Pearl Freier

44.3K posts

Pearl Freier

Pearl Freier

@PearlF

Founder of Cambridge BioPartners, Inc.

Cambridge, MA USA Katılım Mart 2009
6.1K Takip Edilen10K Takipçiler
Pearl Freier
Pearl Freier@PearlF·
@owl_posting I also wonder what impact the war will have in '26 as rumors circulate that sovereign wealth funds may not be committing as much $ to US funds & companies this year because of the damage where they live
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owl
owl@owl_posting·
i feel like im on year three of <$300M AUM VC’s writing blog posts on how none of the ultra large funds could possibly end up having good returns based On The Math, and it is increasingly seeming like the mere existence of oai/anthropic may, in fact, deliver those mathematically impossible returns. im not really taking sides here but there is clearly is something to this whole blind optimism thing that they’ve got going on at the highest echelons of that industry. either that or we’re entering Zimbabwe territory
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Pearl Freier
Pearl Freier@PearlF·
I understand what you're saying, & i misspoke about a delay since the standard is up to 60 days to accept the submission, but from a patient's perspective Makary announcing it as 54 days to a decision sounds misleading. Even if technically he's saying 54 days from when they accepted the submission. It looks like companies selected for the program are going to announce the date or month they filed or submitted in order to keep patients, investors et al informed. The FDA is is promoting the Chairman’s program on social media & on television as accelerated timelines reducing red tape while the selected company still has the standard 60 day wait time to hear if the FDA has accepted their submission. But patients might start the clock in their heads when they hear the company’s submission date from the company.
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PRV Watch
PRV Watch@PRVWatch·
Not sure what you mean sorry. FDA has 60 days to accept the submission, I wouldn’t consider this as a delay as such. I may have caused confusion here and conflated different uses of the word ‘filing’. I’ve just double checked the official FDA definition. In the Novo November PR, ‘Novo Nordisk files for FDA….’, they use the word ‘files’ but they mean ‘submit’. When the FDA says ‘just 54 days after filing’ in today’s approval PR this essentially mean from application acceptance since they have 60 days to ‘file’ the application to be reviewed.
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PRV Watch
PRV Watch@PRVWatch·
FDA has approved Wegovy (semaglutide) 7.2mg under the Commissioner’s National Priority Voucher program. The FDA PR says this was 54 days after the filing but Novo Nordisk disclosed they filed in November. Assume the FDA timeline was from filing acceptance rather than submission.
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Pearl Freier
Pearl Freier@PearlF·
It seems unlikely that if the WH disbanded the ACIP committee that Kennedy appointed last year that the WH would reappoint all the same committee members. Washington DC & 29 states incl Kentucky & Kansas have also stated publicly x.com/jenkatesdc/sta… that they reject the Reject federal vaccine guidance and the current version of ACIP
Jen Kates@jenkatesdc

As of today, 30 states, including DC, have announced that they are no longer going to follow CDC's recommendations for some or all childhood vaccines. kff.org/other-health/s…

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Jessica Adams
Jessica Adams@RxRegA·
If ACIP is disbanded and recreated, would the same members be reappointed under a process less vulnerable to legal challenge? Lots of open questions here.
Robert W Malone, MD@RWMaloneMD

ACIP has been disbanded. The government’s response to the AAP lawsuit and judge Murphey’s injunction is to disband and then recreate a new ACIP committee, as this will take less time than would be required to file and prosecute an appeal. There will be no action from the government to respond to the defamatory characterization of the former ACIP members.

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Pearl Freier
Pearl Freier@PearlF·
@AlecGaffney He said in the video that it's Novo's high-dose semaglutide, did Novartis get an approval today too?
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Dirk Haussecker
Dirk Haussecker@RNAiAnalyst·
$repl in company presentation this month, Replimune said that surprise CRL came following 'leadership changes' at FDA. Since Pazdur's been there before, they clearly point to Prasad having been the culprit.
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Pearl Freier
Pearl Freier@PearlF·
RT @AppleHelix: Okay, Before today, I knew Arnold Ventures funded Vinay Prasad - but I didn't know the amount. Today I learned that: - V…
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Jing Liang 🇺🇦
Jing Liang 🇺🇦@AppleHelix·
Claude was able to find Vinay Prasad's CV from 2023 (for tenure application?). onlinelibrary.wiley.com/pb-assets/CV%2… VP actually received 2 separate grants from the Arnold Foundation. One from 2017-20, the other 20-23. And probably is still supported by the foundation. Total from 2017-23 was ~$4m. Most recently, the foundation was funding VP $800K per year.
Jing Liang 🇺🇦 tweet media
Pearl Freier@PearlF

According to ⬇️, some FDA political appointees have financial ties to the Arnold family foundation/ventures. There's documentation of this elsewhere so it's not only an anonymous X acct saying this. $ from ideological group that's against HIV & hep C drugs too $XBI $BBC $IBB

