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Re: Reyeton post# 462421

Tuesday, 06/25/2024 4:22:27 PM

Tuesday, June 25, 2024 4:22:27 PM

Post# of 519004
NWBO has said that their submission to the UK was 1.7 million pages. That is an extreme case since they are reporting multiple trials over a 15 year period. Also they are filing on a new method for culturing cells.

Anavex's submission will be much shorter since the manufacturing process is pretty standard and they have a lot less data to report. As of 2016 the average NDA was about 100,000 pages. Other sources indicate that submissions are estimated at 500,000 pages.

Since 2-73 has a novel method of action (MOA) it is likely that there will be a lot of material devoted to explaining that novel MOA. Also the support for the various bio markers will likely increase the size of the submission.

So, the Anavex NDA could very well be quite large.

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