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$HIMS 🚨 NEEDHAM'S RYAN MACDONALD SAYS HIS "BASE CASE" IS THAT PEPTIDES WILL BE APPROVED Jonathan Stern: "I have seen a ton of alarmist tweets saying, 'RIP to the peptide bros', essentially. And what you're saying, Ryan, is that it's really not that simple." "We have a process here.... We're going to go to PCAC. PCAC is going to make a recommendation to the FDA. But after the PCAC recommendation, the FDA gets to decide. Is that right?" Ryan MacDonald: "Yeah. That's correct... PCAC can make its recommendation and then from there it goes to FDA to make a final decision." "And based on the research that I've done... the final decision goes to the top, goes to the head of the FDA [RFK Jr.]." "It would be surprising to me if there wasn't some sort of involvement from RFK given how vocal he has been." "It's the FDA leadership's domain to make the final decision on this."show more

Hims House

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The FDA’s recent recommendations on peptides are a *significant* setback for new and existing companies being built around the expectation that they will be able to sell compounded peptides. That’s because the 503A Bulks List is basically a pathway that lets compounding pharmacies use certain bulk drug substances to compound drugs for patient-specific prescriptions. The FDA is recommending against adding seven popular peptides to the list. Unless RFK goes against the FDA staff recommendation, these companies’ path to legally compounding and selling peptides becomes very difficult.

The FDA’s recent recommendations on peptides are a significant setback for new and existing companies being built around the expectation that they will be able to sell compounded peptides. That’s because the 503A Bulks List is basically a pathway that lets compounding pharmacies use certain bulk drug substances to compound drugs for patient-specific prescriptions. The FDA is recommending against adding seven popular peptides to the list. Unless RFK goes against the FDA staff recommendation, these companies’ path to legally compounding and selling peptides becomes very difficult.

TBPN

47,977 Aufrufe • vor 18 Tagen

One of the largest raw dairy farms in America was told to lie on their raw cheese label by the FDA They were told to pasteurize the cheese then put “raw” on the label The FDA has been telling other brands to do this, and it’s true. He shows proof with examples He’s brought to tears saying he works for his customers not the FDA “We refuse to lie to our consumers — Clearly, the FDA is not connected to consumers, and I don't serve the FDA. I serve people. Excuse me for being emotional, but it's that deep” Why is this happening People for “Raw” dairy products argue it offers superior nutrition, enzymes, and gut health benefits when properly produced and testing The FDA and state health departments) warn that unpasteurized products carry significantly higher risks of foodborne illness from bacteria like E. coli, Salmonella, Listeria, and Campylobacter He says they test their products, its negative The bigger issue here is the FDA is telling companies to lie and then letting them package the product with the lie. This is so corrupt

One of the largest raw dairy farms in America was told to lie on their raw cheese label by the FDA They were told to pasteurize the cheese then put “raw” on the label The FDA has been telling other brands to do this, and it’s true. He shows proof with examples He’s brought to tears saying he works for his customers not the FDA “We refuse to lie to our consumers — Clearly, the FDA is not connected to consumers, and I don't serve the FDA. I serve people. Excuse me for being emotional, but it's that deep” Why is this happening People for “Raw” dairy products argue it offers superior nutrition, enzymes, and gut health benefits when properly produced and testing The FDA and state health departments) warn that unpasteurized products carry significantly higher risks of foodborne illness from bacteria like E. coli, Salmonella, Listeria, and Campylobacter He says they test their products, its negative The bigger issue here is the FDA is telling companies to lie and then letting them package the product with the lie. This is so corrupt

Wall Street Apes

199,791 Aufrufe • vor 1 Monat

"Every decision that me and Moug make is to win, and win now. This isn't going to be the last decision I make that will upset some people, and that's okay." Aaron Glenn on if he's talked with players about the decision to move on from Aaron Rodgers:

"Every decision that me and Moug make is to win, and win now. This isn't going to be the last decision I make that will upset some people, and that's okay." Aaron Glenn on if he's talked with players about the decision to move on from Aaron Rodgers:

