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For what it's worth, the patent has entered into the final phase of issuance. That being dispatched to the FDC.
Once the fee and any correspondence and/or drawings are matched with the application and all requirements have been met for issuance as a patent, the application is then forwarded to the Final Data Capture (FDC) stage of the process. The FDC makes any updates necessary to the electronic file and places the allowed patent application in an issue. The average time that an allowed application is in the FDC process is 5 weeks. The “Issue Notification” is mailed approximately 3 weeks prior to the issue date of the patent.
The patent grant is mailed on the issue date of the patent. It includes any references to prior patents, the inventor(s)') names, specification, and claims (to name a few). It is bound in an attractive cover and includes a gold seal and red ribbon on the cover.
NewCardio Presents Results for Cardiac Safety Research Consortium Blinded Drug Safety Study
QTinno reduces measurement variability and improves data quality in independent validation study
SANTA CLARA, CA (December 10, 2010) -
PR Newswire - NewCardio, Inc., (OTC BB: NWCI) a cardiovascular diagnostic solutions developer, today presented the results from a blinded drug safety study conducted by the Cardiac Safety Research Consortium (CSRC) to evaluate the performance of QTinno™ on its "testing" ECG dataset. The CSRC blinded "testing" dataset, comprised of 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent parallel-group Thorough QT Study. The CSRC blinded study results show, by a variety of analytical approaches, that QTinno accurately detects moxifloxacin-induced QT interval prolongation with statistically significant and substantial reductions in measurement variability compared to sponsor-submitted data. In QT studies, lower measurement variability increases the quality of study results and may enable future studies to be done in a more cost effective manner, thereby potentially reducing expenses for cardiac safety studies, which is a significant value proposition for QTinno users.
The study results were presented yesterday (December 9, 2010) to key representatives from the Food and Drug Administration (FDA), pharmaceutical companies, and academia by Samuel George, MD, FACC, JD, NewCardio's Senior Medical Advisor, at the CSRC's Annual Meeting. The CSRC makes its blinded "testing" dataset available to any cardiac safety technology developer who accepts the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any results obtained will be made public by the CSRC (www.cardiac-safety.org/ecg-database/rules_of_engagement.pdf). NewCardio is the first such entity to accept the CSRC conditions and complete the study.
Vincent Renz Jr., NewCardio's President and CEO commented, "We are very excited that QTinno was the initial automated cardiac safety solution whose performance was evaluated against the CSRC blinded 'testing' data set, for two reasons. First, based on the QTinno validation studies done to date with partners from Pharma, clinical trial service providers and academia, we expected, and realized, statistically significant results from this blinded drug safety study. QTinno has consistently returned highly accurate results with lower variability than other comparator methods, be it manual, semi-automated or automated, just as it did in the CSRC study. And second, it provided another opportunity for us to enhance our collaborative efforts with the CSRC in utilizing the underlying science and technology of QTinno to advance the current state of cardiac safety testing."
In the study, the CSRC made detailed comparisons of QTinno measurements to those originally submitted to the FDA by a drug sponsor in an FDA mandated cardiac safety drug study as required under the ICH E14 Guidance. The primary endpoint of this analysis was the accurate detection of the control drug's (moxifloxacin) effect on QT intervals, and the precision of the submitted measurements. Detailed results of this study will be submitted for publication in a peer-reviewed journal in the near future, and will be posted on the NewCardio website after peer-reviewed publication.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, stated, "We commend the CSRC for the excellent design and execution of this very important study, and we are proud that QTinno once again proved its accuracy in this rigorous examination. The study results provide compelling, and completely independent evidence that QTinno returns industry leading, fully automated accuracy in clinical drug studies, and does so with significantly reduced measurement variability. We believe that QTinno has the potential to increase the power of future studies and reduce study expenses for pharmaceutical drug sponsors."
