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Re: hyperopia post# 600409

Sunday, 06/11/2023 4:17:36 PM

Sunday, June 11, 2023 4:17:36 PM

Post# of 702487
hyperopia, I think we are saying the same thing, but in a different way. You are saying you don’t believe that NWBio will apply for DCVax-L approval on a tissue-agnostic basis.

I have said on several occasions that:

(1) I do not know if NWBio is going to ask for tissue-agnostic approval on their initial regulatory submissions with the regulatory authorities;

(2) even if NWBio does apply for tissue-approvals for DCVax-L on its initial applications, it is up to the regulatory authorities to approve DCVax-L on that basis, or not.


But, I have also said that:

(1) both DCVax-L and DCVax Direct are tissue agnostic;

(2) there is a possibility that NWBio could apply for DCVax-L approval on a tissue-agnostic basis, on its initial submissions;

(3) I hope for the sake of solid tumor cancer patients worldwide, both are approved soon on a tissue-agnostic basis.
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