Amarantus Bioscience Holdings Inc (AMBS)

[68-Tele]

Could MANF attain FDA breakthrough therapy designation for Wolframs? RP?

According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.

A breakthrough therapy designation is one of four avenues provided by FDA to expedite drug development for therapies that treat serious or life-threatening conditions. Breakthrough includes all of the fast track program features and provides more intensive FDA guidance involving senior FDA staff. As with fast track, breakthrough provides eligibility for rolling review and priority review of the company’s Biologics License Application when submitted.