NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

eagle8,

FDA, in my opinion, is governed by threats of lawsuits and loss of jobs even when some within want to move faster. FDA said they would have ECA guidance in stone by December 2021. That didn’t happen but the May10th ambush did. The JAMA Oncology journal article didn’t appear until AFTER ECA guidance was written in stone. None of this was coincidence in my opinion. The NYAS conference happened without the clinicaltrials.gov site update because that is part of “the process” that exposes upstarts to potential attacks. NWBO and FDA have had to endure all of this in order to get through the gauntlet.
Now that NWBO is close or at the point where Edens can be validated, FDA May finally be in position to move forward at pace with or ahead of MHRA on Edens because product release is less restrictive in the US. I believe that FDA is ready to move Edens into place quickly and that part of any BLA submission will include Edens which can be fully validated about one month prior to BLA approval with it included, perhaps after MHRA approves the MAA based on the artisan method with CRL Memphis being the backup for initial introduction there then Edens added on after initial approval. Best wishes.