The only opinions that matter regarding LL’s trial results are the FDA and other drug regulating bodies throughout the world. The FDA has spoken rather harshly regarding the agency’s opinion on LL and Cydy for Covid treatment. They say it did not meet trial endpoints or prove efficacy. So there is that little stumbling block to the position adopted.
This is from Cytodyn's own recent press release, under the "About Cytodyn" section towards the end:
CytoDyn has already completed a Phase 2 and Phase 3 trial for mild-to-moderate and severe-to-critical COVID-19 patients, respectively, for which CytoDyn did not meet its primary or secondary endpoints, except for the secondary endpoint in the critically ill subpopulation.
Company never claims they meet endpoints -- they just spin results to make them look good. GvHD failed. CoV CD10 and CD12 failed to meet any endpoints. Long CoV never met any statistical significance -- only spun for directional differences. Phase 1 mTNBC had no comparator and was just a dosing trial. Compassionate use is not a trial. NASH so far didn't have a comparator and they haven't reported the final open label data.
So far none of these have been claimed as statistically significant which is a requirement to meet endpoints and be approvable by FDA.
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