Replies to post #12408 on Intellipharmaceutics International Inc. (IPCI)

[dr_lowenstein]

agreed, IPCI seems to have real experts that understand the FDA. Unfortunately, this is not always the case in this industry. FDA has been conservative in this space for sure, but at least one company in the opioid space made a serious error in assuming that no Phase 3 would be required. Of course that was incorrect. The difference though is that product was a combination product, agonist/antagonist and industry expert knew that the FDA has been very consistent in requiring p3 for such combos, whereas with single agent products there has been more flexibility. It is good that IPCI seems to have the expertise to discern these matters.