Fair enough. What do you think might be a rough outline of the conditions? Sigma 1 WT, and phase 4? Or something more onerous, and share price limiting?
Certainly interested in more details concerning your reasoning. As I stated earlier this afternoon, I don’t think a conditional approval meets the logic test.
Wouldn't a CMA pose a recruitment problem if a confirmatory trial is required? Why would anyone risk a 1 in 3 chance of being in the placebo arm when they can just ask their doctor to prescribe it for them? More likely, perhaps a requirement for collecting real-world data, if 4 years of OLE data is not sufficient.