Your and the sausage's comments are both interesting and stimulating . . . . double-edged sword and Catch-22 all in one -
But, it's never simple and yet, it's never complicated . . . .
On one hand, let's say Corp says delay FDA until our house is in order with SEC - that could be 3 or 4 years, with appeals, so that doesn't fly . . . .
Hold off till our house is in order, meaning we get Hizonor's decision - that could be 8 months, so that doesn't work either . . . .
to simplify it, Corp has been waiting a long and expensive time . . .
If, and I stress, if, counsel came to me and went psssst you're going to get clearance on the 510(k) and that may happen because I assume Corp would be involved in Special Control drafts, labels, etc., then, I would say release it ASAP! Get me the letter! Then, if I'm in trouble with the SEC, which I don't believe will be the case because the whole issue arose because of a clown perhaps trying to work off another issue, then I'm in good shape. If I'm not in good shape, I retire and the stock goes to the moon! I see no tactical or financial advantage in waiting for anything . . . get what you can, when you can. Besides, I doubt FDA would ever play timing games. . . .