Ian Somaiya's questions to MCUR leadership • Q2 2015
Question
Ian Somaiya from Nomura Securities asked for guidance on interpreting the potential outcomes of the upcoming VLU trial futility analysis, particularly the 'middle zone' (31-45% probability of success), and inquired about the possibility of amending the trial protocol.
Answer
President & CEO Nissim Mashiach stated that the company anticipates being in the most favorable zone (46-100%) and that any other outcome would be a disappointment. He explained that the middle zone would still indicate separation between the treatment and control arms, with a chance to meet the endpoint upon full enrollment. CMO Mike Molyneaux added that the middle zone still means the trial is on target. Nissim Mashiach also confirmed the DSMB's role is limited to reporting the probability zone without further detail, as the study remains blinded.