Those days are long gone. Newly discovered biologics are being approved regularly. Recently FDA came out a with a statement on how it wants to expedite review of new biologics. The times are changing; the only thing that never changes is NYMX and Dr A. with constant paranoia, obfuscation and out right lies and blatant disregard of shareholder rights.
Assuming even if that is the case that does not explain the delay. If what you are saying is true DMC would grant a continue and recommend more trial subjects be recruited. It does not explain the delay unless you think NWBO is hiding the news.
Good Luck! I agree the company is not run professionally but hopefully this is more a function of Dr. A's personality rather than a problem with the drug.
In the conference call they stated they might not have to recruit 338 patients that it was events driven. Anybody with more statistical knowledge care to speculate as to how many additional patients they will have to implant; assuming similar results as in the past.
I do not believe this as long a shot as you think. It has worked in both prostate and liver cancer (admittedly only in animal models and the petri dish). I would think the chances are fair that its effective or worst case scenario has no effect.
All he has to do is sell shares make money and award himself more options and control more of the company. Are you and Bou paid by the company or just plain ignorant?
Kicking myself. I sold 10,1000 of NWBO in December at 3.8 to buy some more NYMX #$%$ as I thought the results would be out in Jan 2014. Guess what NWBO is now at 5.8 same price as NYMX.
The submission will not talk about the results at all. If you look at ASCO criteria they don't want results from incomplete trials. The way this is usually done is the submission will be about a new approach to treating inoperable cancer and will focus on the technicals of the process. The positive incomplete results will be announced separately and not at ASCO but everyone will be aware of them. Linda hinted as much when she stated there was a possibility that some results could be released at the same presentation she announced the ASCO effort.
Do you even read what you write?
You wrote a quote which supposedly is from the FDA telling the industry the DMC has no role in addressing unexpected issues but can help implement changes. Where does it say the DMC will decide to change the no. of of trial participants for statistical significance. Its talking about unexpected issues , changes for which are implemented with the help of the DMC.
In my experience people insulting other people on anonymous message boards are usually stupid and cowardly, particularly if they gives themselves grandiose names and do not know how to decipher common vernacular.
You are wrong about the DMC. It has no role in suggesting trial modification. They are there for the safety of patients. They stop trials for futility or dangerous side effects or for good results so placebo patients can cross over and benefit or recommend the trial goes on. The fact that its taking so long can be meaningless or taken as a minor positive.
I would be very curious to find the source of your assertion about the pathology of the P1 trial patients.
It cuts both ways. Agreed the new CFO would require a more lucrative deal but Dr. A would only do it if it was needed such as negotiating a deal. We also don't know the terms of Mr. Wolvins departure, if he is allowed to keep his options etc.
FDA Mulls Faster OK for High-Need Devices
WASHINGTON -- The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals.
The change the agency is considering would create more post-approval studies for products and bring more uncertain devices to the marketplace, Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health in Silver Spring, Md., said Thursday.
Shuren expressed concern that U.S. patients are increasingly waiting longer to gain access to certain devices because of burdens the FDA places on companies. He was speaking at an event hosted by the Pew Charitable Trusts, a nonprofit that lists one of its missions as making sure patients have timely access to safe and effective devices.
"We ensure devices are safe and effective, and that's protecting public health," Shuren said. "But we also have to promote public health, ensuring that there's timely access to those technologies, and facilitating innovation."
Shuren said makers of cardiac devices are starting to turn to countries outside of the U.S. and Europe to launch their products because of the barriers the FDA and other regulators have placed on approvals.
"A safe and effective technology may take longer to get to U.S. patients, and that's contrary to what we are about," he said.
The answer, he continued, is to turn to post-approval studies. While the FDA currently has tools to speed devices to market or require post-approval studies, each has shortcomings, Shuren said.
For example, the FDA can require post-approval studies for devices approved under the pre-market approval application process. However, the standard for approval is still a high bar to manufacturers and may not be quick for products with a high need.
Post-approval studies are harder for the FDA to require for its de novo classification process, which is an ex
I fully realize that results in labs and animals do not equate to results in humans but their prior results for trials/experiments with carcinoma cell lines do seem to indicate that NX1207 might work against localized cancer, prostatic and even liver. There is a decent chance that their phase two trial might be successful and proceed onto a phase three trial. The phase three trial might or might not work but the results of the phase two will provide a ( temporary?) boost to the share price.
These are my reasons for staying in the stock. Meaningful comments solicited.
With all that has happened recently I sat down and thought hard about this stock and I decided to stay the course for the following reasons.
First of I categorically do not trust the company and Dr.A. I think its a second rate company by any standard but unless you discount the results of all the trials that were performed in multiple centers I think they are on to something with NX1207.
If the results are what they are (I ran some statistical studies with their various result iterations )and although the analysis is not exactly scientific they are likely to come up with very similar results to their phase two studies with improvement in AUA score of 8-10 and increase in Qmax of around 2.6. While on this subject although we think of improvement in AUA scores as the most important criteria it is not necessarily the most important criteria. In most BPH studies even placebo gets an improvement of around 6 so 8-10 is not magical and will be roughly in the same ballpark as Flomax. In fact there was a recent letter by the FDA to the company that manufactures Flomax warning against its consumer advertisements which claimed that Flomax was the best drug in its class because of the AUA scores. The FDA letter went on to state that there was no evidence that improvement in AUA scores equated to increased patient comfort and there was no evidence that Flomax was best in class. The letter can be googled by the way.
If AUA is subjective then the best objective indicator is an improvement in Qmax and in this category NX1207 shines. Flomax gets an average improvement of 1.5ml/sec and NX1207 gets an improvement of around 2.6ml/sec. Even the Sophiris product does not get such an improvement in the Qmax with similar/ lesser improvements in the AUA score.