NYMX would get 20% and probably 40% penetration. EU has similar demographics and don't forget Japan and China. Basically you need annual earnings of around 750 million to justify a 10 billion cap.
one drug for a common affliction of all men. 50% of men over age 50, 80% of men over 80 have BPH. Men over 65 are increasing at the fastest rate in the western world. $2000 a shot, do the maths at PE of 15, probably too low.
Really? This is what you said then.
by aquasolutions4u • Jan 7, 2015 7:59 AM
If you have this stock better to get 38 cents on a dollar than zero. If you don't have it. Don't get sucked in by the shysters.
It was from one of their press releases. If you look through my last few posts I have quoted the press release and discussed this.
They were planning to look at BP H results in April this year, results of which should be announced shortly. They have to prove the extension results are maintained and not a fluke before filing.
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