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H2R

Re: beartrap12 post# 805740

Wednesday, 12/31/2025 9:52:23 AM

Wednesday, December 31, 2025 9:52:23 AM

Post# of 819660
That would line up with "we are continuing to be actively engaged. We are going through cycles of questions, follow-up questions, requests for clarification, requests for additional data, information."

If the Company is indeed in this window:

2. The Statutory 28-Day Response Window
Under Schedule 11 of the Human Medicines Regulations 2012, once that (hypothetical) letter arrives, the clock starts:

• The Deadline: The applicant has exactly 28 calendar days to submit their final "clean-up" response.

• The "Clean-Up": During this time, the company's "armies of consultants" (as Linda called them) work around the clock to revise the documents to match the CHM's exact requirements.



As opposed to another RFI.

Thanks beartrap12 (and of course, Lyriki!)

Best of luck to Patients, NWBO, and Longs!
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