Any data you will get from this approval will be very hard to interpret, as no randomization is done, so there is no proper control group. Moreover, proven saf

Any data you will get from this approval will be very hard to interpret, as no randomization is done, so there is no proper control group. Moreover, proven safety is not sufficient to approve a drug. For experimental drugs without alternative treatment, it can be given as part of the compassionate use program. I think you could make an argument that the drug fits there, but approval sends the wrong message (ie. proven safety AND efficacy).