retts syndrome, page-25

ajostu,

An illness doesn't need to be life threatening to gain fast track approval.

Here's what Wikipedia mentions:

"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one."


However, the main causes of death in Retts sufferers are directly related to Retts itself. Including seizure, aspiration and accidents (seizure and aspiration being two of the efficacy parameters in our trial).

So an effective treatment for Retts can claim to help survival.

cheers

http://en.wikipedia.org/wiki/FDA_Fast_Track_Development_Program