Thnx for the read NASDAQ. Our long patient wait on a number of significant fronts is coming to an end soon & clearly IPCI held off as long as they possibly could b4 deciding to secure their recently announced $5.2M raise which along with the revenues from their 2 strengths of FocalinXR will easily get them through to years end and allay the cash crunch fears of these past few months.
As well, there's been absolutely nothing put out into the public domain by IPCI management changing their expected/projected timeline on the pending Rexista NDA submission...so logic clearly suggests that they're still 100% on course to submit their Rexista NDA immediately on the heels of their 6 month human stability and abuse liability studies...which means they're on track to meet their own projected July 2016 timeline!
Furthermore, logic also strongly suggests that a big reason IPCI held off for as long as they could b4 securing the recent $5.2M raise was their own expectation that the endless FDA delay in approving all their additional FocalinXR strengths was almost over...so I still firmly believe the additional FocalinXR strengths should/could be FDA approved at any time moving forward since it's been over a full calendar year since IPCI and PAR got the flip-flop FDA BE studies required on the 40mg FocalinXR strength news.
And since AZ's patent protection expires in another 5 months on SeroquelXR...logic strongly suggests that IPCI along with 4 other companies will all be receiving FDA tentative approval on SeroquelXR sometime this fall. And it should be noted that out of all IPCI's backlogged ANDA's pending FDA approval...SeroquelXR is far and away the only potential blockbuster of the bunch!
So in summary we are now down to the final few weeks ahead of IPCI's Rexista NDA submission to the FDA sometime next month...and the likelihood of the ongoing behind the scenes Rexista partnership discussions being ratcheted up to the next levels directly on the heels of the completion of the Rexista human stability and abuse liability studies and official Rexista NDA submission.
In other words the extended period of uncertainty that's been affecting the stock is finally nearing an end and the long anticipated sunshine days should finally begin!
There's no doubt in my mind whatsoever that any potential Rexista partnership announcement is going to be a monster and if it's going to occur as logic strongly suggests, it's definitely going to occur prior to the FDA granting IPCI their Rexista PDUFA date in Q1 2017.
Good luck to all moving forward as cash wise IPCI's set through end of year...and as we enter July there's a plethora of valuation driving developments and catalysts coming down the pike throughout the entire back half of this year>>>
1. Official Rexista NDA submission to the FDA in July
2. Immediate heating up of potential Rexista partnership discussions!
3. SeroquelXR FDA ANDA approval sometime this fall
4. Potential SeroquelXR partnership/licensing agreement
5. FDA approval of all of IPCI's additional FocalinXR strengths
6. Potential FDA approval of several other IPCI ANDA's that have been stuck in the FDA's backlog for over +4 years
7. Potential partnership/licensing announcements on any of IPCI's +4 year old ANDA's that do finally receive FDA approval
Never buy or sell based on my posts! My posts are just my opinion!
AI