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Pearl Freier
Pearl Freier@PearlF·
@RxRegA If they’ve broken laws, that may be part of the problem. More may come out about what happened with Tidmarsh as well.
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Jessica Adams
Jessica Adams@RxRegA·
In the current FDA media environment, with outlets like WSJ op-eds putting pressure on the agency, I kind of wish FDA would just say “we’re the referee, deal with it.” There’s always been pressure and games, but lately it feels next level. Instead, some of FDA’s communication comes across as bending over backwards in response to pharma pressure, investor expectations, and media narratives, and it’s hard to see. It makes me wonder what’s going on behind the scenes and whether the agency can hold the line seemingly without unequivocal backing to do its job. Perhaps “deal with it” takes it a bit far, but at least not what seems like the opposite. I can also imagine FDA wants to defend itself, especially when it is doing good work to streamline review, be appropriately flexible, and be more industry-friendly. I don’t think I’m alone in seeing this situation play out, and I hope media narratives don’t have that much power, but lately it seems like they might. And that’s concerning, because decisions that should be grounded in evidence-based standards risk becoming too gameable, driven by money and influence in the media environment, not necessarily patients’ best interests.
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Pearl Freier
Pearl Freier@PearlF·
@AppleHelix @docrodwong The FDA Commissioner has also received $ from them. Quick Gemini search showed Makary’s group at Hopkins received at least $1.8M from the family
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Rod Wong, MD
Rod Wong, MD@docrodwong·
this is the first major mention i've seen of arnold venture's influence on this fda. arnold is said to be have been a major backer of prasad's research (i don't have proof of this, have just been told many times), and as wsj notes, szarama worked at arnold before prasad brought her in. most aren't aware arnold ventures was the major backer of ICER, the group that defines the value of medicines for the UK (which is set at a cap of roughly 30k pounds per human life year). it is also the reason the UK has dropped below basically all other developed countries when it comes to access to rare disease medicines. in short, arnold doesn't believe rare disease medicines are worth it, and it's natural to conclude prasad and others were bringing that philosophy to fda. now it's fine to have that view as a society (as the UK chooses to), but the trump administration represented the opposite, which is to accelerate access to rare disease medicines. wsj.com/opinion/one-ex…
Rod Wong, MD tweet media
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Pearl Freier retweetledi
@·
I'm going to make some obvious points. (1) Blowing up all the oil infrastructure in the Middle East is an insane idea, and may well result in a global economic crash and humanitarian crisis unrivaled in the lives of those now living. We're talking about the price of everything
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Pearl Freier
Pearl Freier@PearlF·
They were also spreading the rumor that the Gates Foundation used Covid vaccines to implant chips in those that got vaccinated in '21. A surprising # of Americans were afraid to get a Covid shot in '21 because they were worried it contained "chips to track them."
Pearl Freier@PearlF

According to ⬇️, some FDA political appointees have financial ties to the Arnold family foundation/ventures. There's documentation of this elsewhere so it's not only an anonymous X acct saying this. $ from ideological group that's against HIV & hep C drugs too $XBI $BBC $IBB

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Pearl Freier
Pearl Freier@PearlF·
According to ⬇️, some FDA political appointees have financial ties to the Arnold family foundation/ventures. There's documentation of this elsewhere so it's not only an anonymous X acct saying this. $ from ideological group that's against HIV & hep C drugs too $XBI $BBC $IBB
Pearl Freier tweet media
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Pearl Freier
Pearl Freier@PearlF·
@Sanctuary_Bio I think some of the senators confirmed him because he may have promised them that he would make sure the FDA approval for mifepristone was revoked without the data to support removing it from the market. It was 1st approved in France in 1988 & in US since 2000
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WC
WC@Sanctuary_Bio·
Unfortunately true. Not sure how the Senate thought RFK Jr. was appropriate for the role but whatever We live in an idiocracy
Pearl Freier@PearlF

@Sanctuary_Bio Nothing really changes as long as HHS is the way it is. Makary & VP take orders from HHS. FDA rolled back rules on tanning beds & sunlamps for minors so that kids can have increased access to tanning centers/beds/almps while melanoma cases have increased nbcnews.com/health/cancer/…

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Lulu Cheng Meservey
Lulu Cheng Meservey@lulumeservey·
This is still useful, because a major audience for AI messaging is AI engineers, who do care about those things But the divergent interests of tech people vs normies means AI companies have a hard job balancing bifurcated messaging strategies Luckily, “professional excellence” is at the top for normies, tech people, and company messaging, so it’s a great place to double down
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Lulu Cheng Meservey
Lulu Cheng Meservey@lulumeservey·
These are the top things Claude users wanted from AI Meanwhile a lot of AI companies’ messaging focuses on the things at the bottom of this list: creativity, learning, entrepreneurship, societal transformation ie, things tech people care a lot about
Lulu Cheng Meservey tweet media
Anthropic@AnthropicAI

We invited Claude users to share how they use AI, what they dream it could make possible, and what they fear it might do. Nearly 81,000 people responded in one week—the largest qualitative study of its kind. Read more: anthropic.com/features/81k-i…

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Keşfet

@owl_posting @AlecGaffney @Dancingtapas @RNAiAnalyst @AppleHelix @docrodwong @RxRegA @elonmusk