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Anastasis

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Everything posted by Anastasis

  1. FDA advice in 2024 recommended they use high dose flu vaccine as comparator for individuals age 65+ in the study, but that the SD dose was "acceptable". In 2025 they indicated that use of the standard dose in the study would be a "significant issue" upon review. Clear regulatory guidance is certainly required, but the FDA was signalling this issue under the prior admin. Typically, FDA advice on things like the choice of comparator group should be not be disregarded lightly. Moderna chose not to take the recommendation, which is certainly their prerogative,esp with the "acceptable" out. Ask yourself why they chose the SD comparator route, and the answer is that they likely thought that the HD dose for the 65+ group could put their ability to separate statistically at risk. To their credit they did apparently submit data from a different trial that used a high dose comparator, which would seem sufficient to address the concern imo. But generally when the FDA is involved, both historically and esp under this admin, blowing off their recommendations is generally not a good idea and you better be prepared to justify your decision. The fact that the FDA put on paper that the SD comparator was "acceptable" is sufficient for Moderna to have taken the strong position they did in response to the RTF. Which worked out in their favor in the end. The outcome of the Type A meeting is probably more favorable than if they would have gone to review and received a rejection or an age restricted approval.
  2. Lung cancer (or some other prevalent cancer type) approval in a country not named Saudia Arabia will send this thing running imo.
  3. Congrats to the IBRX longs. Nice day.
  4. I think that this was always the most likely scenario after the RTF. The vaccine is approvable, but the mRNA tech does not seem ideal for a flu shot*. Pfizer and Sanofi both abandoned their mRNA development programs after clinical data was underwhelming. Moderna pushed ahead, which make sense given mRNA is all they do, but made a conscious design decision to contrast with the standard dose flu shot instead of high dose regimens, which may perform better particularly in older individuals. And their clinical data wrt risk/benefit are still not particularly compelling. LMAO at Offit's drama piece. *Primary benefit I see is that in theory they could delay the flu strain selection process (topic discussed up thread) to far later in the year, or push out a mid cycle update to pick up strains that were missed during selection, given the shorter production time for mRNA. This is not a serious place.
  5. https://feeds.issuerdirect.com/news-release.html?newsid=8923338804483797&symbol=MRNA Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026 CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
  6. It's still strain specific. There are other initiatives working on pan-flu shots that target conserved regions.
  7. I guess there is also that.
  8. I don't think that an RTF was the right approach. I think the mRNA flu shot is approvable, but not convinced that it should replace the the traditional flu shots for most people. Here are the most relevant slides from the Moderna deck. The primary endpoint is influenza like illness. The number needed to treat is high with standard dose traditional flu shot as the contrast, esp if the calculations are based on ED or hospital encounters. The number need to harm (see a side effect) is much much lower. Just my own experience, but the side effect profile of the last mRNA shot I took was worse than my last case of flu. These data suggest the side effect profile poses some challenges. We're talking flu, so the key outcomes are ILI, medically attended illness, and productivity/absenteeism. It only really cleanly separates on ILI, and the SE profile doesn't bode well for the latter outcome. I do like having an approved mRNA option though, esp for the theoretical potential to make a quick switch if the strain selection is mismatched. I think it's good to have a variety of technologies at the ready. I think it eventually gets approved unless Moderna abandons as result of the regulatory headwind. Not convinced that it should be preferred, esp for younger pts, which was kinda the whole rub with the RTF. https://irp.cdn-website.com/89dd0539/files/uploaded/mRNA-1010+P304+50-+LB+Oral_IDWeek+2025_FD2.pdf
  9. They had to amend the article and change the headline and publish a addendum that basically said "the sole source we had misspoke".
  10. Ain’t nobody got time for that.gif
  11. Id run that same time regimen at 275 throughout.
  12. F The shorts.
  13. Have you read the Guardian article recently? Did you also read the reporting from the NYT? Guardian's sourcing methods failed. Their single source for those claims was the whistleblower's attorney. They had to walk it back. Running an article like that, based on a single source, and that single source being the fn attorney, who doesn't even have access to the primary material. Yeah guys, tell me more about why you accept the credibility of their reporting without some mild due diligence. But hey, generated some tweets and clicks. You should be more skeptical of the media. You should be even more skeptical about people running to social media to amplify. Avoids things like this and the numerous other dust ups like Prague cell phone towers, etc. I think that is it correct to be suspicious of the US intelligence apparatus getting involved. Here is the probable cause affidavit. I don't see anything in here suggesting something that should require the DNI to be involved in any way. But FWIW: https://storage.courtlistener.com/recap/gov.uscourts.gand.355087/gov.uscourts.gand.355087.22.1_1.pdf?
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