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Re: FishyFingers post# 44150

Thursday, 03/12/2015 9:40:27 PM

Thursday, March 12, 2015 9:40:27 PM

Post# of 426469
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...

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