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Re: DJPele post# 720382

Tuesday, 09/17/2024 7:49:39 AM

Tuesday, September 17, 2024 7:49:39 AM

Post# of 822987
DJ, to add to what you've said here, we'll all know of an approval before that MHRA link is updated, because these linked Summary PDFs are not how applicants are notified that their application has granted.

The Summary PDFs are posted online about a week in arrears following each 2-week reporting period closes. The Summary PDFs list/summarize all approvals that happened during that previous 2-week period.

But these Summary PDFs are not how Applicants find out that their application was granted. Instead, Applicants are notified 'in real time,' meaning that the sponsor is notified directly on (or before) the grant date that is listed in the second column of these Summary PDFs that you linked to (i.e., not the date that the PDF is posted, but the grant date listed in column 2 of the PDF).

To illustrate, here is one recent example where both the sponsor (link) and the MHRA (link) issued a press release on the day of grant (1/29/24), but the Summary PDF which includes notice of the 1/29/24 grant did not post to that link until 2/8/24:
https://assets.publishing.service.gov.uk/media/65c50417cc433b000ca90ad2/Marketing_authorisations_granted_15_January_to_31_January_2024.pdf

These Summary PDFs are posted every two weeks (about 1 week in arrears) to provide notice to the public about what MHRA has granted, but these Summary PDFs are not how the MHRA communicates grants to its applicants. NWBO will know about the grant (and they will tell us and the world), about 1-3 weeks before the Summary PDF listing the DCVAX granted is posted.
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