NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

JR:

I have clearly stated my belief that Primary and Secondary have probably not unequivocally achieved "undeniable" results and may have even fallen short...and that NWBO probably feels this way but does not know for sure.

I do not, for one moment believe that NWBO, botched the trial. The endpoints were chosen long ago and they appear not to be appropriate endpoints for this type of trial. If the trial demonstrates strong results for milestone OS and long tail, I do not believe that failure in the primary/secondary endpoints doom approval especially in light of the now very favorable reg environment.

I think that the FDA will look at all the data. Failure in the primary/secondary endpoints will take on greater weight if the milestone/ long tail results are not so strong. Further, I have not averred that the FDA has made any assurances. Quite the opposite. However, the FDA is enlightened insofar as immuno-therapeutic approaches are concerned and understand the importance of long tail in these types of trials. Thus NWBO is re-writing the SAP with the tacit agreement of the FDA. However, the FDA has not stated that it will sign off on any re-written SAP. Essentially, the FDA with its more flexible orientation is saying....OK you can submit a re-written SAP and then we will see what you got...

Fair enough. Stay tuned.