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
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