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ddls

08/25/14 8:06 AM

#70836 RE: rumper #70834

The FDA "Will Not" grant fast track to ACTC.

No.1:
It is not life threatening.

FDA Fast Track:
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions 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 conditions.

Determining whether a condition 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 condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

ddls

08/25/14 8:40 AM

#70842 RE: rumper #70834

If one wants to hype ACTC one should pick a subject creditably hypeable.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions 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[b] serious conditions.