No, EUA was declined, one trial has been a peer-reviewed success, and the other trial only has a preliminary failure to detect statistical significance.
Haven't you followed LIVE-AIR closely enough to know what is true, versus what isn't? If so, I don't think you're alone in that regard. It astounds me that so many people are faulting management for regulators' negligence (willful negligence?) to approve or authorize this drug.
And whether regulators approve the drug or not, that is no legitimate excuse for governments failing to stockpile lenz.
I do fault management for their stated de-prioritization of lenz for covid, when they also state they are working with NIH on the further analysis of the ACTIV-5 trial data. Why help prove how effective lenz is in the early treatment of covid, if you are not interested in aggressively treating that market? One of those courses seems to clash with the other. I'd be working with foreign regulators on approving our drug, based on the LIVE-AIR trial. That's not a novel concept. And management should be able to answer questions about why ACTIV-5 showed different results. Lenz deserves to be vigorously and factually defended. Foreign regulators aren't so naive that they won't be able to recognize how US regulators are protecting so-called vaccine manufacturers. How are those governments going to protect their own citizens and health care infrastructure when the next more virulent wave hits them? At least, seek purchase authorizations, with the assurance that we will have product available to meet the order quantity we commit to.
There's a good chance management has already done everything they can to obtain purchase agreements from various governments, to no avail. But they know lenz will be needed, and when and where it will be needed. I hope lenz will be there for those patients.
However, I can understand management stating that they are going to support lenz trials for other indications in our pipeline.
