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This S3 is no surprise ...this is old news...
Nuvilex Enters Into an At the Market Banking Agreement With Chardan Capital Markets
and when did we enter into this agreement...May 29, 2014 ...so this is the shelf filing for that agreement...
what did long term investors think this agreement was about when it was enacted...selling shares at market value to fund Nuvilex's future trials...is there any doubt about that...no...
and how many companies file a shelf...most...
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S3 finally filed for the at the market banking agreement with Chardan Capital...good because it takes a little while for the sec to complete what it needs to do...but it is good we have it filed now so when the time comes we can be ready to fund the Phase 2b...getting all our ducks in a row aren't we...good job Waggoner...
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I don't see anyone dumping ...I have seen nothing but RELENTLESS BUYING the last week...all on SUBSTANTIAL NEWS...I can't wait for next week to find out what SUBSTANTIAL NEWS we get...so much more SUBSTANTIAL NEWS to come out...and Nuvilex seems to like Mondays for PR's now... and Tuesdays and Wednesdays...oh and by the way they still like Thursdays and now getting news on Fridays...wow there must be a lot of news building up for them to get out for their shareholders...getting to be exciting times at this NUVILEX...
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I am not going to issue an apology because I know of another reason that Nuvilex and the SEC among other entities have been in contact...and you are right it has nothing to do with the CTO...
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SEC today explains the TOC..We already knew about all of this when the 10K came out and we read the whole thing...this is nothing new...just following up by Nuvilex with the sec which is what any good company would do...and any smart company would keep the figures with the partnerships private and out of any competitors hands...thank you Waggoner for being so diligent with our breakthrough company here...so happy we have a CEO for a lawyer that knows so much about so much...
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I don't need to investigate because I read everything on the amendments to the 10k...so I am good to go...but thanks for your DD...
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CTO reason for SEC contact...and the 2 SEC documents today explains the CTO...between Nuvilex and the partnering for the beginning of the Diabetes studies...hence the CTO ...so this is great...Nuvilex is moving ahead with full steam...
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If progress is a pump and dump then so be it. If announcing news of worldwide licenses that will lead to treatments and cures is a pump and dump then so be it. If telling the market what you're doing to extend lives and improve patient's quality of life is a pump and dump so be it. I guess a public company is just supposed to go about its business and never talk about it to its shareholders... leaving them in the dark. At least this way they'd never be accused of being a pump and dump, but I bet if they said nothing, then they'd be accused of having failed trials or pre-clinical studies.
These German animals we are about to license more closely mimic Type 1 diabetes in humans than any other model systems available world-wide...how about that for breakthrough technology...and Nuvilex will own the worldwide rights to them...
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THIS WILL BE NEXT...
In the majority of diabetes animal models used by others, the diabetic condition is induced by employing drugs to destroy the normal insulin-producing capability of the pancreas in those animals. The University of Munich (“UOM”) in Germany operates a €5-million animal farm that houses animals for research purposes. Scientists at the UOM have developed unique transgenic mouse and pig models of diabetes. Through the use of gene transfer technologies, mice and pigs that are diabetic at birth have been developed. These model systems more closely mimic Type 1 diabetes in humans than any other model systems available world-wide. Through introductions by Dr. Günzburg and Dr. Salmons, the investigators at UOM have agreed to join the Nuvilex team in its efforts to develop a treatment for diabetes based on the Cell-in-a-Box® technology. The Company plans to enter into a research agreement with the UOM in the near term. However, no assurance can be made that such an agreement will be entered into between the Company and the UOM.
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the last thing to get is the German Diabetic pigs and mice...understand these are not injected...they developed them to be BORN WITH DIABETES...that is huge for Nuvilex to be able to acquire the rights for these animals...that will be the next news....getting so exciting ...
wow things are moving so fast...only going to get better from here on out...
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Nuvilex Secures Worldwide License for Insulin-Producing Cells From University of Technology, Sydney, for Use in Developing Diabetes Treatment
Governments have called for better treatments and faster approvals for Diabetes because of all the money spent on treating diabetes and its many symptoms so they are not going to sit back or put on hold something like Cell_in_a_Box...we already have PROOF OF CONCEPT...mice went 6 months WITH NO SIDE EFFECTS and without needing insulin...
things are moving fast and about to get faster....
GO NUVILEX
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Nuvilex will get over a dollar soon enough...give it time...
