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hankmanhub

06/11/23 11:54 AM

#600422 RE: hyperopia #600409

Hyperopia, as much as I would love for NWBO to apply for all solid tumors all at once on a tissue/tumor agnostic basis, I agree with you that I do not think they will do this. They will do as you suggest to apply for nGBM and rGBM only, and after that is in hand they will try for accelerated expansion to the other solid tumors as quickly as possible. To reach out and go for too much would risk the entire application to be denied for having reached too far and lose approval for nGBM and rGBM as well. Better to have your base easily approved on rock solid evidence without risk, and then move on to other solid camcers as soon as possible thereafter.

ATLnsider

06/11/23 4:17 PM

#600490 RE: hyperopia #600409

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.
Bullish
Bullish