Regarding a potential MHRA decision window; some dates to keep in mind:
(note: validation could add a couple of weeks, but the known submission date is used)
80 days from December 20th is Saturday March 9th
150 days from December 20th is Saturday May 18th (80-day first phase assessment + 70-day second phase)
210 days from December 20th is Wednesday July 17th (150 day assessments + 60 day clock off)
Since the marketing application was submitted before December 25th, it corresponds to a CHM meeting on March 21st or 22nd.
If any questions are raised during the first 80-day assessment phase and the CHM meeting, then a letter is sent to the applicant requesting further information. The applicant has 60 days (which can be extended) to respond, (assessment clock is off) and the responses are assessed during the second 70-day assessment phase, and discussed during the next CHM meeting, so these CHM meeting dates are also relevant:
25 and 26 April 2024
30 and 31 May 2024
27 and 28 June 2024
25 and 26 July 2024
29 and 30 August 2024
26 and 27 September 2024
24 and 25 October 2024
21 and 22 November 2024
19 and 20 December 2024
Some potential basic scenarios based on these dates (there are obviously many others):
A
The application receives the highest priority, (like Covid treatments) and the MHRA makes an approval decision before the full 80-day-assessment period is complete, so before March 9th.
B
The application receives high priority, and the MHRA approval decision is made soon after the 80-day assessment, and it’s determined that a CHM meeting is unnecessary, so shortly after March 9th.
C
The application receives high priority, and the MHRA has no questions during the initial 80-day assessment, or at the CHM meeting, and makes an approval decision following the CHM meeting on March 21st or 22nd, so approval decision is made the following week, March 25th to March 29th.
D
The application receives high priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which Northwest Bio responds to immediately, and no discussion at a second CHM meeting is necessary, so approval decision is made in April.
E
The application receives high priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which Northwest Bio responds to immediately, and the information is quickly considered by assessors and discussed at a second CHM meeting on April 25h or 26th, and approval decision is made in May. (within ~150 days from submittal)
F
The application receives high priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which Northwest Bio responds to within 30 days, (end of April) so the information is considered by assessors and discussed at the next CHM meeting on May 30th or 31st, so approval decision is made in June.
G
The application receives high priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which Northwest Bio responds to within 60 days, (end of May) and the information is considered by assessors and discussed at a CHM meeting on June27th or 28th, so approval decision is made in July. (within ~210 days from submittal)
H
The application receives high priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which Northwest Bio responds to within 60 days, (end of May) and the information is considered by assessors and discussed at a CHM meeting on July 25th or 26th, so approval decision is made in August.
I
The application receives priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which requires more than 60 days for Northwest Bio to respond, or assessors require more than 70 days to consider, and is discussed at a CHM meeting on August 29th or 30th, so approval decision is made in September.
J
The application receives priority, but the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which requires more than 60 days for Northwest Bio to respond, or assessors require more than 70 days to consider, and is discussed at a CHM meeting on September 26th or 27th, so approval decision is made in October.
K
The application doesn’t receive priority, the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which requires more than 60 days for Northwest Bio to respond, or assessors require more than 70 days to consider, and is discussed at a CHM meeting on October 24th or 25th, so approval decision is made in November.
L
The application doesn’t receive priority, the MHRA has questions, and promptly (within a week) sends a RFI after the CHM meeting, which requires more than 60 days for Northwest Bio to respond, or assessors require more than 70 days to consider, and is discussed at a CHM meeting on November 21st or 22nd, so approval decision is made in December.
So based on these general scenarios, which seem like the most probable?
I would draw a probability curve (normal distribution) with the high area in July and August, so scenarios G & H being the most likely in my opinion, with scenarios F & I, being a little less as likely, and E & J even less likely, etc.
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