Elite Pharmaceuticals Inc (ELTP): That is a critical question....typically...

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Re: CanesNH post# 94900

Saturday, 03/08/2014 11:14:24 AM

Saturday, March 08, 2014 11:14:24 AM

That is a critical question....typically these studies run for 3 months (from what I've seen in Pharma). Unless there are other studies that are required as part of the filing, I suspect that Nasrat was attempting to underpromise date of filing. Laser or any of the other DD longs, besides the abuse liability study, are you aware of any other study that is needed for filing? Is there a possibility of a 6 month review by the FDA for this product, given the significant unmet need?

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