I wanted to follow up a conversation I posted from ChatGBT yesterday. The reason I decided to pursue this questioning is a thought I and others have had about the possible reason for the growth of the MAA to it's final size. The following picks up after a few initial questions and answers.
Q: But do the regulatory guideline of MHRA permit application for a new treatment and a new treatment +an approved adjuvant in the same MAA?
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.
Q: Would MHRA permit additional data from a study outside and separate from the clinical trial data for DCVax-l? For example, UCLA has Phase 2 data for DCVax-L and Ploy ICLC combined which showed efficacy.
ChatGBT: The MHRA typically accepts data from clinical trials conducted outside of the European Union (EU) when evaluating Marketing Authorization Applications (MAAs), provided that the data meet certain criteria and standards. These criteria include:
Quality and Reliability: The data should be generated from well-designed and well-conducted clinical trials, following Good Clinical Practice (GCP) guidelines, regardless of the trial location.
Relevance: The data should be relevant to the population, indications, and objectives outlined in the MAA. This means that the patient population, treatment regimen, and endpoints assessed should align with the proposed use of the product in the EU.
Consistency: The data should be consistent with the overall body of evidence supporting the safety and efficacy of the product. This includes data from other clinical trials, preclinical studies, and any other relevant sources.
In the case of DCVax-L combined with Poly ICLC, if there are Phase 2 data from a study conducted outside of the EU, such as the one conducted at UCLA, demonstrating efficacy, these data could potentially be included in the MAA submitted to the MHRA. However, it would be crucial for Northwest Biotherapeutics to ensure that the data meet the MHRA's standards for quality, relevance, and consistency.
Northwest Biotherapeutics would need to provide detailed information about the study, including its design, conduct, and results, as part of the MAA submission. Additionally, they may need to provide additional analyses or explanations to address any differences between the study conducted at UCLA and the requirements or expectations of the MHRA.
Bullish
