MEI Pharma Inc

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Mei Pharma And Kyowa Kirin Provide Regulatory Update On Zandelisib Following Meeting With The FDA

Published: 03/24/2022 20:43 GMT
MEI Pharma Inc (MEIP) - Mei Pharma and Kyowa Kirin Provide Regulatory Update on Zandelisib Following Meeting With the FDA.
Mei Pharma Inc - Companies Do Not Plan to Submit an FDA Marketing Application Based on Single Arm Phase 2 Tidal Study.
Mei Pharma - FDA Informed Cos That Randomized Trial is Now Needed to Adequately Assess Drug Efficacy and Safety of Pi3k Inhibitor Drug Candidates.
Mei Pharma Inc - FDA Discouraged a Filing Based on Phase 2 Tidal Study Data.
Mei Pharma Inc - FDA Emphasized That Companies Continue Efforts With Ongoing, Randomized Phase 3 Coastal Study As Planned.
Mei Pharma Inc - FDA Stated That Safety on 60 Mg Intermittent Schedule Appears Reasonable.
Mei Pharma Inc -fda Recommended Continued Dose Exploration to Further Support Current Dose and Regimen.