Mr. Renz, continued, "Validation of new technologies is critical, and FDA representatives have consistently stated that they are willing to accept clinical results using automated ECG measurements from any validated methodology and the results from all of our validation efforts, which now include this CSRC study, more than meet FDA standards for validation, and as such QTinno is acceptable to the FDA. We believe that there will come a point where, based on the quality of performance, the industry will move from validation to the acceptance of methodologies which not only deliver high quality results, but do so in a more timely and cost effective manner. The blinded CSRC study results reinforce the strength of QTinno's performance with both current and potential customers and, more importantly we believe this clearly establishes the critical role of QTinno as the drug development industry accelerates their adoption of the higher quality, cost effective cardiac safety analysis."
About QTinno Technology
NewCardio's patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno's faster, more accurate and less expensive assessment of cardiac status.
NewCardio Study of QTinno Accuracy Selected for Presentation at the National Scientific Meeting of the American Society of Clinical Pharmacology and Therapeutics.
NewCardio, Inc., a cardiovascular diagnostic solutions developer, announced today that the Company has been invited to present the results of a key QTinno(R) performance study at the National Scientific Meeting of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), to be held in Dallas, March 3-5, 2011.
The study, entitled "Intelligent Automated ECG Extraction from Continuous 12-Lead Holter Recordings Reduces Measurement Variability in Thorough QT Studies," was completed in collaboration with physician scientists from a global pharmaceutical partner. Continuous 24-hour ECG recordings (Holters) are commonly used in cardiac safety drug studies. At present, the user visually selects three 10 second ECGs from the recording within 5 minutes of each designated study time point, a labor-intensive approach that is prone to error and variability. NewCardio has developed a novel ECG selection algorithm that evaluates the entire 10-minute window around the designated time point and selects the lowest noise and most stable ECGs in the window. The study chosen for presentation at the ASCPT meeting shows NewCardio's automated ECG selection method yields substantially more accurate and precise data than visual ECG selection. Moreover, the accuracy gain from automated ECG selection is fully additive to the accuracy gain delivered by QTinno itself.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, commented, "We are pleased to have this opportunity to present our results on automated ECG selection at the annual ASCPT meeting. This is a prestigious and well-attended forum, and gives us an excellent opportunity to share our latest QTinno improvements and innovations with scientists and professionals from academia, drug regulatory bodies, clinical trial service providers, and the pharmaceutical industry. The data we will be presenting demonstrate that NewCardio's novel automated ECG selection algorithm substantially improves data quality in drug safety studies. Pharma sponsors can use our automated ECG selection technology and QTinno to increase study power, thereby reducing the risk of a failed study. Alternatively, the sponsor can reduce the number of subjects in a study without sacrificing study power, which may represent a substantial cost savings. We believe this is a powerful extension of our platform technology, and demonstrates NewCardio's ability to add value to every ECG."
About QTinno Technology
NewCardio's patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno's faster, more accurate and less expensive assessment of cardiac status.
About the American Society for Clinical Pharmacology and Therapeutics (ASCPT)
The American Society for Clinical Pharmacology and Therapeutics (ASCPT) consists of over 2,100 professionals committed to promoting and advancing the science and practice of human pharmacology and therapeutics, and is the largest professional organization serving the discipline of clinical pharmacology.
WRONG BOARD! That is for The Juniper Group.
Thank you!
I'm new to this board. I gotta say this whole situation is a circus.
My question, for anyone that can accurately answer it, is what happens to NIR if they loose? Jailtime for Ribotsky? Will they be broken up? What happens to the debt that is owed to NIR by the 66 companies that NIR is involved with?
EPGL management can do nothing but wait until all is said and done. My intelligence in this type of thing is quite low, so any estimate by myself would be nothing more then a complete guess. Until that is, I educate myself on the matter in the coming days and weeks.
But, as for my complete guess, I would say that the plan drawn up from last year is dead in the water. I do NOT believe NIR will win the case. If NIR collapses, then whatever happens to debt owed to NIR by the 66 companies currently involved with NIR will probably be decided in BK court, which will not be a quick process. But like I said, that's just my guess.
