Biotech Values

[zigzagman]

DD...Can you tell me a normal time frame...

For a PUFDA date to be set?...Let's say company XYZ submits a NDA on January 1st 2010...

The FDA has sixty days to accept (or deny the NDA for improper formatting of the application)...

Let's say the NDA is accepted on March 1st, and there is no chance this drug will receive Priority or Fast Track status...

How many months from the acceptance (or submittal?) of the NDA will the PUFDA date be?...I've heard that ten months is the time limit for a Standard Review...Is this correct, and if not what is?...