Dealmaking in the device industry is occasional and incremental when compared with the level of activity in pharmaceuticals, the result of that industry's maturing into a handful of dominant players, not all of which see acquisitions as strategically critical to their long-term success. The less-than-robust public market for small device companies is both symptom and cause of the device dealmaking lull. Because the markets they target are generally too small to sustain years of significant growth, few investors are willing to invest in them as stand-alone companies. And without long-term investor support, smaller firms have few options other than to sell out to large companies and little negotiating leverage when they do so.

US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.