You originally said CUV would require phase iv trials, now...

You originally said CUV would require phase iv trials, now you've agreed they could get approval to commercialise after phase iii trials.

Roughly 25% of drugs have phase iv trials. They are by no means "required" by the fda (or others) in all cases as you implied. Besides that, CUV already effectively has one under way with the EMA pass protocol under which there is already several years of data. Their strict distribution control system has the distinct advantage that all applications of scenesse are closely monitored and observed already.

Will there be post authorisation studies in AIS if trials are successful, and marketing approval is granted after phase iii? I'd be amazed if there wasn't, but so what? You'd imagine any decent efficacy would be able to balance the uncertainties of a short track record in an indication where many patients are currently untreated and death or serious disability is very often the result.

Drugs get withdrawn occasionally after approval, yes. So is your position to avoid investing in all biotech or pharma because this might happen to any drug? Bayer got Baycol pretty wrong for example. But then, if big pharma can screw up, why are you so convinced they have been correct to avoid melanocortins?

Orphan designation gives market exclusivities, tax breaks, and application advice to make developments and applications commercially viable for a small population size. It doesn't lower the burden of proof of safety.