NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Pyrrhonian,

I agree with you on this. To me it looks almost as if the company initiated the temporary hold, sent in data which FDA then reviewed and asked for continuing data as per Dr. Prins " still accruing patients" comment. This essentially leaves us with a rolling review of data up until the scheduled end of the trial unless there is or has been some sort of an ethicist intervention on behalf of pseudo/mesenchymal patients. If NWBO argues that these patients leave the main trial early and this leads to underrepresentation of this subgroup in the main arm, FDA might listen. Linda said they would not apply for AA until the end of the trial. To me this means FDA is actively trying to decipher data which is accruing very slowly while perhaps also working with the other regulator time lines and manufacturing prep so that approval can be expedited if received.