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Re: georgejjl post# 453278

Monday, 03/04/2024 2:15:18 AM

Monday, March 04, 2024 2:15:18 AM

Post# of 458387
George, I do have a sizable position for just getting started in the stock. In terms of production, while they're certainly highly qualified CDMO's, have their manufacturing process for the drug already been approved by the regulators. If not, I'm sure they'll have little trouble, but the regulators often find little things they'd like to change.

I've only recently finally had my solar system approved, it's taken many months. In the end, far more grounding was required than I'm told would have previously been required. Personally I don't understand all that was demanded, like running a line from where my water line enters the house through copper pipe to the newly installed ground where the electrical panel is located, but it's done. I always thought that the copper pipe in a house was a great ground by itself. Different inspectors wanted different things done, I suspect that the regulators are very similar and different ones will want different changes made.

Tax court is much the same, if you go to the IRS for advice, and tax court say it's wrong, then it's wrong and the FDA advisors got it wrong.

Gary
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