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Re: johnking29 post# 17012

Tuesday, 10/15/2013 8:30:55 AM

Tuesday, October 15, 2013 8:30:55 AM

Post# of 426304
I'm not a big conspiracy theorist and nothing makes sense for your theory

1) The placebo lipid profile did increase in a bad way, maybe more than expected for 12 weeks, so what was different between the placebo group and the non placebo? Well, the obvious thing is the placebo so the reviewer would clearly see the difference in lipid profile, Omthera company had already mentioned it themselves at a conference call so not unreasonable for someone charged with playing devils advocate to bring it up for discussion.

2) Why would BP want AMRN to fail? The only similar drug is Lovaza, going generic soon, GSK has nothing to gain from AMRN failure. In fact BP has more to lose, AZN now would need an outcome study for Epanova, any cholesterol lowering drug would require a long term expensive outcome study, and FDA SPA's are now going to be questioned as to the sanctity of them not when science changes, as science still says lowering trigs is beneficial, but when some science clouds the issue. This opens ups severe complications for BP. Inconclusive non related studies can be a basis for denial, YIKES!

So BP loses if Vascepa is denied expanded label. The only "conspiracy" theory that could come into play is BP wants to buy AMRN cheap but seems alot of work to illegally pressure the FDA to fail a drug so you can buy it cheaply and HOPE the Reduce it trial is successful since it is not worth much until completed now that you made sure Anchor is not expanded.

Then BP also has to influence a panel of individuals with people from all different parts of the country with different backgrounds.

The theory that BP is pressuring FDA to not expand Vascepa has a ridiculous amount of holes. The first being BP has more to gain with a Vascepa expansion than a denial. Seems pretty dumb to me to be BP and to push for something harmful to your own business.
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