Replies to post #143913 on Biotech Values

[DewDiligence]

I would bet that this type of study is in the planning stage.

I would respectfully take the other side of this bet. In other words, I think MRK is too scared of failing to show superiority vs Ambien CR or Lunesta to run such a trial. A mere showing of non-inferiority would be a disaster from a marketing standpoint when the comparator is already generic or soon will be.

These folks on the CC stated that it would be difficult to run the study with CR Ambien or with Lunesta. Some truth there?

Total spin, IMHO. Such a trial would be no harder to harder to design and complete than your typical phase-4 trial.

Would you run the study with CR Ambien or with Lunesta?

I would pick Lunesta as the comparator, but I don’t think it matters much.

I could think of many aspects of the study that should show superiority in favor of suvorexant.

If such a trial were run, it might indeed show superiority; the salient point is that MRK isn’t confident enough to take the chance and is thereby willing to forego approval in the EU.