From IHub:
CYDY trial of mild to moderate has been completed for weeks.
This much is true.
They missed on all primary end points in their study per the CEOs admission. In fact my understanding is the only patient death was among a patient who was given leronlimab. The study was a 2:1 ratio of Leronlimab to placebo. Not a good study, not well powered, and not designed to move leronlimab to FDA approval. This was a true phase 2 study.
They did not publish a peer review of their results. They actually have not fully published any results or even given out the data. They have only mentioned, in a conference call to my knowledge (I am a CYDY shareholder) that they achieved significant statistical difference in one secondary measure, the news2 score. However they failed to mention what difference and also did not release the data. My guess is, honestly, they achieved a lower temperature (fever) upon ICU admission. Without a full release of data it is all a guess. Not sure why they are applying for EUA for covid 19. The study was a small phase 2 study, designed to help them focus on a future phase 3 study. If the data is so great why not publish it?
NEWS 2 measures the following:
respiration rate
oxygen saturation
systolic blood pressure
pulse rate
level of consciousness or new confusion*
temperature.
Primary end points measured 02 Sat, and oxygen use and they failed to show a statistical difference in those. So I feel resp rate and Oxygen saturation really couldn't have been that much different to placebo even in the news2 score. Level of consciousness in covid 19 is directly linked to 02 sat, again (02 Sat) a failed in the primary end point That leaves heart rate, blood pressure and temperature. The first two are highly variable upon ICU admissions. Most covid 19 admissions are for low 02 sats or they wouldn't be going there, they would stay on the floor. Some are for hypotension, though not many compared to resp failure, and low blood pressure is linked to increased HR. So my money is on fever reduction. Again without a full release of the data, who knows? If anyone has all the data, peer reviewed, I would love a link. Perhaps I am wrong? Perhaps CYDY just forgot to release the data?
I do feel CYDY will get HIV approval, if not in the USA then in the UK. That will be big news for them. However, HIV patients self injecting at home may be an issue in many countries as what will they do with the dirty needles? I do not see the UK funding CYDY to promote treatment of Covid 19. Warp Speed rejected them. They haven't released the data yet, just some strange words of support from the CEO about meeting a secondary end points and focusing on they drug being safe though not effective. Also the CEO touts many times that leronlimab stays in the system for weeks if not months, per his HIV data review video. If this is true why was there no significant statistical data shown progression to ICU or mechanical ventilation in then mild to moderate study. Leronlimab was no better than placebo. I do not see the data from the Severe to Critical study having a good read out for CYDY. With all that in mind covid 19 is not for CYDY.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very motivated to provide leronlimab to patients throughout the world who are suffering from COVID-19. We believe the statistically significant data of NEWS2 findings, along with impressive safety results (less SAEs or AEs with leronlimab vs. placebo), from our Phase 2 trial set forth in the Top-line Report provides compelling data in support of leronlimab’s use to fight COVID-19. We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use. We are in a very exciting period for CytoDyn in regards to the potential role of leronlimab in three different COVID-19 populations, mild-to-moderate, severe-to-critical, and long-haulers.”
Here is the link to their "data," Would love a better one, or a full release of the numbers and findings.
https://www.cytodyn.com/newsroom/press-releases/detail/460/cytodyn-submits-its-top-line-report-from-its-phase-2