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Wednesday, January 15, 2020 10:45:18 AM
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.
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