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Re: Arby2000 post# 675313

Thursday, 02/29/2024 3:36:17 PM

Thursday, February 29, 2024 3:36:17 PM

Post# of 708462
They don’t have to PR if there is an RFI, as far as I understand. If there is one, it could be easy, moderately hard or difficult to respond to. Meaning, they might need a few days, a few weeks or the entire 60 days to respond. If an RFI is issued.

I think we (longs) are all hoping there was good coordination with regulators through our consultants prior to submission. This coordination is suppose to be easier because this is an orphan indication.
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