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Wednesday, October 04, 2017 8:33:05 AM
The horse is dead....Why do you keep beating it?
The FDA made a mistake when they agreed to the "ANCHOR" SPA..
The mistake was promising Amarin (and yes I am long the stock) the marketing rights to treating a 35 million cohort (mixed dyslipidemia) for which there was no viable competition as far as other drugs (a defacto monopoly). There was no clinical proof whatsoever that V would be an effective therapeutic agent other than one clinical trial (JELIS) that was run in Japan and was not widely accepted by the USA medical establishment who felt there were significant flaws in the study..
This in a background of healthcare cost spinning out of control.. To approve a medication that would have major effects on these costs without an acceptable CVOT would have been irresponsible..
Did the FDA back pedal and change the goalposts...Violate the SPA and then stonewall by using the FDA's built in four corner press...the answer is yes..yes..YES...Did it cost me and a lot of you some money...yes..yes yes..
Was it the right thing to do...yes ..yes ..yes...
I would bet serious money that the FDA struggled internally over this issue and I would not be surprised if Eric Colman was the one who made the mistake and this might of played a role in his cancer and subsequent death...
Timed to move on...Vasceps needs this great R-I trial to shut up the critics ...Meanwhile if you were smart and not wasted by your bitterness..you took the opportunity to buy some very cheap Amarin stock....And your reward will be coming next year...
":>) JL
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