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This is awesome!! Nice find!!
http://www.freepatentsonline.com/8802139.html
Woot, Woot!!!!
Yes I get l2 for all! I'd call them up if you are not getting it!
Etrade gives l2 to me for free on mobile app. And on etrade pro.
I get it here but it doesn't go back that far:
http://quotes.freerealtime.com/dl/frt/M?IM=quotes&symbol=IBM&type=Time%26Sales
Things are going to start looking a whole lot better here soon IMO!!!
I see what you mean:
14:03:44 1.67 200 OTO
14:03:42 2.05 300 OTO
14:02:28 2.05 500 OTO
13:17:22 2.05 500 OTO
12:04:43 2.25 235 OTO
12:04:27 2.25 100 OTO
12:04:17 2.25 334 OTO
11:45:40 2.25 768 OTO
11:45:04 2.24 232 OTO
11:41:43 2.24 768 OTO
11:41:21 2.20 312 OTO
11:41:12 2.10 110 OTO
11:41:11 2.10 110 OTO
11:24:06 1.88 750 OTO
11:23:45 1.87 1103 OTO
11:18:07 1.91 1000 OTO
11:14:43 1.81 1000 OTO
11:10:09 2.08 45 OTO
On the bright side maybe I can get some cheapies tomorrow!! I'm looking for a few more under $1.50.
Nice!!!! Go gcei!!! Got me some more cheapies today!!!
Cool!! Thanks!! Things are looking up!!!
Yes very interesting!!!
Provectus Biopharmaceuticals, Inc. (NYSEMKT:PVCT)
Q2 2014 Earnings Conference Call
August 7, 2014 4:00 pm ET
Executives
Michael J. Porter - IR, Porter, LeVay & Rose, Inc
Peter R. Culpepper - CFO and COO
Eric Wachter - CTO
Analysts
Presentation
Operator
Welcome to the Provectus Biopharmaceuticals first quarter conference call. At this time, all participants are in a listen only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Michael J. Porter, President of LeVay & Rose. Thank you, Mr. Porter. You may begin.
Michael J. Porter
Thank you, Adam, and good afternoon, ladies and gentlemen. On the call today are Peter Culpepper, who is COO and CFO, and Dr. Eric Wachter, the CTO of Provectus.
Before we start the conference call, please note that some of the information appearing today during our discussion will consist of forward-looking statements as defined under the federal securities law. These statements reflect management's current knowledge, assumptions, belief, estimates and expectations and express management's current views of future performance, results and trends. Actual results could differ materially from such forward-looking statements.
For more information, please refer to the risk factors discussed in Provectus' 10-K for 2013, the Form 10-Q for the second quarter of 2014, and Provectus' other filings with the Securities and Exchange Commission. Provectus assumes no obligation to update any forward-looking statements or information which speaks to their respective dates. No claims with respect to PV-10 are intended regarding safety or efficacy in the context of the forward-looking statements contained in these statements.
I'd like now to turn the call over to Peter Culpepper, CFO and COO. Good afternoon, Pete.
Peter R. Culpepper
Thank you, Mike, and welcome everyone. Today's conference call is part of our continued policy of clear communication with our shareholders. We will hold regular conference call's time to coincide with the filing of our 10-Q or 10-K, as the case may be, to allow for greater interaction between the Company and its shareholders. We believe that this will help avoid unsubstantiated gossip from damaging our financial interest and create a better atmosphere for investment.
For today, we'd like to address a few points that Mike and his company had encountered in managing our investor communications. In no particular order, they are, our cash position and financial capacity to complete our clinical trials, activities in China and India, the hiring of an FDA advisor, the roles of our advisory committees, the status of our Phase 3 protocol for PV-10 as a melanoma treatment, and an update on the status of our other research projects. After that, we will gladly answer questions on these or any other subjects you wish.
Our cash and cash equivalents were $18,126,036 at June 30, 2014, compared with $15,696,243 at December 31, 2013. The increase of approximately $2.4 million was due primarily to $4.35 million cash received from warrant and stock option exercises and $4.35 million net proceeds from the sale of our common stock prior to offerings in the six months ended June 30, 2014 offset by $6.3 million of operating cash expenses.
