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Thursday, March 16, 2017 11:39:00 AM
Furthermore remember Keppra was an important proof of concept:
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "FDA approval of our application for a generic version of Keppra XR® is an important milestone for the Company. It is our first approved product developed in house at Intellipharmaceutics without the support or regulatory input of a development partner. We believe that this approval of our generic Keppra XR® product represents a strong validation of our core drug development and regulatory competence and our controlled-release delivery technologies."
http://www.intellipharmaceutics.com/releasedetail.cfm?ReleaseID=957022
So for me the bonus is absoluteley o.k.!
And imho stopping ANDAs bevore the approval just because they might have less commercial value makes no sense. With every ANDA approval IPCI can show partners that they know what they do and that they actually can deliver. So that's an important signal of competence.
And as we all know, they alreday changed their focus away from the ANDAs to the NDAs - you can read in every news release:
Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both RexistaTM and Regabatin™.
cysonic
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