Let me rephrase, there is no concern because FDA clearly indicated “orphan status does not mean that FDA has approved the drug. Orphan stays and FDA approval are not the same.”
The orphan status can be designated but not approved at the same time.
Orphan designation in very common in bio tech. Please do your own research and you will see.
I don’t want to write the full statements because I assumed everyone has the ability to perform basic research.
My guess is that marker did not get advanced notice from FDA. I am sure tomorrow morning we will get a PR, since this was posted on FDA site after market regular trading hour close today.
News 
Market Data 
Discover 
