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Re: Amatuer17 post# 200894

Sunday, 10/22/2017 7:31:29 AM

Sunday, October 22, 2017 7:31:29 AM

Post# of 403025
And my point is we don’t know if the additional data answers issues the FDA brought up regarding the SPA application. But, certainly, the additional data and findings will be included in the response and next draft. It’s not a question whether or not it can be because all safety and MoA data should be included provided the active drug (API) remains unchanged.

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