Uhhh, the FBI has a financial crimes division, so they do have time for this. And it is has been in the news that they are investigating NIR for 2 years.
http://online.wsj.com/article/SB10001424052748703795004575087951450071156.html
http://axcessnews.com/index.php/articles/show?id=19711
http://online.wsj.com/article/SB10001424052748704075604575356914031167000.html
http://in.reuters.com/article/2011/01/28/nirgroup-hedgefunds-idINN288770420110128
Here's the investor Hub site for NIR
http://investorshub.advfn.com/boards/board.aspx?board_id=11792
Email that I received from Joe in response to my inquiry into the matter.
NIR has an ongoing battle with the FBI as well as the SEC. The issues are
all on their side of the fence and do not involve EP in any way except
insofar as they detract from our ability to finalize discussions on the
restructuring
In other words, have yourself a Snickers. We're gonna be here for a while.
As for the debt restructuring, they have to wait for the FBI and SEC court battle with NIR/Corey Ribotsky to be completed before anything moves forward. As for the other stuff, who knows.
Issue and publication fees have now been paid. As of last Saturday, Helix has paid all the fees associated with the patent and it will now become their asset. I was wrong in assuming that they would wait the full 3 months. What will come next?
For me. My thoughts and opinions are as follows. Hell, perhaps I have no clue what I'm talking about. Mere speculation. Oh well.
Although I do believe an R/S will eventually occur, I doubt it will anytime soon. In fact an R/S should be the very least of anybody's concerns as Helix's bigger problem is that they need to increase shares right now, not decrease them as all of the convertible promissary note holders have decided to cash in.
So, an increase in the A/S is more likely to come first.
As long as the convertible debt holders continue to cash in Helix has no choice to continue the dilution process as a result of having no revenue coming in. If the convertible debt holders no longer want to wait for Helix to recover, once the shares are maxed out, they have the option of forcing them into BK to get whatever they can. Hence why adding shares to keep them happy is important. Of course, right now, the note holders wouldn't get much out of a BK anyways giving the lack of assets Helix has. That is until a valuation can be put on the patent and being that they haven't technically been issued the patent until they pay for it ($1055), it's not yet an asset in the true sense of everything. They have until April 18th to do so.
In the meantime they will continue on the road to maximum dilution with the 1.75 billion A/S they currently got, in small doses.
I assume that the convertible debt holders will wait it out once the O/S is maxed out, given that the value of the company will rise on the actual issuance of the patent, giving them a better chance to get money out of a BK deal. I also believe that Helix will try and increase the A/S as the April 18th deadline nears, giving them some time before allowing the convertible debt holders to once again force Helix into more dilution if the status of the company's current revenue problems continue, delaying a potential BK process.
What they do between now and April will decide the fate of the company. We all know that they will max out the O/S. It's inevitable. Bitching about it is a waste of stress, breath and typing time. As are thoughts of an R/S. There will be time for that later down the road if they can survive the Convertible Note Holder's wrath first. In the meantime, cheers to all on this bugger. I gotta focus my time now on another company I'm in that's on a DTC Global Lock down. Ugh.
I did and got a response.
They are waiting for the DTC to tell them basically, WTF is going on.
When they know whats going on, then they will inform us of whats up.
Watch this. Go to 6:20 in. Or watch it all.
Deals with DTC and the huge case Overstock has going against naked short sellers.
http://www.dailymotion.com/video/x1p8j6_naked-shorts-v-2-0_news#from=embed
None of the above. People don't know the difference between an SEC suspension and a DTC suspension. Brokers have the option of using their own judgement in suspending trading when the DTC places a Global Lock on something. Because people generally know nothing about the DTC, they will automatically assume the SEC caused the halt in trading. Nobody purposefully spread a rumor for any ulterior motive.
Personally, I'm glad this happened. It will put a stop to whatever manipulation was going on, that kept the price down.