Now, wearing my hat as CFO, let me be crystal clear. We have enough money on hand this minute to see us through to the interim Phase 3 data for the melanoma study. I believe that by managing variable cash expenses due to minimal fixed cost, our cash and cash equivalents are sufficient to meet our current and planned operating needs now until 2016. We can curtail or defer certain expenditures, and we will do so. This means, we do not anticipate needing to raise additional capital to further develop PV-10 on our own to treat locally advanced cutaneous melanoma, cancers of the liver, recurrent breast cancer or pancreatic cancer and other indications.
Why do I say that? Because we plan to strategically monetize PV-10 through appropriate regional license transactions, and to license PH-10 for psoriasis and other related indications described as inflammatory dermatoses. We discussed this strategy in our filing today, the Q2 10-Q MD&A, particularly the Liquidity and Capital Resources section.
And how can we be so confident those regional licensing deals will happen? We believe our efforts to obtain regulatory clarity will be helpful to facilitate such transactions with potential partners. Additionally, the existing and forthcoming clinical and nonclinical mechanism of action data for both PV-10 and PH-10 are expected to further aid in both regulatory clarity and transactions with potential partners.
Also, management is returning $8.96 million to the Company as a result of the previously announced settlement of a shareholder derivative lawsuit, subject to a 2-for-1 credit to the executives, such that the total actual repayment by the executives may be $1.12 million per executive which would total $4.48 million.
Now that brings us to activities in India and China. We have provided data on a confidential basis to both potential global and geographic partners for both PV-10 for oncology and PH-10 for dermatology via a secure electronic data room. We are encouraged by the number of companies doing due diligence on our technologies. For instance, we recently had a team in India meeting with potential partners and lead Indian pharmaceutical firms are continuing the research into our data, they are regular visitors to our data room. Additionally, we are having discussions on possible commercialization.
Also, we have two teams focused in China working with potential partners there and discussions on working with these Chinese businesses continue. The Chinese talks involve both melanoma and liver indications, the latter being a more widespread problem in China. We also have begun to consider co-development transactions with one or more pharmaceutical or biotech companies to combine PV-10 with immunology agents such as those referred to as checkpoint protein inhibitors. While none of these has yielded a concrete result that we can refer to you, I am comfortable mentioning these activities because I'm confident they will do so eventually, maybe potentially even this year.
At this stage, I will hand the floor to Eric Wachter, our Chief Technology Officer for a discussion of FDA related matters. Eric?
Eric Wachter
Thank you, Pete. I want to startup my remarks by emphasizing that our primary focus is on managing the FDA regulatory process. Provectus is contemplating adding to its consulting advisors a group to help us validate our efforts with the agency. This group is a full-service regulatory consulting firm that provides strategic guidance to companies like Provectus regulated by the Food and Drug Administration in developing innovative solutions to pressing public health challenges around the globe.
Under the terms of the contemplated agreement, this consultant will have several duties. They will review all the correspondence between Provectus and the FDA, they will provide an overview of potential drug regulatory pathways for PV-10, they will review and analyze the FDA's breakthrough therapy designation program to see what more can be gained from what we went through earlier this year.
This group will review and analyze our development program for PV-10, highlighting things like our proposed indication, mechanism of action, primary and secondary endpoints selected for clinical studies, pivotal study designs and available Phase 2 data. They'll analyze the current landscape for marketed and emerging products for melanoma and compare PV-10 to the current care standard for melanoma.
They will summarize their analysis of our PV-10 development program and key regulatory challenges and opportunities. In essence, they will aid us in validating the relevance of the PV-10 drug development program in all material aspects for the treatment of serious or life threatening diseases or conditions such as locally advanced cutaneous melanoma. This comprehensive third-party review will identify our strengths allowing us to build on those, and our weaknesses allowing us to address those.
We have a very unique product in PV-10 and as the inventor and chief proponent of our drug, we have developed unique expertise related to the unique challenges of establishing safety and efficacy sufficiently to support regulatory approval. This consultant relationship will allow us to see how our approach compares to standard industry practice and help us to identify those areas where we can improve our execution. We don't expect this process to drastically change our course but rather to verify that we are on the right course, and make small corrections necessary to ensure that we are successful in reaching our goals.
