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
Download as PDFDecember 24, 2020 7:46pm EST The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12
The CD12 trial completed enrollment with 394 patients on December 16
From this, we know that the trial completed January 13. We are now one month/31 days from trial completion.
We are more than halfway to the interval which Novartis took to announce failure of the con-covid trial (61 days), and more than the 28 days that it took for topline results of the positive CD10 trial,(statistically significant reduction in NEWS2/clinical worsening and 60% reduced SAEs!).
I expect that the next PR will announce positive results from CD12 with EUA or approval.
You may find it helpful to look backward, but I'm looking forward.
Nonetheless, perhaps you want us to look at the PR from another company. I do not see a July 20 PR listed, for what it's worth.