NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I do agree that it will not take NWBio very long to update the revised endpoints in the US clinical trial registry. But for me, I am relying on the June 2019 SAP guidance that NWBio gave us. That guidance tells me that they got buy-in from all 4 RAs.

I do admit, it does allow some shorts, detractors & naysayers to use the fact that the clinical trial registry has not been updated as false evidence that the FDA did not buy-in. But, as we all know, initially only the UK registry was updated and shorts were saying that Germany did not buy-in. But, it was only a clerical issue & a matter of time for PEI to make the update. I think the same will be true in the US.

For me, I have moved on from SAP buy-in, and I am focused on TLD because of the following:

(1) There is only 1 DCVax-L clinical trial.

(2) The 1 clinical trial is being conducted in 4 different countries (US, UK, Germany & Canada)

(3) There is only 1 SAP for this clinical trial.

(4) The SAP is the same in all 4 countries, with all 4 regulatory authorities (RAs).

(5) NWBio said that they would not lock & unblind the data & let the statisticians start the process of reviewing & analyzing the data until they got buy-in on the SAP from all 4 RAs.

(6) In the UK & Germany, the RAs (MHRA & PEI) are responsible for updating the revised endpoints in the clinical trial register. In the US, NWBio is responsible for updating the revised endpoints in clinical trial register.

This tells me that NWBio already has SAP buy-in from the FDA & all the other 3 RAs. Again, here is the SAP guidance & Webster’s definition of “buy-in”: