Replies to post #12692 on Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

For me this has become a new pharma/manufacturing company with a side biz in generics. I think we see some generic money flow to help support a higher pps and the NDA/to market process on the new drug pipeline.

100% same for me umiak...ICPI's NDA's and potential best-in-class designation on their delivery tech platform for narcotics manufacturing is the homerun power here now...while all their generics will provide a plethora of added cash flow.

Still say the market's grossly under-estimating the coming impact of what a potential best-in-class designation on IPCI's Rexista NDA means here.

I bet IPCI's already been fielding enquiries from all the biotech big boys about their opioid manufacturing capability...and we saw a very strong hint of that possibility with the recent PR announcing the pending property purchase to increase their manufacturing capacity right!

The dots are all out there to connect as the market continues to punish IPCI for the ongoing FDA ANDA delays/decisions far outside of IPCI's control.

PAR sues companies and the FDA all the time as they have about 95 ANDA's and know the generics landscape as well as anyone. So whatever recent flip-flop games the FDA's been playing pertaining to IPCI's FocalinXR approvals is and has been in PAR's court this entire time. Sure IPCI's getting punished temporarily by the recent FDA flip-flop games...but it's not like PAR isn't quite capable of dealing with the FDA on the Focalin bioequivalence issue...unfortunately we're left in the dark until PAR's made their decisions then and only then can IPCI tell us what's next ie:

1. PAR agrees with the FDA's latest flip-flop decision and in 60 days bioequivalence gets submitted on IPCI's 40mg FocalinXR immediately followed by the FDA finally approving FocalinXR 5 and 10mg strengths.

2. PAR rattles legal sabres behind the scenes with the FDA causing the FDA to again rescind their latest flip-flop bioequivalence decision which results in the FDA immediately approving the 5mg and 10mg strengths on the very near term horizon after all...since both could already be approved by now since 180 exclusivity has passed.

3. PAR sues the FDA because they disagree with the FDA's requirement that bioequivalence on 40mg Focalin must be submitted b4 they'll approve the 5mg and 10mg strengths.

Those are the only 3 possibilities that PAR's working on behind the scenes with the FDA right now pertaining to all the FDA focalin flip-flop games...and hopefully we'll get clarity from IPCI on what direction PAR is taking with the FDA.

And at any given time now the FDA could finally begin to approve any 1 of the other 4 IPCI ANDA's already in the FDA's pipeline for 4 plus years now as well.

[umiak]

"The average ANDA timeline to approval in 2014 was 44 months mopar44...and as of last month the average timeline to approval for ANDA's in calendar year 2015 is now 49 months.

Which means as of August 2015 IPCI now has the 4 following ANDA's all at or past the FDA's current average timeline to approval:

1. Protonix 58 months
2. Glucophage 58 months
3. Effexor 50 months
4. Lamictaf 46 months"

Thanks Doog I thought it worth repeating!!!