Replies to post #329514 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

The illogical part was the initial statement that they would not move forward to Data Lock until all 4 rages had bought in , so that would mean what ? if one didnt `buy in` then what , all go home ....

Yes then we can go home and NWBO is stuck with the old SAP the trial would have most likely in that case been a failure.

When starting P3 trial biotech will ask the FDA/EMA permission, as you know, to do so based on their SAP protocol in which the endpoints are determined. If the FDA has page after page of objections and or flat out forbids the trial based on safety and or the EMA does not buy-in, then the P3 trial can not start and or it would be incredibly stupid to start the trial. No biotech will submit an SAP without consulting the FDA beforehand, at least any I know of. Since NWBo has moved forward the FDA did NOT object to the new SAP.
The FDA has the same attitude toward a mid way endpoint change in a blinded trial as it has before the trial starts. FDA only condition for a mid way change of endpoints is non-bias.

Please read on FDA protocol when changing endpoints
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159365539

and my post here
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159442565