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I think its worth reminding both of you that this is a phase 2 trial. One of the main objectives of a phase 2 trial is identify the best endpoints (which are then used in phase 3 trials)

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I think it's worth reminding you that if leronlimab is granted an EUA or approval for the S/C cohort before the LH trial reads-out, a properly designed Phase 2 PE might very well obviate the need for a LH Phase 3.

I understand all-too-well that there is no real distinction, other than optics, between a Phase 2 PE and a Phase 2 SE. However, the company's missteps in Phase 2 protocol design have caused self-inflicted damage as recently as the M/M CD10.

In all fairness to the CytoDyn team, that protocol was established very early in the game. However, mild patients with little-to-no symptoms should not have been included in that trial, and the PE should not have been subjective.

We could discuss and debate how that chapter might have ended if patients with only +4 symptoms had been allowed, and the PE was NEWS2 or some other real-world clinical score.

However, as designed, the FDA was not inclined to grant a M/M EUA even though the results were superior to remdesivir, along with having a significantly reduced risk profile.

In spite of the FDA allegedly telling CytoDyn that they weren't interested in approving anything for the M/M cohort, which I find curious because the FDA granted an EUA to remedesivir for the same cohort shortly thereafter -- I think the FDA just couldn't "sell it" to the public or the administration.

We did not hit that subjective PE -- and what we DID hit required quite a bit of data mining to tease-out a compelling argument. Unless there is something more nefarious going on at the FDA, I think they just couldn't "sell it".

Then, of course, there's the argument that the 84 patients in the CD10 did not constitute a large enough N= for approval. I get that argument -- but I counter it with Dr.NP repeatedly telling us that the LH Phase 2 Special Protocol Assessment (SPA) allows for a 60 patient LH interim analysis. He has expressed this at least 3 times in the past couple of months.

That suggests to me that Dr.NP believes that a very favorable LH interim might possibly lead to an EUA or approval, especially on the heels of a S/C EUA or approval.

Now, his motivations for publicizing this 60-patient interim might be misguided, as they have been in the past. However, I'd like to believe that CytoDyn just might be granted a LH EUA right after a S/C EUA or approval -- if the Phase 2 is properly designed with real-world clinical metrics, and is not undermined by not hitting a subjective PE.