The Clock Is Ticking For Nymox Pharma’s European Drug Application – Bet On A Rejection
Nymox drug, fexapotide, to treat enlarged prostate, is about to have its marketing application decided in Europe within a few months, and we’re betting on a rejection.
Nymox did two phase 3 trials for fexapotide in the US with a total of 1,000 patients testing throughout one year. Both trials failed to show improvement over placebo.
Years after the phase 3 trials, Nymox reported follow-up studies with positive data to those trials, but evidence shows it is unreliable data.
For Nymox’s follow-up studies, there was no independent verification party, no pre-specified endpoints, and it’s unlikely that a drug’s efficacy would take effect years later, after having no effect at one year.
Nymox switched from trying to get approval in the US to Europe, but recent events show Europe might actually be tougher to get approval.
Read full report on Seeking Alpha here.