MemberApril 12, 2021 at 6:37 pm
April 6, 2021
To Janet Woodcock, FDA head.This is the revised and edited letter I(“Yanzi Lin”) just sent.
Dear Dr. Wookcock:
As an ordinary U.S. citizen, I would like the FDA to answer some questions regarding its handling the drug Leronlimab from Cytodyn. The questions are based on the following facts:
1. On August 11, 2020, Cytodyn announced “the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. There was no safety problem. The drug ” is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.” And the drug is effective. ” Patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
2. On August 17, Cytodyn submited its Top-line Report from its Phase 2 COVID-19 trial to the U.S. FDA and requested an Emergency Use Approval (EUA)
3. Instead of granting an EUA, the FDA asked the company to conduct a Phase 3 trial for severe and critical Covid patients.
4. The company had to follow the FDA’s order and completed the trial and reported the data on March 5, 2021. The company announced that the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients.” Specifically, the survival benefit was a 24% reduction in all-cause mortality; shortened time to recovery, 6 days, with a statistically significant p-value of 0.005; discharge alive at 28 days was 28% versus 11%, a 166% better rate than in the placebo group.
The company filed an EUA request with FDA. Instead of granting an EUA, the FDA requested the company to do a Phase 4 trial.
5. On March 30, the company further analyzed the data and announced that Cytodyn’s Leronlimab decreased mortality at 14 Days by 82% with statistically significant P-Value of 0.0233 amongst critically Ill COVID-19 patients.
**With the above facts in mind, please answer the following questions:
a) In August 2020, there was no drug in the U.S. to treat mild and moderate Covid patients except Remdesivir which had a lot of side effects and a lot of studies showed that it was ineffective. At the time, 10 thousand Americans died. But now the figure reaches to 590,000. Had the FDA granted the EUA in August, 2020 at least 300,000 American lives would have been saved. American lost more lives in this pandemic than any other country in the world where the FDA played a major part. An excuse of negligence on the job cannot explain this slaughter. Three hundred thousand mothers, fathers, husbands and wives and children of the Americans died in a matter of several months. And millions who managed to be alive are weeping over the loss of their loved ones. Some say that the FDA has their hands with blood and tears. Please answer why the FDA refused to grant an EUA in August 2020 to save lives when they knew that Leronlimab was safe and effective.
b) Why the FDA requested the company to do a Phase 3 trial to see the result of treating the severe and critical patients? Common sense tells us that most severe and critical patients start with mild and moderate symptoms and then progressed to severe and then critical. Why not treat them in the early stage when there is a drug that can stop the progression? Why not FDA granted the EUA and at the same time ask the company to do the Phase 3 trial for sever and critical patients?
c) In the design of the Phase 3 trial, why FDA ordered the company to just have two doses at day 0 and day 7 while the company wanted four doses for four weeks to see the 28 day mortality rate. In most of the trials, one dose per week to see the result at day 28 is a norm. Because of the FDA, the 28 day mortality rate did not reach the statistical significance. However, the 14 day mortality rate of 82% is superb. And the company filed a new protocol for Phase 4 trial. Will the FDA grant this change? Can you predict the result? I believe that based the 14 day mortality rate. Cytodyn will prove that the death rate will be reduced by over 90% if they are allowed to dose the patient one dose per week for four weeks.
6. Why the FDA requests the company to do a Phase 4 trial?
**These are the following sub-questions/issues below:
a). The criteria for granting an EUA is whether the drug is “safe” and “may be effective”. Is Leronlimab safe? Of course. Is it effective? Of course. Who dares to say that a drug reduced a 82% deaths at 14 day is not effective?
b) Leronimab is the only drug to effectively treat critical Covid patients at this moment. And it is safe and effective. Why the FDA does not approve it immediately? We are in a pandemic. Americans are dying. To see the result of the Phase 4 trial another five months (as in the Phase 3 trial) will be needed. How many lives lost?
