Nymox Reports Pre-NDA CMC Meeting with the FDA
Nymox Pharmaceutical Corporation (NYMX)
US:NASDAQ Investor Relations:
nymox.com/default.action?itemid=3
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Source: GlobeNewswire
HASBROUCK HEIGHTS, N.J., April 16, 2019 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced that it has held its pre-New Drug Application (NDA) Chemistry Manufacturing and Controls (CMC) meeting with the US Food and Drug Administration (FDA) regarding its lead product candidate Fexapotide Triflutate, a novel prostate injectable developed for the treatment of enlarged prostate (Benign Prostatic Hyperplasia, BPH). The purpose of the April 15 meeting was to discuss the CMC data package for Fexapotide, an important regulatory requirement prior to the NDA submission. Nymox is pleased to report that it considers the meeting was constructive and positive. The authorities did not raise any serious or unexpected issues with regard to Nymox’s CMC data package, which was submitted prior to the meeting. Mark Staples, Nymox’s VP of Chemistry, Manufacturing and Controls, commented: “We are pleased with the outcome of this important meeting and the feedback we got
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