BeyondSpring Inc

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Beyondspring Pharmaceuticals Receives Complete Response Letter From FDA For Plinabulin New Drug Application For Prevention Of Chemotherapy-Induced Neutropenia

Published: 12/01/2021 13:34 GMT
BeyondSpring Inc (BYSI) - Beyondspring Pharmaceuticals Receives Complete Response Letter From the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-induced Neutropenia (cin).
Beyondspring Pharmaceuticals Receives Complete Response Letter From the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-induced Neutropenia (cin).
Beyondspring Inc - FDA's Crl Indicated That Results of Single Registrational Trial (106 Phase 3) Was Not Sufficiently Robust to Demonstrate Benefit.
Beyondspring - Crl Indicated a Second Well Controlled Trial Would Be Required to Satisfy Substantial Evidence Requirement to Support Cin Indication.
Beyondspring Inc - FDA Issued Crl to Indicate They Have Completed Review of NDA and Have Determined That It Cannot Be Approved in Its Present Form.