Wed-23-03-2016, 22:14 PM
(Wed-23-03-2016, 21:55 PM)Caroline Wrote:(Wed-23-03-2016, 20:38 PM)Fred Wrote: I think it's a matter of governments making the pharma's work harder. They couldn't supply the data requested showing that is as good as or better than a TNF for psoriatic arthritis.
They asked for comparison tests, they didn't get them. So they are saying to pharma's give us what we ask for and we will give you approval, don't come up with the goods and we won't approve.
Sounds fair to me.
No, it is stupid.
You close doors that, if open, could help people.
It is called a tunnel vision.
Well I still would rather a drug manufacturer show the evidence that has been asked for. If not what is the point in having a regulatory body.
The drug manufacturer has failed to give what was asked for, it may be a pointless exercise in our opinion but if they let them get away with it then others will try it on too.
All they want is a simple study to show that Cosentyx is as good as TNFs for treating psoriatic arthritis. If it's not then what is the point in them giving approval for such.