I congratulate OREX management for having the brain to keep Nissen in the dark...I'd still be wary of the FDA...they will try to get even.
Panel 1 Witnesses Hamburg and NIH director...
Don't know if this is the start of something big...but it does precede budget discussions.
Amarin has enough evidence to completely evicerate the FDA at this point. The new theory, amongst some HF managers, is the FDA tanked Anchor so Amarin would be FORCED to finish REDUCEIT. The FDA feared that Amarin would drop the trial after an Anchor approval. Ya know what that's called in America? Illegal antitrust. The FDA has fired numerous maggots that perpetrated the crime but this doesn't protect the US Governments liability for these employees actions. The FDA is beyond repair and the plan is to dismantle it and realocate Food to Ag and likely Drug to NIH. Amarin will start to aggressively go off label and I dare the FDA to try and stop them.
Early spring, yes Amarin has Crestor/Vasepa...this would be a NCE, Crestor/Vascepa would not be NCE
This is a NCE under new FDA combo guidance...the hydroxy formulation has superior bioavailabilty over Lipitor and the Lipitor combo has the greatest inflammatory reductions of the tested Statins... Pravastatin ... is "untested" to my knowledge...
Reformulated drug to not infringe, now have to retest....absolutely stupid idea but AZN won't hire me to consult;)
They're also going to take it to a different indication other than CV...and likely try and combo it with a pschy drug...
At some point in the game Amarin won't be for sale...I'd say we're a few Months out from that milestone.
Also happens to be the day OIG meets with House Appropriations Committee to give the report on 2014 Investigations...this is a public document and I will post any and all Amarin related investigation.
Agree, it is being kept over a dollar so the HHS doesn't have to write a bigger check than they already are on the hook for.
March 2016....More like December 2015, if Amarin longs make it through Dec 2015 without hearing 60 % interim results....then efficacy is tracking 15%...assuming 5.2% event rates