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User-840664

04/27/24 8:35 AM

#687489 RE: Zadie420 #687487

It's working days only and the company would have 60 working days plus an additional 60 working days just to answer after the phase 1 80 working days is up. We don't even know if the got to an RFI yet.
Stop torturing yourself, read the MHRA guidelines instead of MB fools. . Best case is late 2024,...... if they get past phase 1.
If it was calendar days, an RFI would have been issued long ago. These folks do not work weekends and Holidays. They also are known for 6 week Vacations!

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.

Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses.

HappyLibrarian

04/27/24 1:16 PM

#687555 RE: Zadie420 #687487

I will certainly be glad if something with NWBO comes in earlier than I expect. I’ve just learned that padding estimates is best though hopefully the regulator will be different. We’ll see.