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doogdilinger

09/06/17 8:38 AM

#29703 RE: fabius #29698

Settlements when reached always occur well b4 trial dates. Was nice to see the 9 month timeline given on the CAT 3 HAP study...and given the fact that all the while the Purdue patent infringement suit is still out there and not settled...there's still a slim chance that the FDA grants tentative approval with the IV abuse deterrent label while IPCI completes the additional studies.

It may be an ultra-slim chance of 10% and under...but considering all IPCI was ever going to get on their Rexista PDUFA date in the 1st place was a tentative approval and IV abuse deterrent label...the FDA could still go that route since that's exactly what the FDA set up Rexista AdCom to cover.

With or without a tentative Rexista approval...we now know that we're a minimum 9 months away from IPCI completing the CAT 3 HAP studies which pushes us out to next June...which by then will mean IPCI's driving at least +$20M in per annum revenues from FocalinXR and SeroquelXR sales...and if we're real lucky also has at least 1 more already partnered with Mallinkrodt ANDA FDA approved.


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wimuskyfisherman

09/06/17 11:45 AM

#29707 RE: fabius #29698

Fabius- Thanks for remembering I tried to help keep expectations on Rexista release in check by saying it would be on the market 2018 or 2019.

I am very interested to see how IPCI handles manufacturing and I have always said that them becoming a manufacturer is a huge step. I am hoping we see more approvals and more deals that IPCI is the manufacturer on. Also it would be great for them to break into countries other than the US as well.

Lastly, I do wonder if people calling for the sale of Gluco and Keppra ANDAs are being short sighted? Why sell something when as a manufacturer you could reap benefits quarter after quarter after quarter... I do see that Gluco and Keppra are in a very competitive market and may not be a fit for Toronto manufacturing. But I do wonder if part of the grand plan is to scale up manufacturing and markets immensely and Gluco/Keppra will just be two of the products rolling out the doors at IPCI.