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Yes it is huge NEWS for Nuvilex...this is what I have been waiting for...and I knew it would be Ann Simpson because she has had a commercial relationship with Austrianova for quite a while...She will be invaluable to Nuvilex...I know everyone is waiting for the TD2 Study Results...but I am so excited about this...there is only one piece left which is the German Diabetes mice and pigs and then we have the whole package to push forward with help for Type 1 Diabetes...the Diabetes IS going to be the game changer for Nuvilex...
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Nuvilex Secures Worldwide License for Insulin-Producing Cells From University of Technology, Sydney, for Use in Developing Diabetes Treatment
SILVER SPRING, Md., Oct. 16, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company developing cell and gene therapy solutions for the treatment of diseases, announced today that it has entered into a license with the University of Technology in Sydney, Australia (UTS), that grants Nuvilex the worldwide rights to use human insulin-producing cells, termed "Melligen" cells, developed by Prof. Ann Simpson and her colleagues at UTS for the development of a treatment for insulin-dependent (Type 1 or juvenile-onset) diabetes. Type 1 diabetics are unable to produce the insulin required to transport glucose (blood sugar) from the blood to the inside of cells where it is used as a source of energy. The beta islet cells of the pancreas (Islets of Langerhans) of Type 1 diabetics that normally produce insulin have been destroyed by an autoimmune disease.
Prof. Simpson said of the opportunity to further the Melligen cell line, "I am pleased that after many years of diabetes research at UTS, Nuvilex will now be developing this technology for commercialization to a global market. My team and I are excited by the prospect of working with Nuvilex to eliminate daily injections for insulin-dependent diabetic patients."
Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "The execution of this exclusive worldwide license with UTS for the use of the Melligen cells represents a major milestone in Nuvilex's efforts to develop a treatment for Type 1 diabetes. This is a disease that affects millions of individuals around the world. Some of the complications diabetics suffer from are eye disease, foot and leg problems, kidney disease and cardiovascular disease. These complications can be dangerous and even life-threatening. If we are successful, those inflicted with Type 1 diabetes will be freed from depending on daily insulin injections or the use of insulin pumps as well as the constant need to monitor their blood glucose levels and modify their diets."
Melligen cells were originally derived from a human liver cancer cell line. Use of the Melligen cells is contingent upon whether they form tumors when implanted into animals -- in other words, whether they are tumorigenic. Experiments will be carried out at the University of Veterinary Medicine in Vienna, Austria, under the leadership of Prof. Dr. Walter H. Gunzburg, a Professor of Virology at that university and the Chief Scientific Officer of Nuvilex and the Chairman and Chief Technology Officer of Nuvilex's partner companies, SG Austria and Austrianova. These experiments are designed to determine whether or not the Melligen cells are tumorigenic. If the Melligen cells prove to be tumorigenic, attempts will be made to genetically modify them so that they are no longer tumorigenic or an alternative non-tumorigenic insulin-producing cell line will be developed.
If the Melligen cells are not tumorigenic, Nuvilex plans to have them encapsulated using the novel and proprietary Cell-in-a-Box(R) cellulose-based live cell technology as part of its planned treatment for diabetes. It is believed that animal testing of the encapsulated Melligen cells will prove that they are capable of producing insulin "on demand" in diabetic animals. As blood glucose levels rise in animals implanted with Melligen cells, these cells will produce increasing amounts of insulin in response. When blood glucose levels fall, less insulin will be produced by the Melligen cells. Ultimately, encapsulated Melligen cells will be placed into patients with Type 1 diabetes where, hopefully, they will serve as a form of "bio-artificial pancreas." In laboratory studies, Melligen cells have been shown to respond directly to the amount of glucose in their surroundings. They have already been successfully encapsulated using the Cell-in-a-Box(R) technology.
Mr. Waggoner stated further, "Nuvilex's Cell-in-a-Box(R)-based treatment, which will serve as a type of bio-artificial pancreas, will differ from those being developed by other companies in a number of ways. First, unlike the efforts of other companies, the cells Nuvilex will be using are not obtained from the pancreas - they are not insulin-producing pancreatic beta islet cells. Significant difficulties have been encountered in keeping such islet cells alive and functioning after they have been implanted inside the body. Second, we believe the cellulose-based Cell-in-a-Box(R) capsules are more capable of maintaining the lifespan and function of the encapsulated cells inside the body than are the other cell encapsulation materials, such as alginate (derived from seaweed), used by others. Third, when present in the body, Cell-in-a-Box(R) capsules do not cause irritation or inflammation of surrounding tissues. Fourth, these capsules do not break down even after long periods of time (greater than 2 years) after implantation in the body. Finally, the Cell-in-a-Box(R) capsules do not elicit a response from the body's immune system that would destroy the capsules and the insulin-producing cells inside them. In our opinion, similar statements cannot be made for other diabetes treatments based on live cell encapsulation that are being developed anywhere in the world in an effort to produce a long-lasting bio-artificial pancreas."
