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FDA Grants Biovest International Fast Track Status for BiovaxID™

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News

FDA Grants Biovest International Fast Track Status for BiovaxID™

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Biovest International, Inc. has been notified that the United States Food and Drug Administration (FDA) granted Fast Track status to BiovaxID, the Company's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma.

The targeted anti-cancer immunotherapy, now undergoing pivotal Phase 3 clinical trials at over 20 major medical centers throughout the U.S., showed extremely positive Phase 2 results - 9 years after treatment 95% of BiovaxID treated of treated patients are still alive.

Under the FDA Modernization Act of 1997, a promising therapy may be designated "Fast Track" provided the agency feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions.

Granted Fast Track status for BiovaxID, Biovest is now eligible to submit a biologics license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA in advance of receiving the Company's full submission, and permitting Biovest to apply for the expedited review of its BLA.

Steve Arikian, M.D., Chairman and Chief Executive Officer of Biovest, commented, "We are extremely pleased at this very positive FDA action."

"In its letter to us the FDA has indicated that BiovaxID shows the potential to treat a serious and life threatening condition and that our clinical development plan is designed to demonstrate an improvement in disease free survival and an effect on overall survival."

"This action by the FDA will help us bring BiovaxID to patients more quickly by allowing us to move our regulatory filing forward in stages."

Dr. Arikian adds, "BiovaxID is not meant as a replacement for existing therapies, but rather as a complement."

"A premier example of a targeted therapeutic BiovaxID stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other cells."

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