Cara Therapeutics Inc (CARA)

[protagonist12]

I do believe the chance of FDA approval for CR845 is exceptional. According to the last C.C. we are still on track for the 2017/2018 launch for the indications specified. It should also be noted that there will now be three separate phase 3 trials for IV CR845 initiated (one trial each for hard tissue/soft tissue laparoscopic hysterectomy, and one trial for bunionectomy) instead of the two depicted on the chart. This is a good thing and is a "shots on goal approach" which will help better position I.V. CR845 for the strongest possible regulatory submission.

Another development not indicated on the chart is that we have phase 2 trials ongoing in the Uremic Pruritus indication. The FDA currently has no specifically approved drugs for that indication so it might be that we even receive a fast-track designation for U.P. which could mean going to market with CR845 even earlier than 2017.

CEO also mentioned that they were "encouraged by FDA guidance on the non-clinical and toxicology packages and current CMC strategy."