NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

In order for PFS to fail it must be proven that true PFS failed. There is an appeals process that allows proof to be given that true PFS did not fail and proof of treatment induced pseudoprogression can be presented. The fact that PFS had to be adjudicated led to them changing the endpoints entirely as there still is no perfect way to separate true progression from pseudoprogression but the fact that treatment arm patients are living longer in spite of apparent progression confirms the problem.
The issue with endpoint changes on the clinical trials site, unlike Europe where the changes are made by others than the sponsor, is the rational for doing so must be made public first or there could be legal ramifications. This led to the May 10th attack which now is being used to take down the crooks who thought they could get away with what they were doing. FDA will take no issue with what had to happen as the company was blinded and protected by firewall the entire time that changes were made and they had their own blinded data to make determinations about potential PFS problems because of pseudoprogression. They didn’t need others to tell them. Best wishes.