NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

From ChatGTP

Yes, the MHRA has the authority to pause or delay the review of a Marketing Authorization Application (MAA) if a company submits a request to modify an already agreed Paediatric Investigation Plan (PIP), especially when the proposed modifications are substantial and impact key elements of the original plan.?

According to MHRA guidance, modifications to an agreed PIP are necessary when key elements become unworkable or inappropriate. If such modifications are proposed, the MHRA may require a full assessment to align the non-compliant key elements of the opinion with those of the completed study report. This process can lead to a pause in the MAA review until the modified PIP is assessed and agreed upon.?

While specific instances of the MHRA pausing an MAA due to PIP modifications are not publicly detailed, the regulatory framework allows for such actions to ensure that the pediatric development plan aligns with the overall assessment of the medicinal product.?

For the DCVax-L MAA, if Northwest Biotherapeutics has submitted a substantial modification to their agreed PIP, the MHRA may choose to pause the MAA review process until the new PIP is reviewed and agreed upon. This ensures that the pediatric development plan is appropriately integrated into the overall benefit-risk assessment of the product.?

It's important to note that the MHRA's decision to pause an MAA review in such circumstances is discretionary and depends on the nature and extent of the proposed PIP modifications

sources: https://www.gov.uk/government/publications/format-and-content-of-applications-for-agreement-or-modification-of-a-paediatric-investigation-plan/format-and-content-of-paediatric-investigation-plans-and-related-applications-in-the-united-kingdom-uk--2?utm_source=chatgpt.com

If the MHRA pauses or delays the review of NWBO’s Marketing Authorization Application (MAA) due to an issue with the Paediatric Investigation Plan (PIP) — such as requiring a substantial amendment before proceeding — that would almost certainly qualify as a material event under SEC disclosure rules.