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DewDiligence

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DewDiligence

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Re: spongepaul post# 193822

Tuesday, 07/28/2015 8:41:32 AM

Tuesday, July 28, 2015 8:41:32 AM

Post# of 253057

When granting orphan drug status, what other factors does the FDA consider, besides urgent need?

The addressable market has to be fewer than 200,000 US patients.

Do they normally consider unpublished data that a candidate has collected?

Not as far as I know.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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