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Just the facts maam

06/13/16 5:54 PM

#5836 RE: Jp2011 #5835

Jp2011, I believe this is another drug. They did not mention in recent corporate updates, nor did they mention Lansoprazole which are both subject to Prior Approval Supplements. They may not have included them because there is less certainty on getting a timely FDA approval, than if they are filing a CBE-30 or if they are given a Target Action Date. Now that it has been approved they can add it their next Corporate Presentation, most likely with an estimated Q3 launch.

Hopefully the Dexcel approval for Lansoprazole was on behalf of ANI, otherwise we are looking at some competition.

Looks like yet another reason to raise guidance for the year.



JMHO