In the first place, Yooo, I think NASDAQ may be using the wrong listing standard, and that we should just automatically get a 180 day extension. But that may be me just being typical me. I don't trust NASDAQ, they've screwed us twice in the past, and I really think they are using the Market Value of Listed Securities Standard, when they really should be using the Equity Standard.
Secondly, I've been in the position of being face-to-face with an exasperated FDA investigator on my manufacturing floor before. Subordinate management was failing to satisfy the investigator, who was already under pressure because the company was operating under a Consent Decree, and there was a lot of scrutiny on the safety of breast implants, which I was manufacturing as the Production Manager. I got suited-up and met the investigator in the clean room. It didn't take long to assure him that we were in compliance, and luckily I did, because if my boss, a company Vice-President, had to be called upon, the FDA would likely have notified the judge who issued the Consent Decree that we were not in compliance, and we would have been shut down by court order.
But, I would have accepted responsibility if we weren't validated. So a part of me actually agrees with your assessment regarding management failure, including the failure of CDMO's failing to meet production specs, the NIH designing, let alone conducting, a trial that was no way reflective of the LIVE-AIR trial, and FDA's failure to grant us an EUA. These are things that somebody has to be in front of, and that is not likely to be a company Executive Officer.
Here again, I have a recognized and long-standing bias that the company should be in control of their manufacturing, including quality control and process compliance.
Forgive my rambling. But I am really upset by this issue of the appropriate Listing Standard for our extension to regain compliance. Engr and I both independently did a lot of work on this, and there were reasons why we both concluded that the Equity Standard was appropriate for us. That standard only requires $2.5M of stockholders' equity, not $35M. If that is so, an appeal to the NASDAQ Hearing Panel should not be necessary.
It also frustrates me that I can't figure out the basis for NASDAQ's claim regarding the required amount of stockholders' equity.
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