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Re: tassitano post# 4808

Tuesday, 08/20/2013 7:33:08 AM

Tuesday, August 20, 2013 7:33:08 AM

Post# of 6805
You didn't talk to him. I saw your tweet yesterday. Please read that article from my previous post.

From the article:

Dara is currently engaged in dialogue with the FDA on ODD. According to management, they are in round three of responding to questions from the agency. The company filed a response to the FDA on August 8, 2013. If timelines hold, a decision from the FDA should be made in October or November 2013.