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Steady_T

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Re: JoeBear906 post# 444008

Monday, 12/25/2023 1:46:29 AM

Monday, December 25, 2023 1:46:29 AM

Post# of 462015
Ummm, How much do you think it costs to pursue an MAA or an NDA?

The company has $150 million.

Oh and by the way, orphan drug designation means that the FDA waves the NDA filing fee for Rett which is currently about $ 4 Million for 2024.

I'm not saying the compiling the data and organizing it for an MAA or NDA is a trivial task. Such a filing can be up to 100,000 pages.
Much of a filing for one jurisdiction can be reused for another.

I think you are overestimating the cost of preparing an NDA submission.

"Wise men talk because they have something to say, fools because they have to say something."
PLATO

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