- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) has received a Refusal to File (RTF) letter from FDA regarding its marketing application for Fexapotide Triflutate.
- Nymox's position is that clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved.
- In March, the company submitted a Fexapotide Triflutate application for benign prostatic hyperplasia (BPH).
- The letter referred to a new outstanding issue of longer-term safety data and indicated that Nymox needed longer-term safety data.
- Longer-term full safety data (as long as 6 years after a single low dose non-systemic injection given one time only) was not requested by the FDA in any previous pre-NDA communications.
- Nymox will continue to seek clarification and report further material information when available.
- Price Action: NYMX shares are down 67.5% at $0.41 during the market session on the last check Monday.
