- Recently announced Phase 3 lung cancer data is likely weaker than claimed given the lack of standard disclosure and a history of poor trial conduct.
- We identify inaccurate data reporting and contradictory management statements regarding critical trial issues. Both strongly suggest BYSI is incapable of producing an adequate NDA.
- BeyondSpring’s chemotherapy-induced neutropenia US NDA is based on a Phase 3 trial that only enrolled in China and Ukraine. We find it hard to believe such data will satisfy FDA.
- Two leading oncologists express skepticism regarding Plinabulin’s data and approvability in neutropenia and lung cancer.
- Base case: Lung cancer data is less than claimed and FDA denial in neutropenia. Shares are worth $5/share (cash plus protein degrader platform value).
For further details see:
BeyondSpring: Poor Trial Conduct And Lack Of Transparency Create Substantial Downside Risk