While we wait for everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), to finally release the much hyped, and delayed-yet-again (see last night’s press release from the Cytocrew here and an absolute howler of stock promoting stupidity here), interim results from their latest trial (sometimes called CD12) of loserlimab (sometimes called PRO140 or leronlimab) in Severe-To-Critical Covid-19, let’s catch up on what the company has been up to the last few weeks.
Since announcing that the interim enrollment milestone was reached on August 25th the company has had several arduous tasks in front of it:
First, The NaDDer* and his trusty clinical trial wizard, Kooosh Doody had to remember that August has 31 days, so they needed to check on whether the last patient was dead or alive on September 22nd. Then they needed to tally up all the mortality events. It took these geniuses eight days, but they did it, and on September 30th they announced to the world that there were, supposedly, 45 deaths in the trial.
Supposedly? Because it seems they weren’t exactly sure, that’s why that little tilde is hanging out there before the ’45’. Those complicated ordinal numbers. The rigors of higher math. After the deaths are counted, the Data Safety Monitoring Committee (DSMC) is usually the team tasked with seeing if the deaths occurred in Group A or Group B, putting those numbers into a spreadsheet (one so simple any 1st semester or AP Stats student could do it in under 5 minutes), determining if there is a statistically significant difference between the groups, making a recommendation, and finally reporting the results.
What should have taken 15 extra minutes on the 30th of September, takes an additional 20 days in Cytoworld.
While all this has been going on, of course, Cytodyn and the CD12 trial have not been standing still, or have they?
Recall that in late August two sites, Eisenhower Health in California and Yale-New Haven in Connecticut, dropped out of the CD12 trial (read more about that here). One might also recall that on August 20th Cytodyn claimed they would start enrolling patients in the UK “immediately”
On September 2nd they backtracked on that claim, but insisted that UK study could now be “officially initiated”:
Guess that wasn’t true either, because on the 30th of September the company provided this update on clinical trial enrollment in the UK:
Fast forward to today, the 16th of October, and a peek at the list of trial locations on both Clinicaltrials.gov and Cytodyn’s own website, show that the September 30th “update” was just another empty promise (polite term for bullshit) from the Cytodyn Klown Krew. There are still no UK sites for the CD12 trial. Both sources show 14 sites, and not a single one in the UK.
Even if progress in the UK has been stalled, the company surely must be chugging along in the USA, right? After all, as The NaDDer* constantly tells his loyal shareholder base “we are in pandemic!”.
How is trial enrollment going? We know from the press release cited above that on August 25th there were 195 patients enrolled. From a depressing (for Cytodyn believers) presentation given by Dr. Harish “Sad Sack” Seethamraju (available here) it was revealed that on September 4th enrollment was up to 220 patients.
Which makes the trial update from the 30th of September from above all the more curious. Why? Look again:
Why would there be no additional patients enrolled in almost a month? Want our guess?
Simple: “Pausing” a trial by stopping enrollment means never having to say it failed….the company can just pivot to the next pipe dream.
All is not lost, however, the Klown Krew has actually been hard at work. They did manage to get the shareholders to approve a huge, partially retroactive, options package for them on the 30th of September. They even filed an S-8 to register those shares later that same day (see here)! And the next day filed a flurry of Form 4s with the SEC to show where the goodies were distributed. Enrollment might be paused, the study might have failed, but The NaDDer* never stops cashing in while double-dosing the retail shareholder base with his sweet sweet stock pimping.
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