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Re: Maverick0408 post# 522888

Tuesday, 10/18/2022 5:01:48 PM

Tuesday, October 18, 2022 5:01:48 PM

Post# of 822366
Mav,

In reality they are telling us when submissions are accepted. To date the only accepted submissions have been for commercial manufacturing to be inspected and for approval of their PIP trials in the U.K. I'm uncertain, but believe that only the U.K. doesn't have these things included in the overall submission, it's certainly an indication that they're in the process of applying to the U.K. I believe we could be notified that the application has been accepted on any day.

The real question in my mind is whether they're close to, or may have actually submitted to one or more of the other regulators. I believe the only way we'll know is when we're told a filing has been accepted. I can't say if they'll hesitate at all when they receive such notice, P.R. experts say to get the good news out early in the week, and bad new after the close on Friday, ideally on a holiday weekend. We'll never actually know if something is held up a few days for better timing, or if we're notified immediately on something good, or bad happening. I believe they're allowed a certain amount of flexibility on when certain things must be announced as material events.

Gary
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