For a few weeks now paid touts and retail fans were pushing a bizarre conspiracy theory about everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), and epic news to come on January 21st, 2021. Their fantasies included full approval of loserlimab for Covid-19, or an EUA for loserlimab in the USA (virtually impossible at any time, see why here), or an EUA in the Philippines (also impossible, see why here), or an “uplisting” (to use the moron-term, the correct term is “initial listing“) to NASDAQ (also virtually impossible, see why here), or getting Medicare reimbursement (A fantasy based on a monumentally flawed understanding of CMS codes. Hint: Codes that begin with “X” are for experimental treatments, not for approved products), or any of a dozen other fever dreams.
One thing that the Cytodummies likely did not expect to occur on January 21st, 2021 was the complete evisceration of their dreams of HIV riches:
Cabenuva is a once a month injection that replaces a daily oral pill regimen. This completely leapfrogs CYDY’s attempts to get loserlimab approved as a once-a-week therapy in combination with daily pills. Meanwhile, Cytodyn’s long-delayed monotherapy trial, which they call CD03, is still not completed.
And ViiV, the company behind Cabenuva (and the only approved CCR5 inhibitor, Selzentry aka Maraviroc), is not sitting still. ViiV is expected to apply for approval of a once-every-two-month version well before The NaDDir* and the klown krew can cobble together their once-a-week BLA resubmission.
One might ask, what about Pre-Exposure Prophylaxis (PrEP)? Yeah, they have that too. In fact, ViiV received Breakthrough Therapy Designation for that indication in November 2020.
Cytodyn, on the other hand, has been rejected for BTD not only for cancer but also for HIV. Read more about BTD here.
What about Europe? Cabenuva was approved there at the end of 2020.
No market for Cytodyn in Europe either. Meanwhile, HIV market leader Gilead isn’t sitting still:
Gilead expects to be submitting an NDA for their once every six month sub-q injection, lenacapavir, this year.
What is a company whose only asset is an old, unapproved, outclassed, CCR5 entry inhibitor to do? Looks like it will soon be time for a Double Dose of The NaDDir’s* sweet sweet pivoting to the next big thing.
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping