A lot goes on out of view to reach the very important stage of acceptance for filing of an NDA. The application has to be essentially complete in every aspect of safety and efficacy, chemistry manufacturing and quality control before acceptance. The pre-filing meetings with the relevant FDA officers iron out a lot of the potential issues before hand and enhance the prospect of a smooth review process and gives every chance of a 12 month approval date...the clock has already started. NDAs are a new ball game for Mayne Pharma and they would have had some expert consultants working with them on this one.
It was time for me to re-enter and take a position again early this morning (having been on board previously in better times). The NDA filing and potential for USA manufactured generics getting an edge up over imported product, have convinced me.
MYX Price at posting:
38.5¢ Sentiment: Hold Disclosure: Held
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