Stonk, the question I keep asking myself is: if the MHRA intended to deny the application, why would it take this long to reject it after receiving the RFI?
I think they over exaggerated the link between the time to MAA determination and potential denial. If they did any due diligence on typical time frames they would know there's no correlation between time and acceptance/denial and that we aren't currently overdue.
I am not aware of any MHRA failure to approve a NAS/MAA being disclosed so how are you finding your DD?
What is the typical time for a company to announce MHRA rejection?