NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

what I personally believe when it comes to the FDA buy in of the SAP is this.

1. It is material if the SAP/endpoints would have been denied by the FDA.

https://news.bloomberglaw.com/securities-law/insight-the-sec-fda-nexus-best-practices-for-publicly-traded-life-sciences-companies

since they have not PRed a denial it is my belief the same SAP has been accepted by the FDA either by silence after x FDA days revision passed as some suggested or a plain yes its accepted.

2. It would be incredibly risky to unblind if the SAP has not been bought in by the FDA. If the SAP needs to be adjusted then NWBO can be easily accused of post hoc data mining what has happened to Biogen and its Aducanumab recently.

I personally believe NWBO waited for the buy in of SAP/endpoints either in Europe and or with the FDA which could have contributed to the recent delay. But I do believe both are in and perhaps even Canada.