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Friday, January 19, 2018 7:00:58 PM
1. Rexista HAP studies have not started. FDA has not approved protocol yet. IPCI asked for a meeting in November and FDA was supposed to meet with them within 30 days but has not. They do feel they will complete studies quickly though. They still expect to resubmit NDA in July/August 2018 timeframe and feel they are on track for 2019 approval. They noted that the Purdue litigation goes to court in October 2018, so even if they had an approval now, they could do nothing with it.
2. PODRAS human studies have not started. However they are working hard to resolve hoops needed to jump through to commence these. They are shooting at having PODRAS human test results 1H2018.
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