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IRLAB Therapeutics has scheduled an end-of-Phase II (EoP2) meeting (on 20 February 2024) with the US FDA for the mesdopetam programme. This marks an important milestone for IRLAB as it will evaluate the clinical data generated to date and aim to reach a conclusion for the design of the planned Phase III programme. The meeting should also outline a clear path to a possible new drug application (NDA), including if any other information is required to support an NDA submission. Management will announce the outcome of the EoP2 meeting within Q124 as feedback from the regulatory authority is provided up to 30 days afterwards.
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