Nymox Pharma (NYMX) has corresponded with and has met with the FDA during the past few months
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to provide a current update on business developments.
The Company has corresponded with and has met with the FDA during the past few months. The agency has provided very helpful feedback to the Company. FDA has specified what additional information is required in resubmission of the NDA; and the Company is in the process of preparing the requested documentation for the resubmission of requested data, and for further interactions with FDA for additional guidance.
The Company expects to submit a marketing application for Fexapotide in Europe in the upcoming 4th quarter of this year and will provide further information as the time for the Fexapotide submission approaches in the near future.
Paul Averback, CEO of Nymox said, "We are very fortunate to have the benefit of expert advisors both in the US and in Europe who have greatly contributed to the overall project. In addition, the authorities have provided consistently helpful feedback. The Company and its extended team are working constantly to make sure that no stone is left unturned to help this remarkable new treatment become available for the vast number of men who are in need of safer more effective choices to manage their bothersome and distressing lower urinary tract BPH symptoms."
Fexapotide is an office injection that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 BPH patients with over 1600 injections administered including over 1200 Fexapotide administrations. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments.
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