Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

I was able to verify with Domenic that CONCERTA is in fact considered a sister ADHD generic to FocalinXR and the author of the FDA law blog was spot on in all his thoughts presented in the blog in the link of the post I'm responding to.

So in a nutshell...the FDA after a couple of flip-flop decisions has decided to make IPCI's pending FocalinXR strengths(that were previously tentatively approved according to old bioequivalence standards) meet the FDA's newly imposed bioequivalence standards for generic ADHD drugs...mainly due to the fact that other companies out there have been manufacturing inferior generic ADHD drugs.

And therefore IPCI got caught in the quagmire of the FDA's newly imposed bioequivalence standards through no fault of their own...but now it's simply better for them to go ahead and submit bioequivalence on their 40mg FocalinXR(which does in fact take 60 days from the time they start) than it is for PAR and them to bother with any further back and forth with the FDA.

Domenic further advised that by Q3 results in October IPCI would be providing a timeline update on when 40mg Focalin bioequivalence expects to be submitted.

Domenic says that the market continues to completely under-estimate and overlook the significance of the 2 FDA Rexista decisions of a few weeks back and said that their ongoing Rexista progress alone is so much more impactful than any of their still pending ANDA's that when the street does begin to take notice on Rexista progress...none of us will care about the last unforeseen small hurdle the FDA unexpectedly threw in their path on the 2 delayed focalin strengths.

So the way I see it is this...the single biggest impactful driver right now is ongoing progress on Rexista...IPCI's negotiating with potential global partners...a partner should most likely be announced b4 they submit Rexista bioequivalence...which will then mean whatever partner they end up selecting has built in milestone payments into the contract such as...pymt on bioequivalence submission...Pymt on the FDA advising that Rexista bioequivalence is acceptable...pymt on IPCI submitting their official Rexista NDA to the FDA...pymt on the FDA granting them their Rexista PDUFA date...and pymt on FDA Rexista approval!

Still say that if all goes according to expected timelines...we will get FDA approval on Rexista sometime in the back half of next year...and when that day arrives we'll be looking for a minimum $200M per year in Rexista rev's alone...making all 7 of IPCI's pending FDA ANDA approvals just extra gravy for the real coming meat on their best in class NDA's choo-choo;)