“Both the FDA and the industry are interested in methodologies that minimize placebo response, so you can start to reveal a true drug signal in more reasonably sized studies.”
– Richard Pops, CEO, Alkermes plc

“From the time we filed confidentially to when we priced was 2.5 months. We really didn’t think it would be possible if we didn’t have the JOBS Act.”
– Steve Mento, CEO, Conatus Pharmaceuticals Inc.

“While disappointing, this highlights underlying safety concerns that the Street has had for Iclusig and its likely limited commercial potential.”
– Eun K. Yang, Jefferies analyst, in a research report on the news that Ariad Pharmaceuticals Inc. reported follow-up safety data showing increased incidents of arterial blood clots in patients treated with Iclusig (ponatinib), which won accelerated approval late last year for use in patients with chronic, accelerated and blast phases of chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia whose disease is resistant or intolerant to tyrosine kinase inhibitors

“We believe it’s possible that Gilead could file by year-end with a potential approval in 2H14. This was a modest upside surprise to us positioning idelalisib to compete directly in CLL against ibrutinib (Pharmacyclics Inc./Janssen Research & Development LLC) in as little as six months following ibrutinib’s anticipated approval in the indication.”
– Mark Schoenebaum, ISI Group analyst, on Gilead Sciences Inc.’s decision to put an early stop to its Phase III study (Study 116) evaluating idelalisib in previously treated chronic lymphocytic leukemia patients