I want to thank you all for testifying, for coming and taking your time.
But are they going to be an acceptable part of your presentation, do you think, to the F.D.A.?
I think something needs to be done to the Orphan Drug Act to actually maybe separate a category or have a separate pathw...
Quality of life should be the key.
I think, we are maybe, the pendulum is over here, and it needs to come back toward the middle.
But maybe we have a standard now for a design and maybe you can help us with defining what the new design would be.
What we need to do is just take them and turn this into something constructive.
If there is no random improvement like that and you have that dramatic improvement, it should not take us 10 minutes to ...
I think even a layperson might be able to discover that drug seems to be helping.
We have random, double blind studies as this gold standard that has been out there, and we have 1,000 people.
I would agree with you completely.