From Filing on 13th March 2009 we are at 24 MonthsFrom...

From Filing on 13th March 2009 we are at 24 Months
From Acceptance on 11th May 2009 we are at 26 Months
From All Boxes ticked and the final inspection we are 3 months on
Seriously how did the FDA ever think they could deliver approval under the Give Program in 6 Months when it takes them 3 months to find a rubber stamp.

ACL must ask Dr Reddys to press the FDA for approval.

There cant have ever been a priority review otherwise the true time frame for ANDAs not under the GIVE priority review would have to be nearing 60 months.

GSK has an interest in Dr Reddys, GSK has a gigantic interest in ensuring Arixtra has uninterrupted sales.

The CEO must press for a result.