrial services or probation officer afapplicable): Date of last contact with pretrial services or probation officer Wappiknfrie): Case No. 08-80736-CV-MARRA P-011769 EFTA00224512
April 24, 2026 at 7:29 PM
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EFTA00194971 | EFTA00194972 AO 442 (Rev.01/09) Arrest Warrant (Page 2) This second page contains personal identifiers provided for law-enforcement use only and therefore should not be filed in court with the executed warrant unless under seal. (Notfor Public Disclosure) Name of defendant/offender: Known aliases: _ Last known residence: Prior addresses to which defendant/offender may still have ties: Last known employment: Last known telephone numbers: Place of birth: Date of birth: Social Security number: Height: Se; Female Weight: Race: Hair: Eyes: White Scars, tattoos, other distinguishing marks: History of violence, weapons, drug use: Known family, friends, and other associates (name. relation. address. phone number): FBI number: Complete description of auto: Investigative agency and address: Federal Bureau of Investigation, West Palm Beach, FL Name and telephone numbers (office and cell) of pretrial services or probation officer (ifapplicable): Date of last contact with pretrial services or probation officer ofapplicable): Print Reset EFTA00194972
April 23, 2026 at 10:58 PM
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EFTA00103428 | EFTA00103428 From: To: CC: Subject: Memorandum for Record: Routch, 8/30/19 Date: Fri, 30 Aug 2019 18:55:36 +0000 Attachments: Watch Commander See the memo attached, describing the conversation had today with CBPAS U.S. Customs and Border Protection Supervisor, Agriculture Operations Port of Charleston, SC office mobile This document and any attachment(s) may contain restricted, sensitive, and/or law enforcementsensitive information belonging to the U.S. Government. It is notfor release, review, retransmission, dissemination, or use by anyone other than the intended recipient. Ifyou received this communication in en-or, please immediately naafi) the sender and delete or destroy this communication and all attachments. EFTA00103428
April 21, 2026 at 9:21 AM
wildstyledaproducer.threads.net.ap.brid.gy
Indiana State Senator Andrea Hunley has launch event

May 8 2026 5-7pm

Bring the whole family!
May be an image of poster, magazine and text that says 'PARTY far the PEOPLE A HUNLEY LAUNCH EVENT AI DATE MAY 8, 2026 LOCATION TINKER HOUSE EVENTS TIME 5-7PM GOOD FOOD, GOOD MUSIC, and YOU PAID FOR Y ANDREA HUNLEY FOR NDY' May be an image of standing, banner, crowd and text that says 'NO Soa PROTECT PLOUR COMMUNITY!! WER POWER FOR PEOPLE NOT NOTFOR FOR PROFITS! PROFITS! cか No DATA CENTER NO NODA CENTER NTERS! PROTECT OUR PEOPLE: NO DATA CENTERS! 트에시에COE PLE FOR ITS! Secialismaed -Indianapaks FSSHAT POW PEOP NOT PROF И 100 ねたン XμoH MOM u Ppp οИ on lof ALL317HIPHOP'
April 20, 2026 at 2:37 PM
im-computer.bsky.social
existing is low-key Notfor me but i will keep drawing things
March 23, 2026 at 11:14 AM
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EFTA02039071 | EFTA02039104 J. CRAIG VENTER J. Craig Venter, Ph.D., is regarded as one of the leading scientists of the list century for his numerous invaluable contributions to genomic research. He is Founder, Chairman, and President of the I. Craig Venter Institute (JCVI), a notfor-profit, research organization with approximately 300 scientists and staff dedicated to human, microbial, plant, synthetic and environmental genomic research, and the exploration of social and ethical issues in genomics. Dr. Venter is also Founder and CEO of Synthetic Genomics Inc (Sal), a privately held company dedicated to commercializing genomic-driven solutions to address global needs such as new sources of energy, new food and nutritional products, and next generation vaccines. Dr. Venter began his formal education after a tour of duty as a Navy Corpsman in Vietnam from 1967 to 1968. After earning both a Bachelor's degree in Biochemistry and a Ph.D. in Physiology and Pharmacology from the University of California at San Diego, he was appointed professor at the State University of New York at Buffalo and the Roswell Park Cancer Institute. In 1984, he moved to the National Institutes of Health campus where he developed Expressed Sequence Tags or ESTs, a revolutionary new strategy for rapid gene discovery. In 1992 Dr. Venter founded The Institute for Genomic Research (TIGR, now part of JCVI), a not-for-profit research institute, where in 1995 he and his team decoded the