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Targovax receives Fast-Track designation for ONCOS-102

The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package.

The FDA Fast Track-designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast-Track products have improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.

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