RE:I wonder if the FDA is currently working on...I have the exact same tought. Pg is a a protein from the plasma. It is not a chemical coumpound.
PPPS is a 20 year old process from Prometic. The technology is part of numerous already FDA approved drugs and process.
Primary and secondary endpoints were met at 100%.
Pg CD has Potential life-altering consequences.
Pg had Fast Track designation and had a rolling BLA Filing with the FDA so no mistake possible in the filling.
IF the FDA had more questions, maybe it is because they are considering an expeditated marketing approval considering the facts.
Or not. But in any cases, we should get an update soon and Pg BLA should be a no brainer IMHO.