NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

HappyLibrarian,

Since when did you become a believer in everything they say?; ). Lol. They gave you top line data without the journal article so technically their focus on TLD was proven out. The journal article turned out to be more problematic with timing and in my opinion that is because a major journal did not want to front run FDA guidance on ECAs. The path forward to approval requires presentation and general acceptance of any newer measure being considered for use in measuring treatment effect. This requires ECA usage and data interpretation generated to be presented to peers so that FDA has proof that ECA usage is being generally accepted by the medical community as a potentially necessary and adequate change for measuring treatment effect. This does not mean an official peer review must take place. FDA makes their own statements of course but they also look for consensus to be developed in the community. Soooo.. in the mean time, before FDA announces their decision on ECA usage, SAP and endpoint changes in THIS TRIAL, manufacturing, manufacturing, manufacturing because that is what is needed to get the treatment to all potential patients once approval is granted. Best wishes.