"The question that I think we need to answer is why are 27 modules being prepared for submission. That seems excessive for one drug in one jurisdiction. I have read the previous theories but they remain speculative"
My own speculative take on this is that it might relate to the fact that the P3 trial was for nGBM however, as a result of the remarkable results for rGBM there is no way that the company will not include rGBM approval request also, just IMO.
Could be applying for tissue agnostic as well. All they can do is say ok for GBM but for all tissue it is a “NO” or a “YES” with combination studies.
How could it take even these people this long after DL if it was not for more? Just my take. The Italian paper indicated pretty much that path if only for GBM. Doubt any useful information will appear in the 10q.
Reefrad, very logical post based on facts from the trial. The 3 month median improvement in OS is significant if not spectacular with a favorable safety profile. Temodar became part of SOC with the same 3 month improvement in median OS. Dcvax along with adjuvants hold much potential for further improvement but they were not part of the trial and imo such a trial should be conducted in the future. Nwbo really (imo) need to get their consultants preparing submission(s) for approval to move faster and let the regulators decide. I think they will approve but only if applications are submitted. As Dr Liau has said this awful disease needs multiple treatment approaches and dcvax I think should be one of them
Reefrad, I believe that Drs. treating GBM patients will have no trouble getting drugs like Keytruda off label given the evidence supporting its use. It would be malpractice not to do so.
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