The DTC suspended the stock. "The DTC provides securities movements for NSCC's(National Securities Clearing Corporation) net settlements, and settlement for institutional trades (which typically involve money and securities transfers between custodian banks and broker-dealers), as well as money market instruments. DTC is a member of the U.S. Federal Reserve System, and a registered clearing agency with the Securities and Exchange Commission."
The SEC didn't suspend the stock. Thats why it's not showing up on sites that show suspended stocks. Brokers will use their own discretion to suspend trading based on a DTC Global Lock. Hence why there is still some trading. Not every broker chose to suspend trading even though there is potential fraud occurring with settlements.
Personally, when the dust clears, I think ETMM is going to have to answer a lot of questions. As well as CDLR.
Some that need to know what a DTC lock is:
When an issue is designated as global
lock at DTCC it is not eligible for
delivery, transfer or withdrawal. There
is a variety of reasons for global lock
designation but the incidents of greatest
impact and hardest cases to resolve
involve allegations of fraud at an
issuer or agent or some other type of
irregularity that makes the validity of
deposited certificates suspect. While
these restrictions on position movement
are understandable given the underlying
problems with the issuer, a set of
other problems spring forth that the
committee addressed to DTCC. A
meeting was coordinated with appropriate
DTCC subject matter experts to
discuss issues and determine solutions.
According to Scottrade, the suspension could be due to a to a stock split, reorganization, delisting or name/symbol/CUSIP change.
My guess is reorganization.
It is what it is. I'm not going to jump to conclusions until the dust settles.
"An open order for symbol CLDR has been cancelled on your account due to a stock split, reorganization, delisting or name/symbol/CUSIP change."
Hey Dough, from what I understand, they're in no risk of defaulting on the first note. It doesn't mature for 6 months, so they don't have to pay anything on it until then. The additional 2 triggering events will not occur either. One being that the PPS can't trade at or below .0005 over a 5 day average and the other there must be a dollar volume of 10K over a 10 day average.
The next news we get will either be the final dilution of the OS or the news that they received the 2nd batch of 50k from St George, which is due any day now, being that no default triggering events occurred over the last 2 weeks. Perhaps some good news will come out when they reveal what they plan on doing with the St George money.
This is a crap shoot. Lets hope they don't roll a 7.
Nobody can be sure of anything right now.
To claim to be 'sure' of up or down movement is pure fantasy or wishful thinking. This one is roll of the dice.
NIR Group goes to court any day now.
http://www.reuters.com/article/2011/01/28/us-nirgroup-hedgefunds-idUSTRE70R79I20110128?pageNumber=2
February 3rd'ish should be the date that they get the 2nd 50K from St. George, that is if no default occurs.
Ever since you posted that it was Tangarie that got the deal, I have tried again and again, through phone calls to emails, to get an answer from Tangarie, Solar Blue and the Eagles as to verify. I have come up empty every time.
You would think Tangarie would have that on their website. The only reason they wouldn't, would be that they aren't allowed to, which means they wouldn't of told you yes or no.
The Eagles make no mention of it in any of their press releases and their people seem to just ignore my requests either way.
Solar Blue makes zero note of who is doing it. On their website where they go into specifics on it, they leave out all mention of any company to be involved. Even Helix for that matter.
The project manager for the project has yet to get back to me.
So until I have verifiable facts on my end, as I'm not inclined to believe anything of what i hear on a message board, I'll assume that there is chance Helix can land the deal.
No disrespect to you intended, but you have shown to against this company for quite a while now. For me or anyone, to blindly agree with you on information that you can't back up and that has proven to be, at least on my end, very difficult to verify, would be very foolish. If your info is indeed verified, then kudos to you.
Cheers
Nobody does yet. Solar Blue has yet to make a decision.
Worthy of a re-post. I forgot who posted this up before, but it is rather enjoyable. ETMM would be the guy on the right. Lol.
I doubt that $6,000 in buys is going to get Etrade off of the ask.
Lol, you're a riot! Still trying for those 1's eh?
