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Monday, July 22, 2019 11:31:05 AM
1. Odidi has received CRL after CRL on ANDA after ANDA. His approvals always come very late. In my opinion, I feel he puts together rushed and half ass applications that have many flaws.
2. The political climate around opioids make approvals in that space hard to come by. IPCI is a very small company and unless their abuse resistance is very strong in all categories, I feel the FDA will rubber stamp it denied. In particular, oral abuse will be a key deciding point. If those results are strong, they could very well get approval. But they have not released the HAP results, so we have no idea what to expect.
I would like to see an approval as much as anyone. That way I might be able to recoup some of my losses. This approval is a longshot and I would say less than 5% chance.
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