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Atom0aks

09/09/19 4:33 PM

#213311 RE: rafunrafun #213309

We are 19 days away from the original PDUFA and still no official word from the FDA.

If Thero did not make that (tentative) ADCOM announcement on August 8, everyone would have expected the FDA approval any day now (tomorrow or next Tuesday would have been my top 2 choices). Imagine the outrage, if instead of the approval, we would have gotten ADCOM + 3 month delay. Would have been a much harder pill to swallow now than it was on August 8.

If Thero would not have made that August 8 announcement, we don't know if the FDA would have acted quicker with regard to publishing it on their registry. But it is a scary thought that they could have let it go unannounced for all this time.



That sounds oddly like a prediction someone made in one of their very first posts. Weird... ;)

invest2992

09/09/19 4:36 PM

#213313 RE: rafunrafun #213309

great post.we might be trading higher today, but the hammer would have been much heavier.

Webster_iam

09/09/19 4:53 PM

#213314 RE: rafunrafun #213309

Raf, I'm sure this has been discussed ad nauseam, but I just can keep it straight. So the FDA hasn't scheduled or posted the Adcom, for all we know approval could still happen on 9/28? Do we expect any information from FDA or Amarin before the 9/28 date? Or we just wait for the eventual posting in the Federal Registry for the 11/14 (or whenever) adcom? When is the FDA required to announce SOMETHING?

Cupo

09/09/19 5:07 PM

#213317 RE: rafunrafun #213309

I wrote a very similar post on Stocktwits today. We’d probably be cruising along trading in the $20s somewhere. We’d be thinking surely it’s approved then possibly get slammed with an ADCOM right before. The PPS would’ve taken a major beating.
JT did the right thing.
We will probably never know why the FDA asked him to keep it disclosed. I have an idea, but it is probably just wishful thinking.