Insmed Inc. claims the phase III study demonstrated the still-experimental Arikace was just as effective as currently approved Novartis' TOBI in treating bacterial lung infections afflicting cystic fibrosis patients, however, the recently published data does not support these claims.
After the drugmaker released a poster presentation outlining this effectiveness, critics suggested that had Insmed relied on the intent-to-treat population rather than the findings from the per protocol population, its drug may not have achieved the primary endpoint.
Further igniting suspicion is the fact that the company chose to publicize the Arikace phase III results during a self-imposed quiet period ahead of third-quarter financial results to be released on Nov. 5th.