I agree acceptance of an application will have zero effect on the SP. Rejection might. I read, but do not know for certain, the application is 1.7 million pages. That seems rather large. Hard to imagine how something that big could be processed in the 150 day window. From what I've read 1.7 million pages would indeed be an extremely large number of pages for a typical MAA. In practice, such a massive volume of documentation would likely be considered excessive and far beyond what is customary or necessary for a standard MAA submission.
Most MAAs consist of extensive documentation that includes data from preclinical studies, clinical trials, manufacturing processes, pharmacovigilance, quality control, regulatory documents, and more. However, the number of pages tends to vary widely based on the specific drug, its complexity, and the amount of data generated during the development and testing phases.
Submitting an MAA with 1.7 million pages would be highly unusual and could raise concerns regarding the relevance, completeness, and manageability of the submitted information. Regulatory agencies generally prefer concise, well-organized, and relevant data to facilitate their review processes efficiently.
If such a large number of pages were indeed part of an MAA, it would likely require extensive resources and time for regulatory authorities to review, potentially leading to delays in the evaluation and approval process.
