RE: funding16 Feb 2019 18:37
Yes ivy...that would be good.
To be honest, i would prefer it if mtfb have made an error in their submission and they have the additional data needed.....while that might be quite galling and time consuming, we could live with that.
However, if they dont know the exact issue, even before they meet with the fda, i would hope that they employ some of the best consultants in the business to be reviewing every factor of liver tox info they have against every other piece of info against all drugs that is effected by liver tox, they need to go into that meeting very heavy handed or they have no chance imo.
Ofcourse vany is the main comparator but it sounds like there is little difference so how is a wider subset going to prove much!