Nuvlix put the CTO out just like a lot of companies do...exhibit 10.1 and 10.2 is with BBB and BAVARIAN NORDIC....and exhibit 10.6 is the consulting agreement with Vin-de-Bona Trading Company Pte Ltd....which is Salmons and Gunzburg...and exhibit 10.7 is the Master Consultancy Agreement Between
Nuvilex, Inc. And BB Biotech Consulting GmbH...
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Nuvilex might be ready to announce the Diabetes...looks like tying up loose ends with all the legal stuff going on for acquiring what we need for the diabetes ....look through the 10k ....
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I have been in bio's before and quite a few of them and I know the excitement that can build before the FDA has even given their answer...
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A press release is a PR which comes directly from the company about the company...it is company news...no different with Nuvilex...may be a penny stock but it is definitely NOT a penny company...
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TD2 Results...seriously what if they are seeing remission with the mice...could you imagine going into a human trial with those results...not just slowing of ascites but remission...they would fill that patient roster so fast it would make their head spin...
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TD2 Results...could you imagine REMISSION...taking longer than I thought...the longer the better...
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I don't see Nuvilex going negative for the day....
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Everything Nuvlilex does is linked together now... Von Hoff...Gunzburg being hired by Nuvilex...Lohr chairman of the Scientific BOD...
TD2 Study Results are going to be awesome...
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it is a big deal...Hoff has a lot of pull with the FDA...
go Nuvilex
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there is no PR out there on Nuvilex applying to the FDA for anything ever before...based on the phase 1/2 trials or not...so this is brand new never done before news...and they don't need anything new to give to the FDA to gain approval for ODD...
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If we receive an early or even on time approval from the EMA that will speed up the approval from the FDA now that they collaborate together...
and yes if you know your DD and know that everything that will be coming out in the way of a PR is going to be pertinent to the pps ...it is the right time to buy...and this stock is not going to .10 so if anyone wants to own it now is the time to buy...
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Nuvilex Applies to FDA for Orphan Drug Designation for Its Cell-in-a-Box(R) Treatment for Pancreatic Cancer
SILVER SPRING, Md., Oct. 13, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its Cell-in-a-Box(R) treatment for pancreatic cancer. If granted, Orphan Drug Designation in the United States will provide Nuvilex special development and commercial assistance from the FDA, including a 7 year period of marketing exclusivity. This latest submission of Nuvilex's pancreatic cancer treatment for the Orphan Drug Designation follows the application Nuvilex recently made to the European Medicines Agency (EMA) in September, 2014.
Nuvilex's pancreatic cancer treatment combines the Cell-in-a-Box(R) cellulose-based live cell encapsulation technology with low doses of the anticancer "prodrug" ifosfamide to provide "targeted chemotherapy" to patients suffering from pancreatic cancer. The cells that are enclosed in pin-head-sized capsules during the Cell-in-a-Box(R) encapsulation process convert ifosfamide into its cancer-killing form at or near the site of the tumor to increase the efficiency and effectiveness of a patient's treatment.
"Submission for Orphan Drug Designation in the U.S. is the next logical step for the development of Nuvilex's pancreatic cancer treatment, and we look forward to hearing back from the FDA regarding our application," commented Kenneth L. Waggoner, Nuvilex's Chief Executive Officer and President.
Orphan Drug Designation in the United States is given to drugs or treatments for "rare," life-threatening diseases. In the United States a rare disease is defined as one that is diagnosed in less than 200,000 individuals per year. According to incidence estimates, the prevalence of pancreatic cancer in the United States is less than 50,000 cases annually. As in Europe, there is no doubt that pancreatic cancer is a life-threatening disease in the United States. Even with the best available chemotherapy, those with advanced pancreatic cancer are destined to live less than one year on average, and the 5-year survival rate is less than 7%. On these bases alone, Nuvilex's pancreatic cancer treatment qualifies for consideration by the FDA for Orphan Drug Designation.
Nuvlilex...it is the right time to buy...
"The turn could come next week, or they might be more turmoil to go. We will see. In any case, if you don't take advantage of this downturn, one month from now you'll be wondering why you didn't have more foresight."
http://www.otcjournal.com/Why-Is-My-Market-Crashing/af/archive/20141011-1/
Nuvilex and Diabetes...Could this be Nuvilex's future...
