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.