InvestorsHub Logo

wimuskyfisherman

07/22/19 11:31 AM

#22 RE: dontknowsht #21

dontknowsht- Personally I feel the Rexista approval is a long shot for two reasons:

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.