NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Where did you get an earlier submission from the purported DI conversation with H2R? Instead, H2R and another poster inferred the FDA has been looking at the SAP and talking to NWBO’s contractors and/or people about it, who are cleaning it up for formal submission.

According to the FDA real time evidence review, submission of final SAP occurs after topline, not before. What H2R’s and one other poster’s reported recent phone calls with DI suggest is that the FDA has already been reviewing and commenting on the SAP without having it formally submitted to them. Thus the logic would be finalization of the SAP via FDA comments and revisions is underway. This would skip any formal prior submission that NWBO previously told us was necessary before any regulator response/comments.

They are, if all this is correct, playing word games with the word ‘submit.’ Everything the two posters related make it sound like the “dialogue” between them is already occurring and efforts to “clean up” the SAP are underway. If that can occur without submission, then formal submission of a final SAP would only need to occur one time — after topline, as the FDA real time evidence review timeline suggests.