Cytodyn Inc (CYDY)

[SF Anony]

The meatiest thing to chew on in this release are these words directly from the FDA:

“As there are now several completed, ongoing, or planned randomized trials of PRO140 (leronlimab) that include severe or critical hospitalized COVID-19 patients, any integrated or meta-analysis would be strengthened if you prespecified analysis details and submitted these for review before results of ongoing or planned trials are Unblinded.“

What that, along with the rest of the PR contents, says to me is that CYDY asked the FDA for approval to include an analysis of the results of other past and ongoing LL usages (not just Trials; also eINDs, right to try, etc.) with the CD20 analysis. The FDA appears to have approved (?) but wants to see that “meta” analysis of all those “other” uses before CD20 data are unblinded.

Anyone else reading it the same way? If so, what are you thoughts on the implications?