RE:RE:RE:RE:RE:Any-news about the meeting?Qwerty - I did hear Harrison say something to the effect that the FDA is very willing to listen to all proposals from the industry. Made it like they are amenable to anything that's helping the science, learning from industry, willing to work with serious companies. That's also a good statement he made in light of the THTX issue you bring up. Having that strong relationship on a drug they already approved shoudl help.
qwerty22 wrote: Paul was much better, contextulizing the drug and the importance of this drug as opening up a new Mechanism of Action to tackle the disease. The second question to Christian is the one I'm hung up on and still I think they are talking around the issue rather than dealing with it head on, shame he got cut off but that seems basically to be the way they are dealing with it. Maybe emphasizing the positives is a reasonable strategy but again with this question I think you can see an understanding of how the regulatory process moves forward without robust histology data is the key question on the minds of keen observers of the NASH field.
Paul's confidence on this issue can't really be knocked, he's clear unbending in his belief in Ph3, I have to love that even though it worries me that part of it relies on assertion rather than facts.
I think ultimately there may just not be an answer that satisfies me on this particular issue of trying to resolve how this particular dataset get to Ph3 with the degree of certainty you would get if you were following a cookie-cutter program. It's not a failure of messaging by the company just the reality of the situation. Maybe their strategy to just continually emphasize the positive is the best we can hope for until the regulators decide.
Adonis wrote: Any-news ??