genome of the first free-living organism, the bacterium Haemophilus influenzae, using his new whole genome shotgun technique. In 1998, Dr. Venter founded Celera Genomics to sequence the human genome using new tools and techniques he and his team developed. This research culminated with the February zoos publication of the human genome in the journal, Science. He and his team at Calera also sequenced the fruit fly, mouse and rat genomes. Dr. Venter and his team at XVI continue to blaze new trails in genomics. They have sequenced and analyzed hundreds of genomes, and have published numerous important papers covering such areas as environmental genomics, the first complete diploid human genome, and the groundbreaking advance in creating the first self-replicating bacterial cell constructed entirely with synthetic DNA. Dr. Venter is one of the most frequently cited scientists, and the author of more than 250 research articles. He is also the recipient of numerous honorary degrees, public honors, and scientific awards, including the 2008 United States National Medal of Science, the 2002 Gairdner Foundation International Award, the zoos Paul Ehrlich and Ludwig Darmstaedter Prize and the King Faisal International Award for Science. Dr. Venter is a member of numerous prestigious scientific organizations including the National Academy of Sciences, the American Academy of Arts and Sciences, and the American Society for Microbiology. EFTA_R1_00553530 EFTA02039104 Epstein Web iOS app on the App Store.
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EFTA01734942 | EFTA01734956 Contains Nonbinding Recommendations Draft — Notfor Implementation 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 The FDA may request additional studies based on specific characteristics of the drug, such as its pharmacology, signals that emerge during drug development, or the intended route of administration. Sponsors should discuss these specifics with the FDA during drug development. Development programs for all new molecular entities, including treatments for low sexual interest, desire, and/or arousal, should include an assessment of cardiac repolarization potential.19 Development programs for drugs with a potential psychotropic mechanism of action should also include prospective assessment of treatment-emergent suicidal ideation and behavior.20 2. Pharmaeokinetie/Pharmacodynamie Considerations We recommend conducting an adequately designed dose-finding study with measurements of systemic exposure to assess the dose and exposure-response relationship. If feasible, blood samples collected during the phase 3 trials would also be helpful in correlating efficacy or safety findings with systemic exposure. l° See the guidance for industry EI 4 Clinical Evaluation ofQT/QTc Interval Prolongation and Proarrhythmic Potentialfor Non-Antiarrhythmic Drugs. 2° See the revised draft guidance for industry Suicidal Ideation and Behavior Prospective Assessment of Occurrence in Clinical Trials. When final, this guidance will represent the FDA's current thinking on this topic. 12 EFTA_R1_00015170 EFTA01734956
March 8, 2026 at 12:51 PM
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EFTA01734942 | EFTA01734955 Contains Nonbinding Recommendations Draft — Notfor Implementation 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 intended to treat low sexual interest, desire, and/or arousal disorders, with SSEs relegated to a secondary endpoint:8 The FDA also considers this approach acceptable. 2. Other Secondary Endpoints Definitions of a responder demonstrating improvement in SSEs, interest, desire, arousal, or distress also can be assessed as secondary endpoints. Responder definitions should be prospectively described before starting the trial and should be based on actual data that establish that the change is clinically important. Responder definitions should be derived using anchor-based methods. At a minimum, a static current-state patient global impression of severity (PGI-S) should be used as the anchor to evaluate the responder definition. The PGI-S is not subject to recall error like the patient global impression of change (POI-C) anchor. A PGI-C can be used in addition to the PGI-S to provide additional evidence in interpreting a clinically meaningful change. See the PRO guidance for additional information. The FDA is open to considering other anchor-based methods as well. If the investigational drug is expected to have an effect on both sexual desire and sexual arousal, the sponsor should designate, a