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Re: dmb2 post# 599782

Thursday, 06/08/2023 12:53:38 PM

Thursday, June 08, 2023 12:53:38 PM

Post# of 822496
dmb2, are you completely ruling out the possibility of the regulatory authorities approving DCVax-L on a tissue agnostic basis now, because of: (1) its non-toxic and excellent safety record. As of result, it will not harm cancer patients, but it probably will benefit most cancer patients; (2) it’s mechanism of action (MOA) of using the patient’s own dendritic cells, pulsed with the patient’s own tumor lysate (regardless of which organ(s) the tumor(s) is/are located), to activate T Cells to find, destroy and continue to fight the cancer tumor(s). This MOA is not just specific to the brain, but should work for every organ in the human body.

Then, require NWBio to complete post-approval Phase IV, confirmatory basket trials to validate the efficacy results, and to keep the tissue-agnostic approvals?
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