Replies to post #82739 on Cytodyn Inc (CYDY)

[BioInvestor4]

I wasn’t aware of that! Thanks for the info!

[RetiredandHappy]

I have a high degree of confidence in the positive results of the trials based upon Bruce's comments. Also it won't take much to be better than Remdesivir.

We are playing with a stacked deck.

[z_smith]

Yes, per the protocol, Dr. P measures "the Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]"

That is how he knows which pts are on LERO vs. placebo.

[cytodyn storm]

NP.. Is able to see the Clinical status of the patient’s AND their corresponding Labs..

Rockleo,

Thanks very much for your post.

It makes complete sense that Dr. BP's companion assays allow him to either detect the presence of leronlimab in blood samples, or see clear evidence of leronlimab's MOA working in the blood samples. In short, he must have a very good idea of who is receiving the drug, and who is receiving placebo.

Until reading your post, what was not clear to me was that Dr. NP (or anyone else for that matter) was in a position to cross-reference and correlate each participant's labs -- against their clinical responses.

Questions:

1. Is it a standard practice that the sponsor, in this case Dr. NP, is provided with the ability to see a ‘running update’ of the clinical status of each trial patient?

2. Are the same naming conventions used to identify each patient's labs -- and each patient’s clinical responses? For example would you expect Dr. BP is receiving a Day 3 blood sample in a vial labeled "Patient #12" -- and Dr. NP is provided with the ability to see a ‘running update’ of the clinical response of "Patient #12"?

If the answer to both of these questions is “Yes” – then Dr. NP effectively has a somewhat "unblinded" preview of the trial outcomes (minus the statistical analysis).

And if that is true, Dr. NP maybe has a better sense of how these trials will end, and the chances that leronlimab will be approved for one or both COVID indications.

This is important for because I had been operating under the assumption that the confidence being expressed by Dr. NP, Dr. BP and Dr. JL in recent calls and videos was due ONLY to favorable lab results. And while I was happy they were seeing good labs, I was concerned they were operating in somewhat of a vacuum -- without correlated data on the clinical results of those patients with good labs.

This is especially important for the P2 Mild-Moderate trial, because the Primary Outcome Measures are Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) -- and not labs.

Looking forward to your response. Thanks.