Nymox Pharmaceutical Corporation received a Refusal to File letter from FDA on May 20 at 2:48 pm EST, with regard to the Company's New Drug Application (“NDA”) 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. The letter referred to a new outstanding issue of longer-term safety data and indicated that Nymox needed to have longer-term safety data in its NDA.

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. The Company's position is that Fexapotide safety profile is superior to any other conventional BPH treatment. 2. Fexapotide is a local injection with no detectable drug outside of prostate in patients after treatment.

For a single injection (ie, given only one time) low dose local administration treatment, typical human clinical safety data duration requirements for approvals are in the few months range or less. Animal testing requirements are generally 2 weeks. 3. The FDA agreed at the end of Phase 2 that for eventual approval one-year safety data after a single injection of fexapotide 2.5 mg was adequate for Phase 3 pivotal studies, for clinical safety duration requirements.

In Nymox pivotal Phase 3 trials 0017 and 0018, this data was achieved, and 12-month full safety data was provided in the NDA. The FDA provided detailed safety requests at the fexapotide pre-NDA meeting, which categorically did not include a longer-term clinical safety data request for fexapotide. 5. In addition, the NDA does include even longer-term (2-3 years) full safety data for fexapotide from n=344 subjects in Phase 3 Studies NX02-0020 and NX02-0022.

There is no evidence of any long-term adverse safety outcomes in the pivotal study data for fexapotide.