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Re: Pharmboy46 post# 627824

Saturday, 09/02/2023 9:13:32 PM

Saturday, September 02, 2023 9:13:32 PM

Post# of 698732
I'm uncertain if they'll PR the submittal, or wait for the acceptance. If they feel very confident in acceptance, it's a good PR move, but if the regulator requests a change that requires delay, then it becomes a negative as investors question if something is wrong. Most companies announce acceptance, rather than submissions, though if they do announce the submission they'll also note acceptance normally.

In our case, if it's a rolling submission in which nearly all the application has been accepted, the only question is about what's being newly submitted. Of course it's possible that the last part to be submitted is the one that they're most concerned about, perhaps the acceptance criteria the company believes should be applied, if it's up to them to make such a recommendation.

Gary
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