SNY Jets

216,467 Aufrufe • vor 1 Jahr

This clip will shock you to your core US Congressional Subcommittee hearings on dental mercury asks the FDA that now knowing that mercury “gets into the bloodstream and it goes to the brain and other organs of the body” would they still approve it for use? The FDA “Yes” The FDA even says they recommend mercury when it “cumulates in the brain”

This clip will shock you to your core US Congressional Subcommittee hearings on dental mercury asks the FDA that now knowing that mercury “gets into the bloodstream and it goes to the brain and other organs of the body” would they still approve it for use? The FDA “Yes” The FDA even says they recommend mercury when it “cumulates in the brain”

Wall Street Apes

39,185 Aufrufe • vor 1 Jahr

🚨Where is the $200M allocated for illegal vape enforcement going? RFK Jr. told Congress: “We confiscated a million vapes that were Chinese” BUT “a regulatory complication with FDA, because we were not able to get enough American vapes approved for this country.” RFK and MAHA want the FDA and Dr. Marty Makary to step up and keep the crackdown going.

🚨Where is the $200M allocated for illegal vape enforcement going? RFK Jr. told Congress: “We confiscated a million vapes that were Chinese” BUT “a regulatory complication with FDA, because we were not able to get enough American vapes approved for this country.” RFK and MAHA want the FDA and Dr. Marty Makary to step up and keep the crackdown going.

Breanna Morello

16,931 Aufrufe • vor 3 Monaten

🚨 BREAKING: Flanked by Joe Rogan, RFK Jr. and others, President Trump announces executive order directing the FDA to EXPEDITE their review of certain psychedelics already designated as breakthrough therapy drugs "If these turn out to be as good as people are saying, it's going to have a tremendous impact on this country and other countries too." "These treatments are currently in the advanced stages of clinical trials to ensure that they're both safe and effective for the American patients, and the nice part is we're actually doing this early, but it has been going on." "Research has been going on for quite some time. But usually with things like this, nothing ever happens, no matter how the research ends up, but we're changing it." "This order will clear away unnecessary bureaucratic hurdles, improve data sharing among the FDA and the Department of Veterans Affairs, and facilitate fast rescheduling of any psychedelic drugs that become FDA approved."

🚨 BREAKING: Flanked by Joe Rogan, RFK Jr. and others, President Trump announces executive order directing the FDA to EXPEDITE their review of certain psychedelics already designated as breakthrough therapy drugs "If these turn out to be as good as people are saying, it's going to have a tremendous impact on this country and other countries too." "These treatments are currently in the advanced stages of clinical trials to ensure that they're both safe and effective for the American patients, and the nice part is we're actually doing this early, but it has been going on." "Research has been going on for quite some time. But usually with things like this, nothing ever happens, no matter how the research ends up, but we're changing it." "This order will clear away unnecessary bureaucratic hurdles, improve data sharing among the FDA and the Department of Veterans Affairs, and facilitate fast rescheduling of any psychedelic drugs that become FDA approved."

Eric Daugherty

75,158 Aufrufe • vor 3 Monaten

NEW: Joe Lonsdale flips AI regulation debate on its head Maria Bartiromo: AI is moving faster than regulation. Does that concern you? Joe: What I'm concerned by is that AI is moving faster than the ability for the government to allow us to do this. AI is helping cure all these new diseases... But we have an FDA that's not letting us save lives... The FDA is not set up for the AI age. It's set up to let China take over the sector... There are more big [pharma] deals buying Chinese drugs [than U.S. drugs]; there are more clinical trials going on in China. We need a leader of the FDA that will push back on the bureaucracy, that will say, we are going to both be safe and we're going to go faster and save more lives.

NEW: Joe Lonsdale flips AI regulation debate on its head Maria Bartiromo: AI is moving faster than regulation. Does that concern you? Joe: What I'm concerned by is that AI is moving faster than the ability for the government to allow us to do this. AI is helping cure all these new diseases... But we have an FDA that's not letting us save lives... The FDA is not set up for the AI age. It's set up to let China take over the sector... There are more big [pharma] deals buying Chinese drugs [than U.S. drugs]; there are more clinical trials going on in China. We need a leader of the FDA that will push back on the bureaucracy, that will say, we are going to both be safe and we're going to go faster and save more lives.

