RE:RE:RE:RE:RE:Getting a Green Light rather than a Yellow Light from FDA My take is progressively every time they address the NASH trial they sound more confident for instance in the previous CC the CEO was stating they know the drug is working and want to get the chance to proove it, the PR states they got the formal positive response from FDA with the recommendation to discus the trial's design and yesterday he hinted it is fine details which needs to be adjusted. Based on the change of language they seem to be more certain as the time passes.
Give it what ever colour you want but after all the conversations with agencies, multiple presentations re NASH, the backing of scientists and getting letter may proceed for Phase 3 not 2b or 2b/3 from FDA it is to me a go.