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Re: FDA approves PLAC test, could have huge ramifications for AMRN I dunno. There are many markers for cardiac risk. Approving a test for a marker is not the same as accepting the premise that using a drug to lower that marker would have an effect on outcome. I don't think the FDA would argue that: high LDL-c low HDL High trigs are all markers for increased cardiac risk. However, they feel that only lowering LDL-c is an approved surrogate for clinical benefit (multiple outcome trials). Having said that, how long does it take to write a CRL? Something may be going on behind the scenes. (if not for the fact that the lead reviewer passed away 3 months ago I would say something is definitely going on) |
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Msg # | Subject | Author | Recs | Date Posted |
1690 | Re: FDA approves PLAC test, could have huge ramifications for AMRN | ex_hacker202 | 2 | 12/16/2014 1:30:47 PM |
1691 | Re: FDA approves PLAC test, could have huge ramifications for AMRN | tastygreenwafers | 0 | 12/16/2014 2:34:08 PM |