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Re: jessellivermore post# 23729

Saturday, 01/11/2014 11:16:30 AM

Saturday, January 11, 2014 11:16:30 AM

Post# of 426725
I believe FDA (maybe just Coleman, Parks and their supervisors) want to make sure Amarin do not get ANCHOR approval, due to BP influence. A 9-2 ADCOM "no" vote is not sufficient to reject ANCHOR because Amarin did everything asked to be done according to the SPA. As a result, the only out for the FDA was to rescind the SPA. Otherwise, FDA could just issue a CRL without even rescinding the SPA. Therefore, if we get SPA reinstated (big IF), the minimum we get will be label expansion. However, I am sure FDA will try to delay it as much as possible so that BP can continue to benefit from the whole fiasco.
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