I think that the efforts of this advisor group dovetail very well with the function and expertise of our existing Strategic Advisory Board. As many of you know, our advisors take an active role in helping Provectus. For example, Craig Eagle, a Senior VP with Pfizer Oncology, is a co-inventor on our drug patent application with Pfizer covering certain uses of PV-10 in combination with systemic therapies. Bob Miglani, Head of Medical Advocacy and External Medical Affairs at Pfizer, has played an instrumental role in advancing our efforts to establish global and geographic partnerships for both PV-10 for oncology and PH-10 for dermatology. And Joe Chalil, Associate Director, Health Science Executives at Boehringer Ingelheim, has been very instrumental in advancing our efforts to establish key partnerships for PV-10, in particular across Asia.
Let's turn now to the status of protocol for our Phase 3 study of PV-10 for melanoma. This study will assess response to intralesional PV-10 versus that of systemic chemotherapy in patients with disease confined to cutaneous and subcutaneous sites. These patients who have failed or been ineligible for systemic immunotherapy and thus have extremely limited options, consisting principally of systemic chemotherapy, such as DTIC or temozolomide, or a clinical trial.
As we've indicated previously, the primary endpoint of the study is progression-free survival assessed using standard criteria. Secondary endpoints are complete response rate and overall survival. Progression-free survival and overall survival are standard endpoints for oncology approvals. With these assessment methods and endpoints, we're following what the FDA has suggested to document the clinical benefit to patients after intralesional injection.
Furthermore, our endpoints with complete response rate should allow us to highlight one of the key features of PV-10, and we'll measure patient reported outcomes to better characterize the relationship between complete response and symptoms of locally advanced cutaneous melanoma, such as pain and bleeding.
We're working with several leading CROs with specialized expertise in the assessment of patient reported outcomes to show that our planned assessments are rock-solid. This is an important but complex topic and the experience of these expert groups is allowing us to put into place the final missing pieces of our protocol.
We've indicated previously that we plan to commence the study this year and this work is allowing us to put the finishing touches on the protocol before it undergoes final review in the next few weeks by key melanoma investigators and consultants in clinical operations and regulatory affairs.
So to summarize so far, we are finalizing the process of combining our expertise gained from years of clinical testing of PV-10, inputs from meetings with our scientific advisors, investigators and advocates in the field, and design input from multiple CROs having specialized expertise in key areas such as assessment of patient reported outcomes, radiologic and clinical image management, bio-statistics, clinical data management, and so on, to ensure that we have a robust protocol that can address the needs of licensure.
We are also adopting, to the extent possible, important design elements from successful pivotal trials of other drugs recently approved in melanoma and other cancers that address issues pertinent to pivotal testing in PV-10. These include details on scheduling of response assessments, handling of issues pertinent to our comparative drugs, and the collection and interpretation of patient reported outcome.
While the study design process is being wrapped up, I'd like to note that our prior guidance on design of the study remains unchanged, with approximately 210 patients needed for the study and 2 to 1 randomization. We use a dosings team based on our current expanded access protocol which was updated about a month ago incorporating all that we've learned since we began our melanoma program.
To hit the ground running, we expect to start enrolling patients at our existing PV-10 sites in the United States and Australia, which are currently enrolling melanoma patients into our expanded access protocol. And then add additional sites in these two countries while we expand traditional sites in other parts of the world.
Our initial focus on the United States and Australia will allow us to leverage almost a decade of clinical experience working with leading investigators in these countries, and that together represent a very substantial fraction of the global population of melanoma patients.
As we finalize preparation for launching the study, we expect to add a few additional standards to our expanded access program allowing us to establish the local operational, contractual and regulatory framework for rapid transition of these centers to participation in the Phase 3 study. We're also adding a number of closely held consultants and CRAs or clinical research associates who will play important roles in management of this trial as well as our other ongoing and future studies.
As is standard in our industry for Phase 3, routine management of study operations and data collection and analysis will be handled by a full-service international CRO with expertise in clinical operations and integrated data management. This key member of our team, a quarterback as it were, will coordinate the global efforts of the study team, including that of our investigators as well as independent review committees analyzing study data, and an independent clinical trial data monitoring committee or DMC that will periodically review the accumulating data to ensure that our study provides patients with maximum possible safety while protecting the scientific validity and integrity of the data we gather.
