Genzyme’s Lemtrada Experience Offers Lessons for “Breakthrough” Sponsors

When it comes to asking for special attention for priority drug development project, sponsors should remember the old adage, “be careful what you ask for, you just might get it.” Inviting FDA review teams to offer more explicit advice on clinical trial designs can be very helpful, but it also carries the implicit obligation to hew more closely to the advice that FDA gives—or face major complications later on.