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Wednesday, May 15, 2024 9:52:32 PM
Your submission will be validated on receipt and an acknowledgement letter will be sent to the person submitting the application. This is the person named in section C of the CTA application form (Annex 1) and Declaration of the End of Trial form (Annex 3) or section D of the Substantial Amendment Notification Form (Annex 2). If the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application. If the application is not valid, then the person making the application will be told of the deficiencies. A new application containing all the necessary components will need to be provided.
https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/common-issues-validation
And that passage argues that the date began on the date of the receipt of the valid application... and that date was 12/20/23, according to the Q.
The January 23, 24 "notification" sounds a lot like an "acknowledgement letter".
The March 7, 2024 confirmation of validation was 77 days after the company submitted the validated application (almost 80 days).
Could that second letter have indicated the end of Phase 1 (which possibly may center around the process of validating the application? And when that process is completed, maybe Phase 2 starts?)
That said, these are purely my hypothetical musings.
Additionally... if an inspection hasn't already taken place... and IF one of Sawston is still required (despite the existing MIA) to have one, then the facility may not be ready for that until after any possible deep cleaning maintenance and installation of C suites.
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