2017 FDA Kang Zhang
p. 2
Enrollment criteria, return to baseline pre-disease visual acuity
Enrollment criteria, return to baseline pre-disease visual acuity
Enrolled five subjects ...
Enrolled five subjects ...
Failed to perform an evaluation on sixth patient
Failed to perform an evaluation on sixth patient
first subject enrolled in August 2011
first subject enrolled in August 2011
p. 4
Validity concern 2
Validity concern 2
Never submitted a corrective action plan
Never submitted a corrective action plan
25 units of a study drug
25 units of a study drug
You did not provide sufficient details about your plan 1
You did not provide sufficient details about your plan 1
drug supply had been destroyed
drug supply had been destroyed