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He is a good guy and I bet you will occasionally see his crazy 8 purchases. Pete is a huge $NVLX supporter. No Doubt...
And shame on anyone who tries to insinuate this is a scam to scare off investors. But soon smart money will learn of this company. Smart money is not so easily manipulated.
Yep, that's the insight he provided us a while back. Thanks...
And why would I sell? Because a short wrote an article? I think not... I await news from Dr Von Hoff, a humanitarian, and I do not follow the opinions of a self-interested short. Never...
Shorts writing articles for purposes of self-interest. If you are patient, you will hear from Pete again. :). He is incommunicado right now.
Seems a Seeking Alpha article just released... Readers must be easily persuaded. LOL...
What I do notice is all of these speakers are speaking to written abstracts. I don't know how it works but since we don't have any knowledge yet of written results, they may have registered under the category of "late breaking data" by the deadline of November 20th since these trials were done so recently.
Time will tell... Only a couple of weeks before we know for certain.
http://gicasym.org/abstracts
Dr Von Hoff spoke 2013 at this same symposium regarding Abraxane's phase3 trial results. We are in attendance this year. He recently conducted preclinicals that had "exceptionally" good results.
Would love to follow the links you used that show no evidence of Von Hoff speaking. I find nothing regarding this year's agenda. However, I have provided the 2013 agenda where Dr Von Hoff did share clinical results.
No reason to not expect the same to happen this year. Connect the dots...
http://gicasym.org/2013-meeting-program
http://www.nuvilex.com/latest-news/137-nuvilex-announces-preliminary-data-from-preclinical-study-of-effects-of-its-pancreatic-cancer-treatment-on-ascites-fluid-formation
I agree...
I believe efood alerted us a few months back to this annual meeting that Dr Von Hoff usually attends. I also believe that in 2013 Dr Von Hoff shared the Abraxane results at this same symposium and before year end, Celgene had FDA approval.
I think Von Hoff will assist with Fast Track Approval since his study was primarily for "quality of life" improvements with Cell-in-a-Box(R) technology. This will get to patients must faster with him driving this process.
This is great news!
Very nice tutt, thanks...
Thanks...
Great article, Setay. A nice reread...
Looking forward to hear from Dr Von Hoff and the PCRT regarding preclinical results and subsequent trials.
Nice to start the year closing GREEN $NVLX
I am enjoying our first day of trading in 2015! Happy Nuvilex Year, all!
$NVLX - We now have over 500 followers here!
The FDA gives ODD to credible treatments. That makes this product marketable... They see it is a viable treatment, marketable...
Not selling for a long while. I will see this to market before I sell. Market is very plausible with recent Orphan Drug Designation, upcoming trials and Dr Von Hoff's golden touch. :)
Just getting started. Trials set to commence this year will be significant for this company. I see a lot of market potential here.
I have a much greater vision for this technology.
http://www.nuvilex.com/shareholder-updates
$NVLX
Probably won't get the audience here to accomplish that objective, lots of true longs here. I bought today on the ASK. However, I do believe Dr Von Hoff will get the attention of many when TD2 shares the ascites preclinical trial results... He will get the attention of those who have deep pockets.
Confident that the value of Cell-in-a-Box(R) will be realized in due time...
Nuvilex has exclusive rights to a delivery system that has now been tested with 2 FDA drugs. The first trials went well and the delivery system, Cell-in-a-Box(R), proved to reduce toxicity from the drug ifosfamide. So yes, I do believe this company to be worth that much and more....
Happy New Year, Bill! I am looking forward to getting some trials started next year... Just around the corner.
:)
Absolutely.. Things slow down during this time of year and it is good to take advantage of it and rest. Next year is just around the corner... Looking forward to trials in the upcoming year...
No...
I always appreciate you being straight up. I do have to say, however, just because something is legal does not make it right...
Here is some good info on how shorting hurts others, especially the company and its shareholders. But we do live in a world where people think as long as you make money, it's all good. I could not agree less..
Eventhough the SEC has passed legislation to protect shareholder value, it is not enforced...
http://www.sec.gov/news/press/2010/2010-26.htm
So true... nothing lasts forever though. The tide will change. In the meantime, I will just go along for the ride and not concern myself with the PPS. Just too volatile right now with all the ATM uses... I can play it like this because I do not need the money I have invested here...don't take risks with my livelihood...Can wait for the big payoff which will come later...pretty confident about the long term possible gains here with the progress the company is making...
I think most people do not have the patience for this stock unless they are trading or have a Stong belief in the long term potential. It will be interesting to see who is still around when we complete trials...
Hear, hear! You are on fire today, Bill...
We always have a choice. I will hold long after this reaches $1. I own only what I can afford to treat as a savings. So I never worry when this drops because the company continues to progress forward. I understand not everyone operates this way. It is the week of Christmas and people want money to spend.
I don't begrudge anyone whoever they are. I have made peace with this being the way the game is played. But I walk to a different drummer and money is not king in my world, honestly...
