RespireRx Pharmaceuticals Inc (RSPI): Anyone have any idea about the length of...

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Re: Hlong post# 39115

Wednesday, 07/09/2014 1:39:00 PM

Wednesday, July 09, 2014 1:39:00 PM

Anyone have any idea about the length of time for an sNDA compared to a "normal" NDA process with the FDA?

The FDA’s review timeline for an sNDA is the same as for an ordinary NDA; however, the sponsor’s clinical-development timeline is likely to be shorter for an sNDA since the sNDA may be able to reuse some of the safety data from the original NDA.

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