I disagree with you. Management did exactly the right things from a strategic viewpoint. The FDA would never approve a drug that you could not produce in the quantities expected upon approval. In fact, that is part of the approval paperwork work: Who is manufacturing, How much is on hand, How much can you have in coming months after approval, etc., etc.. The FDA would never approve a drug, especially an EUA, if you might run out in a month or two. Moreover, the manufacturers of the drug have to go through their own inspection/paperwork, and approval for the manufacturing of your drug before EUA or any approval. They HAD to set up the supply chain as they did IF they wanted approval.
Sample sizes were not too small. LiveAir was not the first group who had been infused safely with Lenz. Lenz had been given safely to many more than that. The FDA just used that as an excuse. Then, after the ACTIV-5 NIH trial, over 1000 people had safely been administered Lenz, with very good efficacy…. and Lenz is virus strain agnostic!
Covid is not gone (I had it last month), nor Flu, nor RSV, etc., etc. which Lenz can be useful for those who need it.
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