Leave it to everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), its CEO The NaDDir* and his klown krew, to gift the world an absolutely stunning Christmas Eve Surprise in the form of a 7:45pm press release even more insane than their previous holiday stunners. The press release, like many, is designed to draw attention away from the real news, and instead focus the attention of inexperienced retail investors on some truly misleading hype. First the “shiny object” to distract:
Sadly, these morons have absolutely no clue what an Open Label Extension (OLE) is, and neither do their investors that are being pumped, dumped and chumped. The Klown Krew are claiming that the Open Label Extension will allow the company to enroll additional patients who will all receive loserlimab. This is NOT what an OLE is, nor what it allows. Here is some background reading on Open Label Extensions. From the British Medical Journal:
Given that CYDY constantly declares loserlimab is safe, why would they choose to do an OLE, when OLEs are meant to collect even more safety data? The article continues:
More from the Journal of Medical Ethics here. And since the extension is open label, the data is almost certainly useless, as explained by Applied Clinical Trials, here:
As one now knows, an OLE is merely an, often shady, continuation of an existing clinical trial designed to collect safety data that allows all of the patients already enrolled in an existing trial the following:
- Existing patients can choose to participate and thus are guaranteed to receive (or continue to receive) the study drug.
- Existing patients can continue to be monitored past the study completion date.
Which of these two possibilities explains why Cytodyn would be asking the FDA for guidance on extending the much hyped CD12 trial of loserlimab in severe-to-critical Covid-19? According to The NaDDir* patients are only given loserlimab on days 0 and 7, they do not continue to receive loserlimab. From the October 20, 2020 CONference call:
This eliminates the first reason. Existing patients who choose to continue will not receive any more loserlimab, since they already received their two doses. Which leaves us with the second reason. The company is trying to find a way to continue to monitor patients after the 28 day mark. Why?
Perhaps because the DSMC asked for an analysis at 42 days. Recall back in October, when The NaDDir* explained they had to get 42 day data:
and then only a few weeks later, on December 10th, The NaDDir* abruptly changed his mind and announced that there would be no second interim analysis and no look at 42 days?
The OLE would allow for the company to continue to collect data past the 28 day mark. Our guess is that someone demanded the 42 day look and to save face Cytodyn is putting up a blatant smokescreen to distract people.
If that is the distraction, what is the real news that Cytodyn management is trying to bury? That is easy. Look at the bizarrely worded final statement from The NaDDir*:
Far from being the “amazing” trial that The NaDDir* announced, the CD10 trial of loserlimab in mild-to-moderate Covid-19 failed. Obviously. And completely.
[Did you know Cytodyn is being sued by a group of former directors? What to know why? See here and here.]
[Did you know Loserlimab has virtually no chance of ever getting an EUA in the United States? Want to know why? See here.]
[Did you know Cytodyn’s claims of non-dilutive financings (with notorious penny stock player John M. Fife) are complete bullshit? They are highly dilutive. Learn more here.]
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping