While we patiently wait for everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) to add up two sets of mortality numbers from their much hyped CD12 study in severe-to-critical Covid-19, and plug them into an Excel spreadsheet, let’s look into what else is going on with that study (full details here NCT04347239).
Keen readers might recall that at the end of 2020 Cytodyn issued a series of bizarre press releases. The first, the famous Christmas Eve surprise, buried the tacit admission that the earlier CD10 trial of loserlimab in mild-to-moderate Covid-19 patients was neither “impressive” nor “fantastic”, but rather so ineffective that the FDA, which already rejected Cytodyn’s attempt to get an EUA, would not even consider granting any EINDs for this population. Admitted The NaDDir*:
In order to bury that little morsel, the press release is mostly about the company asking the FDA about submitting a protocol change to the CD12 trial, in order to add an Open Label Extension. (Don’t know what an Open Label Extension is? You aren’t alone, The NaDDir* and the rest of his Klown Krew, don’t seem to know either, read up on that right here.) Said the company:
On December 30th, 2020 the company announced in a second press release that they had indeed submitted the protocol amendment to the FDA and it had been accepted (not approved, the FDA does not approve trials!):
Strange then, that as of today, the 20th of January, 2021, there is still no record of any Open Label Extension for the CD12 trial at Clinicaltrials.gov, in fact the latest update is from mid-November.
That update highlighted one particular red flag, as the rather curious clinical trial site in Gainesville, Georgia, suddenly stopped recruiting, and the names of the people involved vanished:
One might try to defend the Klown Krew and suggest, perhaps, that Cytodyn management forgot to update the Clinicaltrials.gov records for a development so important they issued two press releases. This seems highly unlikely, given that the Klowns did manage to update the records for the Long Haulers trial (NCT04678830), clearly the next chapter of the stock promotion saga that is CYDY. The Long Hauler trial records were updated on January 3rd, 2021, four days after the company announced that the FDA had accepted their protocol changes to the CD12 trial. Check the records for yourself, right here.
If one recalls the Christmas Eve Surprise press release, highlighted earlier, the supposed Open Label Extension would only be treating patients until the CD12 study was unblinded. Given that unblinded top line mortality data should have been available to the company a week ago, the extension is now basically moot, if it even truly existed. Will we ever see the actual Open Label Extension details, or were these late December press releases really just a double dose of The NaDDir’s* sweet sweet stock pimpin’?
PS Read a great thread on the Cytodyn CD12 trial here.
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping