The fast track status will facilitate to develop and expedite the review of drugs intended to treat serious or life-threatening conditions.
The fast track priority review products are likely to be approved on the first review cycle than those without the designation.
Opexa president and CEO Neil Warma said the receipt of fast track designation from the FDA will advance Tovaxin through the clinical and regulatory process.
”We have accelerated our plans for SPMS and are planning to initiate a Phase IIb clinical trial with Tovaxin in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tovaxin in Relapsing Remitting MS at a later date,” Warma added.