BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin

- December 27th, 2018

BeyondSpring (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead asset, Plinabulin. As quoted in the press release: The focus of this meeting was the content of the chemistry, … Continued

BeyondSpring (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead asset, Plinabulin.

As quoted in the press release:

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 (NSCLC) and chemotherapy-induced neutropenia (CIN) 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,” said Dr. Lan Huang, CEO and co-founder at BeyondSpring. “We have been working diligently on these submission packages, assembling their regulatory, preclinical, and most recently the clinical components of these indications. Now with agreement on the CMC sections, we are well on track to submit these NDA packages for Plinabulin to the FDA.”

“We truly appreciate the guidance provided by the FDA during our recent pre-NDA meeting for Plinabulin, and look forward to working with the Agency to achieve our goal of addressing the unmet clinical needs of cancer patients,” added Dr. Gordon Schooley, BeyondSpring’s Chief Regulatory Officer.

Click here to read the full press release.

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