Marijuana: The next diabetes drug?
http://www.cnn.com/2013/05/23/health/time-marijuana-diabetes/index.html
Nuvilex acquiring the worldwide rights to the Human Cell Line for Diabetes that was developed...keep an eye on this
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Nuvilex and Diabetes
http://www.scientificamerican.com/article/a-diabetes-cliffhanger/?page=1
Nuvilex acquiring the worldwide rights to the Human Cell Line for Diabetes that was developed...keep an eye on this
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I have been talking about this a lot for a while now...
Nuvilex acquiring the worldwide rights to the Human Cell Line for Diabetes that was developed...keep an eye on this because this is where the real money is for Nuvilex...we are not using embryonic stem cells...we have encapsulation to protect the immune system already...we have a delivery system already...all protected by patents...we should have the signatures any day now to own these rights...and the collaboration to acquire the rights to the German mice and pigs developed that mimic human Diabetes to the tee...the ones we will be using in our studies...that should be finalized soon also...so the one thing we were missing is the cells...but not any longer...Diabetes will be where the big money is for Nuvilex...all the big pharma are working to find a cure for type 1 Diabetes...I wonder which one will be keeping an eye on Nuvilex...
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Yes Nuvilex is on the OTC and Yes many of us did invest in a company on the OTC and that company's name is Nuvilex...it is very hard to find an upcoming company on the OTC that you think is not going to stay on the OTC...and has a bright future...most of them stay on the OTC or disappear... but to get in on the bottom floor at this pps and ride the company all the way up...that is where you make your money...the real money...and Nuvilex is that company...it is just harder for some to have the insight to see it...that insight comes from relentless DD...I have done that relentless DD like many of the investors of this small under the radar hidden gem bio and after that it was so easy to pull the trigger on this one...and with the amount of shares I have it will make a difference...to me...that is the beauty of having that insight...the amount of shares you can buy with your money for a company like Nuvilex...which had the insight to buy CiaB at the stages that it was already at...that is what changes your financial situation drastically...so we have patience to wait it out...we have patience to put up with the ups and downs...that doesn't matter to us...because we have the insight to know what is coming and soon...
good luck with your trade
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Things happening FAST at this Nuvilex...all the old efood out...and they already had things working behind the scene to bring about the drastic changes that are happening to the company...Gunzburg employed by Nuvilex now...Lohr heading up our Scientific BOD's...my guess is Von Hoff is next appointed to the BOD along with Gunzburg...getting VERY EXCITING her at this Nuvilex...I can't wait for the next PR...
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(READ) We are not only about to get the results of a preclinical study that was asked for from Nuvilex by the most renowned pancreatic cancer doctor that has a very well known relationship with the FDA...but we are about to start Late Phase 2b/3 clinical trials ran by the same expert doctors who did the previous trials...and when finished the results will be taken to the EMA and the FDA and Australia and Canada for approval...I for one want to own this little magnificent hidden gem of a bio...
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Isn't that the truth...and I would not want to be one that was waiting for Nuvilex to go to .10 before I bought...this is going to be an exciting couple of months for nvlx...
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PANCREATIC CANCER AWARENESS MONTH: NOVEMBER
I hope they announce the TD2 results next month...with Lohr chairman now and all the changes...you know the results must be great...
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getting very exiting here at this Nuvilex...Now can you imagine having Von Hoff on the BOD also...with his connections to the FDA and Celgene...
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Dr. Matthias Löhr has agreed to serve as Chairman of Nuvilex's(NVLX) newly formed Scientific Advisory Board. ....there is the first of our magnificent BOD we are going to have now...
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Exactly...as a CEO you would not want to clean house slowly...do it and get it over with...so it hurts the stock temporarily...so what...the truth is the stock has been beaten up...so do it now...while the stock is down...get rid of all the remnants from efood...before the results come out...these TD2 results mean more than investors and non investors think...
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They did not resign...that is a nice way of removing them...Waggoner broke their contract that was renewed per the 10K...Nuvilex moved into a shell of a company that Gruden and Matula had...Waggoner would not have broke contracts if there was not something bigger in the works that we don't know about...they were not going to leave without something...and all this being done right before the results of the TD2 study...and they hire Gunzburg as our CSO...not as a consultant or put him on the BOD...they hire him...to work for Nuvilex... I can connect the dots...and with what I think is about to happen I don't care about the shares...
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