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  4. CytoDyn Inc (CYDY) Message Board

MGK: My "research" regarding biomarkers was confin

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Post# of 154062
(Total Views: 483)
Posted On: 07/18/2023 11:20:25 AM
Posted By: Jake2212
Re: MGK_2 #135795
MGK: My "research" regarding biomarkers was confined to reading pages 24 and 25 of CYDY's Form 424(b(3 as published on its website under SEC filings and the CYDY summary report of the CD02 clinical trial that I found through Google. Other board members with medical/scientific backgrounds would be far more qualified than me (lacking any medical/scientific background) to suggest suitable surrogate biomarkers that might be cost effectively available from the CD02 trial data that could satisfy the reasonably likely to predict clinical benefit standard for accelerated approval in the unmet medical need space. But even without a medical/scientific background, it strikes me that "reasonably predictive of clinical benefit" provides a pretty wide latitude for data mining the CD02 info and that HIV MDR patients would fit into the unmet medical need category.

As a very interested shareholder and someone who fervently desires that LL be made available to sick people, I plan to wait for the CC in the hope that management will address/confirm that accelerated approval of LL for HIV MDR patients is under consideration by the FDA and that CYDY has submitted to the FDA the requested protocol for a confirmatory clinical trial. Is it possible that I have misinterpreted the content of pages 24, 25 as being descriptive of an accelerated approval process under consideration? Of course it is, but I plan to wait for the CC in the hope of finding out one way or the other.


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