Dew, from time to time there has been discussion on this board re Geron. I have not been following this board lately much since I post on the MNTA board once in a while but this seemed to be a good place to ask my question. Anyway I wanted to get your take (and anyone else knowledgeable) about the structure of the impending myelofibrosis trial involving both Geron and mostly Janssen (of J and J). As you know imetelstat is a promising (not so) new drug that inhibits telomerase and is the only drug that has successfully modified disease in MF (and maybe MDS). The large phase II sponsored by Janssen is about to start and will target Jakafi drug failures, a clear unmet needs medical population. Clinical trials.gov lists 39 world wide sites. In the US there are only thirteen but they look very high quality e.g. Mayo, Stanford, Duke etc. My question is this. Janssen has stated that they are looking to file in 2017 in the US and that they expect this to be a product with 1 B sales/yr. They already have orphan drug status. Since they have so many multinational sites, Spain, France, South Korea, Germany etc etc do you think this implies an intended path to approval outside the US that might have a faster timeline? Or is it just a desire to enroll the 200 patients fast and get the study done. Time to response in many cases seems to be measured in weeks so they may have results fairly soon. I am unfamiliar with the paths to approval in Europe and Asia and wondered if the choice of study sites and the skewing of site selection outside the US tells us anything about future intention. TIA bp
