Monday, March 25, 2013
FDA's new draft guidance on Alzheimer's disease is being
alternately hailed as a breakthrough in FDA thinking about how to get new AD
drugs to patients faster and attacked as a radical, risky step toward
unleashing minimally tested new drugs on a desperate patient population.
Both the hype and the hope are
misplaced, as the scientific and regulatory breakthroughs needed to make real
progress don't yet exist.