Cleveland BioLabs' (CBLI) CBLB502 Granted Fast Track Status Print
By Staff and Wire Reports   
Thursday, 22 July 2010 00:00
Cleveland BioLabs, Inc. (Nasdaq: CBLI) today announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.

"We are extremely pleased that the lead indication for CBLB502 has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program's review process," said Michael Fonstein, Ph.D., President of Cleveland BioLabs.

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