Could it be that it's 17,000 pages due to the extensive history already associated with monepantel/nuz001.
Decades of use in food chain animals. Huge amounts of safety data. Manufacturing data. Numbers of pre clinical trials. A few human trials.
I imagine most ind submissions are for a new drug altogether. Ours is different in that its being repurposed and so has quite an extensive history.
Gliving the FDA all the historical data can only help the ind submission, to prove just how safe it is and how much proof we have of a MOA (covid testing, cancer testing dog trials, phase 1, pre clinical etc).
Ann: Neurizon Files IND Application to Support HEALEY ALS Trial, page-78
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