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Friday, February 09, 2018 12:16:41 PM
So despite the lengthy time involved...perhaps all the Regabatin patent maneuvering that took place over the last calendar year was a needed pre-requisite to take the ongoing behind the scenes negotiations with potential Regabatin partnership suitors to the next level.
I just don't see IPCI mgmt. telegraphing the Phase III studies launch without them believing that they'll soon be securing a partner on Regabatin...but of course I could be wrong and only time will tell...and I totally agree with you that Regabatin(Lyrica) is a way more impactful NDA than their ongoing pursuit of securing approval on their OxyContin NDA candidate.
And finally, I too am glad they've completely removed the blue dye probable future hurdle and finally received FDA approval on their oral and nasal protocol studies launching...as now we can confidently look to their already telegraphed August 2018 timeframe for them resubmitting their OxyContin NDA to the FDA and receiving another PDUFA date and AdCom meeting. With Purdue lawsuit scheduled for October 2018 we can now confidently look towards an early next year timeframe for when IPCI's OxyContin NDA candidate can finally be FDA approved. I just hope that mgmt. comes up with a name for it soon lol.
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