Wouldn't phase III assume that IHL-42x would be presented as a direct competitor to the CPAP? I thought the point of Phase III was to compare against standard of care. Is there precedent in comparing SOC with a new treatment when one is a medical device and one is pharmacological?
Either way, I think we are going to be getting juicy takeover offers anytime from now. Personally don't see us going to phase III. All IMO, DYOR.