NorthWest Biotherapeutics Inc (NWBO)

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IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs)

Plus , if your idiotic analysis is correct, we have well passed the 80 day phase 1 assessment!

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. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
A little bit of knowledge is a dangerous thing....

Does that mean MHRA already rejected it?


Location of Applicants
The Applicant/marketing authorisation holder (MAH) must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. It is anticipated that the MAH for an application via the IRP is the same company or belongs to the same (legal) group of companies as the MAH for the RR procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all their legal obligations, such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).

Provided an Applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept applications from third parties.



Northwest Biotherapeutics
Headquarters
4800 Montgomery Lane, Suite 800
Bethesda, MD 20814
Phone: [phone]