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Oramed Oral Insulin End-of-Ph2 FDA Meeting Provides Ph3 Development Clarity
Oramed announced it had a positive end-of-Ph2 meeting with FDA for its oral insulin (ORMD-0801). Following the meeting, Oramed said it plans to initiate two concurrent Ph3 trials. The company did not provide an updated timeline for Ph3 trial initiation, but it previously indicated the trials would begin in Q3 ’20 (previous FENIX insight). Below, FENIX provides brief thoughts on the Oramed news, including readthrough to Biocon’s oral insulin tregopil.