Replies to post #215368 on Amarin Corp Plc (AMRN)

[Toddrobertking]

That’s my understanding - this does not help with our adcom or our PUDFA decision. - at this time

[CaptBeer]

That Maybe true but you can't "Un-Learn" something that you already know. If top line results are released before ADCOM you can always post those results as a comment in Regulations.Gov for the panel to read. Like I said, you can't "Un-Learn" something you've already learned.

[sts66]

Not sure that the reason they couldn't be used is because they weren't in the sNDA, but it could be because they wouldn't be in AMRN's BD's unless Budoff violates the AHA embargo, which I highly doubt he would risk. If just topline results are released prior to the AHA conf. (and I doubt they will be), they wouldn't be of use to AMRN at the AC - it's the SE's of EVAP that AMRN needs to support a proposed MOA of EPA, The PE is pretty much a yes or no answer, does 4 g/EPA/day reduce plaque volume or not, the SE's are about correlations with lipids levels and inflammatory biomarkers, the real meat and potatoes of the MOA. Wonder if they tracked EPA/AA ratios? That would be great to have too, an easy and cheap test to screen patients.

[massulo52]

So if it were determined that it cured Cancer for example, would it not be Germaine in helping the FDA getting it correct....