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Poor Man -

10/18/22 4:40 PM

#522898 RE: Maverick0408 #522888

I completely agree with this. My guess is that relying on outside service providers rather than in-house staff for the RA submissions has slowed the process.

That wouldn’t surprise me at all. Anybody who has worked with contractors and service providers on a professional level — in any sector — can attest to the need to keep on top of them. Otherwise there’s the risk they’ll let things slip since they’re handling multiple projects — unless, of course, there are LDs built into the contracts that serve as a financial penalty for being off schedule.

I asked Crash to throw me a bone - I should have asked for a bone with some real meat on it.
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skitahoe

10/18/22 5:01 PM

#522903 RE: Maverick0408 #522888

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