Although few of them might have realized it when they woke up this morning, but for the rabid retail fanbase of everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), today is the day their delusions about being granted an EUA for treating Severe-to-Critical patients with Covid-19 died.
Why? The answer is in section 564 of the Federal Food, Drug, and Cosmetic Act, as explained here:
And unfortunately for Cytodyn, yesterday the FDA issued a full approval for remdesivir for use in hospitalized Covid-19 patients. These are the same patients Cytodyn is attempting (poorly) to treat with loserlimab in the CD12 trial.
This means that there is now an approved treatment, and barring unforseen supply issues, no further coronavirus treatments for this population group can qualify for Emergency Use Authorization. That game is over. Don’t worry, The NaDDir* and the rest of the Klown Krew, including new hire, Mesoblast refugee Manboob, will find some new tale to spin and print more stock for more of that sweet sweet stock pimpin’.
THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.
Is the author of this educated beyond 5th grade?
[Yes. Advanced degree in snark. – Editor]
Remdesivir shown to be useless now. DSMC gave Cytodyn a positive finding at halfway point of CD12 trial and will look again at 75% enrollment. UK and Canada approved BLA filings for HIV. Any update comments? Are you even remotely unbiased?
[Ask yourself the following questions. Has the FDA rescinded the approval of remdesivir? Has Section 564 of the FD&C Act been rescinded? Until one of these is true loserlimab has no hope for an EUA in hospitalized patients. The United States, as a sovereign nation, is not bound to the whims of the WHO. Contrary to the NaDDir’s stock pimpin’, the DSMC did not give Cytodyn a “positive finding”, they allowed the study to continue. This is a neutral finding. The unplanned second interim look, contrary to NaDDir’s spin, is also not a positive. Typically unplanned interim looks are a bad sign. Finally, allowing a company to send in a bunch of paperwork is hardly newsworthy or notable. It is the ho-hum everyday work of drug development and regulatory oversight. It is no different than the Motor Vehicle Registrar “approving” you to fill out your vehicle registration paperwork. And here is the best part, ask yourself (or better yet ask The NaDDir) if Cytodyn has actually sent in their BLA filings for HIV. You might be disappointed with the answer. – Editor]
Curious who pays you for all this research? Good stuff.
Bagholder tears are reward enough.