Saturday, May 31, 2025 5:51:22 PM
exwannabe,
MHRA can take plenty of time deliberating responses before another RFI is granted so how does anyone know how much total response time there has been vs MHRA deliberation time that is not on the clock and the non expedited review is longer anyway which likely possible to roll back into if MHRA has lots of questions that are being dealt with expeditiously. Under expedited review it is supposed to be 150 days of consideration (80 first stage and 70 second stage) but I don’t see a set limit on amount of time for each consideration of response and then add as much as 60 days for 1 RFI response or 210 days total. A normal review time line is longer and you can add on the backlog time if you don’t agree with the response Lykiri received from MHRA; ). Throw in any additional clock off time for special CHM consideration as noted by you and the timing becomes almost indeterminate. Sure looks to me like multiple factors are being considered and aligned for a very significant transition by multiple entities. But hey, that’s just me; ). Best wishes.
MHRA can take plenty of time deliberating responses before another RFI is granted so how does anyone know how much total response time there has been vs MHRA deliberation time that is not on the clock and the non expedited review is longer anyway which likely possible to roll back into if MHRA has lots of questions that are being dealt with expeditiously. Under expedited review it is supposed to be 150 days of consideration (80 first stage and 70 second stage) but I don’t see a set limit on amount of time for each consideration of response and then add as much as 60 days for 1 RFI response or 210 days total. A normal review time line is longer and you can add on the backlog time if you don’t agree with the response Lykiri received from MHRA; ). Throw in any additional clock off time for special CHM consideration as noted by you and the timing becomes almost indeterminate. Sure looks to me like multiple factors are being considered and aligned for a very significant transition by multiple entities. But hey, that’s just me; ). Best wishes.
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