However, we all need money to live so I am working towards a nice retirement here. Either way, it is all good...
It appears the nature of the business provides a good arena for traders to flourish. It is this trading behavior that is the problem with the current pps. It is not what the company is doing in terms of progress toward milestones. And it does cost money to get us there..
Even Celgene traded for pennies at one time. This too will pass...
You are right. Just the name of the game until we get to patients and then to market...
You have to read the article not just the date to understand what he is getting at here...
Nice, Bill. Thanks and Happy Holidays to you...
Nice article to refer to, rudy. This is very encouraging as Ken W has been a man of his word so far...
Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patient
NEW YORK, NY--(Marketwired - May 23, 2014) - Nuvilex (OTCQB: NVLX) is calling it a "two pronged attack" on pancreatic cancer, but investors may be calling it an "end-around" or another avenue of sorts, a quicker avenue to FDA approval. This week Nuvilex peeled back another layer of its work with pancreatic cancer, and this time it was to tell the market that the well-respected Translational Drug Development (TD2) will be studying the company's pancreatic cancer treatment, the combination of Cell-in-a-Box®/ifosfamide, for the deadly disease. TD2 will study an area of great interest to the Food and Drug Administration (FDA), and an area that may be key to the FDA granting accelerated approval -- "quality of life."
Nuvilex and TD2 have begun preparing for US-based preclinical and then clinical studies on the unbearable pain and the accumulation of fluid, referred to as ascites, in the abdominal cavity. These are two commonly occurring symptoms associated with advanced pancreatic cancer as well as other abdominal cancers.
In two earlier Phase I/II clinical trials, Nuvilex's pancreatic cancer treatment was shown to reduce the size of tumors in a significant portion of those patients being treated, and thereby reduced their pain, improved their quality of life, and did so with no negative side-effects. Nuvilex and TD2 may very well be on the path to proving that the combination of Cell-in-a-Box/ifosfamide can benefit those suffering from pancreatic cancer and all other abdominal cancers where the growth of tumors is causing intense pain and where ascites is prevalent.
Nuvilex could be about to demonstrate a real breakthrough for cancer patients and increase their willingness to live with an improved "quality of life." This "quality of life" angle is a much talked about topic inside the FDA, and is a basis for accelerated approval if the studies performed by TD2 appear to provide a "clinical benefit." Accelerated approval is based on a surrogate endpoint that is reasonably likely to predict a "clinical benefit," such as prolonged life or a better "quality of life."
Although improvement in survival (being developed in Nuvilex's Phase 2b) is the gold standard, a better "quality of life" is an acceptable bases for regular approval of a drug or biological product. Drug and biological product approvals that are based on a better "quality of life" have generally included drugs or biological products that prevent or ameliorate cancer-related symptoms, including, those that prevent or relieve pain.
So, let's set the scene for investors. Preclinical studies can be relatively quick to discern a potential "clinical benefit" or to recognize an endpoint such as any amount of shrinkage in a tumor that can lead to the relief of associated pain, and the duration of time for the onset of ascites with and without the use of Nuvilex's Cell-in-a-Box/ifosfamide combination. If TD2 is successful, the company could then enter Phase 1 clinical trials in humans and again, these trials could be relatively short, and if they too are successful, Nuvilex could receive accelerated approval using Phase 1 data. Yes, companies have been granted accelerated approval based solely on Phase 1 data as the designation is designed for drugs or biological products in early phase trials.
TD2 and its world class Pancreatic Cancer Research Team (PCRT) obviously saw the results from earlier Phase I/II trials and feel Nuvilex's pancreatic cancer treatment can make a difference in the "quality of life" for those suffering what will be the second leading cancer killer in the US by 2030 according to a new report published this week in the American Association for Cancer Research's journal.
Flippers create the pump and dump. They buy when low and sell on news. They encourage others to sell to manipulate the price and help them make their pennies. It is very clear to me what is happening here.
ODD does change things for Nuvilex but quite frankly, the flippers are winning this pps game for now. I will continue to hold and watch the flippers take advantage of this poorly regulated OTC.
Fortunately, the FDA is aware and supportive of Cell-in-a-Box(R) technology., We have trials upcoming and patients will start getting treatment.
It is certainly not easy being long here especially with gloating from flippers who could care less about this company, the technology and the people for whom it could benefit. However, longs do care and know that this technology will prevail over all these attacks.
I will still be here when that happens...
I think some do take advantage of news to flip for gains. Probably bought Friday, knew news was coming today and made some pennies. The short report will tell all...
Great post, Bill...
Unless we get Fast Track Approval with Dr Von Hoff's trials. He appears to be driven and he has the means to make it happen. FDA ODD in about 60 days from application. Furthermore, we are now on the FDAs radar under leadership that is looking to get drugs to patients more quickly. Things appear to be moving slow but quite a lot of business has been accomplished; new facility to market CiaB, ODD FDA approved, trials for quality of life under design by Dr Von Hoff and Phase 2b to commence 1Q15. A lot can happen in the next 6 months...