ziploc bag, the conversation relates to a discussion I was having with sts66 about whether the FDA can revise a previously agreed to SPA or not. My response with the link attach merely shows that the FDA can in fact change a previously approved SPA. Given that the FDA rescinded the SPA, it obviously has nothing to do with the safety of Vascepa but rather with the FDA's belief that "..substantial scientific issue essential to determining the efficacy...", is now available which wasn't back in 2009 when the ANCHOR SPA was agreed to to. That "substantial scientific issue essential to determining the efficacy', must be coming in the form of the various clinical trials and/or reports which seem to indicate that maybe TG levels are a "biomarker" and not a true "risk factor" of CVD. I'm just providing an explanation of what is happening...I'm not saying the FDA is right or wrong but only that this is what appears to be happening AND from what I've read, the FDA seems to have all the proper authority and guidances in place to do it and there's little that we can do to stop them.
I've also said that i don't believe this would put a final nail in Vascepa's/Amarin's coffin because I also believe that the FDA and Amarin will come to some agreement that could involve a slight change to the ANCHOR SPA, for example, rather than requiring just a 50% enrollment for submitting the ANCHOR sNDA, the FDA could now possibly demand to see REDUCE-IT interim analysis results at the 60% events point like was discussed during the Adcom meeting. It is possible that this point could come as early as late 2014. again, this scenario would still be a win-win for all parties. Amarin still has lots of cash that can certainly sustain the REDUCE-IT trial at least through 2015 (my guess). Of course, the worse case scenario could be that the FDA holds their ground and maintains the ANCHOR SPA rescinded until Amarin has full results of the REDUCE-IT trial. This scenario would obviously not be good for Amarin and this would likely cause them to abandon the REDUCE-IT trial. I don't think the FDA is stupid enough to let that happen which is why I believe they would be more interested in finding another, middle-ground, solution such as the interim analysis approach.
No nned to keep arguing with me about this post man, it's my view of what could/should happen. You are free to make your own analysis.
GL
News 
Market Data 
Discover 
AI
