Elite Pharmaceuticals Inc (ELTP): Very few 505b2s are approved without an...

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Re: no2koolaid post# 136530

Wednesday, 11/26/2014 2:40:15 PM

Wednesday, November 26, 2014 2:40:15 PM

Very few 505b2s are approved without an efficacy study. Typically these trials take 1 year for the inlife portion of the study. That does not include time the get the study up and running, then time for analysis and submission- 2 years is more likely.

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