Dear President Biden,

As a 38-year professional pilot I am a type A personality; see a problem fix the problem, if you can’t fix it report it. Sir, I am writing to report a very big problem that requires immediate attention from someone with the horsepower to override the influence Big Pharma has in DC.  It is with the greatest sense of urgency I can convey that I write to inform you that a lifesaving COVID therapeutic is being suppressed by one of the Big Pharmaceuticals and millions of avoidable deaths have occurred and thousands of people are still dying daily as a result! I will present proof that the FDA is being coerced by one Pharma to assist in suppressing Leronlimab because it will compete with their product line and obsolete many of their drugs. 

The therapeutic I’m referring to is a monoclonal anti-body called Leronlimab* and it’s the property of Cytodyn, a small Biotech with 22 employees and no revenues. I invested in Leronlimab early last year and have been following closely as Cytodyn has been attempting to gain FDA approval to treat HIV and COVID. Leronlimab has a stellar safety record with zero significant adverse effects in over 1200 people injected subcutaneously, it met its primary endpoint in a three-year HIV trial and reduces mortality by 82% in the critically ill COVID population. 

Cytodyn recently completed a phase 3 trial for the severe/critical COVID population. While designing the trial they requested a 4-dose protocol in the application but were denied and directed to administer 2-doses over 2 weeks. Post-trial data showed an 82% reduction in mortality at the conclusion of the second dose!** Spectacular efficacy in and of itself but almost unbelievable when you consider these patients were at deaths door.  However, since the FDA disallowed further dosing, 10 days after the second dose the effects of the drug wore off and many of the patients relapsed and either died or recovered with life changing damage. To put this in perspective, the critical population - the sickest of the sick, intubated or on ECMO with a 30-50% chance of survival - are the trial patients.  Someone at the FDA made the conscious decision to disallow 2 additional treatments of a potentially life-saving drug from a dying person whose worst side-affect is headache and diarrhea! 

If ever there existed a smoking gun, this is it! What possible justification exists to deny a dying person 2 additional doses when the FDA had previously approved weekly in-home self-administration based on safety data from their 800 patient HIV trial? 100’s of patients had received 100’s of doses, some spanning 6 years! No scientific nor medical justification exists to withhold 2 additional treatments of Leronlimab! The only possible rationale for rejecting a 4-dose protocol was to hinder Leronlimab’s ability to reach Statistical Significance and to delay the inevitable EUA that will keep Cytodyn from revenue in an attempt for a hostile bid for Leronlimab.  That single decision will result in hundreds of thousands of additional, avoidable deaths as it effectively moved the earliest EUA back at least 5-6 months due to the requirement for additional trials. That clock doesn’t even start until the FDA stops finding reasons to delay the approval for a request made in March for a trial protocol consisting of 4 doses of a drug that is remarkably efficacious and is almost as safe as water!  The FDA is either short staffed, mentally challenged or blatantly corrupt. My bet is on corrupt and that will be verified when the next trial is completed and they find a reason to move the finish line yet again 

There are numerous examples of manipulation of this tiny Biotech, but I think the most compelling evidence for BP influence and FDA compliance is the simple fact that there was no medical nor scientific justification for not issuing an immediate EUA when it was applied for August 2020, after their phase 2 trial for mild/moderate! Leronlimab has a safety and efficacy record far superior to any BP COVID therapeutic currently available.  Why has it been on Dr. Woodcock’s desk for 8 months awaiting an EUA with no valid justification not to issue one?  That’s some impressive leverage by this company. Trust me Sir, if Leronlimab was owned by any of the BP’s it would have been given full approval by the FDA last August and millions of deaths would have been avoided. 

If these two glaring examples of manipulation are not enough, consider the paper*** noted virologist Dr. Bruce Patterson co-authored last year.  He discovered that Leronlimab quieted the cytokine storm and restored immune homeostasis thusly preventing disease progression, organ damage and ultimately death. Had Leronlimab been approved and available on a global scale, it would have enabled the administration of a treatment plan Doctors were screaming for; a single subcutaneous injection upon positive COVID diagnosis thereby preventing the Cytokine storm. Disease progression stopped, done, pandemic under control. He gave a Ted Talks**** lecture on the subject. This would have been global headline news had Leronlimab been owned by a Big Pharma! Apparently, this Pharma can influence the media also. The FDA didn’t open the front doors and roll out the red carpet for Cytodyn as they should have, instead they locked the door and turned out the lights as this BP stood behind them looking ominous and threatening while the body count climbed.

It is standard practice for Big Pharma to hunt for new drugs under development by small Biotech’s then attempt to partner or acquire them. But never in our history has a Big Pharma identified, targeted and executed a plan to acquire a life-saving drug (by any means necessary) during a pandemic that resulted in millions of deaths. Leronlimab has indications in over 20 auto-immune deficiencies, multiple cancers, HIV, NASH and other life-threating diseases. Couple that with a safety profile unheard of in the industry and you have the making of multi-billion dollar/year drug! Quite a prize and apparently worth killing millions over! 

I’ve been following the war being raged against Cytodyn for a year. These are just a few of the many events I’ve observed that point directly to one very powerful company that is coercing the FDA into ‘guiding Cytodyn towards approval’ via the longest, most expensive and time-consuming route possible. This is a deliberate attempt to slow the progress of this unstoppable new drug so they can try and own it in order to survive.   This has resulted in millions of avoidable deaths and people are still dying by the thousands on a daily basis!  I believe your March 11^th speech was heart felt and that you feel strongly about finding a way to manage this Pandemic. Your best possible option at this point is Leronlimab, as much and as fast as Cytodyn can produce it.  If this letter reaches your desk, it was pushed there by a social storm of outrage over Leronlimab being suppressed when the world desperately needs it. The eyes of the world are watching and waiting for you to approve this drug asap. Sadly, the rest of the world looks to the U.S. FDA as the premier agency for drug approval and since they are a puppet agency for Big Pharma the rest of the world will suffer as a result of the single abhorrent decision to limit the trial protocol to 2 doses! I most respectfully urge you to call for an immediate congressional inquiry to find out who made the decision that resulted in millions of deaths.

  We had a saying in Naval Aviation “results count, everything else is B.S”. The fact that Leronlimab was not issued an EUA last August is nothing short of criminal! There is only one way to stop the war against Cytodyn and the corruption that is killing millions, an immediate EUA for Leronlimab, period! Cytodyn is positioned to execute its business plan to bring this life saving molecule to the world as quickly and efficiently as possible. You have the power to stop the unnecessary dying and direct an immediate EUA for LERONLIMAB! The life you save could be your own. North Star🙂

Very Respectfully,
Alan Hassall
Capt. FedEx Retired