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IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August 2023. Management met a key efficacy secondary endpoint and the drug has shown dose-dependent anti-dyskinetic and anti-Parkinsonian effects, which support continued development, in our view. Our valuation currently assumes a 40% probability of success for mesdopetam in levodopa-induced dyskinesias (PD-LIDs) and we plan to revisit our assumptions following the results from the FDA meeting.
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