NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Ohhh, looks like longusa is keeping gold from the group!:

Relative to the discussion on the interim results still 'outstanding', I reread the guidance to companies on endpoints and accelerated approvals: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
I found this passage in the section on accelerated approval that may be instructive (pdf pg 25):


"Another approach is to use an interim analysis of the surrogate endpoint data as the basis for accelerated approval, with continuation of the randomized trials during the time period when the surrogate endpoint and interim safety data are being: (1) analyzed, (2) prepared for submission to FDA, and (3) reviewed by FDA. When the ultimate clinical outcome can be expected over this additional timeframe, the data to verify the clinical benefit may be nearly complete by the time of accelerated approval. "

From the point of view that the company is not a scam, this could be what is happening with all this time delay - a dialogue with the FDA on how to proceed with an accelerated approval filing of a BLA and what would happen to the trial. --longusa

Well, great point! Just maybe...