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Re: Samsa post# 16897

Friday, 08/05/2016 8:37:40 AM

Friday, August 05, 2016 8:37:40 AM

Post# of 38634
I can't see how it would be different for 505(b)(2).

I expect to see a news release around the time of the NDA application, stating that they've hired a US contract manufacturer OR a partnership with a company with US manufacturing capability.

I suppose they could use a CTO (confidential treatment order), if for some reason they didn't want to release the name of the manufacturer or partner or the details of the arrangement.

In any case, should be soon.

I wonder if IPCI and/or the partner were waiting to see the fate of ELTP and their PDUFA a few weeks back? That will have a direct impact (positive) on market potential if Rexista is approved.