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Re: Arby2000 post# 434473

Wednesday, 01/12/2022 12:32:41 PM

Wednesday, January 12, 2022 12:32:41 PM

Post# of 701570
No there is no public release requirement, and they do not have to make public the filing or the acceptance of the file, and in fact can prevent FDA from making these public.

Recall the clin trials.gov requirement is enforced by FDA, or not enforced, as they usually handle these things.

Negative data, however, would need to be shared with any new potential research subject before consenting them to receive DCVAX. This is not only US requirement, but International law. Would you be eager to try the combination of two failed products? Or pay £150k for access to just the DCVax portion of the failed combo?
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