Replies to post #287663 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

Beartrap is right. Any significant amendment or update to the SAP, particularly the last one for unblind would be sent to the regulator for them to comment if they wish to do so.
You don't want your BLA laughed out of court in five minutes, so you run the last revision of the SAP past the regulator.

Im not arguing with that. My point is that we dont know if and what the response is of the authorities on the last changed SAP. NWBO did not PR anything on this. How do we know that the FDA had so many problems with the new SAP it can be regarded as disapproval?