BeyondSpring has positive pre-NDA meeting at FDA about Plinabulin
BeyondSpring (NASDAQ:BYSI) had a positive pre-NDA meeting with the FDA about its lead asset, Plinabulin.
The focus of this meeting was the content of the chemistry, manufacturing and control (CMC) sections of the company’s planned NDAs for Plinabulin for the treatment of non-small cell lung cancer and chemotherapy-induced neutropenia prevention.
“We are very pleased with the outcome of this meeting, as we have confirmed our alignment with the FDA regarding expectations for the CMC sections of our planned NDAs for Plinabulin,” Dr. Lan Huang, co-founder and CEO, said in a statement.
“We have been working diligently on these submission packages, assembling their regulatory, preclinical, and most recently the clinical components of these indications,” Dr. Lan Huang, co-founder and CEO, said in a statement. “Now with agreement on the CMC sections, we are well on track to submit these NDA packages for Plinabulin to the FDA.”