Replies to post #1081 on Conatus Pharmaceuticals Inc. (CNAT)

[JeansOnFire]

All i know is that the results were good enough for novartis to enter into the license agreement with conatus. It was probably a surprise for conatus too how well emricasan works for high meld score patients. Otherwise there would have been more patients.

Next trials are big enough to make conatus world famous if the results are similar.

[staccani]

The trial was a relatively small one, hence no suprise. Moreover the efficacy indication was reached only in subgroups after post hoc analyses (NASH subgroup and all etiologies High MELD subgroups). That is why you do first a ph2a which is normally a proof of concept study and then followed by a ph2b. As a consequence of interactions with FDA , ph2b will include only the sickest NASH patients (decompensated), basically combining the two subgroups with highest efficacy, and will include also clinical endpoints , hence bypassing the stalemate of deciding if surrogate endpoints are approvable or not.

All of this was and is very clear to NVS, which used the option exercise as an incentive for CNAT mngt to start the trial asap (q2 2017)

[Inoviorulez]

Perhaps I can add some insight to this.

The p-value data from 3 months to 6 months gets better compared to placebo. While not all 6-month data is significant the data is for 6 months or 24 weeks. Most of the trials are designed for longer periods of time. For example the NASH fibrosis trial is designed for 72 weeks or 18 months. think of it this way. Emricasan mechanism action is that the drug works the more a patient takes it. If it gets close to statistical significance at month 6 what do you think will happen by month 18? If you said improve you would be correct. Although it will need to be tested to see how many months. It could be possible that statistical significance is reached by month 9. That is what is being tested and we will know once more data is out.