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toomorrow

04/02/14 12:46 PM

#6722 RE: dtstx #6718

I am afraid you are basing approval timelines on PAST approval history's. If you haven't already heard, the FDA recently hired over 200 additional employees within the past 18 months to clear the back log of ANDA's. The FDA is addressing the backlog issue and has made a substantial dent in the backlog. There are several articles with direct quotes from the FDA backing this up. Therefore, approval timelines are becoming SHORTER in a compounding fashion and one can't draw out approval timelines on the past history. Once the backlog is addressed, the FDA plans to continue to overhaul the ANDA process by using the additional staff for compliance, etc. Also, the FDA plans to have announced ANDA approval dates like they do for PDUFA's. Things have changed and they are going to change even more. IPCI's ANDA applications have move up significantly in the approval que.
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doogdilinger

04/02/14 12:59 PM

#6727 RE: dtstx #6718

I'm going off what CFO Shameze said at the most recent Roth Conference about their next 3 ANDA's k dts bro...Shameze specifically stated that those next 3 have all already passed the 42 month timeline to approval mark k;)