Although there is skepticism toward the company management, particularly its secretive approach to providing information,ClinicalTrials.gov indicates a conclusion date for both phase 3 trials as April 2014. So it is likely we will have the verdict in 2Q2014.
A Google search indicates that many urologists involved in the trials( who are not paid consultants for the company) have publicly praised the ease of use and efficacy of NX-1207. The drug only has to do significantly better then the saline placebo in the phase3 studies, which seems highly likely. The independent safety review board has already cleared the drug. Hence, I see a high likelihood of FDA approval. Urology colleagues tell me there is a strong need for a simple, office based procedure for BPH, which afflicts 40% of men over 50. The procedure will almost certainly be a money maker for urologists, and there is a huge reservoir of symptomatic men who are afraid of surgery but would be eager for a simple office procedure, so a rapid ramp-up is very likely. Add on the possibility of an effective Rx for low grade prostate cancer, and I think you have a compelling risk reward scenario.
There are many ill elderly men with BPH and potentially low grade prostate ca that are not great surgical candidates.
This therapy would be ideal if it works.This alone makes it a money maker If it became a preferred treatment the rewards would be huge.
Clinical Trials only reports what NYMOX tells them. Reliance on that site for data is a mistake. Beginning of April they will show the reporting date one month later and they will do this for the rest of the year.
This goofball running this company is learning as he goes. There should be no reason to combine these two trials, or if there is a reason this was or should have been know long before now. These were two different trials and thus should be reported separately. If this joker can't get the results analyzed and reported any sooner than 6 months after the last data point something is WRONG!
I call that failure. Must have big advantage over current treatment. The test for comparator was against finasteride in phase 2 and the .125 dose was neutral The .25mg was the winner thus our present study.