I do think the FDA is experiencing behind the scenes pressure — and the BPs provide FDA seniors with the next step in their careers — the one where they monetize their access.
I personally think the pressure isn’t to shut this down, but it could be to limit the label. My fear is secondary only, and there are spurious but make-able arguments for that.
The medical community, as represented by the panel members and the horde of “amicus” commenters, needs to bury this bad inclination to “err on the side of caution”... which is really just appeasing the big players with the sexy jobs. There is nothing responsible about limiting access to a cheap miracle drug.
A great summation!!! This has been analyzed every which way from Sunday. I’m not a doctor, a scientist, nor an academic. I’m a Construction guy with a history of heart disease. I’ve found in most instances during my life that the answer is usually the most obvious. And I do thank you for providing that!
Good summation. It does appear though that, based on previous FDA actions, there is always the chance that the FDA once again admits a mistake, this time regarding considering MO an inert placebo, and the ADCOM is about whether a DDI is necessary. I just don’t see any other potential negative reason for an ADCOM (if not the MO issue, then it’s all about label expansion). How long would a DDI take to establish certainty about MO interaction?
JL, there is a part of the actual story thats missing in this message about ANCHOR. I dont know if you remember but originally the sNDA about Anchor was reducing TG for patients between 135 to 499. Thats all that was, extension of Marine. However when the briefing documents came out we found out that Amarin had changed the sNDA and included the CVD wording in it. Stock starting falling like crazy. Obviously the Adcom question was changed to focus on CVD rather than TGs. This was not FDA, or perhaps not FDA alone. Amarin was being oversmart and their behind was handed to them at Adcom.
News 
Market Data 
Discover 
AI