These preparations and the fact that we're closely following precedent of recent successful pivotal trials in melanoma and other cancers as well as the advice with the agency in the fundamental design of our study, are intended to ensure to the full extent possible that we have a successful trial.
As Pete mentioned earlier, we're also looking beyond single-agent therapy with PV-10 to address the needs of patients with more extensive disease, particularly those with visceral tumors that are not injectable. One attractive and complementary approach may be to combine PV-10 with a systemic immunotherapy, such as an immune checkpoint protein inhibitor. Immune checkpoint protein inhibitors, such as anti-CTLA4, anti-PD-1, and anti-PD-L1 agents, are an important advance in the treatment of melanoma and other cancers, another subject of intense development in our industry.
However, while these drugs represent an important step forward, like any drug they are not perfect and they might be improved. As was clearly presented by the medical oncology community earlier this summer at ASCO, using an agent like PV-10 to prime the immune system could be synergistic in combination with such a systemic agent.
Our patent application on this strategy was published in 2012 and we've been vigorous by pursuing this approach since. The nonclinical research we first presented at the Society for Immunotherapy of Cancer Annual Meeting in 2012, together with ongoing translational clinical research on PV-10's mechanism of action that we were sponsoring at Moffitt Cancer Center and our own Phase 2 data, provide a rationale for combination testing of PV-10.
This development track, separate from the Phase 3 study I discussed earlier, could represent a path forward for patients with significant disease burden not amenable to intralesional injection, and is a possible candidate for co-development with one or more pharmaceutical or biotech companies.
So to reiterate, we expect to commence the Phase 3 melanoma study by the end of the year, including filing the protocol with the agency and starting patient enrollment at sites already using PV-10 under our expanded access protocol.
Moving from melanoma, I want to discuss what we're doing with PV-10 in other cancers, along with development with PH-10 for skin conditions. We recently expanded our exploratory Phase 1 study of cancers of the liver to three centers, St. Luke's University Health Network in Bethlehem, Pennsylvania and The Southeastern Center for Digestive Disorders & Pancreatic Cancer in Tampa, Florida in addition to Sharp Memorial Hospital in San Diego, California. And we're evaluating addition of several additional centers to further advance this study.
We've been working with our investigators to report results from long-term follow-up of our initial patients at one or more conferences and in the literature in coming months, and we're assessing strategies to accelerate transition to Phase 2 testing in a randomized controlled trail, either alone or in combination with systemic therapy. Any combination studies in the liver are likely to follow similar development strategies to those outlined earlier for melanoma and rely on much of the same foundational science.
The current Phase 1 study, initially intended only to establish safety of percutaneous injection of PV-10 into liver tumors, that is injection on the tumor through the skin, is providing valuable safety and efficacy data crucial for planning such Phase 2 development. This trial is open to patients with hepatocellular carcinoma or other cancers that are metastasized with liver who have at least one tumor that has either originated in or spread to the liver.
All patients receive the same treatment. An interventional radiologist injects PV-10 percutaneously into a single liver tumor. Patients with multiple injectable tumors may later receive further PV-10 to their other tumors. In addition to comprehensive Phase 3 monitoring, we are assessing both the short and long-term effects on injected lesions and any effects on uninjected lesions in the patient's liver. We have received numerous inquiries about this study from researchers as well as patients and their doctors, and refer these to our investigators through the contact information available on the clinicaltrials.gov Web-site.
As we continue to learn more about the effects of PV-10 on both HCC and other metastatic cancers, the data on non-HCC tumors may shape plans for future indications. And as Pete mentioned at the start of the call, given the well-known public health crisis posed by HCC in parts of Asia, what we're learning in this study may have direct bearing on potential partnerships in China.
During our studies in melanoma, hepatocellular carcinoma, and other cancers, metastatic liver and breast carcinoma, well over 240 patients have received PV-10 since we started clinical work with our first patients in Australia. Over 200 of these are melanoma patients, representing the 100 patients who participated in our Phase 1 and Phase 2 melanoma trials and over 100 melanoma patients who've been enrolled under our expanded access protocol since then. These numbers are based on our 2013 Annual Report to the agency and we will update these totals later in the year as we prepare our 2014 Annual Report.
