THE GUARANTEED REASON WE GET NCE...AFTER ALOT OF RESEARCH
This is wrong. I have a PhD in organic chemistry. These isomers structural isomers not stereoisomers. As such, they cannot be enantiomers and do not fall under the guidelines he sites. Having said that, I will tell you with absolute certainty that if the FDA follows it's own rules to the "T", then we will not get NCE. However, in the spirit of supporting innovation and therefore promoting it, I believe the FDA is strongly considering making an exception in this case given the completely different clinical profile of this isolated drug compared the the mixture (Lovaza).
Drugmaker's comments make more sense to me. Vascepa is an exception that FDA is making. I do agree that it's in line with the strategic goal of NCE even though it may or may not meet the verbatim definition of NCE. But NCE definition is just a mean to the end. It's the end that is more important - encourage/protect innovation and clinical data.
nice to hear from a voice of reason after a long hiatus. tell me drugmaker2005; what do you think of my recent post "The De Facto Informative Thread to quell the paid,misaligned Bashers/Shorts"; does the data provided sit right with your thesis?
You make a huge number of points in there. I can't say I agree with all of them. What I will say is the near term event, and the reason for swings in PPS, is the approaching NCE decision. All this other stuff is background noise for now. The way I see it, if we don't get NCE, we're probably in trouble since a buyout is less likely to happen. Couple that with the fact that Amarin is not equipped to sell and market this drug--they will get crushed by bigPharma, trust me.
If you don't want to make a calculated bet on whether we get NCE or not, I suggest you sell now since that's what we are basically doing by holding. I believe there is a pretty good chance we get NCE since the FDA should promote innovation and thereby make an exception in this case. However, as I said before, as a PhD organic chemist from a top 10 institution, I'm telling you that if the FDA follows their rule to the "T", we will NOT get NCE.