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Re: no_mo_Butterfinger post# 19208

Friday, 10/25/2013 9:07:55 PM

Friday, October 25, 2013 9:07:55 PM

Post# of 426910
Nomo,
I did not mean to mislead you. My impression from both CC and the reduction in force was in preparation for a CRL. I think given the 9-2 vote, AMRN believes the likelihood of approval is low. However, they were clearly wronged by FDA- whether by the director or the reviewer (Mary). They are in the process of pursuing all possible revenue to convince a positive vote. In this particular case, I also believe that FDA were way out of line. Hopefully, the public outcry- if intense enough- will pressure FDA to do the right thing- Conditional approval pending the outcome study.
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