Replies to post #171252 on Cytodyn Inc (CYDY)

[Blue Man]

Well, 18 of 24 symptoms where affected which is 75% of the symptoms, right? Will be interesting to see which symptoms were affected in a positive manner. Will cognitive symptoms be among those? :-)

[Grip it and Sip It]

Was just deciphering the PR. Wow, what a grasp at straws. These are a few quotes that are laughable:

Patient symptoms were self-reported daily throughout the 56-day evaluation period and reported electronically. The symptom scores were rated as severe, moderate, mild, and none.

Aw, yes those self-reported criteria with Cytodyn tallying the results. Yeah, nothing could go wrong there!

Although the study was not designed to show statistically significant differences due to the small sample size of 56 patients, clinically meaningful improvements in leronlimab over placebo were observed for cough, stuffy/runny nose, shortness of breath, tightness of chest, feeling of fast heartbeat, fatigue, muscle aches/cramps, muscle weakness, joint pain/swelling, chills/shivering, feeling hot or feverish, difficulty in concentration, sleep disturbance/insomnia, headache, dizziness, tingling/numbness, sense of taste, and sense of smell. Of the remaining 6 symptoms, sore throat, exertional malaise, anxiety, nausea, and vomiting had no clinically meaningful change. Diarrhea was worse in leronlimab treated compared to placebo.

Hmm, no “meaningful change” in some of the most vital areas of LH syndrome!

Nader Pourhassan, Ph.D., CytoDyn's President and Chief Executive Officer, concluded, "Prior to the commencement of this trial, the FDA advised us that our long-haulers trial is considered an exploratory trial; thus, a follow-on trial will be necessary prior to potential approval. Our hope, following the FDA's review of all data, is that the agency will grant us a Breakthrough Therapy designation and provide guidance for a Phase 3 trial protocol. It is important to note that we must await the review of regulatory agencies in the U.S. and abroad and their guidance on how to proceed forward.

There it is! The Nader hedge! Exploratory, guidance needed, maybe get a Phase 3! Do y’all know how long this will take!

Here’s a summation of this PR:

With pencil and paper, Cytodyn asked people now they felt (anecdotal and subjective) then jotted those down. (Maybe in the correct category, maybe not). The most vital symptoms showed no statistical improvement and the trial is very small!

This is not laughable, it’s sad. I’m sure there will be a small spike through the day but I can’t wait to hear Nader stumble and bumble his way through the CC today! When the tough “Yes/No” questions come at him, listen closely how he answers!

Grip