aha, and what is your reference for this. I can tell you one that was 18 months, but that drug had been studied 20 years prior and it was the first drug for AIDS.
Clinuvel with Orphan status started 29 months ago and is now still waiting for months . So it's not automaticaly a short track! The outcome must be 100%. If not.......... The EMEA had more questions over and over again. If all goes well this month we'll get the final answer.