RE:RE:Bioniche will not receive FDA orphan drug designationThey failed and now they have an excuse. Its not an orphan status drug, its much bigger than that. Yeah sure.
Just how does anyone know the orphan drug status wasn't a ploy to see if the FDA wouldn't lower the bar?
If a drug company was going to submit a drug that may be of benefit to 1000 people how many chorts do you test? 10 or 100 or more.
If you are submitting a drug that might be of benefit to 200,000 people, or 2 million people how many cohorts are needed. 2000, 200,000, Get my point. We are farther away than ever.
These people now running the show tried to pull a fast one. It didn't work. Lets stop being their pigeons and tell them to get the fkg trials on the road.