As long as convertible debt holders continue to cash in on their notes, it'll max itself out soon enough. That's most likely why they got the additional loan from St George. If anything, that loan by St George has bought them time. 4 months perhaps. Which is an eternity. Maybe they'll increase the A/S and get even more time. Who's to say. There will eventually be a RS, but I doubt that will happen anytime soon.
I highly doubt that St George would of given them that loan if they thought the company was going down. St George knows about the dilution and they know about every other negative thing going on. I assume they know whats going on behind the scenes as far as new deals coming up as a result of the patent as well. St George owns 10% of this company. Its in their best interests to see it succeed and to protect their investment.
Which leads to Solar Blue. What Solar Blue is doing, simply put, is looking for a wind turbine model to use for Lincoln Field. They want to use somebody's design and take it to their own manufacturers, etc, etc. Basically, IF SELECTED by Solar Blue, Helix, as a result of the patent, will franchise out their turbines to Solar Blue, allowing Solar Blue the right to produce and sell Helix's products using its name and trademark. And they'll assist in whatever way Solar Blue wants them to. In return, Helix will receive various fees and royalties. Additionally, Helix will be free of the burden of having to manufacture the turbines themselves.
Who knows whatever else they have in the mix, now that they can protect their intellectual property and license out their blueprints. St George thinks they will overcome their obstacles and betting 455K that they do. So, at present date, as much as basic logic says to sell, I'm going to cautiously hold, for now. Take it day by day and possibly buy more on the dips. If there are any dips, that is, and see how this thing unfolds.
This is, without a doubt, a very scary stock to be in right now because of all the unknowns. Had there not been a patent allowance, the decision to buy, sell, or hold would be much easier.
Right now, the whole game plan has changed. So, here's a toast to a maxed out O/S coming soon, a 455K loan to survive, and at least 4 more months for Kevin Claudio to get things moving.
Cheers
Well, at least we'll only get one more 8K after today regarding dilution.
163,545,270 shares are left in the A/S to be diluted. At .0003, which seems to be the going rate, that's about $49,603.58
I say you all call them up and congratulate them!
Phone: (619) 501-3932
What D-Bag sold a $1.50's worth? Not to mention trading fees. Had to be an MM. Anything to get it back to .0001 I guess.
In my opinion, next bit of news should be out in February, which appears to be a month where they focus on Nutrition. Which would make it logical that the launch of the highly anticipated, Nutraceutical Product Directory should become a reality.
“We hope to have this product available in early 2011,”
"It's a Resource Guide for the Nutraceutical Community, working collaboratively with Stephan DeFelice, MD." said Valenzano.
"This new directory would help to review the thousands of nutraceuticals (nutritional supplements) in terms of their efficacy and safety and potential interaction with Rx medications. Preliminary work on this new product is already underway. The market for nutraceuticals is in excess of $100 billion."
I'll take today any day. There were enough sells, enough buys to establish a healthy bottom. And we're #2 on the breakout boards!
Who knows what the rest of the week will bring.
Good luck to all who stuck with it.
Pick'em up while they're hot. St George LLC, won't be selling for too much longer.
Thats only $200K in transactions.
When you're in the .0000's, it takes upward of 500 mill to get a stock going. Remember, by nature, MM's are short. Its in their best interest to keep it flat. Add to that, the selling by St George.
The day is still young. St George will complete their strategic selling soon enough. At least that my theory. Then if we can get some buying volume, the MM's will have to take it back up.
Its my opinion that the main seller right now is St George. All of the dilution over the last 10 months has been to pay them off, as well as Ian Gardner. They have been cashing in on their convertible notes. And the fact they have been issued roughly 400 million shares over the last month at under .0005, they are taking money off the table and then will re-lend the profit back to Helix to payoff Bluewater.
Once they finish, they'll let it go.
It is in the best interest of St George to do what they are doing.
Bulls$%#, yes, but when you're swimming with sharks, you have to sit back and wait for them to do their thing.
Ladies and gents, it looks like the 1 tick flippers have arrived!
Great. Welcome.