BeyondSpring: Poor Trial Conduct and Lack of Transparency Creates Substantial Downside Risk

BeyondSpring: Poor Trial Conduct and Lack of Transparency Creates Substantial Downside Risk Recently announced Phase 3 lung cancer data is likely weaker than claimed given lack of standard disclosure and a history of poor trial conductExpect a denial at the upcoming FDA decision for chemotherapy-induced neutropenia, BYSI’s only other late-stage effortWe identify inaccurate data reporting and contradictory management statements regarding critical trial issues. Both strongly suggest BYSI is incapable of producing an adequate NDAWe estimate only 10% of enrollment in BeyondSpring’s mid and late-stage trials is based in US. Majority of sites and subjects are in China and Eastern Europe where trial conduct is questionableBeyondSpring’s chemotherapy-induced neutropenia US NDA is based on a Phase 3 trial that only included patients from China and Ukraine. We find it hard to imagine how such data will satisfy the FDATwo leading oncologists express skepticism regarding Plinabulin’s efficacy ...