This is why I think the EU trails is a big deal, even the placebo patients get Flomax. The only problem is that its only single blind not double blind. In US you need double blind studies.
We can speculate. Typically placebo responders in previous trial have averaged round 5 and the NX1207 patients between 7-8. Typically trials are powered at 80% so I am assuming a two point difference would allow the trial to succeed.
As per Dr. A in the Conf. Call, the drug performed as expected but the placebo was higher and that is what failed the trial. Sheer speculation but assuming say the drug averaged around 7 and the placebo at around 6 ( the drug was superior to the placebo at all times).
They had a number of very high placebo responders; say 20 placebo patients with scores of 25 ie 20 points more than they should have ie an 20 into 20 ie 400 extra points over the placebo group. this translates into an extra point per placebo patient ie 6 instead of 5 per placebo patient.
This is enough to move the trial from success to failure.
This is just speculation but my point is a limited no. of high scoring placebo patients determine the outcome of the trial. If they can be thrown out or as in my previous post some of the low responding patients who took other drugs can be thrown out or a combination of both; the results can change.
Since you know so much tell me what is the current status of the negotiations for prostate cancer for US rights that you talked about in one of your posts.
Thanks for the information; that's helpful.
Regarding the Recordati trial, I E mailed them and they said they would announce a final decision on Feb12th on their Investor Conference Call. I believe NYMX will continue the trial if Recordati pulls out as the bulk of the money has already been spent by Recordati.
The interesting thing about the Recordati trial is that its only a single blind trial and the comparator is a medication not a placebo. The patients who are getting the sham injection do not get an intraprostatic saline injection so there is no prostatic discomfort or blood in the urine so less convincing for the placebo patient.
Its also being conducted at a few university centers.
Research has shown that the placebo effect is more powerful when there is an injection involved and large number of centers are involved and when its double blind as compared to single blind. Its very possible this trial might succeed as I believe the NYMOX trial also showed a difference at all time points but was not statistically significant.
and yet continued on the trial in order to get paid or for whatever reason,
Do you have any information on how much they were paid per visit?
How about asked your other moniker the question. Do you want to repost under aqua?
I believe if they ask trial patients in a questionnaire as to who took other BPH medications the FDA will ask them to ask all subjects not just the placebo patients. If the subjects give honest answers and that is a big if; logically speaking the people likely to take medications are the once who did not improve much with the Nymox drug and thus had low scores.This is all conjecture but if their scores are removed the overall score for the shot takers will improve as the low scorers would be taken out.
The wild card is the people who improved significantly with the placebo.
My understanding is that they have 15-16 patients with an improvement of 25 points in the placebo group; if they can throw them out they can get an extra 1.5 point improvement which is all they need for the trial to be statistically meaningful; particularly as there are no safety issues.
They should already know who was in the trial and used additional medications. If they had permission from the pateints when they entered the trial they can easily look up pharmacy records and find out. There are companies who can do this fro them.
If they can throw some of those placebo patients out with high scores or alternatively the low scoring treatment patients( who took additional medications) and improve the score of the treated patients they might have a chance.
Can't wait to see the summary of results etc !
NYMX in its entire existence has never published results of any trial. This is one of the reasons people think it is a scam.
If securities were pledged they have to be disclosed and none were.
Of the two board members who left, one was a buddy of his a GP and second their legal consul who as far as I know still works for NYMX, so I am not sure how significant this news is.
What did Paul tell you is going to happen in these 30 days. He wants the price up so the class action suit can be dismissed. Is he finally going to sign a deal for prostate cancer or come out and tell us the drug works for a subsection of the population?
It is more honest for you to post under your real name WRB; all of us know this is you.
One thing the Co. is not doing is going bankrupt; they have zero debt and covenant with LG which seems to be working.
FDA has nothing to do with them. The competitor vanished because of similar unsuccessful results.
Tell me one thing; the stock has collapsed and have you had one investor conference call to tell you what steps the company is taking to regain shareholder value. Do you think Paul owes that to the shareholders ? If they can not get him on anything else they will get him on dereliction of CEO responsibilities; although it means nothing as the insurance company will pay and will not affect NYMOX.
Wonder who is buying; interesting the last sec. filing after the phase three results announcement mentioned possible sale of securities. This has been in planning for some time. Wonder if LG is the buyer?
Sophiris Trial fails! See below.
What would be interesting to find out is if the drug did not meet efficacy endpoints because it was not effective or because of the high placebo response. People seem to think it was the former unlike NX1207 which might give it another chance. Explains the buying since yesterday.
Sophiris Bio Inc. (SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of symptoms of benign prostatic hyperplasia (BPH, enlarged prostate) and the treatment of localized prostate cancer, today announced findings from an administrative interim analysis of efficacy in its ongoing Phase 3 “PLUS-1” trial of PRX302 as a treatment for lower urinary tract symptoms of BPH. The Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved. This administrative interim analysis was conducted specifically for planning subsequent clinical trials. The ongoing “PLUS-1” study is unaffected by this recommendation, and all patients in the study will continue to be followed to enable the evaluation of the primary efficacy endpoint at 52 weeks.
You are no scientist! Look at your own posts for the last ten years. they are arrogant,abusive and reek of self aggrandisement.These are not the hallmarks of a scientist, particularly of the stature you claim for yourself. You did the same thing on the ARIAD board.
What is your motive in posting here for the last five years?
You enjoy being tough on anonymous boards and use mutiple aliases, all the hallmarksof a coward. This says enough about you.
You are no scientist!
What is your motive in posting here for the last five years.
You enjoy being tough on anonymous boards and use mutiple aliases, all the hallmarksof being a coward. This says enough about you.
You are the one on parade strutting around for five years parading your knowledge on this board. What has your purpose been for the last five years and before that the Ariad board? No respectable pharma would allow anyone in a responsible position to prattle on these kind of message boards. There are strict rules against this kind of stuff. Lets hear who do you work for and in what position; please no more talk about being a scientist; you bring disrepute to the word.