Cytodyn Inc (CYDY)

[CTMedic]

Kgro,

Thank you for reminding us of the importance of DATA (not suppositions) to demonstrate that a treatment works.

The evidence that leronlimab works includes:

64% reduction in SAEs vs SOC/placebo (severe adverse events such as death, life-threatening condition, hospitalization, disabilities)

140% increase in the number of patients with improved NEWS2 scores (23% placebo, 55% leronlimab, p=0.0185)

DMSB recommendation to continue CD12 trial to completion without modification (indicating that the trial as designed should hit its primary endpoint).

CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint

https://www.cytodyn.com/investors/news-events/press-releases/detail/477/cytodyn-receives-positive-dsmc-recommendation-after-interim

15% mortality in the EIND cohort at a time when SOC mortality was ~50%.

Of course, these EINDs were documented by what you have characterized as "cult phyisicians"

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249894.

It is interesting that the "cult physicians" and their research colleagues have their results published in peer reviewed Journals.

These are:

Ahmed E.ElSharkawia
Alina Lelic
Alina P.S. Pang
Amruta Pise
Arash Naeim
Benjamin N. Bimber
Bruce K. Patterson
Bryant Yang,
Byung S. Park
C. DavidSuddutha
Christopher Sugai
Christopher Bonivete
David Goodman-Meza
Edgar B. Francisco
Eisa Mahyari
Enver Akalin
Eric Hall
Gabriela M. Webb
Hallison Rodrigues
Harish Seethamraju
Helen L. Wu
Helen L.Wug
Jacob P Lalezari
Jane A. O’Halloran
Jennifer A Fulcher,
Jenny Ahn,
Jonah B. Sacha 
Kabir Mody
Kazem Kazempour
Kush Dhody
Lama Kdouh
Lishomwa C. Ndhlovu 
Merlene Berro
Matthew Plassmeyer
Michael J. Corley
Monica Herrera
Nader Pourhassan
Nicholas Agresti
Oral Alpan
Otto O Yang
Philip A. Mudd
Phillip P Amodeo
Raavi Gupta
Reejis Stephen
Scott Kelly
Seth A. Gross
Steven F. Mosher

Published here:

Clinical Characteristics and Outcomes of Coronavirus Disease 2019 Patients Who Received Compassionate-Use Leronlimab

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277

CCR5 inhibition in critical COVID-19 patients decreases inflammatory cytokines, increases CD8 T-cells, and decreases SARS-CoV2 RNA in plasma by day 14

https://www.ijidonline.com/article/S1201-9712(20)32305-5/fulltext

Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case
Series of Four Critically Ill Patients Treated with Leronlimab

https://www.sciencedirect.com/science/article/pii/S2589909021000034

And yet this is how you have characterized the CD10 leronlimab study:

Failed primary endpoint, 17/18 secondary endpoints failed, last secondary endpoint datamined with a post-hoc change of its definition, no regulators interests in any country, detailed data never published by the company. These 5 points are the very definition of a complete failure.

5 out of 5. Impossible to do worst than that.

Not to be too much of a stickler, but CD10 had one primary endpoint, 12 secondary endpoints and four "other outmode measures". So technically, CD10 had 13 endpoints, generously 17 endpoints, but never 18 endpoints.

CD10 did fail to meet the primary endpoint (subjective criteria including cough and myalgia, as nearly all patients improved by day 14).

However in the objective assessment of the NEWS2 score, statistically significant improvement was observed.

Lest we continue to abase this criteria, please recall that this is an objective measure of clinical deterioration, utilized as an endpoint in 151 Covid 19 trials.

You have stated :

last secondary endpoint datamined with a post-hoc change of its definition

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249239

As a review, these trials were created in conjunction with and approved by the FDA. Certainly an company can look for subsets of patients who improve more than the entire patient population, but that is not was happened here.

The NEWS score remains unchanged. The application of this assessment tool in the trial was also unchanged. Clinicaltrials.gov provides users the ability to see changes made during the trial.

After checking, no changes in endpoint.


Very simply, 140% more patient treated with leronlimab had and improvement in their NEW2 scores, and thus lower indication of clinical deterioration.

Your statement: "To be approved a treatment must prove that it performs better than standard of care, not that it doesn't perform worse" is partially true. Treatment must prove that improve patient outcomes.

Reduction of serious adverse events (like death) versus placebo or standard of care is a clinical indicator that a treatment is working (again, stopping patients from dying).

I looked AGAIN on clinicaltrials.gov for Covid19 trials in which SAEs were utilitized as clinical trial endpoints.

440 Covid19 clinical trials listed with SAEs as an endpoint. Interesting.

You noted:

At some points the medical "science" has to be confirmed or rejected by unquestionable hard statistics. That's another "science", different skills, different rigor, and it often rejects the medical theories. Like it already did for the first Leronlimab COVID trial (a failure, the Leronlimab MOA didn't work as expected!).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162249894

Please see previous discussion. Statistically significant improvement in NEWS2 scores and reduction of SAEs (like dying).


You have argued that CD12 MUST fail, based on your statistical analysis. First, statistics is the science of probability. Not knowing the constitution of the CD12 trial (100% of patients on ECMO?), none of us can know unequivocally what the expected mortality is of the placebo group.

Nonetheless, reasonable assumption from the experience of the IL-6 and aviptadil studies indicated that a mixed trial population has ~30% mortality. Leronlmab CD12 has 22% mortality. So perhaps Cytodyn has done a poor job enrolling critical patients, or perhaps leronlimab works as advertised and reduced the mortality to 22%. If that is the case, and if the placebo mortality is 30%, and assuming the reported 87 deaths are correct, that indicates a 40% reduction in mortality with the administration of leronlimab.

Perhaps this why your statement is seemingly premature in its conjecture that:

As for the FDA, they are precisely the only ones, along with regulators from other countries, to block Cytodyn.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162210033

Last I checked, Cytdoyn is in conversations about the CD12 trial results, with not just the FDA, but the MHRA and health Canada. Unless of course we are to believe that these regulators agencies have joined the aforementioned physicians and researchers in perpetuating the Cytodyn "fraud".

"Old" news perhaps in today's fast-paced world, but here are the salient points from last week's press release.

CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients

and

CytoDyn expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks

[14-21 days] - [8 elapsed days] = [6-15 days]

CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.

The wait is excruciating for all of us, but there is no recourse but to be patient.

GLTU/A