While we're encouraged by the sustained enrolment of patients by our investigators, I'll note that this demand illustrates the need for new options for cancer patients. We expect to greatly increase these numbers in the coming months as we continue to build our case in support of initial approval of PV-10 and in support of extending approval to additional indications.
And finally, just a quick update on PH-10, our lead investigational drug candidate for dermatology. So far, over 220 patients have participated in Phase 1 and Phase 2 trials of PH-10. We anticipate posting results from these studies on the clinicaltrials.gov Web-site in the coming months and are encouraged by what we've observed to-date.
Following the model we have successfully used in oncology, we have designed translational clinical study to better understand the possible immunologic mechanism of PH-10 in the skin. This mechanism of action study will focus on the suspected cellular and structural changes in psoriatic plaque upon treatment with PH-10. We have observed structural changes since our first trial of PH-10 in psoriasis and clinical observations from subsequent studies point to a possible immunologic response to PH-10.
Looking at concordance of clinical changes with any changes observed inside the skin should provide insight into this apparent response. We have designed the study with numeral input from several leading experts on the immunology of psoriasis. We have completed nonclinical validation of the concept to show with PH-10, which is pink in color, does not interfere with the immunologic testing of skin samples from study participants, and reviewed our previous psoriasis studies as a template for the operational aspects of this study.
We expect to conduct the majority of the clinical work at major academic centers in the United States to ensure the integrity of the results to be generated. The knowledge we expect to gain from this study should enable us to design bench trials in psoriasis, eczema and other inflammatory dermatoses and potentially differentiate the product among a range of options for these conditions.
Well, that covers the material that we wanted to discuss so far, Mike. So I think it's time for questions.
Michael J. Porter
Thanks, Eric. Before we turn the call over to the operator, I've had a number of calls today about one question everybody would like to know, and that is, why is it taking so long to start the official Phase 3 trial?
Eric Wachter
Okay, Mike. As I outlined in my earlier comments, we're working to address both long-term and recent guidance from the agency, and particularly the recent guidance provided via our interactions with the agency since December concerning the relevance of symptom assessment in our patient population, those patients with locally advanced cutaneous melanoma. We're working with leading partners in this area to finalize this aspect of our study design and expect to send our protocol out for review by our team of CROs, regulatory consultants and investigators in coming weeks.
We have a significant advantage that when this process is complete, we can access existing relationships with our investigators to accelerate progress. We also have clinical drug supply at hand and a distribution system that has been tested to ensure that PV-10 is available when the first patients are enrolled.
Michael J. Porter
Thank you, Eric. Operator, we're ready for questions.
Question-and-Answer Session
Operator
(Operator Instructions) Our next question comes from the line of [Max Azenheimer] (ph), who is a private investor. Please proceed with your question.
Eric Wachter
Are you there, Max?
Operator
Thank you. Our next question comes from the line of [Bruce Benzel] (ph) who is a private investor.
Unidentified Participant
My question about Phase 3 trials, first off, Eric, can you be more specific about the lessons learned in Phase 2, are we going to dose patients differently than earlier, can you talk about that a little bit?
Eric Wachter
Sure, Bruce. So we've progressed from Phase 1 to Phase 2 and now on the threshold of starting Phase 3, we have progressively dosed patients more aggressively based on what we've learned from those prior studies. For example, in Phase I we treated patients once, a single course of injection. In Phase 2, we waited eight weeks before we re-treated patients. In recent past in our expanded access program, we waited four weeks between possible injections and we've recently amended that to now treatment every two weeks. We'll apply those learning experiences certainly in the Phase 3 study.
Unidentified Participant
Do you see then, two remaining questions, do you see a potential for better results in Phase 3, and second, exactly what be FDA's role with the protocol be, will you simply file the protocol with the FDA or do they have some other, some advanced roll in that?
