RE:RE:RE:At what point...eric40 wrote: 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.
you guys have an answer for everything, and by answer I mean excuse. At what point do you accept that Pierre constantly over promises and under delivers? It's honestly sad watching you grasp at every little possibility as to why we didn't hear something by June 5th. I think it's pretty obvious THERE IS NO PRIORITY REVIEW. You guys blasted this board with FDA articles that clearly stated the FDA has 60 days to respond. It's gone from comical to plain sad listening to you guys make excuses for PL poor management. Stop blaming the FDA, stop counting work days and holidays, stop making up fictitious reasons as to why Fred is out of the office and just accept that facts. Pierre Laurin is a brutal CEO. He does make it super easy to exploite this company though. Took me some time to figure this out but has been much easier making money once I did. Next stop $1.50-$1.75.