RE:RE:At what point...Prometic had a rolling BLA where the FDA Staff help them fill the different module of the BLA.
This mean that once the last module of the BLA was submitted on april 5, the BLA was completed and NO ADDITIONAL INFORMATION will be require.
Also, since the election of Trump, a new FDA director was appoited. Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017.
This is right in the middle of the 60 day period since Prometic finalise the BLA.
M. Gottlieb was already a director at the FDA. I believe, IMO that there is a lot of seats that are changing right now and that it might create some short term delays.