Once again -- NWBO P3 completely changed their protocol 2 weeks before the END OF THE TRIAL. The PIP design is the same but meets the requirements that the External Comparator would be developed and approved BEFORE THE TRIAL IS STARTED. Notice FDA told NWBO not to bother filing for approval with the FDA so NWBO had only had options like the UK, a miserable oncology treatment market. NWBO violated FDA guidelines for ECA being done BEFORE the trial began NOT at the very end of the trial.
The placebo-controlled pilot study does not factor in, no. Compassionate use, same.
And why would MHRA have approved the PIP if they thought the design was ‘questionable’ ??
Who said the PIP design was questionable?
DCVax-L (and the Roswell DC technology) are currently in placebo-controlled RCTs.
Excellent, this is something worth following. And perhaps if robust enough, could serve as the confirmatory trials. Further supporting my suggestion that this would be conditionally approved.
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