NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

Do I have this right? There is no such thing as approval of a SAP by the RA. The pivot point is the company's ability to AMEND the SAP which is the issue - which they MAY only do prior to unblinding. What the company looks for from the RA when they provide an amended SAP to the RA is issues that the RA sees with the new amended SAP or suggestions for possible improvement or correction of the SAP - not APPROVAL of the SAP, which the RA does not ever provide. It is always up to the company to decide which SAP they will go with and hope that the changes they have made in consonance with the RA "suggestions" or "questions" will have the RA look upon their final submission with favor. It is always up to the company to say we are ready now and confidant in our SAP, and roll the dice and go with it. But at no point does the RA say "We approve this SAP."

The most they might get from the RA after the back and forth of discussion about issues and suggestions (if anything at all) is "We have no further issues or suggestions concerning your SAP" but they will never get a final response from the RA that reads "We have approved your SAP."