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Dr Bala

05/11/22 2:51 PM

#471264 RE: br8k0ut #471249

That question from br8k0ut (from the Virtual Audience) is at the 40:10 mark in the video posted:

https://www.dr-bala.net/NWBO/NYAS2022/NYAStalk2022.mp4
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HappyLibrarian

05/11/22 3:22 PM

#471304 RE: br8k0ut #471249

He [Dr. Bosch] smiled and quickly answered they couldn't comment on that but that DCVAX-L would be submitted like any other product is to the FDA [emphasis added].



This puts to bed the notion that NWBO spent the last year getting thing expedited at the FDA with rolling this or that. 'Would be' means that a submission hasn't started yet assuming that you heard him right (I have not had a chance to go to the audio).

None of this precludes getting a more rapid regulatory approval in the UK or on the continent but given how poorly the last year was used to strategize the TLD rollout, I would not expect that a ton of work was gotten out of the way with the regulators.