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Re: Maverick0408 post# 509908

Wednesday, 08/31/2022 5:08:01 PM

Wednesday, August 31, 2022 5:08:01 PM

Post# of 823423
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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