no_mo_Butterfinger - Well he was not exactly wrong. By listing a reduction of CVE's as their ultimate endpoint, they were not lying. It's just that the FDA just changed their rules as to what you can sell, whenyou can sell it, and why you can sell it... They are now requiring endpoint proof and if Amarin's sole goal is to reduce CVE's, the FDA is saying they need to prove it.
On the Marine note:
Vascepa was not created to Improve Pancreatitis. It was an (apparent) doorway into the market. Reducing Trigs though has been proven/tested/assumed (not sure which) to better Acute Pancreatitus so the FDA could not or did not disallow it.
Now they have to somehow convince the FDA without a proven endpoint that taking Vascepa will better peoples lives of people with Trigs between 199 and 500 by bettering Lipid Panel results.
So far the FDA has not said that is NOT an acceptable option.
They just said that Amarin cannot say Vascepa will reduce CVE's.
Until they reject Amarin's request to sell Vascepa to the 199 thru 500 Trig class with the same exception noted on the Marine label regarding "No Proof in a Reduction in CVE's", I will hold out hope that Anchor will be approved in a modified version (again, without any comment about CVE reduction)...
The problem is the FDA is caught between saying YES or NO to the modified version. They want to say YES because it does better the Lipid Panel results yet they want to say no because there is no proof that bettering the Lipid Panel results will reduce CVE's (which is Amarins sole reason for selling the Drug).
YET they did approve Vascepa for treating Acute Pancreatitus YET that was not Amarins reason for selling Vascepa!
Kind of a sick twist or snafu!
That brings me back to hoping the FDA approves Anchor with the exception.
The FDA has NOTHING to lose by putting a product on the market that betters Lipid Panel results...
Or do they: I am open to comments...
