InvestorsHub Logo
Followers 14
Posts 949
Boards Moderated 0
Alias Born 01/03/2013

Re: TRUISM post# 6422

Tuesday, 11/24/2015 9:05:10 PM

Tuesday, November 24, 2015 9:05:10 PM

Post# of 16885
Again, my links are from FDA themselves those are from wikipedia and RTT news? The PDUFA is NOT what is being approved it is the NDA that was submitted to the FDA. The definition of PDUFA is "Prescription Drug User Fee Act".

Since you prefer wikipedia

https://en.wikipedia.org/wiki/New_drug_application

Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter.[7] A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months.



also, taken from your own wikipedia link (why you didn't including it in bold underline in your post don't know).

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted



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.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent TTNP News