American Optimist

57,521 Aufrufe • vor 1 Monat

🚨 Chairman Comer opens hearing on oversight of the FDA “Congress must ensure the FDA is prioritizing safety and effectiveness but also incentivizing innovation. “Unfortunately, the FDA under President Biden is suffering from dysfunction and is failing to do the bare minimum to carry out its core mission—make certain our nation’s food and drug products are safe and effective. “Further, the FDA appears consistently unprepared for crises. “That is why our Committee has conducted several investigations into areas of concern at the FDA. These investigations have identified a pattern of issues within the FDA.”

🚨 Chairman Comer opens hearing on oversight of the FDA “Congress must ensure the FDA is prioritizing safety and effectiveness but also incentivizing innovation. “Unfortunately, the FDA under President Biden is suffering from dysfunction and is failing to do the bare minimum to carry out its core mission—make certain our nation’s food and drug products are safe and effective. “Further, the FDA appears consistently unprepared for crises. “That is why our Committee has conducted several investigations into areas of concern at the FDA. These investigations have identified a pattern of issues within the FDA.”

Oversight Committee

22,243 Aufrufe • vor 2 Jahren

The F in the FDA stands for food. That is why we are going through a sequential inventory of all of the chemicals in food products and determining what can be done to make the food supply healthier.

The F in the FDA stands for food. That is why we are going through a sequential inventory of all of the chemicals in food products and determining what can be done to make the food supply healthier.

Dr. Marty Makary

63,274 Aufrufe • vor 1 Jahr

"It's a choice. A choice to be all in on this. Whatever decision my coaches make, I am going to accept it and act upon it positively. I am going to give everything I have to make sure that we win. It doesn't matter what the role is. I will do whatever is asked of me." Jay Bilas

"It's a choice. A choice to be all in on this. Whatever decision my coaches make, I am going to accept it and act upon it positively. I am going to give everything I have to make sure that we win. It doesn't matter what the role is. I will do whatever is asked of me." Jay Bilas

The Winning Difference

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Seahawks HC Mike Macdonald says they’re “really optimistic” Sam Darnold is going to be able to play against the 49ers. Sam will test it out tomorrow and they’ll make a final decision at that point via: Brian Nemhauser

Seahawks HC Mike Macdonald says they’re “really optimistic” Sam Darnold is going to be able to play against the 49ers. Sam will test it out tomorrow and they’ll make a final decision at that point via: Brian Nemhauser

Coach Yac 🗣

92,015 Aufrufe • vor 6 Monaten

NEC Director Kevin Hassett on whether POTUS has taken him out of the running for Fed Chairman: HASSETT: "From the beginning, he and I have talked about whether it's better for me to be here in the West Wing or over at the Fed. I don't think he's made a final call on that, but I gotta to say that I'm even humbled still, perhaps, to be in the running...There are a lot of great candidates and it could well be that the president's right to make the decision that this is the best place for me right now."

NEC Director Kevin Hassett on whether POTUS has taken him out of the running for Fed Chairman: HASSETT: "From the beginning, he and I have talked about whether it's better for me to be here in the West Wing or over at the Fed. I don't think he's made a final call on that, but I gotta to say that I'm even humbled still, perhaps, to be in the running...There are a lot of great candidates and it could well be that the president's right to make the decision that this is the best place for me right now."

Jacqui Heinrich

34,589 Aufrufe • vor 6 Monaten

Q: You and RFK Jr. just said that pregnant women are not recommended to get a COVID vaccine. I've heard from multiple doctors that they are hearing from pregnant women who are unable to get the COVID vaccine now because of the change in recommendation. FDA Commissioner: You can't get it at every Starbucks, but there is no rule that somebody cannot get it

Q: You and RFK Jr. just said that pregnant women are not recommended to get a COVID vaccine. I've heard from multiple doctors that they are hearing from pregnant women who are unable to get the COVID vaccine now because of the change in recommendation. FDA Commissioner: You can't get it at every Starbucks, but there is no rule that somebody cannot get it

