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Saturday, January 20, 2018 10:27:35 AM
So yes, there's nothing in stone that says 9 months...but I think collectively we'd all be pretty foolish thinking this company has the 1st clue about completing CAT 2 and 3 HAP studies in a timely manner...especially since we just discovered that even though it's been 6 full months now since their AdCom disaster...and sadly they haven't even been able to sit down with the FDA and go over their protocol parameters on their planned Human and Abuse Potential studies.
So for mgmt. to even suggest that they anticipate completing said HAP studies quickly and being in a position to resubmit their NDA this july or august to me is as overly ambitious as every time they give us a timeline expectation then miss it!
July is only 6 months away, and I for one certainly don't believe for one minute that IPCI's gonna resubmit their OxyContin NDA Candidate to the FDA in this timeframe...and I find it comical that they would even give a 6 month timeframe considering they haven't even sat down with the FDA yet k cheers!
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