I am cautiously optimistic but not quite sure of what they are doing with these new pivotal results. I know initially when they declared the initial phase three results Dr. A stated the drug performed as expected but the placebo response was higher than in previous trials and that is why the topline results were a failure. As per my conversations with other people on this board who had been in the trial a questionnaire was sent to all participants subsequently (to phase three results) asking them if they had participated in other therapies apart from NX1207 when in the trial. Since the trial lasted several years its logical to assume that the placebo patients tried other things while in the trial and those that did should ideally be no longer included in the analysis and I presume this is what they are doing now after excluding the noncompliant patients.
I do wonder though why would any of those placebo patients admit to being noncompliant as they were being paid to participate in the trial.
You have the right to be skeptical but you wont get in on the other side of 2. It will either be other side of ten cents or ten dollars. I personally think they would not have reteirated the results news again last week unless they were fairly confident of having something.
See transcripts dated July 17th, 2015. Most interesting part, he does not get paid until the company is solvent again.
The Company shall pay to Employee a salary at the rate of $600,000 US Dollars a year during the Employment Period, however Employee will forgo 100% of his salary until the Company receives a significant increase in its financing to expand its operations and execute its business plans at which time the Employee will have the option, at the Employee's sole discretion, to receive the cash salary above or to continue the equity compensation (based on the January 2015 stock price) detailed below under Section 3(d).
He makes a fortune if the SP goes up.
Restricted Stock. Effective on the date of this Agreement, Company shall immediately award and said shares shall immediately vest to Employee 3,000,000 shares of its “restricted stock”. The Company shall also award, and said shares shall immediately vest
upon award, an additional 250,000 shares of its "restricted stock" for each month that Employee remains in the employ of the Company. In the event there is a corporate restructure whereby the Employee is no longer Chairman of the Board of Directors, President and/or Chief Executive Officer, or if the Company is bought out, then all of Employee’s non-vested stock that would vest under this agreement if the Employee would have remained Chairman of the Board of Directors, President and/or Chief Executive Officer for the term of this agreement will immediately vest and become due the Employee. The Employee does not need to take any action to receive the shares of stock, except to make such demand in writing to the transfer agent of the Company.
The reason they are not out is because Dr. A was waiting for his new CEO contract. Signed end of last week, so results should be out by next weekend.
That tells me what kind of an urologist you are. Study has not been submitted to the FDA; its a long time off before that happens.
I see your ID was created this week; go away short!
What is the source for your 978 number. Interesting, from what I remember its a few less than when they announced the failed initial results. I cant find that information anywhere. Do you have any idea of the number in the Nov 2014 press release? Thanks
I am a longtime investor in NYMX and long a lot of stock but the issue of the discrepancy in results does bother me.
FYI the results the second time were still blinded and in fact even now the company is blinded. This is standard practice. There is a committee that oversees the trial that communicates with the statisticians.
What bothers me are two issues.
Firstly in November and now the drug has worked as planned only the placebo patients had higher scores then and less now. Why? There is only a five month gap between the two results in a trial which has lasted several years so time is not the issue.
I know the company after failure the first time sent out a questionnaire to all participants asking if they had taken other medications/treatments for BPH. It might be that some placebo patients admitted to trying other measures. Initially I was thinking that they dropped the placebo patients who had violated protocol and that is why they had significant results this time. Although dropping patients who violated protocol is not easily done in an intent to treat trial. Also in that case the number of subjects now in the present extension would be less than the number in November if they dropped some subjects but the number is higher. In Nov. they said 973 patients (582 treatment arm and 391 placebo) and now they have 978 subjects so instead of dropping they have five more subjects. I am not quite sure what to make of it.
This is the only thing keeping this stock from flying. Once this issue is resolved the stock will fly or tank depending upon market perception.
In all fairness the trial was outstanding in a number of respects. First the numbers almost a thousand patients in both trials that is a huge number enough to answer any question about safety or efficacy. Secondly the minimal no. of dropouts; total subjects in both trials were 997 (498 in one and 499 in the second one) and they were able to track 978 subjects over five years - a dropout rate of less than 2%-outstanding and some of them might be deaths in this age group. Thirdly an intent to treat trial, this is the one most difficult to fudge and no one in big pharma does them these days.
You can call the company and confirm it but I believe both trials individually achieved statistical significance. If you know this company's history it has been reprimanded by the FDA in the remote past for unjustified claims and has also been sued for this. As a result, they are very closemouthed and careful with their claims and PR now. If they say they will be filling for regulatory approval, it is very likely they have been in touch with FDA and have been given tacit approval to go ahead and file for a NDA.
Hi welllookyhere, good to see your post here among all these newbies.
I have corresponded with recordati and NYMX about this. Recordati was very frank about it. Recordati has given up all rights to the drug and if they want it back they will have to pay for it. As I understand NYMX is not interested in Recordati any longer since they dragged their feet on the trial.
IMHO watch for US and ROW licensing deal for BPH in the next three months and after that an abbreviated phase three for prostate cancer. The ROW deal will likely have an European trial for BPH attached to it.
I agree completely, this stock is now my main holding and now its just a matter of holding patiently. The biggest risk with this stock is selling too early as there will be a number of catalysts to make the SP rise. GLU
Agree, Licensing deal before NDA is the way it should be done. BP is hungry for a new drug and I think its a matter of them performing their DD before a deal is anounced.