c) Which officer in the FDA insisted a two dosing regimens and what motivated him or her to do so. It is a norm to have four doses if the trial intends to see the day 28 result. Knowing such trials and Cytodyn’s Phase 2 trial (8 weeks, one dose each week for eight weeks) the officer knew or had reason to know that with just two doses, the trial would not reach the primary endpoint. And the officer got the anticipated result. The day 28 mortality rate, though still good, was not statistically significant. Obviously, the officer wanted to kill the drug although he or she knew that the drug had the potential to save tens of thousands lives. I urge you to investigate the matter no matter the FDA grants CytoDyn’s request for conditional EUA or not in the future. We simply cannot let such corrupt officials determine the life and death of so many Americans.
d) Why the FDA requests the company to do a Phase 4 trial? The criteria for granting an EUA is whether the drug is “safe” and “may be effective”. Leronlimab has no safety issue and has proved the efficacy. Even with a 24% death reduction the benefits surely outweigh the risk. Will there be a 5th trial, a 6th trial and a seventh trial? FDA can invent all kinds of reasons to ask CytoDyn to do the trials indefinitely, each trial needing 5 months. Trials need money. The small company with only 20 employees may not have the money to do the trials. The FDA is slowly walking CytoDyn to death at the expenses of tens of thousands American lives. To get the Phase 4 trial result five more months are needed. Each day we have about 1,000 deaths. The number for five months is 150,000. With a 82% reduction, over 120,000 lives will be saved. But the FDA does not care about the lives. Killing the drug that has about 50 other indications and protecting big pharmacies is their priority.
e) Why the FDA wants the placebo volunteers to die in the 4th trial? They now know that the drug reduces death by 82% at day 14. A two arms trial is unethical and amoral. I would have to sue the FDA if my loved ones die in the placebo arm. What is the FDA’s philosophy in not giving the volunteers the drug that will save their lives but instead putting them in a placebo arm and let them die?
f) What if other counties buy the entire stock from CytoDyn, leaving Americans without the drug at hand to save their lives? CytoDyn has applied EUAs from other countries. CytoDyn probably knows that the FDA is violating their due process rights of equal protection and fair dealing. In addition, and surprisingly, until now no government funds has been allocated to CytoDyn to support their trials.
A U.S. citizen
MemberApril 18, 2021 at 10:01 am
Where is Janet Woodcock, who is Therapeutics authorized by the overseers of Operation Warp Speed, when it comes to using RWD/RWE to provide guidance and EUA status for therapeutic agents other than vaccines?
Elements of Operation Warp Speed
Operation Warp Speed is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.
Leadership: In addition to the expertise of Dr. Slaoui and General Perna, each countermeasure area will be overseen by a
highly qualified and accomplished career HHS scientist:
Vaccines: Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.
Therapeutics: Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.
Diagnostics: Bruce Tromberg, Ph.D., Director of the NIH’s National Institute of Biomedical Imaging and Bioengineering.
The alternative therapeutics for COVID-19 that are considered efficacious for prevention and different stages of infection and contagion, alongside vaccines, in Real-World Evidence, yet the media will not spotlight anything but vaccines.
Government heads of state are still fearful of speaking in support of alternative therapeutics and seem oblivious to the fact that THEY CAN SAVE LIVES. Can leaders do anything but the parroting of the centralized world health administrators who only emphasize efforts of “more vaccines, more vaccines”?
Here is a link.
There are people for whom the BUSINESS of therapeutics is just another wealth-seekimg investment. Who cares about urgently saving lives…
Here is a link.
There are people for whom the BUSINESS of therapeutics is just another wealth-seeking investment. Who cares about urgently saving lives…
MemberApril 18, 2021 at 10:16 am
<div>Oops please note that I do not intend to double up my posts here and in other topics. If the Administrator is seeing this and the duplications, please feel free to edit and delete. There is sometimes a glitch after posting a reply, where it stays in editable format and I pressed send a second time because it was not clear if the reply was posted.</div><div>
Sorry about it.
Log in to reply.