priori, whether all these components will be evaluated as coprimary endpoints or whether some of these components will be tested as secondary endpoints. The sponsor should include justification for the proposed approach in the protocol, including the plan for controlling type I error for endpoints the sponsor hopes will lead to labeling claims. F. Other Considerations I. Safety Considerations Drugs treating conditions of low sexual interest, desire, and/or arousal are likely to be taken long-term (defined as continuous or intermittent use for at least 6 months during the course of a lifetime). Therefore, the safety database should meet the patient exposures outlined in the ICH guidance for industry El The Extent ofPopulation Exposure to Assess Clinical Safety: For Drugs Intendedfor Long-Term Treatment ofNon-Life-Threatening Conditions. Note that these are minimum patient exposures and that larger exposures may be needed for specific drugs depending on safety concerns identified during drug development. Drugs intended for as-needed use may also cumulatively lead to use of at least 6 months during the course of a lifetime, and, in this case, should meet the patient exposures outlined in ICH El, unless the sponsor provides adequate justification for why cumulative use would not exceed 6 months. 18 See the Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction Web page at http://www.fda.gov/Drugs/NewsEventsittem401I67.htm. See also the public meeting minutes The Voice of the Patient, A series of reports from the U.S. Food and Drug Administration's (FDA's) Patient-Focused Drug Development Initiative: Female Sexual Dysfunction, accessed at http://www.fda.govidownloads/Drugs/NewsEvents/UCM4537I8.pdf. I EFTA_R1_00015169 EFTA01734955
March 8, 2026 at 12:51 PM
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EFTA01734942 | EFTA01734953 Contains Nonbinding Recommendations Draft— Notfor Implementation 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 whether women experiencing sexual desire all or most of the time would identify this as a benefit, or whether this could represent a different concern to women. If a sponsor elects to use the FSFI, or a modified FSFI, some potential approaches for doing so are delineated below: (1) A sponsor could develop a new modified FSFI desire domain that includes individual assessment of the components of desire captured on a daily basis with subsequent validation (evaluation of measurement properties). This approach is preferred because it addresses each of the concerns delineated above. (2) A sponsor could use the FSFI desire domain and 28-day recall as currently designed and show that this recall period does not affect conclusions by comparing these results with a subset of subjects who use a shorter recall period (e.g., daily assessment) for the individual desire items. (3) A sponsor could use the FSFI desire domain but remove the multibarreled instructions in the current instrument, and consider including secondary endpoints assessing other components of desire. (4) A sponsor could use the FSFI desire domain and 28-day recall as currently designed without any modifications. This approach carries more risk because the aforementioned issues could make it more difficult to detect or interpret changes in a trial. b. Female Sexual Distress Scale-Revised, Item 1315 Question 13 of the Female Sexual Distress Scale-Revised (FSDS-R) instrument is considered acceptable for measuring bother (a component of distress) related to decreased sexual desire. This question asks "How often did you feel: Bothered by low sexual desire?" Subjects assess their sexual distress over a 7-day recall period and respond on a scale of 0 (never) to 4 (always). c. Other scoring proposals Total scores of the FSFI and FSDS-R are not specific to the outcome measures of interest for the conditions addressed in this guidance. Therefore, the total scores will not be considered acceptable for any labeling claim. E. Trial Endpoints Primary efficacy assessments for adequate and well-controlled trials should be well-defined and reliable to provide a basis for determining whether there is "substantial evidence" to support the claims of effectiveness for a new drug." Endpoint decisions should reflect the primary IS DeRogatis L, Clayton A, et al.. 2008. Validation of the Female Sexual Distress Scale-Revised for Assessing Distress in Women With Hypoactive Sexual Desire Disorder, J Sex Mai, 5:357-364. 16 21 CFR 314.126 9 EFTA_R1_00015167 EFTA01734953 Epstein Web iOS app on the App Store.
