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    Bruce Nudell

    Senior Research Analyst specializing in medical technology and healthcare at Credit Suisse

    Bruce Nudell is a Senior Research Analyst specializing in medical technology and healthcare at Credit Suisse, where he covers major companies such as Baxter International and MCUR. He is recognized for his expertise in the medtech sector, often participating as a lead analyst in industry conferences and delivering incisive equity research for institutional clients. Nudell began his healthcare analyst career at UBS Investment Bank from 2007 to 2011 before moving to Credit Suisse, where he has built a reputation for rigorous company evaluations and impactful investment insights. He holds FINRA registration and maintains securities licenses, reflecting his professional credentials and commitment to compliance standards.

    Bruce Nudell's questions to MCUR leadership

    Bruce Nudell's questions to MCUR leadership • Q4 2014

    Question

    Bruce Nudell of Credit Suisse inquired about the FDA's potential weighting of the Mechanism of Action (MOA) study and whether it could reduce the number of required pivotal trials. He also asked about the company's commercialization preparations following the anticipated positive DFU trial results in October.

    Answer

    President & CEO Nissim Mashiach explained that while the FDA encourages MOA data and it will be valuable for review and reimbursement, the company's agreement for a broad label indication still requires two pivotal studies (DFU and VLU). Regarding commercialization, Mr. Mashiach stated that upon positive results, the company will proceed with building its manufacturing facility and completing both studies to support a BLA filing in the second half of 2016, targeting a U.S. product launch in early 2018.

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