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jtaylor68

08/18/17 5:39 PM

#11340 RE: Biotech Pharmer #11337

If that ANDA was flawed, INNV would have received a CLR by the FDA and they would be obliged to inform shareholders. So no, this explanation doesn't make sense.

It's nothing more than bad luck that the ANDA is considerably delayed when compared to competitors. You can neither deduce rejection, nor a flawed application from the situation.
In fact, saying that the ANDA is unlikely to ever be approved, because it takes so long to be responded to (what you often claim) is not logical, since a sure-fire rejection would probably the first thing the FDA would process to thin out the backlog.