Eric Wachter
I can't really speculate on what effect size we anticipate seeing in Phase 3. Classically, there is a phenomena of effect size compression and the effect of the drug is smaller progressing from Phase 1 to Phase 2 and then again from Phase 2 to Phase 3. We've seen the opposite so far going from Phase 1 to Phase 2. I don't know if that is necessarily going to be a continuing trend, but it certainly is directionally favorable. We will be using fully conforming RECIST assessments in the Phase 3 study versus modified RECIST assessment. So, really it's not directly comparable.
Having said, we do expect to see a very high rate of complete response consistent with the patients in the Phase 3 study where we treated all in existing disease, we'll be treating all existing disease in our Phase 3 patients and so we can use that group from Phase 2 as a model.
In terms of the agency's requirements, we are required to file the protocol with the agency prior to commencing the study. I can't comment on any further activities we might have with the agency in that regard.
Operator
The next question comes from the line of [Bill Hamming] (ph). Please proceed with your question.
Unidentified Participant
I don't know if you just sort of answered this and I missed it, but is there a certain timeframe once you actually submit the process or the plan, the trial design, to the FDA, is there then a certain amount of time before it starts, is it a definitive amount of time, do they have 60 days, 30 days, or is it an automatic, once you're in, once you've supplied it, if you don't get a 'no', you can go forward?
Eric Wachter
There's a 30 day wait that's required when you submit a Phase 1 study, particularly the first Phase 1 study for an indication. Subsequent studies with progressive phases, there is no mandatory wait prior to commencing the study. That being said, the agency has the option to comment or take other action on a protocol at any time after it has been submitted. So, in terms of commencing a Phase 3 study, the requirement is that we submit the protocol prior to commencement of the study.
Unidentified Participant
Okay. So then, you would submit it and then you would give places like [indiscernible] the green light to go forward?
Eric Wachter
That's correct. They would have to pursue IRB approval. That does not have to occur after submission to the agency. You simply have to have the IRB approval and submission to the agency in place prior to starting enrolment.
Unidentified Participant
Okay, great. Thank you.
Operator
Our next question comes from the line of [Bruce Benzel] (ph) who is a private investor. Please proceed with your question.
Unidentified Participant
I guess I'm in here for two questions then. There has been confusion, this is a Peter question, there's been confusion in terms of cash flow, whether to include the $4.48 million portion of the settlement or the $8.96 million. In terms of somebody projecting out cash flows, which is a more relevant and which is a better estimate of the impact on cash?
Peter R. Culpepper
For cash forecasting purposes, I would use the $4.48 million. The settlement as we disclosed is for $8.96 million. So that's the gross amount, but it is subject to the 2-for-1 credit, given certain conditions. So conservatively, I use the $4.48 million in forecasting that presumes that we will meet the terms and then have the 2-for-1 credit. So that would be my response, Bruce.
Unidentified Participant
Thank you, Peter.
Operator
Our next call comes from [Dr. Gollum] (ph) who is a private investor. Please proceed with your question.
Unidentified Participant
I have two questions. One, before a licensing deal can be inked, would it be necessary to have an acceptable protocol with the FDA?
Peter R. Culpepper
This is a gray topic and we are actively discussing with potential partners in both India and China in particular when to enter into a transaction, but I think conservatively it does make sense for a protocol for both melanoma and liver that's appropriate for those respective countries to be in place prior to at least a transaction be consummated. It's possible that MoU could be signed in advance, but conservatively I think it makes sense for say you as an investor, Dr. Gollum, or any to see that protocol filed on clinicaltrials.gov and then you could make a logical assumption from there, once the Phase 3 melanoma study or the Phase 2 liver that Eric touched on has been filed, that that makes sense for potential global partner or geographic partners. Eric can comment.
Eric Wachter
As the CTO, I cover both clinical development and intellectual property portfolio of the Company and I'll point out that in those sorts of scenarios, it's almost certain any protocol that we entered into in Asia would be an international protocol because there are certain implications of a single country of protocol and intellectual property rights. So, you can expect that that would be one of the aspects of such protocol.
Unidentified Participant
Okay. The second question I have, we're facing a share price below $1 and I just would like to know if you expect or are looking to take some type of action to avoid the potential delisting threat that moves over us?
Peter R. Culpepper
I'll just say we're very optimistic about our future, short-term as in this year, and I call to your attention in the MD&A and the 10-Q filed today, in the Liquidity and Capital Resources section, fourth paragraph in particular, that we believe our financial position and corporate governance are such that we will continue to meet the relevant listing requirements of New York Stock Exchange MKT, although there can be no assurance that we will continue to be listed.
