Intarcia re-filing mid-2019

Yesterday, Intarcia announced a corporate update, where the main news was that it intends to re-submit the ITCA-650 NDA in “mid-2019”. The announcement also quoted its three new senior team members, including Fred Fiedorek as Chief Medical Officer and Head of Regulatory (previous FENIX insight), Thane Wettig as Chief Marketing Officer (previous FENIX insight), and Anders Vinther as Global Head of Quality & Engagement. Intarcia’s 2017 CRL was well-publicized (previous FENIX insight), but Intarcia has seemingly been given a path to re-filing “…after several consultations with the FDA during 2018…”. If Intarcia re-files in June, it should have a PDUFA date……

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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