Intellipharmaceutics will ultimately get a CRL, with the AdComm ending with a mixed to solid No vote. The first time around, it was clear there was no chance of approval. Relevant HAP studies were missing, data was poor, and making claims using the dye guaranteed there would be no approval. However, after reformulating and conducting additional studies, Intellipharmaceutics was given a huge opportunity for a positive outcome. FDA mostly wants ADF applicants to follow their guidance and conduct the necessary studies; check the right boxes and you get approval with labeling. Today's meeting was an especially good opportunity given recent events at FDA. There hasn't been a meeting of the Analgesic committee in a while, and several key members of CDER involved in the first CRL are no longer with FDA.
Just by looking at the background documents, you can tell Intellipharmaceutics blew it. Study data is again poor and incomplete. Stemming from what looks like attempts to save money, the little that was done is clearly below expected quality and rigor in the CII industry. On top of that, yesterday's meeting set the tone for the new committee. For those who didn't see the results, the meeting ended with an extremely harsh 27-0 No vote. It's clear the FDA and this AdComm have an eye toward the epidemic, and Intellipharmaceutics needed a strong backgrounder to overcome this concern. I predict Esteve, the applicant in the current AM session, will receive a solid Yes vote. This will lend the committee some credibility as opposed to blocking every applicant currently under review. Then Intellipharmaceutics will comfortably be given a No vote in the afternoon.
