$CAPR The case does Capricor proposal for accelerated approval Cap 1002: • extraordinary results based on pul 2.0 based line on Hope 2 trial. Results show no adverse reaction, safety concern. • exigent condition, raging covid pandemic, making these kids travel 4 times by plane to la is dangerous and life threatening The most important case for approval, narrow approval for only non ambulatory dmd kids with a post confirmatory study. By opening the open label extension on the placebo kids capricor can collect safety data in replacement for phase 3. Sarepta get 5 years to do post confirmatory study for their exondys 51. This is following precedence for fda.
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