NorthWest Biotherapeutics Inc (NWBO)

[Astavakra]

From my friend ChatGBT:

The Medicines and Healthcare products Regulatory Agency (MHRA) follows the European Union regulatory framework for medicinal products. Under this framework, it is possible to include multiple indications or formulations of a medicinal product in a single Marketing Authorization Application (MAA) if they are closely related and supported by appropriate data.

The addition of an approved adjuvant to an existing treatment would typically involve additional data demonstrating the safety and efficacy of the combination product. If the combination product (in this case, DCVax-L+Poly ICLC) is considered to be a modification or extension of the original product (DCVax-L), and if the regulatory requirements for combination products are met, it may be feasible to include both in the same MAA.

However, it's important to note that each case is assessed individually, and the MHRA evaluates applications based on the specific characteristics of the products and the supporting data provided. Therefore, Northwest Biotherapeutics would need to ensure that they provide comprehensive data supporting both the original treatment and the combination with the adjuvant, and they should consult with regulatory experts to determine the most appropriate regulatory strategy for their products.

Afterthought: The reason for the expansion of the MAA to a billion pages?