NorthWest Biotherapeutics Inc (NWBO)

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In the case of a novel biologic undergoing a 150-day accelerated review for marketing authorization application (MAA) in the UK, inspections or a Request for Information (RFI) may not always be necessary if the therapy has been used for ten years as a compassionate treatment for a specific cancer indication in the country.

The need for inspections or RFIs during the MAA process depends on several factors, including the existing knowledge and data available for the therapy, its safety profile, and the level of scrutiny required by the regulatory authority. If the biologic has been used for a significant period and there is already substantial data and evidence supporting its safety and efficacy, the need for additional inspections or RFIs may be reduced.

However, it is important to note that each MAA is evaluated on a case-by-case basis, and the regulatory authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, has the discretion to request inspections or RFIs if deemed necessary to ensure the therapy's safety and quality.

The purpose of inspections is to assess the manufacturing facilities and processes involved in producing the biologic, ensuring compliance with Good Manufacturing Practice (GMP) standards. RFIs, on the other hand, may be requested to seek additional information or clarification on specific aspects of the MAA, such as clinical trial data or risk management plans.

Ultimately, the decision to conduct inspections or request RFIs during the accelerated review process will depend on the regulatory authority's assessment of the available data, the therapy's history of use, and the level of confidence in its safety and efficacy.— ChatGPT