FactPost

528,340 Aufrufe • vor 10 Monaten

Bob Malone/RFK Jr. think you're stupid. Malone says the latest Moderna jab was FDA authorized while RFK Jr. & he were on a "boat" (yacht) in Italy & the decision wasn't "communicated up the chain of command." Oh, and RFK Jr's right-hand was taking vacay at the exact same time. This clip of Malone is taken from an interview with Tommy Carrigan posted to the Tommy's Podcast Rumble channel on July 27, 2025. ---------------Partial transcription of clip--------------- "The decision to authorize the Moderna product was not communicated up the. Up the chain of command. Now, it turned out that Bobby was on the boat at that particular time and his right-hand person, Stefanie Spear, had just gone on vacation. Also. Neither one of them were notified. "And, the people don't realize that the secretary does not have a magic wand that he can wave, and he or she can wave, and past FDA decisions go away. There are firewalls between the secretary and the political apparatus and the decision-making at FDA, so all of this. Well, can't. How come Bobby didn't stop that? And this kind of jibber jabber, it. That's not the way the system works. And good thing too, because administrators, administrations change and we would have absolute chaos if. If it was anything otherwise. "So, but. But absolutely there was a failure to communicate. And, that's a reference to Cool Hand Luke, in case you didn't get it. And, and whether this was cause and effect or not, as soon as Bobby got back, there was a major restructuring of, leadership underneath him, chief of staff and deputy chief of staff. And that. That restructuring is ongoing right now. So after, whatever it's been six months or whatever, I think it's less than that. They've kind of done the trial run, the shakedown crews. They've determined that, they got to move around some of the positions. Some people have to find nice lobbyist jobs and no longer work for the administration. And, I hear that that reorg has gone fairly well, but it's still a fair amount of chaos, as you'd expect."

Bob Malone/RFK Jr. think you're stupid. Malone says the latest Moderna jab was FDA authorized while RFK Jr. & he were on a "boat" (yacht) in Italy & the decision wasn't "communicated up the chain of command." Oh, and RFK Jr's right-hand was taking vacay at the exact same time. This clip of Malone is taken from an interview with Tommy Carrigan posted to the Tommy's Podcast Rumble channel on July 27, 2025. ---------------Partial transcription of clip--------------- "The decision to authorize the Moderna product was not communicated up the. Up the chain of command. Now, it turned out that Bobby was on the boat at that particular time and his right-hand person, Stefanie Spear, had just gone on vacation. Also. Neither one of them were notified. "And, the people don't realize that the secretary does not have a magic wand that he can wave, and he or she can wave, and past FDA decisions go away. There are firewalls between the secretary and the political apparatus and the decision-making at FDA, so all of this. Well, can't. How come Bobby didn't stop that? And this kind of jibber jabber, it. That's not the way the system works. And good thing too, because administrators, administrations change and we would have absolute chaos if. If it was anything otherwise. "So, but. But absolutely there was a failure to communicate. And, that's a reference to Cool Hand Luke, in case you didn't get it. And, and whether this was cause and effect or not, as soon as Bobby got back, there was a major restructuring of, leadership underneath him, chief of staff and deputy chief of staff. And that. That restructuring is ongoing right now. So after, whatever it's been six months or whatever, I think it's less than that. They've kind of done the trial run, the shakedown crews. They've determined that, they got to move around some of the positions. Some people have to find nice lobbyist jobs and no longer work for the administration. And, I hear that that reorg has gone fairly well, but it's still a fair amount of chaos, as you'd expect."

Sense Receptor

26,556 Aufrufe • vor 11 Monaten

Rick Hendrick said it would be "extremely hard" to pull Kyle Larson out of the Indy 500 if there is weather in order to get him to the Coke 600 on time. He explains who will make the decision and then talks about the difficulty if they have to make a decision.

Rick Hendrick said it would be "extremely hard" to pull Kyle Larson out of the Indy 500 if there is weather in order to get him to the Coke 600 on time. He explains who will make the decision and then talks about the difficulty if they have to make a decision.

Bob Pockrass

409,663 Aufrufe • vor 2 Jahren