Fast Track Designation
OncoVAX®, which is being developed to prevent disease recurrence in Stage II Colon Cancer patients following surgical tumor resection was granted “Fast Track” designation from the US Food and Drug Administration (FDA) for this development program.
Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This designation allows for a rolling submission of a potential Biologics License Application (BLA) to the FDA for OncoVAX® and ordinarily provides for a 6 month priority review cycle as opposed to 10 months for a standard review.