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Re: skitahoe post# 457264

Sunday, 04/21/2024 2:14:04 AM

Sunday, April 21, 2024 2:14:04 AM

Post# of 461853
The NWBO trials were over a much longer period of time with a more complicated treatment process. I suspect that had a significant effect on the required size of their submission along with the manufacturing information for their novel and complicated manufacturing process. Their manufacturing process is customized for each patient and involves living cells with all of the biological contamination protocols involved.

AVXL is a small molecule that is manufactured in dry pill form and a liquid form. It is a much simpler process to produce the drug.

On the other hand, Anavex has to submit EU labeling and marketing materials in multiple languages as part of the approval process.

Nunc est Bibendum

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