While we all anxiously await today’s no-live-q&a CONference call by everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), let’s take a look at the status of their much-hyped “CD12” trial of loserlimab in severe-to-critical Covid patients.
For many months now, Cytodyn’s CEO, affectionately known in these parts as The NaDDir* and his Klown Krew have been talking up potential business in the UK. As early as April 27th, they made claims about starting the process for “Compassionate Use” of loserlimab, and starting trials, in the UK:
Then without much more from the company, this bizarre press release was issued on August 7th. No mention of the trials, and no mention of Compassionate Use, instead Cytodyn claimed they would submit their BLA for HIV and request Emergency Approval in the UK during August:
Obviously neither of those things actually transpired (as of the 4th of November it appears no BLA for HIV has actually been filed in the UK, and there has been no emergency approval of loserlimab in the UK). On August 17th the company issued another press release, reiterating the claim that they will be requesting emergency approval in the UK (and the EU) and additionally that they have requested emergency approval in Mexico:
Yet again, it is obvious that none of these things have come to pass. No EUA in the USA, no EUA in the EU, no EUA in the UK, and no EUA in Mexico. If the Klown Krew at Cytodyn actually did submit for emergency approvals they were rejected.
As everyone must now be familiar, nothing stops The NaDDir* from that sweet sweet stock pimpin’, and just two days later the company is back at it with a new press release:
The company subtly changes its claim from “emergency” approval to “fast track” approval. Loserlimab yet again was still clearly rejected.
On the very next day CYDY keeps up the UK hype with yet another press release. In this one, the company announces that the MHRA (the UK equivalent of the US FDA) has given permission for the company to begin its study of loserlimab in the UK. Cytodyn claims that patient enrollment will begin immediately:
Strangely enough, as we noticed in early September, this statement by the company was untrue. The listing of clinical trial sites as of August 28th included zero sites in the UK. In early September, The NaDDir* made some curious comments on one of his many CONference calls:
The “UPH Scheme” is a program in the UK to provide financial support for clinical trials. The company elaborated on its plans in a press release that same day:
Given that it is now early November, it seems clear that Cytodyn’s requests for both “Fast Track Approval” of loserlimab in the UK and UPH designation for the CD12 trial were rejected.
Soon after some of Cytodyn’s retail fans started to realize something wasn’t kosher. The constant stream of CONference calls began to get angrier and angrier, and people started asking pointed questions. The company was more and more evasive. It is not a surprise that CYDY is no longer taking live questions on their calls.
In mid-September one caller pressed the company on their claim that the CD12 trial was supposed to begin enrolling August 20th. Cytodyn’s Klown Krew management responded:
Weird, considering the company stated it was going to enroll UK patients starting August 20th, then again September 2nd, meanwhile it turns out they had not even selected any UK investigators or UK sites!
On the 30th of September the company provided this update on UK enrollment:
Fast forward a few weeks later, and surprise, still no UK trial sites and no UK patient enrollment as of the 20th of October:
Yet as of the 29th of October, at the list of trial locations on both Clinicaltrials.gov, Cytodyn’s own website, and in a PDF file available here, show that there are still no UK sites for the CD12 trial. Not one.
Maybe we’ll get to hear some new excuses this afternoon?
Keep in mind that because of the FDA’s recent granting of a full approval for Remdesivir for hospitalized Covid patients, there is virtually no hope of Cytodyn receiving an EUA in this population, even if the drug is as amazing as its retail fanbase believes. Section 564 has crushed those delusions. Don’t know what Section 564 of the FD&C Act is? Better learn about it here.
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