Bernstein you're not paying attention to what I've been saying about this IPCI0006 NDA submission!
It's going to cost an exorbitant amount of money and take at least 3 full years of extensive human trials due to the overdose prevention claims!
So you're dreaming if you think all the extensive associated human trials involved to even dream about getting it in front of an adcom panel won't take an absolute minimum of 3 full years. Because each and every 1 of the human trials that it's gonna take will take several months to even set up then a minimum 6 months to complete...and there's going to be numerous and extensive human trials involved to even dream of remotely substantiating the overdose claims!
Also, we're talking about absolute minimum costs of approximately $30M to get through the minimum 3 years worth of extensive human trials involved...$30M this company simply doesn't have!
Furthermore, IPCI's still not a remotely established bio company with an extensive rolodex of approved FDA drugs commercialized...and they haven't produced a single NDA that's ever made it through the FDA's NDA approval process to fruition! And we're talking about a bio company that's already been at for 10 full years now! So over the course of an entire DECADE already this company only has partial/tiny market penetration on 2 generics(Focalin and Seroquel) and has yet to get a single NDA approved let alone commercialized. So what that tells the market is that they're woefully equipped to even dream about getting this newest IPCI0006 NDA candidate through the lengthy FDA approval process ahead themselves...and therefore must seek and try to obtain a large established R&D partner before the market will even take this newest IPCI0006 NDA candidate seriously!
I'm just keeping it real because IPCI can't even prove capable of getting their 1st OxyContin NDA candidate through the FDA approval process let alone pretending they have the resources, money or in house capabilities to even dream of trying to get this newest IPCI0006 NDA through the extensive FDA approval process road ahead. And it's definitely not a 12 to 18 month approval timeline ahead simply due to all the extra and extraordinary human trials they'll have to do to even dream of being in the position in some future day to get in front of an AdCom and attempt to substantiate the extraordinary overdose prevention claim!
Never buy or sell based on my posts! My posts are just my opinion!
