Last week,  everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), began issuing a barrage of press releases (read about one here) culminating in one of their now-famous CONference calls, which you can watch here. In these calls, The NaDDiR* and his klown krew mumble incoherently, throw around tons of buzz words, and generally try to keep the suckers happy as the stock promotion lurches from one pivot to another.

On December 9, 2021, one of the Cytodyn press releases trumpeted the filing of an Expanded Access Protocol request by the company with the FDA, to allow for the use of loserlimab in HIV patients. Read it here. Expanded Access allows companies to offer unapproved drugs to patients outside of a clinical trial. Said the company:

Just five days later, on the December 14th CONference call, The NaDDiR* let this slip:

Ooops. A problem with the protocol. Did NaDDiR actually admit they “didn’t do a good job” with the submission? What could be the problem? The FDA accepts ~99% of EA submissions, so what are the reasons why the FDA would reject a submission for Expanded Access? That’s easy. The list is here:

If the curmudgeons at BuyersStrike! HQ had to guess, the FDA probably determined that either under part 2, Cytodyn was not actually pursuing marketing approval with appropriate diligence (ie the BLA submission was a pathetic joke) or part 3, there is not sufficient clinical evidence of effectiveness. Cytodyn only reports the results of one tiny Phase 3 study in HIV, and has offered no confirmatory evidence.

Just more of the endless Cytoklowning from the Klown Krew.

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.

Starting yesterday, December 8th, everybody’s favorite pink sheet reverse-merger Coronacrapper, Cytodyn (CYDY), has issued a flurry of press releases. As always, it is important to read anything The NaDDiR* and his Klown Krew put out very carefully. Not just for what is said, but for what is unsaid.

One of the December 9th press releases, entitled “CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population” has a classic NaDDiRism:

Of course, this is misleading because the FDA does not APPROVE trials. The FDA only ACCEPTS or REJECTS trial protocols. Legitimate companies that are not trying to hype their prospects to gullible investors use the proper language. Scams and cons, on the other hand?

But that is just routine Cytobullshit. The really interesting bit is this, where they excerpt some communications with the FDA, but fail to provide context:

For months now Cytodyn has been trying to restart the EIND/Expanded Access loserlimab for Covid program, or as we call it here at BuyersStrike! HQ, the perpetual anecdote machine. Naturally, Cytodyn has failed. It appears that back in August and again in November the company asked the agency to accept an Expanded Access program. Expanded Access allows patients to try an unapproved therapy outside of a clinical trial. The FDA has clearly said “no, you have to do a proper trial.”

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter? After all, didn’t the FDA say the trial “appears feasible“, that has to be good, right?

Actually no, one of the criteria for the FDA to allow Expanded Access to a drug outside of a clinical trial, is that a clinical trial must not be feasible. By stating that running a trial is feasible, the agency is actually telling Cytodyn why their request for Expanded Access was denied.

While this is a flat out rejection, will the company and its shills try to pitch this as some sort of support from the FDA, instead of just a boilerplate rejection letter?

When the FDA gives CYDY lemons, of course The NaDDiR* will try to make lemonade!

* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.