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vator

06/20/23 10:01 AM

#603009 RE: dennisdave #603007

He is just posting useful information. We all expect them to file for GBM. Once approved they can Tissue Agnostic and I hope they are working on it now.

Why shoot the messenger with good regulator action information?
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FeMike

06/20/23 10:04 AM

#603012 RE: dennisdave #603007

They are not applying for tissue agnostic. This is just more unwarranted optimism to explain the inexplicable delays.

As I've said all along, they are doing exactly what it seems. Applying for n/rGBM to RA's one at a time, starting with MHRA. They aren't going to surprise anyone. They are just slow.

This pie in the sky stuff has to stop. Now when they finally announce MAA submission/acceptance/approval/whatever, the market reception will be disappointment that it is only MHRA and only GBM, instead of being excited that they finally got something done. The grand delusions can only hurt this stock when they constantly and consistently do not come to fruition.
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ATLnsider

06/20/23 10:36 AM

#603046 RE: dennisdave #603007

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.