Biotech Values

[DewDiligence]

Fast Track vs Accelerated Approval, and what it means for Squalamine:

To get Squalamine to market as a treatment for AMD, GENR and partner will have to demonstrate efficacy, at a minimum of one year from the time of initial treatment, in one or more randomized, controlled phase-3 trials. Multiple phase-3 trials may be needed to segment the patient pool by AMD subtype: predominantly classic vs minimally classic vs occult.

Fast Track refers to an FDA process by which the agency accepts an NDA/BLA in stages. (Normally, the manufacturing and preclinical data are submitted first, followed by the clinical data.) Fast track helps speed an application slightly because the FDA can review some portions of the filing as soon as they are completed. Squalamine may qualify for a fast-track submission; however, this is a relatively minor matter in the overall scheme of things.

Some people (especially on Yahoo) appear to be confusing fast track with Accelerated Approval, which is another matter entirely. Accelerated Approval is an FDA program that allows a drug treating a life-threatening condition to be conditionally approved based on phase-*2* data. Barring a change in FDA policy, accelerated approval will not be available to Squalamine in AMD.