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CytoDyn Inc CYDY
(Total Views: 564)
Posted On: 04/29/2020 9:34:53 PM
Post# of 154884
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Posted By: ClosetInvestor
Re: Brman #30212
The simple answer is no, as the FDA will require CYDY to show efficacy for each indication. For example, leronlimab has shown great efficacy for HIV combo therapy but the FDA still requires a placebo controlled COVID19 trial. No, leronlimab is not yet approved for combo therapy, but even if it was, that would have little bearing on a separate indication (minus the safety profile and CMC portion). Also consider that despite excellent results in HIV combo trials and in an uncontrolled open label mono trial, the FDA is still requiring a pivotal trial before a BLA for mono therapy can be filed.

For example, I don’t see approval for mTNBC any sooner if leronlimab receives quicker approval for COVID19.













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