So what we're doing is we're making sure that our financial position and corporate governance are appropriate to enable the share price to appreciate or to facilitate that, is exactly what we're doing with the clinical trial activities and what that means to the market and to potential transactions with partners. So, I would argue that we're doing what we need to do on all fronts to ensure that we continue to be listed.
Unidentified Participant
Thank you, gentlemen. I have a lot of faith and confidence in you.
Peter R. Culpepper
Thank you. We appreciate your comment.
Operator
Our next question comes from the line of [Max Azenheimer] (ph) who is a private investor. Please proceed with your question.
Unidentified Participant
I got cut off before, I don't know what happened. I was under the assumption from last conference call that Phase 1 for liver was going to be out soon. Am I wrong in that?
Eric Wachter
I don't think we indicated that the Phase 1 data would be out soon. We indicated that we were working to get that data available to the public. We have been working since the last call and since we issued the shareholder letter month after or so ago to advance that process, and I can say that we have made great progress in that but the process of preparing those sorts of materials for dissemination through either the purity of literature or through technical conferences has fairly substantial lead time. So we can't tell you right now where that is and we can't tell you exactly when that's going to happen, but I will assure you that we're moving that forward.
Unidentified Participant
You think it will happen before the end of the year?
Eric Wachter
That's possible. There are a number of conferences that are in the fourth quarter that we are looking at and it depends upon whether we are able to get our data into shape in time for submission to those in advance of their deadlines.
Unidentified Participant
Alright, one last quick one, when you mentioned interim results on the Phase 3, what kind of general timeframe are you looking at, sometime towards late 2015, mid 2015?
Eric Wachter
So we have previously stated that we expect that approval for the study will require approximately 18 months with an additional 12 months follow-up for the last patient. Interim assessment would be roughly at halfway point in that study. And so, it would be somewhere on the order of 15 months after commencement of the study, so sometime at the end of 2015 or early in 2016 presumably.
Unidentified Participant
Thank you very much. I appreciate it.
Operator
Thank you, gentlemen. There are no further questions at this time. I would like to turn the floor back over to management for your closing comments.
Michael J. Porter
Everyone, I want to thank you all for attending our conference. We will talk to you next quarter. Have a good Labor Day weekend. Thank you very much. Goodbye now.
I'm still holding...waiting for something.........or nothing!
Beautiful absolutely beautiful!!!
Money's outta jail!! Woot woot!!
I need to get more AASP--I got a small order at 1.43 and more down in the .80's. Come on NITE give me some of your shares!!!
Joey I just don't get why your enlightening posts are always deleted from the AASP board!!! LOL!!!
This stock has been so good to me! Go AASP!
FOR IMMEDIATE RELEASE
2014-159
Washington D.C., Aug. 5, 2014 — The Securities and Exchange Commission today charged four promoters with ties to the Pacific Northwest for manipulating the securities of several microcap companies, including marijuana-related stocks that the agency has warned investors about in recent weeks.
The SEC alleges that the four promoters bought inexpensive shares of thinly traded penny stock companies on the open market and conducted pre-arranged, manipulative matched orders and wash trades to create the illusion of an active market in these stocks. They then sold their shares in coordination with aggressive promotional campaigns that urged investors to buy the stocks because the prices were on the verge of rising substantially. However, these companies had little to no business operations at the time. The promoters reaped more than $2.5 million in illegal profits through their schemes.
Two of the companies manipulated in this case – GrowLife Inc. and Hemp Inc. – claim to be related to the medical marijuana industry. The SEC has issued an investor alert warning about possible scams involving marijuana-related investments, noting that fraudsters often exploit the latest growth industries to lure investors into stock manipulation schemes. Other schemes by these four promoters involved an oil-and-gas company – Riverdale Oil and Gas Corporation – and three other microcap stocks, ISM International, Allied Products Corp, and Aden Solutions.
The SEC was able to unearth the schemes through the work of its recently created Microcap Fraud Task Force.
