A "catch me if you can" type of strategy? Talk about devaluating the prospects for leronlimab, Motley Fool just fanned the flames engulfing CYDY.
I don't think the author of the article has an appreciation of how vulnerable small, independent biotechs are to the arbitrary will of the FDA.
I wouldn't want the author of that article viewing our overtures to foreign regulators in the same way he did for CYDY. For Humanigen, we had to struggle to supply enough lenz for our internal trial. In terms of the ACTIV5 trial, where we also have to supply lenz, there does not seem to be the full scope of CRADA, BARDA, OWS financial support for us that can be made available.
We have to begin selling our finished product wherever it is approved, even if the initial approvals are from foreign regulators.
In addition, I deeply appreciate a therapeutic that can help save the lives of Covid patients that are on mechanical ventilation. I know sotrovimab just got an EUA for the treatment of that market population, but I'm not sure, without researching it, if it is more effective than leronlimab. My recollection is, though, that sotrovimab is NOT as effective.
I bold-typed my reason for wanting to see leronlimab succeed, as they have for HIV. That doesn't mean that I defend their CEO, or that I think they took the right approach to their trial design. It only means that if our management team gets overseas regulatory approval before FDA approval, as CYDY did to an extent, that doesn't mean that our executives are trying to escape the tentacles of US regulators. It means they are doing what they must, trying to raise revenue from an approved product.