RE: Very Good Interview24 May 2019 12:49
Yes very positive
If anyone can direct me to when the FDA has ever asked a company pre approval to carry out a prospective longitudinal study for surveillance of DILI id be much obliged. I can't find a single occasion. Mainly due to the time frames involved would make it uneconomical. You either fail the drug or do post market surveillance. So cant really see option 3 at all. But hey ho, didn't see the CRL either