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written by reader NYMOX

By Anonymous Questions, December 1, 2014

Dr KSS article on SOPHIRIS BIO INC. Dr KSS, I have been a NYMOX owner for years and lost badly in the recent FDA phase 3 failure. One doctor lost 2 million. I was struck by your saline placebo comment and I feel it did harm to the NYMOX FDA test outcome. I think it resulted in a temporary ”feeling of a fix” that is a false outcome, hurting the comparison with NX1207 patients. Several urologists were talking on the post FDA conference call in disbelief. Some had patients that benefited from NX1207 received before the FDA phase 3 tests (phase 2) and were highly elated before the outcome announced by FDA. Could big pharma have bought out FDA to protect other older existing treatments under patent in your opinion? NYMOX is seeking NX1207 approval in Europe through it’s investment partner corporation in Spain, so there may still be hope. What is your opinion?

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DrKSSMDPhD
December 2, 2014 10:47 am

Hi. Nymox has been up for discussion in the biotech threads here before (some months back). The group’s concerns were the lack of transparency in how the company is run, and also its highly murky finances, with unexplained infusions of cash coming from unexplained Caribbean sources. CEO ownership of shares was felt to be strangulatingly excessive and not in the company’s interests.

Pharma companies did not conspire with the FDA to fell Nymox’s agent. The drug failed very much on its own. The FDA had set forth guidance on what would be needed for approval, and the Nymox product did not meet them. The “high placebo response” rate isn’t exactly accurate in that, in the case of Sophiris, patients do get considerable improvement beyond what is imparted by injecting small pockets of saline into the prostate. The FDA would not respond to attempts at bribing except by filing criminal charges, and meanwhile, any success by Nymox would not affect the fortunes of a drug manufacturer in an adverse way. Drugs for BPH basically don’t work or are only minimally effective. Transrectal approaches will never totally supplant transurethral approaches; rather, the latter will still be invoked in severe cases.

I think it is highly risky to stay invested in Nymox, and I mainly feel that way because too little about it is credible and worthy of respect. There have been too many feints, dodges and odd actions in the run-up to the phase 3 failure. And even if the agent were to be approved in the EU, which I doubt, it will then be trampled by Sophiris, which has what I regard as the superior method. The urologists were irked mainly because they were looking forward to new income from a new office procedure.

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