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Re: NotSure2 post# 691173

Monday, 05/13/2024 4:55:53 PM

Monday, May 13, 2024 4:55:53 PM

Post# of 699445
In the quarterly the company states in black and white no RFI. They also specified validation days. If the submission date isn't when the 150 day clock begins it certainly would be by the initial validation date, a little over one month later.

I don't believe you ask for an extension when you aren't asked for anything more. We all know that regulators don't alway meet their own deadlines, but I believe the 250 day average people discuss about the UK includes products not getting priority review. Les may be using 250 days out of caution, but with no RFI, I still believe in 150 days, the only real question is whether it began on December 20th, on submission, or a little over a month later, on initial validation. I'll believe submission is possible until we're past about May 25th, allowing some time to make the announcement after receiving notice by roughly May 21st.

You can criticize as much as you wish, but this week is still in play until it's over.

Gary
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