Jim Brown CEO stated the following: "The FDA ha
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Posted On: 08/14/2024 3:31:46 AM
Jim Brown CEO stated the following:
"The FDA has confirmed that a single pivotal trial would be sufficient to support an NDA filing in AH. They also clearly recognize the unmet need in AH and the strong results of larsucosterol and our Phase IIb trial AHFIRM."
"Under this distinctive designation in July, we had a very productive and positive Type B meeting with the FDA to discuss our trial design. In fact, this meeting was the most productive interaction I've had with the FDA in my 30-plus-year career in drug development. We are awaiting the written minutes from this meeting and look forward to sharing more details about our proposed protocol in the near future once we receive those minutes."
"The FDA has confirmed that a single pivotal trial would be sufficient to support an NDA filing in AH. They also clearly recognize the unmet need in AH and the strong results of larsucosterol and our Phase IIb trial AHFIRM."
"Under this distinctive designation in July, we had a very productive and positive Type B meeting with the FDA to discuss our trial design. In fact, this meeting was the most productive interaction I've had with the FDA in my 30-plus-year career in drug development. We are awaiting the written minutes from this meeting and look forward to sharing more details about our proposed protocol in the near future once we receive those minutes."
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