Letter to President Biden

5K people will die every day until an effective therapeutic is approved for COVID. Leronlimab has demonstrated that it could save 4K of them but it is being intentionally suppressed. Leronlimab has the potential to disrupt a pharmaceutical company with a market cap of $90b and obsolete much of their product line. To this company, suppressing or owning Leronlimab is a matter of corporate survival.

Email the 12 Senators that oversee the FDA in 20 seconds then repeat daily by opening the sent email hit forward then send - 5 seconds. There is no plausible excuse for not doing something that takes 20 seconds. Results count-everything else is B.S.

  1. New email to:[email protected]
  2. Copy and paste this list and CC
  1. Subject: EUA LERONLIMAB
  2. Copy, paste and sign this letter (move the date to the right-hand corner, MSW/Reddit editor issue)

 

Dear Senator, 5/14/21

If you read nothing else, scroll down to the bold italic paragraph.

Cytodyn is conducting COVID trials in Brazil and India. When they are complete, they will show the world how safe and effective Leronlimab is which will be in direct contrast to the FDA’s recent decision to refuse an EUA. I urge you to look into this immediately. If you wait 4 months for trial results another 400k people will die needlessly. One way or the other the world will be asking "how could the FDA suppress this amazing molecule and let so many die as a result"?

Anecdotal evidence exists that the FDA is being coerced by xxxxxx’s lobby and it comes as no surprise that they have rebuffed your initial inquiry into Leronlimab. The attached references from doctors will testify to a fraction of the events that point to a single conclusion; xxxxxx is at war to suppress Cytodyn as a matter of corporate survival and influencing the FDA is only one front of the attack.

Two highly questionable decisions were made recently by the FDA that resulted in hundreds of thousands of avoidable deaths and the time is approaching for accountability!  Last year a single decision was made by someone inside the FDA to limit the dosing for a COVID phase 3 trial request on a potentially life-saving therapeutic without scientific or medical justification. One of the highest safety endorsements awarded by the FDA is in-home, self-injection during a clinical trial. Cytodyn’s phase 3 HIV trial was approved for a weekly self-injection protocol in which multiple trial participants injected 100’s of doses spanning 6 years. Cytodyn’s next request was for 4-doses in their CD12 phase 3 COVID severe/critical application and they were told no, you may only administer 2-doses!!  There is no plausible justification for reversing a standing 6-year safety endorsement to the detriment of someone intubated or on ECMO, essentially on a global basis during a pandemic?! These unfortunate souls were dying, what possible harm could come from 2 extra doses of a medicine whose worst side effect is headache and diarrhea? If that’s not bad enough the FDA does another about face 4 months later and approves a Cytodyn request for 8-doses over 8 weeks to a long hauler trial. Since no justification exists to support that historical policy U turn, one must come to the conclusion it was an attempt to handicap CD12 and thereby avoid an EUA. Allow me to present a different perspective. You’re standing in front of a firing squad with one live round. It may be fatal or not. In either case it’s going to be extremely damaging. Cytodyn comes along and says, “wait we have a bullet proof vest, it’s not perfect but it works 82% of the time”. The FDA then replies, thanks, but we don’t want them to get a headache or poop themselves so run along and conduct more tests”. How does one live with themself after making that call?

The other ruling that shows the FDA was suppressing Leronlimab was the denial of their request to ‘age adjust’ their CD12. Unfortunately, due to a DSMC “oversight” the Leronlimab arm of the trial was heavily weighted by over age 65 patients (high risk) and the trial missed its p-value by .005. The FDA has the authority to allow an ‘age adjustment’ to the trial data and it is commonly approved for Big Pharma. How does the FDA justify the decision to disallow CD12 age adjusted data when there was no down-side to permitting it? These are dying people that had nothing to lose and the FDA denied them 2 extra doses of a drug with a NNT5, the single most effective therapeutic to date! Did they not think someone would eventually ask them how they arrived at that abhorrent decision or are they so callous that they just don’t care?  An EUA would have been saving an estimated 4K lives a day since March!

The FDA’s reluctance to discuss the matter is understandable.  As an educated individual I try to keep an open mind, to look at all the angles for a logical explanation but the only one that fits is xxxxxx is coercing the FDA to suppress Cytodyn in an attempt to acquire Leronlimab and the FDA is complying. The trial data has been reviewed, the science is solid, the molecule is safe and effective and after all I’ve stated the EUA is basically being held back on a technicality, a p-value missed by the slightest of fractions (we’ve all heard Dr. Woodcocks p-vale quote).  Leronlimab could be given immediate (like next day) approval if the right pressure was brought to bear. The world needs an effective therapeutic NOW with the emergence of more deadly variants that vaccines can’t protect against. Cytodyn has the infrastructure in place to immediately deliver to the Philippines, Brazil and India. They are not immune to the pressure of xxxxxx and they need Leronlimab more than we do. They typically follow U.S. FDA policy so it is imperative this gets an urgent classification. 

When the trial results from Brazil and India become public, they will clearly demonstrate CD12 was handicapped by the FDA. WOW, the FDA has problems coming their way! Hundreds of thousands of avoidable deaths to account for with no possible justification leads to the irrefutable conclusion that CD12 was suppressed!! I’d do my best to get this drug EUA’d ASAP if I were you.

Some of the letters and videos****** I’m including have links to scientific papers *****written by renown doctors and scientists validating Leronlimabs efficacy and safety***.  Here is an open letter*to President Biden and an open letter** to the public. For those who are aware of Leronlimab;**** doctors, scientists and the thousands dying daily, this is an agonizing situation. The people that are dying don’t have the power to open the FDA’s doors and demand and explanation but you do, please help us sir. For the thousands dying daily every minute counts. The life you help save may be your own.

 

Very Respectfully,
Alan Hassall
Capt. FedEx Retired

Links provided in the even senate.gov servers filter live links


* https://blockcerts.com/app/healthcertin/letter_to_president_biden/
**https://blockcerts.com/app/healthcertin/this-concerns-you/
*** https://951217f1-eeef-4b64-88e6-a52aefaa6edc.filesusr.com/ugd/2a39c2_0d6a1a5141f3402da26563ce071c7990.pdf
**** https://www.youtube.com/watch?v=fHbF6nWzbe8
***** https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1
******https://www.questclinical.com/video-hope-for-critically-ill-covid-19

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