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SGLT2i, Topics

September 13, 2018

CREDENCE and CANVAS Filing Update & Implications

Here is a brief preview of this blast: J&J hosted its pharmaceutical business review and provided a brief update on its diabetes business. J&J disclosed its intention to file CREDENCE in "2019", which is later than initially projected by FENIX (late Q3 ’18 / early Q4 ’18). There was no discussion in the prepared remarks on the US review of CANVAS/R. Below, FENIX discusses a hypothesis where delaying the CREDENCE filing to 2019 could signal the CANVAS FDA discussions are going well and Invokana is likely to receive a CV protection indication.

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.