A poster on YMB sent email to Dr Scott Atlas, the new Covid adviser to the White House. Suggest we forward this widely to raise awareness of this important therapeutic.
“Congratulations on your new role. You have a chance to make an immediate impact on all Americans exposed to COVID-19.
Following the successful and statistically significant results of their Phase 2 FDA registered clinical trial for mild to moderate symptoms, Cytodyn has submitted a request to the FDA for Emergency Use Approval (EUA) of leronlimab, their drug therapy for the treatment of COVID-19. They have also submitted the trial results information to the EU, UK, Israel, and Mexico for their approval consideration. Will the U.S. be a leader or a follower?
The FDA created the Coronavirus Treatment Acceleration Program. One of the Program’s stated intents is "...to engage with pharmaceutical sponsors and other government partners to facilitate patient access as soon as possible when favorable results are observed..." Well, this is the FDA’s chance to do just that, or be exposed as beholden to competing forces, at the expense of the public health. An EUA for leronlimab is the access americans deserve, given the statistically significant and favorable results observed for the objectively based NEWS2 endpoints at days 3 and 14. 65% safer than placebo. 150% more effective than the current Standard of Care (SOC). Not a single drug related Serious Adverse Event (SAE) observed either in this trial or in the over 800 patients treated in other past and ongoing trials. Subcutaneous injection and no hospitalization required. Keeps people out of the hospital, and significantly reduces related health care costs.
An EUA review process and timeline is described on the FDA website and considers the product profile, the existence, if any, of pending applications for the product, the nature of the emergency, and other relevant factors. Although the length of time required for FDA action will vary, the Agency recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an EUA will be acted upon within a matter of hours or days.
From my perspective, COVID-19 is an emergency situation that is occurring, and “facilitating patient access as soon as possible” means CytoDyn’s EUA request should be acted on and leronlimab should be approved immediately. My parents are in their 90's, and I'm no spring chicken. There is only one right choice. Anything else would cost time and lives and be illogical, unethical, and immoral."
“Congratulations on your new role. You have a chance to make an immediate impact on all Americans exposed to COVID-19.
Following the successful and statistically significant results of their Phase 2 FDA registered clinical trial for mild to moderate symptoms, Cytodyn has submitted a request to the FDA for Emergency Use Approval (EUA) of leronlimab, their drug therapy for the treatment of COVID-19. They have also submitted the trial results information to the EU, UK, Israel, and Mexico for their approval consideration. Will the U.S. be a leader or a follower?
The FDA created the Coronavirus Treatment Acceleration Program. One of the Program’s stated intents is "...to engage with pharmaceutical sponsors and other government partners to facilitate patient access as soon as possible when favorable results are observed..." Well, this is the FDA’s chance to do just that, or be exposed as beholden to competing forces, at the expense of the public health. An EUA for leronlimab is the access americans deserve, given the statistically significant and favorable results observed for the objectively based NEWS2 endpoints at days 3 and 14. 65% safer than placebo. 150% more effective than the current Standard of Care (SOC). Not a single drug related Serious Adverse Event (SAE) observed either in this trial or in the over 800 patients treated in other past and ongoing trials. Subcutaneous injection and no hospitalization required. Keeps people out of the hospital, and significantly reduces related health care costs.
An EUA review process and timeline is described on the FDA website and considers the product profile, the existence, if any, of pending applications for the product, the nature of the emergency, and other relevant factors. Although the length of time required for FDA action will vary, the Agency recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an EUA will be acted upon within a matter of hours or days.
From my perspective, COVID-19 is an emergency situation that is occurring, and “facilitating patient access as soon as possible” means CytoDyn’s EUA request should be acted on and leronlimab should be approved immediately. My parents are in their 90's, and I'm no spring chicken. There is only one right choice. Anything else would cost time and lives and be illogical, unethical, and immoral."
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