March 8, 2026 at 12:51 PM
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EFTA01734942 | EFTA01734952 Contains Nonbinding Recommendations Draft — Notfor Implementation 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 and distress. We encourage the research and drug development community to collaborate with the FDA in development of a publicly available fit-for-purpose PRO instrument that can be used across multiple drug development programs over time. A framework for such collaboration is available within the FDA Development Tool Qualification program. See the guidance for industry and FDA Staff Qualification Processfor Drug Development Tools. a. Female Sexual Function Index14 The Female Sexual Function Index (FSFI) is a 19-item instrument that has been used in clinical trials to measure overall sexual function, although the FDA is unaware of data that adequately establish the validity of the instrument as a whole for regulatory purposes. Individual domain questions from the FSFI have been used to measure specific components of sexual function such as sexual desire (questions 1 and 2) and sexual arousal (questions 3 through 6). Below we focus on the FSFI sexual desire domain. To date, the FDA's experience with the FSFI sexual arousal domain is limited. Sponsors who wish to use that domain or other portions of the FSFI to establish efficacy for other aspects of sexual function should provide supporting data consistent with the recommendations in the PRO guidance. The assessment of desire in the FSFI includes introductory instructions that define desire as being "a feeling that includes wanting to have a sexual experience, feeling receptive to a partner's sexual initiation, and thinking or fantasizing about having sex." Question I asks "How often did you feel sexual desire or interest?" with response options ranging from 5 (Almost always or always) to 1 (Almost never or never). Question 2 asks "How would you rate your level (degree) of sexual desire or interest?" with response options ranging from 5 (Very high) to 1 (Very low or none at all). These two questions ask the subject to reflect on her symptoms over the preceding 4 weeks. The two response scores are summed, and raw scores are multiplied by a factor of 0.6, providing a sexual desire domain score that ranges from 1.2 to 6.0. The FDA has the following concerns with the content validity and response scale of the FSFI desire domain, in addition to the long recall period (28 days) as discussed in section 111.D.1., Recall Period. • The FDA's content validity concerns for the sexual desire domain arise from the multibarreled instructions that make it unclear what is driving any change identified on the assessment (e.g., receptivity, sexual fantasies, or initiating sexual activity). For example, if only one component (e.g., sexual fantasies) is increased with the drug, but other components (e.g., wanting, initiating, or feeling receptive to sexual activity) have not improved, a score change suggesting improvement could be shown; however, it is unclear whether this represents a meaningful benefit to patients. • The FDA's concerns with the response scale relate to the response option of "Almost always or always" feeling sexual desire or interest (question 1) and a response indicating a "Very high" level of sexual desire or interest (question 2). For example, it is unclear 14 Rosen R. Brown C, et al., 2000, The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function, Sex Marital Ther, 26(2):191-208. 8 EFTA_R1_00015166 EFTA01734952
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EFTA01734942 | EFTA01734950 Contains Nonbinding Recommendations Draft — Notfor Implementation 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 The FDA recommends subgroup analyses based on the cause of menopause (natural versus surgical) if both naturally and surgically menopausal women are enrolled in the same trial. The FDA also recommends subgroup analyses according to baseline hormonal contraceptive use (for premenopausal women) and according to baseline hormone therapy use (for postmenopausal women, if these drugs are allowed during the trials). The FDA also requires additional subgroup analyses based on age and race." D. Clinical Outcome Assessment Instruments Because decreased sexual interest, desire, and/or arousal are symptomatic conditions, a PRO is the most appropriate clinical outcome assessment for evaluating symptoms. It is essential that sponsors use well-defined and reliable PRO instruments.12 For any PRO instrument proposed as a key study endpoint to support labeling claims, the sponsor should provide supportive information for FDA review (e.g., a copy of the assessment, the instrument's conceptual framework and scoring, evidence of the instrument's content validity" and other measurement properties including reliability, construct validity, and ability to detect change). See the PRO guidance for additional information. I. RecallPeriod Key signs and symptoms should be recorded