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"Nonetheless approval will not be easy, as it is not easy for any opioid drug"Why do you think this? It is already an approved drug...they are merely improving the delivery, which also has the effect of possibly lessening the abuse.
My impression that the FDA procedure for approval for old drugs with new delivery seems to be very similar to new drugs especially if the delivery method is new.
An SPA for the phase 3 trials will take that risk out of play.Randy