Tuesday, November 24, 2015 9:05:10 PM
Since you prefer wikipedia
https://en.wikipedia.org/wiki/New_drug_application
also, taken from your own wikipedia link (why you didn't including it in bold underline in your post don't know).
PDUFA, law passed to collect a substantial application fee from the drug manufacturers 'AT THE TIME THE NEW DRUG (NDA) OR BILOGICS LICENSE APPLICATION (BLA) WAS SUBMITTED. Again the company can end up paying the fee upfront and never implies approval. The law was brought about to offload the cost of drug reviews from the govt. to the drug companies. The 'PDUFA date' is the date 'hijacked' from the NDA application, the NDA application is what is being approved not your up front PDUFA fee. Oh, and the NDA approval date is set from the date that the NDA is ACCEPTED by the FDA not the date the PDUFA fee is paid.
See you all in Jan. because nothing of merit is going to happen the rest of this year, FDA wise or stock price wise.
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