The FDA has waited this long and now just cleared up the rest of the NCE stuff with GSK. So therefore we are ONLY roughly 45 days or so away from OCT 16th Panel... WHY WOULD the fda give NCE before if they have waited this long and it all seems to revolve around ANCHOR!!!
They most likely 99% WILL NOT make a decision at least until a positive ADCOM ruling... But once Adcom comes back positive in Oct then any day you can expect NCE...
SO give up the NCE talk please...... I don't wanna hear about it in Sept... Not to mention AMRN's 27 patents have already proven it's POWER way beyond what NCE can do...
So like I said 100 x's NCE WILL COME WHEN THE FDA IS READY, NOT SOONER... So until then there are many bigger things with AMRN to focus on....
And with that everyone HAVE A GREAT WEEKEND!!!!!!! :)))))
In all due respect to those that have replied to this post and to Harvey, I too have a right to an opinion. This first thing I would like to clear up is this: If you polled a hundred investors, I think you will find them split on the NCE issue for many reasons. One, no one can say (or has said) with certainty what the effective date of NCE would be; is it based on Marine (7-2012) or Anchor (TBA). Two, It leaves uncertainty as to which way FDA leans when it comes to EPA and leads to speculation on how amarin has been treated by them. Three, tell me how the outcome of the Adcom meeting will certify whether V is a NCE. Four, the strength of our patents are very strong indeed, but that does not protect them from being challenged and incurring unexpected legal expenses to fight,( irregardless of amarin inevitable win) whereas NCE will prohibit companies from even attempting for five years. Five, whatever the direction Amarin goes, unexpected issues such as legal fees will effect BO price, partnership negotiations, and possibly their balance sheet if they go it alone. and last but not least, it has allowed shorts to play with stock for over a year.
And to be clear, I am long on Amarin (for two year now) and have a large stake in their success, but that does not mean I will not question what the FDA is thinking,even though I agree the rest (scripts, margin, etc) is important as well. So going forward think about what NCE means,the designation means protection and adds value. Yes, I know we saw a measley 20 cents hop this am, possibly on hopes of NCE, but I am referring to added value over the five years of protection.
And one last comment. I do not appreciate derogatory and vulgar comments. If you do not like what I post put me on ignore or don't read.
Good post. I can tell you with certainty that the NCE clock starts with Marine approval. This is simply because it's the original 505(b)2 NDA for vascepa. The FDA exclusivity FAQ tells you that an sNDA, which is what Anchor was filed as, is NOT eligible for NCE exclusivity.
"Full new drug applications under 505(b)(1) and 505(b)(2) can receive 5 years of exclusivity for a new chemical entity drug product. A 505(b)(1), 505(b)(2) application or a supplement to a new drug application can receive 3 years of exclusivity."
Let's go at this from another angle. Without an NCE granted, the FDA is under no pressure to OK Anchor, or be nice at the ADCOM. If they had approved it this month, that would telegraph a fairly positive view of the value and benefits of this drug. However, without that NCE, it would seem that the FDA really isn't sure of what it's direction may be on Vascepa. They could take a really long term view and tie the ReduceIt results to their final decisions on this drug.
Any thoughts ?