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Re: dennisdave post# 603007

Tuesday, 06/20/2023 10:36:25 AM

Tuesday, June 20, 2023 10:36:25 AM

Post# of 821994
No, that is not what I said. I said I believe that DCVax-L will eventually be approved on a tissue agnostic basis.

I also said the following:

(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 the following:

(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) eventually, both DCVax-L and DCVax Direct will both be approved on a tissue agnostic basis;

(4) eventually, both DCVax-L and DCVax Direct, and their combinations with PD-1 inhibitors and CSF-1R inhibitors will also be approved on a tissue agnostic basis;

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