NCE denied (hopefully, better than delay), then stock rallies because... (& detailed NCE explanation)
Smart $ has known from the get-go that NCE doesn't factor into squat w/ the existing patent port and future Anchor Indication. They have just used this in order to suppress the stock, and create volatility where there has been no near term catalyst to otherwise cause trading noise.
Why won't NCE be granted NCE? According to some very smart individuals whom I've had the pleasure of speaking to, it's very simple:
People are getting lessons in structural isomerism and using this as their basis for positive NCE. Here's the deal, EPA or eicosapentaeonic acid in both Vascepa and Lovaza come from the same source; the acids are produced in algae, consumed by fish and harvested by humans. The biochemical processes which produce things like fatty acids have been hardwired into nature for perhaps many hundreds of millions of years: they produce the same fatty acid with the same conformation over and over; the configurational isomer is stable (cis-trans isomerization). The chemical process used to produce the ester won't change the isomerization. More importantly, Amarin filed a 505(b)(2) application to the FDA; this type of application almost always presupposes that clinical data already exist, but to which the company doesn't have the right of reference, that can be used to support safety and efficacy. Amarin was required to run truncated clinical trials to support its NDA. The active ingredient, the eicosapentaeonic ester, where the active ingriedient is likely eicosapentaeonate, is identical in both Vascepa and Lovaza. Vascepa has just a much purer form, but it is the same molecule, form the same biosource. It will have the same conformational isomeric configuration--unless evolution had a sudden burst in the last few years, in which case, since Lovaza comes from the same biopool, it will have a new configuration too! If Amarin really did have a different conformer, it would have filed a patent to protect it--it hasn't. The patent would give the company up to 20 years of protection: once again, patents are more important in this case than is any guarantee from the FDA.
I go all in this week and sit on it until I get double return. Good luck!
what will happen is they get NCE and all the shorts and bashers will then start saying NCE just not that important....WATCH AND SEE......i can guarantee they will start saying that when its APPROVED.......
You aren't getting it man. The active ingredient/moiety in Lovaza is A COMBINATION - I repeat A COMBINATION of EPA and DHA. The active moiety/ingredient in Vascepa is purely EPA. EPA has never been approved purely as an NCE. EPA and DHA have, but not EPA. Go read Dr. Goldenberg's article for more analysis.