Replies to post #691420 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Of course, of course. Right as always, Flip.

[FeMike]

This is odd, though. According to what you posted, it sounds like the inspections are the 'if necessary' part. Not Phase II itself. This statement sounds an awful lot like Phase 2 happens necessarily:

During Phase 2 of the MHRA 150-day Marketing Authorization Application (MAA) approval process, the MHRA (Medicines and Healthcare products Regulatory Agency) assesses the clinical data submitted by the applicant. This phase focuses on the evaluation of the safety, efficacy, and quality of the medicine.

Regarding inspections, the MHRA may conduct inspections during Phase 2 if necessary. Inspections help ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards. These inspections may be carried out at the manufacturing facilities, clinical trial sites, or other relevant locations.

The decision to conduct inspections during Phase 2 depends on various factors, including the nature of the medicine, the complexity of the manufacturing process, the risk profile, and the available data. The MHRA may also consider previous inspection history….

It's important to note that the MHRA's decision-making process is dynamic and tailored to each application. Therefore, the need for inspections during Phase 2 may vary on a case-by-case basis.

"This phase focuses on the evaluation of the safety, efficacy, and quality of the medicine"

I guess it isn't always necessary for them to review the safety, efficacy, and quality of the medicine, though.