NorthWest Biotherapeutics Inc (NWBO)

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Source? I’d have to look back, but it’s been discussed here many times over the years by people in the field.

Think about it, there are some trials with 8000 patients. Excluding everything else that goes on in an MAA, that would only take 251 pages per patient to exceed one million pages on patient data alone.

But MAA’s are not only patient data alone. Not even close. Consider the following.

Comprehensive Data Requirements: These applications require extensive data to demonstrate the safety and efficacy of a medicine. This includes:

Clinical trial data: Vast amounts of patient data, study protocols, statistical analyses, and reports.

Real World Evidence: Compassionate Use Programs, etc.

Preclinical data: Results from animal studies, toxicology reports, and pharmacokinetic/pharmacodynamic studies.

Manufacturing information: Detailed descriptions of the manufacturing process, quality control procedures, and stability data.

Facility Certification: Highly regulated and extremely time consuming process and documentation for Clinical, Compasdionate and Commercial MIA.

Chemistry, Manufacturing, and Controls (CMC) information: Extensive data on the drug substance and drug product, including chemical characterization, analytical methods, and stability studies.

Electronic Common Technical Document (eCTD): Applications are submitted electronically using the eCTD format, which has specific requirements for organizing and presenting the information. This can significantly increase the volume of data submitted.

Complexity of Modern Medicines: The complexity of modern medicines, such as biologics, gene therapies, and advanced therapies, further increases the volume of data required to support marketing authorization applications.