It's not interesting whatsoever...IPCI's already done extensive BE studies, the 6 month stability comparison and abuse liability studies & completed a Rexista food effect studies just 2 months ago.
The targeted/anticipated Rexista NDA submission date was always projected as IPCI's Q2 2016...and IPCI's fiscal Q2 ended July 31st(which was the same month they had just completed their last Rexista food effect study)...so they put out a statement in their July 5th PR saying that they now anticipated filing their Rexista NDA submission in August.
They also made sure to specifically state in the July 5th PR that there could be no assurance they would file their Rexista NDA in August...but if you call IPCI IR they will inform you that IPCI's still planning on submitting their pending Rexista NDA on the very near term horizon.
The FDA isn't the 1 delaying their Rexista NDA filing...IPCI themselves is simply making sure that when it's submitted, it's submitted right the 1st time...and if it was even remotely an FDA delay issue(let alone a supposed FDA safety concern issue with their stigmatizing blue dye) not only would we know about that already because that would be a material event that IPCI would've had to inform the market of...the FDA wouldn't have allowed all the BE, stability, liability and food effects studies that have ALL taken place already ;)
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