Tuesday, September 05, 2023 7:58:04 AM
This is my understanding of the 150-day assessment route that Northwest Bio intends to use to apply for marketing approval in the UK: There are two assessment phases, totaling 150 days, plus a clock-off period up to 60 days, so approval may actually take longer than 150 days. How much longer than 150 days, may depend on how long it takes Northwest Bio to respond to the MHRA’s information request. If Northwest Bio takes the full 60 days to respond with the information requested, then it could potentially take up to 210 days. Additionally, the assessment clock doesn't start until the application is validated, which could take up to 2 weeks from submittal.
The initial phase of assessment takes 80 days. Then the MHRA reviewers will request further information to clarify a multitude of complex issues in the 1.7 million pages, and Northwest Bio has up to 60 days to respond. When Northwest Bio’s response is received by the MHRA, this will start a second 70-day phase of assessment.
As much as I would love an approval within 80 days as some here seem to believe, nothing in any guidance that I have read, indicates that the application will be approved immediately after the initial 80-day assessment. If 92% of applications are approved in 80 days, (as you and others have posted) then why not call it a 80-day assessment route? I believe that just means that the first phase assessment is completed on time in 92% of cases, in preparation for the CHM meeting. Even the Rolling Review, where all the modules are pre-assessed, takes 100 days, so how can the 150-day route be faster than that?
The submission dates are aligned with a CHM meeting after the 80-day assessment, which would be on December 21st or 22nd, if the application is submitted by September 25th, or January 25th or 26th, if the application is submitted by October 30th. So even in a best-case scenario: the application is submitted by September 25th, and the MHRA has zero questions on the 1.7 million page application for a novel cell therapy, (which I think is unlikely) and a very busy regulator is able to act immediately after the CHM meeting to approve the application, the earliest approval would be the last week of this year during the holiday week between Christmas and New Years. (which also seems unlikely) I believe some of the questions raised will occur during this consultation with the CHM.
However, a next-best case scenario is potentially possible, that the issues needing clarification are minor, and Northwest Bio is able to respond rapidly, and the second phase of assessment does not require the full 70 days. I believe a more likely MHRA approval timeline is somewhere between 4 to 7 months from submittal of the application. So approval potentially in Q1 next year, but probably more likely, beginning of Q2.
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