Fabius, I agree with this view. I think Odidi over estimated himself and underestimated how complicated the approval process can be. With a strong partner, it will be a different story. Of course you get better deal after a full approval, and it makes it easy for the partner to hit the ground running.
Good thing is that NDA path has higher success chance as long as FDA agrees to what was required for approval. The panel review pointed out issues that needed to be address. You would think after fulfilling the additional requirements, FDA would give the green light.
I couldn't remember but I thought IPCI had PR about the completion of the additional tests by year end. So we're looking at early 2018 approval at the earliest.
If we get further problems it will depend on how bad the problem is. Just hope we see another ANDA approval under MNK deal, IPCI needs to get things moving on those.
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