Re: NIH Funding or Trial Assistance I've seen i

Re: NIH Funding or Trial Assistance

I've seen it mentioned on the boards several times that perhaps Cytodyn should have done a combo trial with Remdesivir or requested funding from the NIH, and that this might have led to faster approval or EUA from the FDA. Unfortunately, I don't believe this would have helped Cytodyn.

Consider the drug Aviptadil, a drug that has been known for about 20 years and trialed for respiratory issues with no SAE's. When Covid hit, they performed several small studies on their own which led to promising results. They also had fast track status. They applied for an EUA after an open label trial, and again after completion of their clinical trial, but their applications were denied. For over a year now, they have been participating in the NIH trial Activ 3, which was supposedly designed to speed approvals of promising drugs for critical covid. Every drug was being trialed against and with SOC (Remdesivir). There were numerous drugs included in the trial, but they all were stopped for futility, except Aviptadil. It's the last candidate standing. They have enrolled over 448 patients and there have been no SAE's reported. Still, there is no EUA from the FDA. They even narrowed the focus of their most recent EUA application to just patients who did not respond to Remdesivir, (I'm assuming because they felt that no drug in competition with Remdesivir would get approval?), but still no approval of their EUA to date.

Over 800 patients have been treated with Aviptadil and their right to try program continues. However, the NIH trial enrollment has been stalled for months and NIH is refusing to take action until it is is fully enrolled.

Fauci was called on the carpet about the lack of action on NIH's part at a Senate hearing just last week. He put all the responsibility on the DSMB and showed very little urgency in his responses. He even admitted it was unlikely the trial would even be completed given the current pace of enrollment. It was patently obvious that HE-DOES-NOT-CARE.

Sorry for the long-winded rant, but while Cytodyn may have made some errors with trial design along the way, the fact of the matter is, there is absolutely no guarantee that they'd be any further along had they worked with the NIH. It seems to me, Cytodyn's most grievous error was believing the US was sincere when they claimed they would bring promising and safe drugs forward through the EUA process. Fun fact, certain NIH employees get royalties on drugs they helped produce, and Remdesivir is one of them.

In my opinion, Cytodyn's path to success will not come through covid, but Nash and oncology, and eventually longhaulers. But the pursuit of covid was not a loss when you consider how much they have learned about it's MOA and potential.