Replies to post #19056 on Intellipharmaceutics International Inc. (IPCI)

[wimike]

Is the painkiller Ofirmev similar to Rexista with all it's abuse deterrents
or is it a drug that will be outdated when Rexista comes out since it is BEST IN CLASS?

[doogdilinger]

Absolutely love last nights news with Mallinckrodt Angelo as it proves what many have been speculating here for ages that it's never been a matter of IPCI not being able to start delivering the goods...it was solely the FDA's generics backlog that had stalled their ANDA approvals and ANDA licensing agreements!!!

With that said I think it's a great time to review the IPCI catalysts from 1 month ago as follows>>>

doogdilinger  
Thursday, 09/15/16 08:34:58 AM
Re: None

Post # of 19078 


Imminent IPCI catalysts>>>

1. PODRAS patent approval
2. Rexista NDA submission
3. Rexista partnership
4. SeroquelXR ANDA tentative approval
5. Ringing of the opening bell on the NAZ
6. Any number of IPCI's other 5 year old ANDA's receiving FDA approval and IPCI announcing licensing agreements on them
7. Remaining 4 strengths of FocalinXR FDA approved

As we can see from the above IPCI has now in fact received their FDA tentative approval on SeroquelXR prior to November 1st which I've been adamant would be the case for months here!

And last nights news with Mallinckrodt proves that IPCI had held extensive licensing agreement discussions for months ahead of many other expected ANDA approvals...as logic strongly suggested is/was obviously going on behind the scenes while waiting for the FDA to work through their generics backlog.

So with IPCI now signing licensing agreements with Mallinckrodt on SeroquelXR, Pristiq® and Lamictal®XR which collectively represent annualized sales of approximately $2.5 billion...we still have IPCI's 3 oldest ANDA's all coming down the pike for FDA approval in Protonix®, Glucophage®XR and EffexorXR®, which collectively have all been stuck in the FDA's backlog to approval for 6+ years now!

So although we don't yet know what IPCI's exact plans are for Keppra, Protonix®, Glucophage®XR and EffexorXR®...we now know that the long overdue 4 additional strengths of FocalinXR should soon be FDA approved and Protonix®, Glucophage®XR and EffexorXR® should ALL be arriving like clockwork in relatively short time since the FDA is mandated to clear their generics backlog by next September.

The biggest thing last nights $3M non-refundable upfront pymt does is put IPCI in a strong cash position to carry them through their fiscal Q1...which is more than enough time for IPCI to secure themselves a very lucrative partnership on Rexista with a large upfront payment and several key milestone payments as you've previously outlined!

We also have their PODRAS patent approval quickly approaching, as this Thursday will mark 5 weeks since the USPTO mailed IPCI their allowance letter...so logic strongly suggests that any day now the USPTO will be electronically exporting the PODRAS application to the Final Data Capture(FDC) stage for issuance as a patent...and many here have speculated that IPCI's pending Rexista NDA submission is waiting for this patent approval to hit as a key element/catalyst to IPCI's Rexista NDA filing and Rexista partnership!

So in summary IPCI's finally operating from a ROCK solid foundation with licensing agreements on 4 of their ANDA's with SEVERAL more long overdue FDA ANDA approvals forthcoming...along with the even bigger Rexista NDA and PODRAS patent approval forthcoming on the very near term horizon!

Now through next spring is going to be a great time to watch IPCI finally enter the era so many of us have been patiently waiting for...the era when CEO Odidi begins delivering on a multitude of long anticipated valuation driving goods glta:)

PS: The GOLDEN CROSS occurs today as well...so any market participants who sold on Fridays news or who sell on last nights news, are going to be risking missing out on the perfect technical and fundamental storm...as the fast approaching Rexista NDA filing, PODRAS patent approval and Rexista lucrative partnership catalysts quickly approach on the imminent horizon and ROCKTOBER madness continues here choo-choo!!!