There are CEOs all over the country and world whose predictions about FDA timelines have been shown to be fantastically overly optimistic.

The CEO of a medical device company I own promised in March of 2022 that the commencement of their early feasibility study was "imminent". It finally started a few weeks ago. That CEO had "imminent" thrown back at him so much that eventually he started using it ironically to poke fun at himself.

We went through it with Nader when with a little bit of a self-effacing manner, he absolutely, positively guaranteed Christine that the BLA would be submitted by the end of Jan 2020.

And I'm in two other companies with partial holds have gone on and on without resolutions while their management has tried and failed to give guidance on when they would be lifted.

Any regulatory release or approval is on the regulator's schedule. There's nothing anybody can do about that and regulators always reserve the right to ask for more detail, so predicting timelines is an extremely inexact science.