Progenics FDA Delay Is Just A Flesh Wound

Recently, Progenics Pharmaceuticals (PGNX) announced that it would have to delay its New Drug Application (NDA) to the FDA. The reason being is that its third-party vendor that is manufacturing AZEDRA needs more time to prepare before the pre-approval inspection by the FDA. While this news was somewhat disappointing, it is not the end of the road for the company. That's because Progenics has already submitted all necessary items for approval. The only thing needed for approval now is the third-party facility inspection by the FDA. In my opinion, that is not a negative at all. To me, it indicates Progenics's willingness to make sure that AZEDRA ultimately ends up being approved by the FDA. The delay itself isn't too long either, only about three months. That means that investors have a chance to buy the stock ahead of a potential approval.


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