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PHAT – Phase 3 PDUFA

The PDUFA is the day that the FDA makes an official decision about whether a drug gets approval or not.  Generally speaking, if the company is gets the FDA approval, […]

BCLI – Type A Meeting with FDA

A "Type A" meeting, in this case, to discuss the contents of a refusal to file letter previously issued regarding the company's New Biologics License Application (BLA) for NurOwn® for […]