Thoughts for the board: In the PR from 2 weeks
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Posted On: 03/05/2021 7:22:30 PM
Thoughts for the board:
In the PR from 2 weeks ago, CYDY said they would released the data once discussions with regulator agencies were complete.
“CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.”
https://www.cytodyn.com/newsroom/press-releas...and-health
With the PR released today, and the statement above, are we to assume the discussions have concluded? If so, I’m assuming the discussions were only for an EUA?
IMO, CYDY knew the primary endpoint failed two weeks ago. NP delayed releasing this PR with the goal of discussing an EUA with the US, UK, and Canadian UK based on the reduction in days hospitalized and the other promising endpoints (that weren’t statistically significant). I’m guessing the various FDAs, especially the U.S. FDA, will now give guidance on how to build on the reduction in mortality (100-200 more patients?).
In the PR from 2 weeks ago, CYDY said they would released the data once discussions with regulator agencies were complete.
“CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.”
https://www.cytodyn.com/newsroom/press-releas...and-health
With the PR released today, and the statement above, are we to assume the discussions have concluded? If so, I’m assuming the discussions were only for an EUA?
IMO, CYDY knew the primary endpoint failed two weeks ago. NP delayed releasing this PR with the goal of discussing an EUA with the US, UK, and Canadian UK based on the reduction in days hospitalized and the other promising endpoints (that weren’t statistically significant). I’m guessing the various FDAs, especially the U.S. FDA, will now give guidance on how to build on the reduction in mortality (100-200 more patients?).
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