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Wednesday, August 09, 2017 7:26:02 AM
2. All the Rexista Adcom panel demanded was CAT 3 HAP studies not clinical phase III trials
3. With just their 1st 2 commercialized ANDA's they're now on track to generate $20M in revenues over the course of a calendar year...and they already have 2 more generics partnered with MNK simply awaiting FDA approval which could literally occur anytime now which will dramatically increase their per annum revs even more.
4. The CAT 3 HAP studies for nasal and oral aren't even expensive and take about 6 months to complete...so hardly huge time and most definitely not a huge expense
5. Again...you're totally wrong for claiming that IPCI is required to do Phase III clinical trials...they're definitely not...Human Abuse Potential studies are not that hard to complete...and the FDA had already approved 1 of the CAT 3 HAP studies IPCI was already planning on completing after Rexista Adcom.
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