"The only way for the FDA "to save face" is to approve Anchor sNDA before REDUCE-IT is profoundly clear.
Otherwise the FDA will look like complete fools...Senate HELP Committee isn't holding a series of FDA Hearings because the FDA's doing a great job.
This price rise IMO is confirmation the FDA plans to take action on sNDA 005. It's oddly the same volume and price before FDA first SPA reconsideration meeting. Something oozed out of the FDA to some players.
Add Steve K. comments about diabetic trials... and define stopping points written into REDUCEIT...Amarin won't reach interim analysis without tripping the overwhelming "safety & efficacy".
Potential first dates of communication Q1 & Q2 after DSMB reviews current Hazard Ratios.
The FDA has nothing to gain at this point and everything to lose...
BB"
You have absolutely nailed it.
I have a strong suspicion that Amarin's highly connected Washington D.C law firm Covington & Burling have finally ironed out a deal with the FDA after meetings behind closed doors with Senators. The Baker Bros involvement is of major significance as was the Suntrust coverage. That pair are major players.
The bottom line is that the FDA have made a complete mess of this and they havent got a leg to stand on in a court of law which is why this charade will never end up there. There is simply too much money being squandered as a result of the FDA's scandalous actions. This is the U.S.A where capitalism is king and God is money. We are talking about a drug that is safe, efficacious, and worth multi Billion $$$'s. It has the very real potential of becoming the best selling drug of all time and its pretty much just sitting there on a shelf. Makes no sense.
2015 is going to be a very good year for Amarin longs.
As far as the stock price goes, yesterday saw it break through the major resistance at $2.27 on massive volume. There is a massive gap after that all the way up to Suntrusts $6 target. Funny that....
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