Prasad signals flexibility with Precigen decision, but will it generalize? 

CBER Director Vinay Prasad’s messaging around the approval of Precigen’s rare disease therapy helps to convey a climate of regulatory flexibility that supports rare disease drug development, but it’s not yet clear how broadly the relaxed stance toward randomized-controlled trials will apply.

Late Thursday, FDA granted full approval to Papzimeos zopapogene imadenovec, a vector-based immunotherapy from Precigen Inc. (NASDAQ:PGEN) to treat recurrent respiratory papillomatosis (RRP). Patients with recurrent HPV 6 or HPV 11 infections present with benign tumors in the respiratory tract, which can affect breathing and speaking. Papzimeos is the first approved therapy for the disorder, which Precigen says affects about 27,000 people in the U.S...