Based on the phase 3 results of the Anchor trial, can anyone present a reason the FDA might not grant marketing approval for Vascepa in the 200 to 500 Tg population?
"Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031. Epub 2012 Jul 20.
Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).
Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN."
Nothing in the future is 100% known but Anchor will be approved by Dec 20 of this year. It would take some really bizarre, unlikely scenario for it not to be approved.
The question is the cost involved to launch. They will have over 5 times the sales force, how does that happen? What kind of financing/partnership/BO?
I've got an order in for another large truck but I want to be close to 100% sure I've covered all the bases before I back them both up and load 'em to capacity!
A few concerns/anomalies bother me:-
1. The short position is a tad big
2. Management dumped a large glob of shares into the pps advance prior to the Marine results.
3. Paid mouth pieces like the Street are working furiously to plant doubt. How are the likes of AF planning to regain credibility if the Anchor gains marketing approval.
There are things here way out of whack which seems odd given the introvertible nature of the trial results.