Biostax Corp (BTAX)

[H1C]

Normally a NDA would come after a Phase 3 trial. No NDA for the treatment of Covid-19 has been filed for any drug; a NDA would take too long given the urgent nature of the pandemic.

So far, the FDA has been granting Emergency Use Authorizations for diagnostic tests and treatments for Covid-19. Chloroquine, Hydroxychloroquine and Remdesivir have gotten EUAs.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

If the Beaumont trial goes well for LDN, the doctors conducting the trial would apply for an EUA for LDN for the treatment (and potentially prophylaxis) of Covid-19. Legally an EUA wouldn't do much since Naltrexone is already FDA approved, and doctors are already legally allowed to prescribe FDA-approved drugs for off-label uses.

But practically, an EUA would be absolutely huge because it would suddenly thrust LDN into the awareness of the medical profession, and of the world. The vast majority of medical doctors are unaware of the low-dose uses of Naltrexone. The few who are aware have no idea that IMUN owns the patents for LDN's uses. I doubt the Beaumont investigators know about IMUN.

The next steps after a successful Beaumont trial for IMUN, if they can get their act together would include: reaching out to the FDA and Beaumont investigtors and coordinating with them for application for the EUA; working with the FDA to get their manufacturing facilities cGMP compliant and up and running; getting the word out to medical professionals and to the world that hey, this awesome drug LDN that just got an EUA for Covid-19, we have all the patents for its uses, we have cGMP manufacting in place for it -- all you doctors who want to prescribe it for Covid patients, why not use our branded version instead of having it compounded, etc.

All of this will require funding. But if Beaumont's phase 2 trial of LDN for Covid-19 is as successful as I think it will be, IMUN should be able to get funding to put the manufacturing, distribution and marketing in place. I wish they were already doing this -- the concept sheet was good, but there was no follow through. They should have been involved in the Beaumont trial, and should be the ones supplying the meds being given to the trial participants.

I really hope that IMUN can get its act together and be ready to immediately capitalize on a positive trial result. Unless they can, it doesn't matter that they own the patents for LDN's uses. They wouldn't be in a position to enforce them, to stop doctors from getting LDN from compounding pharmacies. I mean they could try, but they'd just be assholes in that case, if they weren't ready and able to supply the branded version of the product.