Press release
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MedinCell MedinCell provides an update on its product portfolio , following the FDA Acceptance of New Drug Application for the product mdc - IRM Conference held today for shareholders and the financial community : Conference in French at 6:00 pm ( CEST ) • • Conference in English at 7:00 pm ( CEST ) Connection link : invest.medincell.com/conference Euronext : MEDCL • Montpellier - France • September 1st , 2021 • 8:00 am ( CEST ) MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc - IRM for patients with schizophrenia This first long - acting injectable treatment based on MedinCell's technology could be commercialized as early as 2022 by Teva in the U.S. Upcoming portfolio milestones expected : ■ ■ ' mdc - TJK and mdc - ANG : Announcement of next steps by Teva expected by year - end . mdc - CWM : Our partner AIC is targeting FDA approval to initiate Phase 3 efficacy studies before the end of 2021. The start of the safety study has been postponed . mdc - TTG : MedinCell is awaiting the approval of health authorities in several European countries , including France , to initiate a multi - center , randomized , double - blind , placebo - controlled Phase 2 clinical trial to confirm the prophylactic efficacy of ivermectin in regular , daily , oral form to simulate the continuous release of the active ingredient by a long - acting injectable . Portfolio of products based on BEPO® technology in regulatory development mdc - GRT Tacrolimus Organ Transplant mdc - TTG Ivermectin Covid - 19 mdc - WWM progestin molecule ( non - MPA ) Contraception mdc - ANG Confidential Antipsychotic mdc - STM Ivermectin Malaria mdc - KPT Confidential Pain mdc - TJK Confidential Antipsychotic mdc - CWM Celecoxib Pain & inflammation Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 In partnership with Teva Pharmaceuticals Internal programs In partnership with AIC With the support of the Bill and Melinda Gates Foundation . * NDA : New Drug Application 1/3 mdc - IRM Risperidone Schizophrénia NDA / Commercialization With the support of Unitaid Animal Health product ( different clinical development process )