FDA Panel a Joke ..... FDA Approval around the corner!!!!
Read the briefing documents Vascepa will be approved. The primary goal was reduction of TG levels which the trial clearly showed as there was also dose related reduction which will impress the FDA. The mineral oil objection by the panel can be 100% refuted by AMRN as the FDA approved mineral oil as the placebo before the trial was even started and also because they ran the results against baseline numbers which is the group not taking Vascepa or a placebo. All results are impressive. JMO.
Less than desirable, and many benefits to Vascepa , and many other "strange" things happening, however, what a lot of people are losing sight of is the specific language of the sNDA. There is great debate as to whether it was somehow changed to include the cardio component. IF this is the case, the whole focus of consideration will be on what was submitted and, yes, we might be hooped. AMRN might have to go through a whole new process if the FDA is "black and white" and bureaucratic.
Ya know ... we can get into all the scientific jargon ... the technical, and the bottom line here is ... it ends with the money ... and not just WS, but especially WS ... BP has $$$$$$$$$$$$$$$$ tied up in this.. and unfortunately, I bet against them this time based on DD ... for months and got really hurt by doing so .... had my eye on the data .... not the p.o's.
All this stuff about other fish oil studies not showing benefit and no reduction of CV events are all noise as they are not parts of the study or an enpoint of the Vascepa study. Reduction of TG and LDL are the primary and secondary endpoints -- as long as there is a coorelation between high TG levels and hardening of the arteries and increased CV events the FDA will approve the therapy. You have to remember that all the drugs that the FDA approved already are based on this correlation and you can't go back in time and say that this coreelation no longer exists!!!!
Unfortunately mike, the FDA an do whatever it chooses .... this is, and has been about the $$$$$ ... it's political, not scientific .... the saddest part is, great science has minimal chance at "getting it to the market" because of that .... (without writing a War and Peace novel)