Idiots on parade. Interesting.
WRB, this is a line used by Monkey brains aka munkus. Instead of accusing others of multiple aliases look at yourself. Take your own advice and have no more children. One of you is enough entertainment.
You are right SPHs is not the same; its a piece of garbage compared to NYMX. The company has diluted so many times and even changed its name to hide its past.
My post was about the BPH indication being dormant. If and when prostate cancer trial begins NYMX will be doing a phase three pivotal trail while SPHS will start with a proof of concept trial AKA phase two and will be behind NYMX.
So today after the Recordati announcement NX1207 for BPH is finally laid to rest. The company keeps on hinting at a possible deal for prostate cancer based on its failed/inconclusive prostate cancer phase two trial but nothing as yet. They have been hinting at it for the last one year so I doubt its going to happen anytime soon. Sophiris is in exactly the same situation.
My sympathies and commiserations to the patient, longsuffering investors of both companies.
Thanks. I listened to it. It was not up this morning.
Apart from the trial they said they are discontinuing the development of the drug; so I guess they are handing back the European rights to Nymox.
It will be interesting to know what the results are from the trial so far if NYMOX will ever tell us.
Did you listen to the conference call, if so, can you write what was said. The slides on their website do not give any information. Thanks.
This is the guy who used to come on the NYMOX Board and rub NYMOX investors face in the mud after the NYMOX trial failed.
How does it feel to be on the other side?
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.