Replies to post #692007 on NorthWest Biotherapeutics Inc (NWBO)

[attilathehunt]

and hired a number of new inspectors late in the fall, and continue to hire inspectors currently.

And our "friend" didn't get the job, thus his heavy drinking and hard on for the company.

[hankmanhub]

Northwest Bio also seems well prepared for the manufacturing and clinical trial site visits that occur in the second phase of assessment.

Hyper, in your opinion, are these "manufacturing and clinical trial site visits" the inspections that are referenced on page 23 of the recent May 10, 10Q? If so, are the planned to be completed within the 70 day period, and thus not the cause of any delay to the fall? If they are not the same thing, then what are the inspections on page 23 referring to in your opinion? Might they be inspections of EDEN or some other matter not directly tied to the MAA?

[flipper44]

You just said two opposing things.

1. You believed no rfi from phase 1.
2. Linda was busy answering rfi during phase I.

Can you tell me how you distinguish these, as I believe the standard rfi comes at the end of phase I.

For reference, here is what the mhra says.

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.

[dennisdave]

https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines

Updated 15 May 2024
All eligible national Marketing Authorisation applications submitted before 1 January 2024 that were awaiting first assessment have been converted from the national route to recognition pathways, to speed up our regulatory assessments, where applicants requested this.

https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure-supplementary-information

No delay to see here...