Angelo.....I would agree, that would make sense. We can not afford to dilute at this point. besides, the lack of preparation going into adcomm clearly shows they need a big player on their side. I hope they are listening.
That or either start putting the screws to the FDA, which they didnt do last time with Focalin. while, IPCI has to accept blame for their lack of preparation. Clearly, IPCI can make a case for detrimental reliance in the event the FDA does not approve. However, with the recent PR stating they would just do the phase 3 its unlikely they would follow through with litigation.
Its 50/50 though as to that fiasco. someone had the responsibility to inform adcomm as to what the issues were and that the FDA granted the waiver and for what reasons. with it being IPCI's application I say they had the greater duty of care but clearly the FDA saw the thing was going south which is why they revised the question to vote on. which in turn just confused the panel more.
sad all the way around. lack of preparation all the way around. even the panelist seemed like they didnt read the packets given to them.
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