NorthWest Biotherapeutics Inc (NWBO)

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Phase II is optional and only needed if an RFI is issued.

No, Phase II of the MHRA MAA 150-day assessment process is **not necessarily** required if no Request for Further Information (RFI) letter is issued in Phase I.

Here's the breakdown:

* The 150-day process is divided into two phases:
* **Phase I:** This lasts 80 days and focuses on the initial assessment of the application. The MHRA may identify potential issues and request additional information through an RFI letter.
* **Phase II:** This occurs if there are outstanding issues after Phase I. The applicant responds to the RFI, and the MHRA uses this information to finalize the assessment and reach an opinion on approvability within the remaining 70 days.
* **If no RFI is issued in Phase I,** it indicates that the initial assessment did not raise any significant concerns, and the application meets the necessary criteria.
* Therefore, **Phase II is not required** and the MHRA will proceed to directly finalize the assessment and issue their decision within the remaining 70 days.

To be sure, it's always recommended to refer to the official MHRA guidance on the 150-day assessment process, which you can find here: [https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines](https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines).