RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Financial and othersI think some of that is CYA and some of that reflects the Ocaliva situation and the somewhat fluid nature of endpoints, biopsy readings, etc.. with NASH and the regulators. You need to leave a lot of wiggle room since it's still all developing. The regulators have agreed to their trial plan according to today's discussion. So that is all they can go on.
palinc2000 wrote: Found this in the first page of the MD&A .....OF THE Second Quarter
Does this make sense ?
In addition to the risks inherent to the conduct of clinical trials, there exist risks that the FDA will not approve tesamorelin for the treatment of NASH without the Company having substantial evidence and data from the conduct of Phase 2 clinical trials evaluating tesamorelin for the treatment of NASH in the general population and solely relying on data emanating from the conduct of one Phase 3 clinical trial. There is also risk that the FDA may require additional clinical trials to be conducted in order to obtain approval. Moreover, there exist risks that the EMA will not approve tesamorelin for the treatment of NASH because the trial design that the Company intends to pursue does not include the primary endpoint required under the current EMA guidelines