Roman, have to listened to the interview with the company with Survax-m? He said in their trial the fda would accept an external control arm so long as they had patient level matched data. As of now the nwbo trial does not have this level of data so yes imo the fda will not accept this as approvable data. Imo this kind of data could be obtained from program AGILE but do not have it as of now so imo that is why nwbo did not apply to fda
Ridiculous -- FDA doesn't publish their discussions or decisions out of the post trial meeting. Only the company can if they chose. NWBO didn't but knew they weren't going to get approved so shifted their application process to UK's MHRA.
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