Thursday, August 25, 2016 9:39:31 PM
My read of the 505(b)(2) NDA is that a manufacturer name/address must be explicitly stated in the NDA.
Therefore, I think IPCI is reviewing proposals for a contract manufacturer verses a full partner (marketing and manufacturing), trying to decide the best path forward for shareholders.
If you look at ELTP, who also filed a 505(b)(2) NDA, they had a contract manufacturing agreement before filing their NDA.
I think (hope) we're close.
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