Final stretch

Following a long and bumpy regulatory road, it appears Heplisav-B from Dynavax Technologies Corp. is finally in the home stretch. But how the company and FDA handle the final hurdle -- the design of a postmarketing CV safety study -- may determine whether bigger challenges lie ahead.

What makes the problem interesting is that the patients in whom Heplisav-B is most effective are also those most at risk of myocardial infarction...