FDA Panel Votes Against Nymox’s Kit Form of NTP Test

Panel says more data is required for the approval, including post-mortem verification and clarification of how to use the test results.Maywood”s Nymox Pharmaceutical (Nasdaq: NYMX) announced Monday that on Friday, July 15, an FDA advisory panel voted 5-2 against approval of the kit form of the company”s NTP test (AlzheimAlert).
However, AlzheimAlert is approved for sale in the U.S. as a laboratory testing service through the company”s clinical reference laboratory in New Jersey.
“We are very pleased to have had the opportunity to present the results of the blinded nine-center trial which showed that 89.5% of clinical cases of probable AD had elevated NTP and 91% of definite non-AD had normal NTP levels,” said Paul Averback, CEO of Nymox.
“The panel, however, felt that more data was required for approval, including, for example, post-mortem verification and clarification of how to use the test results. We anticipate working with FDA towards fulfilling the further data requirements that the agency may have in conjunction with the panel suggestions.”
At the close of trading Nymox shares were down $0.33 to $1.87.