frequently by subjects to minimize inaccurate responses resulting from problems with subject recall. We recognize that shorter recall periods may be more burdensome to subjects over the course of a lengthy trial and could lead to diaty fatigue, which could adversely affect compliance with diary entry over time. However, longer recall periods (e.g., monthly) may adversely affect the ability to accurately reflect on symptoms. For example, the longer recall period may increase noise in the assessment making it more difficult to detect or interpret change during a trial. With a longer recall, it is also possible that subject recollection could be more heavily influenced by other experiences or by more recent experiences. Because of the problems with long-term recall, we recommend using a short recall period (sponsors using a short recall period who are concerned about subject burden can propose approaches to minimizing burden). Sponsors who wish to use a longer recall period should evaluate the accuracy of the longer recall period compared to shorter recall. " 21 CFR 314.50(dX5Xv) I2 21 CFR 3I4.126(aX6) 13 Content validity is defined as the "Evidence from qualitative research demonstrating that the instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. Testing other measurement properties will not replace or rectify problems with content validity." See section 111.D., Content Validity, of the PRO guidance. 6 EFTA_R1_00015164 EFTA01734950
March 8, 2026 at 12:50 PM
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EFTA01734942 | EFTA01734949 Contains Nonbinding Recommendations Draft — Notfor Implementation 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 in different geographical regions. These differences may affect the generalizability of efficacy data from patients outside the United States to the U.S. population. If the development program includes trials conducted in other geographical regions, these data can be used to support safety. To support efficacy, the trial population should be representative of U.S. women in whom the drug will be intended for use and should reflect the demographic characteristics of the target population with the disorder. Trial subjects should be North American patients who are sexually active and are at least 18 years of age. They should have a documented history of personal distress related to low sexual interest, desire, and/or arousal. Although women who are not in a stable relationship may also experience sexual dysfunction, the FDA recommends that the clinical trials limit enrollment to women who are in a stable relationship. This approach reduces the likelihood of having changes in relationship status during the trials, which could confound the results. Patients should be excluded if the symptoms and associated distress are related to a comorbidity, problems within the relationship, or the effects of a drug or other drug substance. Female sexual dysfunction occurs in adult women. Sponsors can request a full waiver for pediatric studies on the grounds that necessary studies would be impossible because the condition does not exist in the pediatric age group. 2. Eligibility The exclusion criteria (e.g., coexisting medical conditions, concomitant medications, restrictions based on body mass index, history of substance use) should be limited to ensure that the trial population is representative ofNorth American women anticipated to use the drug, if approved. We also encourage sponsors to include patients with a broad range of severity of sexual dysfunction at baseline, provided that the dysfunction causes marked distress (see section III.D.3., Instruments for Measuring Patient-Reported Outcomes, for an assessment of distress). Furthermore, because the eligibility criteria do not need to be identical in all phase 3 trials comprising the clinical program, subsequent trial(s) can have less restrictive entry criteria than the first trial. 3. Menopausal Status Because conditions of low sexual interest, desire, and/or arousal occur in both pre- and postmenopausal women, both groups represent appropriate target populations. Development programs targeting only one of these subgroups should be justified by safety concerns or other clinical grounds. Sponsors can choose to study pre- and postmenopausal women in separate trials or study these populations within the same trial. If studied in the same trial, randomization of subjects should be stratified by menopausal status. Regardless of the approach chosen, dose-finding, safety, and efficacy should be established independently for each of these populations, because the benefitrisk profile may differ and there may be differences in etiologies and treatment responses. Therefore, if both pre- and postmenopausal women are included in the same clinical trial, the trial should be powered adequately to demonstrate statistical and clinical significance for each of these subgroups. 5 EFTA_R1_00015163 EFTA01734949
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