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Posted On: 12/27/2020 10:26:04 PM
Post# of 153930
“I can confirm, via a friend, that the FDA reached out to CYDY regarding the expansion.”
We already knew the FDA contacted CYDY via the first few words in the title of the PR, “FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded.” NP didn’t need to confirm it. The label expansion will stop the need for EINDs at approved trial sites, lessening the burden on the FDA and making it easier to offer the treatment to patients.
We already knew the FDA contacted CYDY via the first few words in the title of the PR, “FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded.” NP didn’t need to confirm it. The label expansion will stop the need for EINDs at approved trial sites, lessening the burden on the FDA and making it easier to offer the treatment to patients.
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