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ATLnsider

08/31/22 5:08 PM

#509923 RE: Maverick0408 #509908

Thanks, I will stick with my theory. I know you indicated you have some regulatory experience with getting medical devices approved. But, when it comes to getting new biologics approved to treat oncology / cancer patients, I will stick with Dr. Pazdur's knowledge and experience.

I believe you are overestimating how difficult and challenging it will be for other non-EU countries like: Japan, Israel, Australia, Switzerland, etc. to approve DCVax-L, after the DCVax-L journal article is released, and after DCVax-L has been approved by regulatory authorities in the US, UK, Canada, Germany and the rest of the EU.

You are also overestimating how much time it will take for NWBio to get those other ROW approvals. NWBio will be able to use the exact same DCVax-L Phase III clinical trial results to apply for other regulatory approvals around the world.
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Poor Man -

08/31/22 5:19 PM

#509931 RE: Maverick0408 #509908

Mav, everthing you describe resonates with the reality of conducting business internationally. Relying on medical tourism to a few select countries is a better option. And there might be some of that sooner rather than later if there ‘s a significant lag between a UK approval and anywhere else.

And having said all of that, any strategy will require BP partners for all the heavy lifting.