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Re: Ajax133 post# 8386

Wednesday, 06/12/2013 2:25:22 PM

Wednesday, June 12, 2013 2:25:22 PM

Post# of 429261
Ajax133; Thanks for all you bring to the board. I have an opinion differing from yours on a couple of points.
First: while its true with regards to NCE being awarded at the time of drug approval the FDA puts out talking points for the ADCOM which include NCE, and the ADCOM addresses these points and later before adjourning the meeting votes to recommend approval or disapproval. Their position with regards to NCE could not or should not hinge on the forthcoming Anchor indication but solely on what is before that ADCOM at that time with respect to safety, efficacy, and the best interests of the medical community and people on a whole.
Secondly: "Prior Art" speaks more to the point of not awarding NCE based on the fact that their has been drug approval prior to of one or more chemicals of the drug in question, simply put. For AMR101 this prior art was not so clear cut due to the fact that the FDA did not clearly identify the active moeity in Lovaza, this fact and cleaning up the mess has been the delay IMHO. Best Wishes.
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