I have to throw down the flag on some of these thoughts. The FDA does not care one bit about Amarin's business plan, can they ramp-up, etc. Their concern is one dimensional : from a regulatory standpoint do we grant an expanded label and what is that label. That is based 100% on the scientific data to efficacy, safety, and reliability / repeatability of the REDUCE-IT trial. The FDA does not care one whit about how Amarin executes their business plan.
Frankly, this is not riding on subtle things like body language! What Amarin knows (and we don't) are the two key questions - did they submit additional data since 28 March 2019 submission or did FDA ask for more information since 28 March? If it has been silent, then I'd say 99% no ADCOM and broad approval. If there has been additional data transferred, then FDA would have grounds to alter their deicison and or timeline. Let's hope that FDA has not asked for more data. I think that is the case for one reason: if the FDA asked for follow-up since 28 March, Amarin should have disclosed that in the prospectus dated 16 July. Failure to disclose that very materially relevant information would set them up for some damn big shareholder lawsuits, basically from anyone who purchased shares at a date after the FDA's request for more data. That would mean all the big money behind this offering would be lining up to sue the pants off Amarin.
I don not like IR's answer that they don't discuss communication with the FDA. In this case, they better not be hiding anything. I think they aren't because from what I've seen their legal team has done a very good job over the last 3-4 years.
