Dr. Tefferi and his group of world class oncology experts told us at ASCO-2016, that approvals are coming for "unmet needs". Since Imetelstat has met all of the necessary criteria, there is an excellent chance that July 2016 will be the month. Who will be first, the FDA or the EMA? JNJ has accumulated and analyzed a great amount of data since June 2015, and the process is continuing.
***Excerpt from ASCO-2016-----"Ruxolitinib, a JAK1/JAK2 inhibitor, is the only approved therapy for MF, and there are no approved treatment options for pts who fail ruxolitinib. There is a great unmet need for effective therapy for this pt population. A pilot study of imetelstat therapy in MF demonstrated complete and partial remissions, including some molecular remissions (Tefferi et al, N Engl J Med2015). Based on the novel mechanism of action imetelstat may provide clinical benefit to pts with intermediate-2 or high-risk MF with refractory/relapsed disease after JAK inhibitor therapy."***