RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

The question is whether this will start to also be seen in the CNS area. As BioCentury noted in its most recent issue: <<Most of the expedited approval mechanisms require circumstances that currently are rarely found in neurology: thoroughly validated biomarkers, well-defined subpopulations at high risk of death, and few therapeutic options. Over the last decade, only 18% of CNS drugs received Priority approvals, compared to 46% of other drugs, according to
the Tufts Center for the Study of Drug Development.
Tufts also found that from 1996 through 2010, the “mean clinical phase time for CNS drugs, compared to non-CNS drugs, was 40% longer, while mean approval phase time was 13% longer.>>

Both the directors of the FDA's Psychiatry and Neurology divisions have (Laughren) or soon will (Katz) resign. The big unknown is who will replace them, and how much risk will they be willing to tolerate in accelerating drug approvals.

NP