Approve for the Anchor indication (it is the extended PDUFA date after all). Reinstate the SPA (though this doesn't matter if they're ready to approve). Approve subject to a labeling change such as "Vascepa has been shown to reduce tryglyceride levels in some patients. However, reducing triglycerides has not been shown to increase longevity". Issue a CRL for some or other reason currently unknown as the FDA continues to act ignorant about the potential clinical and life extending benefits for the hypertriglyceremic population - maintaining the now untenable position that there is new (since the SPA) scientific knowledge (which there isn't) that indicates reducing elevated triglyceride levels has no long term health benefits.
The FDA does not want to approve Vascepa without the outcome study but they have a problem with rescinding the SPA. The easiest thing for them to do at this point is reinstate the SPA & approve Vascepa in a few months with some sort of warning on the label that Vascepa has not been proven to reduce cardiovascular events.
I agree: the FDA will likely reinstate SPA but with a broader warning label, like in other similar cases
e.g. Aria, although a significant difference is there here unlike with Aria's Iclusig which has proven potentially dangerous side-effects (BUT is life-saving for many patients who gladly take those risks) Amarin's fish oil product has no negative side-effects nor are any claimed: it's that benefits are not proven to the FDA's satisfaction, so some qualifiers are needed. I frankly think that's fair,
as a balance between not erring on the side of pulling a useful medicine off the shelves vs.
giving people the impression that taking a tablet will somehow "cure" very high triglycerides.
It's LIKELY to help along with life-style and diet changes.
Still that would increase the market ten-fold, I'm all IN.
That seems to be the feeling of investors: Bid and Pre-Market price was UP as 1/15 approaches.
The latest analyst estimates are that shares could be valued at $8.00 if that's the case.
Sentiment: Strong Buy
The SPA was withdrawn due to failed logic on the part of the experts. They have openly stated that clinical data proves fish oil does not reduce CV events. The problem with that opinion is trials have never been conducted in patients with these triglyceride levels & with this dose of fish oil. Previous studies were done on healthier individuals with low dose fish oil.
Yes, its a possibility.