So the legislated timeframe for the delivery of an opinion is...

So the legislated timeframe for the delivery of an opinion is 210 days. However, there are clock stops when you ask questions or list issues to allow the company to respond. That's OK because the delay in response is out of the EMA. So how does EMA extend the 210 day timeframe. Easy, simply refuse to accept the company's response until such time as you feel like looking at it again. I daresay if you challenged that in court you'd win but then you risk them delaying or refusing further down the track. I'm sure they're saying "It's only a month, no-one would be stupid enough to challenge that!" As I said - Got us by the globes!

Rev