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.
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