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:
-
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).
-
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)
-
Instead of granting an EUA, the FDA asked the company to conduct a Phase 3 trial for severe and critical Covid patients.
-
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.
-
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.
- 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.
Best Regards Yanzi Lin A U.S. citizen
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:
-
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).
-
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)
-
Instead of granting an EUA, the FDA asked the company to conduct a Phase 3 trial for severe and critical Covid patients.
-
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.
-
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.
- 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.
Best Regards Yanzi Lin A U.S. citizen
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:
-
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).
-
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)
-
Instead of granting an EUA, the FDA asked the company to conduct a Phase 3 trial for severe and critical Covid patients.
-
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.
-
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.
- 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.
Best Regards Yanzi Lin A U.S. citizen
Community Reinvestment Act. Carter started it I think to stop red-lining. Clinton blew the doors off it and mandated that banks make ever increasing %s of subprime loans. I read that by the time the train left the rails, half of Fannie's were subprimes.
If not tranny, she beats his ass. I was in a Jewish 'hood growing up, and we used to listen to them get their asses beat. Just next door Mrs Eisenburg used to throw little Max down the basement stairs, slam the door and continue screaming at him. We were just kids, thought it was funny. Matriarchal group I guess.
28 states changed voting rules to boost mail-in ballots for 2020.
I cannot overstate this:
2022, Nov.8th, there will be 20 Republican Senate seats open, but only be 14 Democrat Senate seats open. Not good odds for us.
Get rid of the voting machines before 2022 elections, or else.
The state legislatures are Constitutionally, explicitly empowered to do this - not the Governor, not the Secretary of State nor Attorney General of a state, and not a judge. And not Stacey Abrams (GA).
Especially in the swing states and Senate race states. But, "all states matter". Quietly!
Republicans presently have legislative majorities in all "swing states". And many others. All have "defective" Dominion/Smartmatic machines.
Those state legislatures need to reclaim their electoral responsibilities (i.e. the Constitution).
The procurement process probably differs in each state. Maybe not, find out. Soros found out.
Expect opposition, even death threats-we're dealing w/ subhumans.
We only have xx months till Nov. 2022 elections. Hop on this?
Perhaps there will be a need to pre-select the right Courts, in case it goes there. But it shouldn't. The legislatures have plenary power here.
And get rid of mass mail-in voting in such states. With COVID gone there will be no basis for mass mail-ins.
Do this while you can - 2022. It can be done. The state legislatures are Constitutionally empowered. And don't forget the corrupt voter rolls, and "new voting laws".
If you don't, then America died on Nov.3, 2020.
see attached file(s)<<
Texas and Louisiana (1 week after Biden was sworn in)
Jan. 27, 2021 Harris County, TX is replacing "paperless" voting machines with machines that produce a paper trail. I guess TX wont be turning Blue after all. (media.patriots.win)
"..to spend $54 million on new voting machines
"..newly announced contract with Hart InterCivic..(Verity Voting, from Hart InterCivic.)
"..plans to have 2,300 of the new devices delivered by March 1.
"..the system tabulates from human-readable text choices, through OCR; no voter choices hidden in QR codes. Same system as Tarrant Co.
"..includes Houston, is the third-most populous county in the United States, with more than 4.7 million residents and 2.5 million registered voters, more than 1.6 million of whom cast ballots last November.
https://statescoop.com/harris-county-texas-ditches-paperless-voting-machines/
Jan. 27, 2021 "Louisiana, which is the last state to use paper-free machines statewide, announced on Wednesday a new search for a replacement system, which will include a paper trail.
"BATON ROUGE, La. — The Office of State Procurement has issued a Request For Proposals (RFP) to secure new voting equipment to replace the state's current stock of approximately 10,000 machines.."
-Voter Verifiable Paper Audit Trail -Background Checks For Those Working On Project -Disclosure Of Foreign Ownership -Disclose All Countries In Which The Proposer Operates -Forbid Political Spending From Contract Funds -Follow All Applicable Laws
https://www.sos.la.gov/Pages/NewsAndEvents.aspx#faq317
In a states where Republicans how sway, especially the swing states and 2022 Senate races, contact their "Office of State Procurement". Not to mention Georgia. Dominion/Smartmatic machines are "defective", therefore, contracts are void. Buh bye.
Obama was behind this. It's how he won in 2012.
This was beta-tested in other countries and around the USA,
before they went for the big cheese.
The gov't has no legit' authority. They went outside the Constitution.
If your employer is requiring the CV shot, contact [email protected] Informed Consent Action Network
Remember to make them put in writing that the experimental treatment shot is:
“A Condition of Employment”
Attorneys love that. . .
Against the law to require a shot for employment. They can't even ask.
They do it for the flu shot...
However this is very different, legally. This gene therapy is not FDA-approved, it is approved through an emergency declaration. There is a legal framework around this type of approval, and that includes it NOT being able to be required under any circumstance.
It can't get FDA approval because it can't pass animal testing protocols. They've been trying for 20 years.
FDA approval would essentially be the end of their(pharma's) legal immunity.
My company now requires it if u come to work. It's a great excuse to work remote forever
email [email protected]
Nuremberg Code The voluntary consent of the human subject is absolutely essential.
I believe the type of tear gas used turned out to be flammable. They made Reno the fall guy, but I've read that it was Hillary who decided.
Somehow the metal door vanished, which would have indicated who shot first.
They were not making drugs or weapons. David K. went running/walking. They could've picked him up any time.
The media were already there before the main event. Years ago I saw film that made me puke.
-
He's into currency arbitrage. If he can bring about the fall of the US dollar, he'll be perhaps the wealthiest man on the planet. He did it to the Asian currencies and the UK.
-
We have deported elderly, former NAZI death camp guards in the past. A naturalized citizen can be denaturalized and deported. Soros is from Hungary.
-
He's 90. sometimes despicable people live long lives.
So, what gives? I don't even know which state he's a resident of. NY I assume.
Barry S. could be deported too.
then maximize isolating, so as to maximize mail-in ballots, so as to steal the election.
Just what were the Germans afraid of?
weimar...hyperinflation.. the marxists...great depression
what exactly or combination was it?
Mostly peaceful bricks.