Cytodyn Inc (CYDY)

[KCRoyal2004]

3X:

Of the 98 applications, 54.1% (53 [47 NDAs and 6 efficacy supplements]) had been resubmitted after the RTF letters were received and the FDA’s refusal reasons were potentially addressed. The median time to resubmission after RTF letters was 182 days (interquartile range [IQR], 100-460 days), with 16 applications taking more than 1 year to resubmit. Of the 53 that were resubmitted, 71.7% (38 [34 NDAs and 4 efficacy supplements]) were approved at time of analysis within a median of 784 days (IQR, 529-1283 days) from the original submission date; approval of 21 applications took more than 2 years. This approval time includes all intermediate regulatory steps, including the time applicants took to address the RTF letter and potential multiple review cycles after FDA nonapproval. Four of 53 applications had been withdrawn and 3 received another RTF letter. Applicants withdrew 6 applications after receiving RTF letters without resubmitting.