Shots:
- The FDA decision to lift the hold of P-I clinical trial for RP-A501 is based on the modification of the trial protocol and other supporting documents with revised guidelines for patient selection and management
- The FDA allows the company to restart the patient enrolment. Additionally, the company is expected to initiate the dosing of the low-dose pediatric patients in Q3’21
- The P-I trial evaluates the safety and tolerability of RP-A501 therapy (IV infusion) in both pediatric and young adult male patients. The company will report the updated data from the low-dose and higher-dose young adult cohorts in Q4’21
Click here to read full press release/ article | Ref: Businesswire | Image: Businesswire
The post The US FDA Lifts the Clinical Hold of Rocket’s RP-A501 Clinical Trial to Treat Danon Disease first appeared on PharmaShots.
