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Opexa (OPXA) Tovaxin® granted FDA Fast Track Designation for MS

OPXA’s Tovaxin® has been granted Fast Track designation by the FDA for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).

 

Products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review.  Fast Track priority review products are more likely to be approved on the 1st review cycle than those without the designation. Fast Track also entitles OPXA to more frequent interactions and dialogue with the FDA, further benefiting the development of Tovaxin.

The Bottom Line:  The receipt of Fast Track designation from the FDA represents an important step  to advance Tovaxin through the clinical and regulatory process.