I'd say that the filing for 4 doses vs 2 is just "filing" (not approval) and wouldn't need a PR, normally.
And while that's great and what we would all hope and expect, the real news is Brazil here. That is technically early as well (just let us know when patients start getting injected), but the odds of Brazil following through are much higher than the Philippines, for example.
Canada, believe it or not, has cause for serious concern as well.. right over the border, Vancouver BC is the North American epicenter of the Brazilian P.1 variant. If they, unlike the US, understand the implications of that, I expect them to be the first movers (always have).
The greater message here is that we're moving forward with or without the FDA. They can delay deciding on an EUA for CD12 but they'll be hard pressed to justify not allowing 4 doses. History will be extremely unkind if they manage to:
a) impede the trial with 2 doses again
b) not EUA it after seeing it in action for several years
c) lose the bulk of supply to other countries
Blame will be assigned and it will be deserved.
And while that's great and what we would all hope and expect, the real news is Brazil here. That is technically early as well (just let us know when patients start getting injected), but the odds of Brazil following through are much higher than the Philippines, for example.
Canada, believe it or not, has cause for serious concern as well.. right over the border, Vancouver BC is the North American epicenter of the Brazilian P.1 variant. If they, unlike the US, understand the implications of that, I expect them to be the first movers (always have).
The greater message here is that we're moving forward with or without the FDA. They can delay deciding on an EUA for CD12 but they'll be hard pressed to justify not allowing 4 doses. History will be extremely unkind if they manage to:
a) impede the trial with 2 doses again
b) not EUA it after seeing it in action for several years
c) lose the bulk of supply to other countries
Blame will be assigned and it will be deserved.
Quote:CytoDyn Files New Protocol with U.S. FDA for 4 Doses of Leronlimab for Critically Ill COVID-19 Patients with the Objective to Duplicate or Surpass 82% Survival Benefit with P-Value of 0.0233 Originally Achieved from Two Weeks of Treatment in CD12 Trial With 2 Doses
April 01, 2021 6:00am EDT
Trial commencement will be expedited by enrolling patients in Brazil, U.K., and Canada while immediate EUA requests are pursued in multiple countries
VANCOUVER, Washington, April 01, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company", a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that after several weeks of discussions with the U.S. Food and Drug Administration (“FDA”) and analysis of CD12 trial data, and in particular the 82% survival results over placebo after two weeks of leronlimab treatment, with statistically significant p-value of 0.0233, the Company has filed a new protocol to extend treatment to four weeks.
The Company will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU.
CytoDyn believes four weeks of leronlimab treatment to be sufficient to calm the cytokine storm and to have a positive effect on survival rate at 4 weeks and potentially 8 weeks.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “As recently reported, our further analysis of the CD12 trial data demonstrated a statistically significant 82% reduction in mortality at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on ordinal scale with discharge rate much better in leronlimab with p-value statistically significant.
These results were achieved with just two doses of leronlimab, one dose at day 0 and a second dose at day 7. The half-life of leronlimab is 10 days and with only 2 doses, it is impressive we observed a 24% survival benefit at 28 days in critically ill COVID-19 patients, which we believe is as good or better than any reported results achieved so far with any other product for the critically ill population of COVID-19.
Based on these results, we believe an increased dosage regimen will result in an equal or greater mortality benefit.”
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