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933 Posts.
1446
12/01/23
01:06
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IHL have already held a successful Pre-IND meeting with FDA on IHL-42X. That was announced on 17 May 2022.
The next step is a 116 person BA/BE study and submission of an IND (investigational new drug) application in Q1, 2023.
The BA/BE was part of the feedback from FDA during the Pre-IND process.
The feasibility study has been completed for the blended P2 / P3 trial which will involve up to 30 sites and commence H1, 2023.
I’m not sure how much information you’re looking for so let me know if want more detail.
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