meirluc: Years ago, I witnessed this norm with the FDA . Once an application was submitted, if they did not come back to the applicant within 30 days, or less, the applicant could assume acceptance.
Re: Bright Boy post# 660879
Tuesday, January 02, 2024 10:40:19 PM
Post#
660991
of 661026
[If the MHRA had refused to confirm or accept the MAA, that would be a material event. Did you hear that that was the case when the company filed the MAA??? NO!!! So, the message here is that the MAA has been filed and the world received that message in a PR on Dec. 21st, 2023./quote]
I am somewhat confused about this statement. It would be correct to say that if the MHRA
had refused to confirm or accept NWBO's MAA, this would be a material event and should
be PRd but of course NWBO would not have heard of that calamity the day they filed the MAA
or even days or perhaps even a few weeks thereafter and therefore there is no reason to believe
that we should have already heard of a non acceptance.
So I tend to believe that if we don't get a PR within 30 days from submission that announces
that the MAA application was accepted or rejected, we can begin to believe that it was accepted.
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