Question · Q4 2016
Sa'ar Yaniv from Roth Capital asked for specifics on the NASH cirrhosis study timeline, including last patient completion and data compilation. He also inquired about interim analyses, the rationale for the high expected dropout rate, pre-specified subgroup analyses, the status of the non-cirrhotic NASH program, future plans for the dermatology programs, and publication plans for recent data.
Answer
President and CEO Peter Traber confirmed the last patient's final visit would lead to a database lock around mid-October, with top-line data reported in December. He noted that while there are three scheduled safety reviews by a DSMB, there is no interim efficacy analysis. The high 25% dropout rate was a conservative estimate recommended by the FDA based on historical trials. Dr. Traber also stated the non-cirrhotic NASH program is not being pursued, the atopic dermatitis program may be advanced pending funding, and that manuscripts for the NASH-FX and psoriasis data are in preparation.