regulatory
confidence high
sentiment positive
materiality 0.80
Fennec resubmits NDA to FDA for PEDMARK to prevent pediatric ototoxicity
FENNEC PHARMACEUTICALS INC.
- Resubmitted New Drug Application (NDA) for PEDMARK (sodium thiosulfate anhydrous injection).
- Indication: prevent platinum-induced ototoxicity in pediatric patients (1 month to <18 years) with localized solid tumors.
- CEO Rosty Raykov cited close work with FDA during the review process.