Volume over 2 million. First one million mainly buying, second mainly shorting. Lets see where we end up.
The reason they have not filed is because the study is still ongoing. They had only one data point in which the drug was superior to the placebo and they and presumably the FDA wanted to make sure the improvement was maintained. I have quoted some of their previous PRs in which they said they will be following the patients and look at the data in April of 2016. This is the reason in the PR yesterday they cited only historical control data for prostate cancer as the placebo patients are still blinded. I assume the final data and their plans will be released shortly.
As far as I know they still need an EU trial for filling in EU. It could be a 100 patient study with 6 month end point and completed in a year. It would not stop them from filing a NDA withe FDA because the study would be done by the time the FDA date came up.
Yesterdays data was a potential game changer, imagine a drug given to older males which prevents BPH and prostate cancer both with no side effects. I could imagine every male in his 60s asking for it.
One aspect that is being overlooked in today's news is the relevance of this to prostate cancer treatment not prophylaxis. Prostate cancer particularly in its early stages arises at multiple sites and that is why the Sophiris approach of identifying each cancer site in the prostate and treating it is ludicrous. In our prostate cancer studies we injected the tumor site under ultrasound and although the tumor regressed there was always a possibility that the tumor at other sites could get bigger and cause clinical cancer. From today's study we know this does not happen and this virtually guarantees a successful phase three trial for prostate cancer.
Could we be waiting for another P3 data release (early July)? One more year of information that also includes a new group of patients that originally received the placebo
Rih, What new group are you referring to? Some new data is supposed to be coming out, in their prior statements they had talked about reviewing additional data in April so June/July seems to be the right time in conjunction with a possible partnership announcement.
Dr. A has been talking to FDA since the failed initial result and he would not have put money in the extension trials unless the FDA was receptive. The problem as I see it is that the FDA has never granted approval on the basis of two failed trials, even granting all the arguments about the placebo effect and would not like to start a precedent, so I am fairly certain the FDA will want another trial. It could be a small number of patients as safety is already established. there are ways to minimize the placebo effect such as a washout phase. Since EU needs a trial in EU patients I was thinking it was logical to do it in the EU.
I am hoping for a partnership announcement with a cash infusion and start of three trials, one for BPH and two for prostate cancer with the partner sharing/bearing the costs of the trials. Along with this I would like some followup on the results announced last July.
I think for EU they need a EU trial in addition. This is beginning to look like the Recordati deal, t would be funny if Recordati was the company again.
I don't think so; this is going to be a Recordati kind of deal with a company with EU presence paying cash and for an EU trial for EU rights. I think the only other places he can file without another trial would be Japan and China. He will probably say in the US he is talking to the FDA as he can not file without another trial, IMO
I looked at your last 20 posts and they are all the same. Guess this your way of feeling powerful, being abusive on anonymous boards. Based on your posts you have have a couple of thousand dollars worth of SPHS shares and you stoop to this. What a wasted life.
SPH has spewed all it had and it is an abject failure. The company will go bankrupt shortly but not until serial dilutions have bankrupted all the ostriches with their heads in the sand who still tout the company but are terrified inside. It takes a particularly stupid individual to come an brag about a failing competitor on the NYMX Board. For the sake of humanity please don't have children.
To be honest,I do not think the shares are a big issue for him. He owns enough of the company to make them meaningless in a relative sense. He is no spring chicken and I think is in a hurry, wants his cash and glory now.
We are all nervous and jittery and the increasing volume to the downside suggests some investors are bailing. I am no fan of Warren Buffet but agree with him when he said something to the effect that the stock market is a mechanism for transferring money from the impatient to the patient.
GL to us all.
I did not say a trial is going on I said discussion about the trial and when they announce a trial they will obviously announce an agreement and funding through BP.
My mistake about the Feb announcement, you are right it refers to the Recordati trail which is now over. The rest about looking at the BPH results in April still stands and is from a more recent update as below.
Jul 15: Nymox announces that an extension of two PIII have produced positive results. After 3.5 years, there were positive long-term improvements in symptoms of BPH, fewer BPH surgeries and a good safety profile. Nymox announced plans to take a look at the post-12-month data in April. Additional new blinded protocol data from the same pivotal studies was prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo .
Still implies to my mind further news out shortly.
I have made no secret of my belief that they will need a small EU trial for BPH both for EU approval and to increase their chances of FDA approval. I ran a search for new trials and this is what I came up with
Jul 15: Nymox now intends to meet with authorities with extension data and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories .
... approvals for fexapotide triflutate in various jurisdictions and territories . .... Feb 12: A European PIII trial is to start following discussions with the EMA. ... and no current drug treatment for their BPH and had an ongoing mean improvement ...
Ukmi nhs uk. This is the source of the information.
Suggests that there are ongoing discussions for an UK trial and as some other poster reported recently additional data on the BPH trials is coming soon.
Show me the line where it states the higher dose ablated the tumours and the non responders received the lower dose. The question was asked at the end but they detoured to higher doses per cancer. Don't believe me, ask SPHS or your gambler friend.