The US FDA Lifts the Clinical Hold of Protagonist's Rusfertide Clinical Development Program
Shots:
- The US FDA has lifted the clinical hold on the rusfertide development program & allow to resume patient dosing in clinical studies of rusfertide
- The company provides the information to the FDA on the basis of complete response & also give patient clinical safety reports & update the investigator brochure- patient informed consent forms- safety database- and included new safety and stopping rules in the study protocols
- The company plans to start P-III registrational study for polycythemia in Q1’22 & will continue to work with the FDA to ensure patient safety
| Ref: Protagonist | Image: PR Newswire
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