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Wednesday, September 27, 2023 1:27:16 PM
It appears that Veru, perhaps at the FDA's suggestion, may also be thinking of using sabizabulin in a broader market focused on treating Acute Respiratory Distress Syndrome.
"Veru Reaches Agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication: Hospitalized Adult
September 26, 2023 "
https://www.bloomberg.com/press-releases/2023-09-26/veru-reaches-agreement-with-fda-on-new-phase-3-clinical-trial-for-sabizabulin-for-broader-indication-hospitalized-adult
This is the company that reported outlandish mortality benefit in trying to get sabizabulin authorized for covid. The FDA Declined to grant their EUA.
"Veru's EUA ambitions crash after FDA declines to authorize its COVID treatment
By Max BayerMar 3, 2023 11:17am"
https://www.fiercebiotech.com/biotech/verus-eua-ambitions-crash-after-fda-declines-authorize-its-covid-treatment
I wonder if the FDA suggested the same thing to Humanigen. I happen to think a broader market use makes sense, as I said, perhaps even extending to non-viral respiratory infections.
Hopefully, it's a moot point. The additional safety and efficacy data we have obtained since LIVE-AIR will likely prove sufficient for the FDA to grant our resubmitted EUA, especially with covid hospitalizations and deaths on the rise from a highly mutated covid variant.
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