“Our Microcap Fraud Task Force is taking direct aim at abusive practices and serial violators within the microcap markets like these four promoters seeking to exploit retail investors for personal gain,” said Michael Paley, co-chair of the SEC’s Microcap Fraud Task Force. “In this case, we meticulously reviewed trading records and developed the evidence necessary to connect these four promoters and their coordinated trading efforts.”
The SEC’s complaint filed in federal court in Tacoma, Wash., charges the following individuals:
Mikhail Galas, a stock promoter who lives in Vancouver, Wash.
Alexander Hawatmeh, a member of Worthmore Investments LLC, which owns a stock promotion website called stockhaven.com. He formerly lived in Vancouver and currently resides in Lincoln City, Oregon.
Christopher Mrowca, a stock promoter who operates Money Runners Group LLC, which has an affiliated stock promotion website called MoneyRunnersGroup.com. He lives in Bradenton, Fla.
Tovy Pustovit, who owns a stock promotion website called Explosive Alerts. He also lives in Vancouver.
In a parallel action, the U.S. Attorney’s Office for the Western District of Washington announced criminal charges against Galas, Hawatmeh, and Mrowca.
According to the SEC’s complaint, GrowLife Inc. was part of a broader online promotion of several marijuana-related stocks in early 2014. Mrowca specifically promoted GrowLife through his Money Runners Group website and predicted that the stock price would nearly double. Mrowca, Galas, and Hawatmeh meanwhile engaged in manipulative trading designed to increase the price and volume of GrowLife stock, and they later sold their shares for illicit profits.
Similarly, the SEC alleges that Hawatmeh, Galas, and Mrowca bought and sold approximately 41.7 million shares of Hemp Inc. in January and February 2014 while the stock was actively promoted on the Internet. For example, one Internet tout on February 6 claimed that Hemp could reach “a REAL Possible Gain of OVER 2900%.” During the promotion, Hawatmeh, Mrowca, and Galas engaged in manipulative wash trades and matched orders to manipulate Hemp’s common stock before selling their shares for illegal gains.
“This was a carefully planned operation by Galas, Hawatmeh, Mrowca, and Pustovit to distort the performance of specific penny stocks as they were simultaneously promoted through social media and the Internet. As the companies’ stock prices increased, these four promoters opportunistically dumped their shares for illicit gains,” said Amelia A. Cottrell, associate director in the SEC’s New York Regional Office.
The SEC’s complaint charges Galas, Hawatmeh, Mrowca and Pustovit with violating antifraud provisions of the federal securities laws. The SEC seeks temporary, preliminary, and permanent injunctions along with an emergency asset freeze, disgorgement, prejudgment interest, financial penalties, and orders barring the promoters from participating in a penny stock offering.
The SEC’s complaint names Nadia Hawatmeh as a relief defendant for the purposes of recovering ill-gotten gains in her brokerage account, which was used by the promoters to conduct some of their manipulative trades.
The SEC’s investigation has been conducted by Michael Paley, Eric M. Schmidt, Mona Akhtar, Joseph Darragh, and Tejal Shah. The case was supervised by Ms. Cottrell, and the litigation will be led by David Stoelting. The SEC appreciates the assistance of the U.S. Attorney’s Office for the Western District of Washington, the Federal Bureau of Investigation, and the Financial Industry Regulatory Authority.
How bout them raisins?
Agree! Very nice article!
A Few buys today!!
Today, I'm considering an emerging pharmaceutical company called Intellipharmaceutics (NASDAQ:IPCI). In order to gain more insight on this opportunity, I conducted a phone interview with Mr. Shameze Rampertab, Vice President of Finance and CFO of Intellipharmaceutics. As stated on the company website, "Mr. Rampertab joined Intellipharmaceutics in November 2010. He is a chartered accountant (NASDAQ:CA) since 1994, brings public company experience to Intellipharmaceutics, having previously served as the Director, Finance and Secretary-Treasurer for then-public Drug Royalty Corp. Mr. Rampertab also served as health sciences and biotechnology analyst at several investment banking firms including Canaccord Capital, and was until recently a Partner, Healthcare Investment Banking at Loewen Ondaatje McCutcheon Limited, where he specialized in raising equity funds for life-science companies. He received an MBA from McMaster University and a BSc. from the University of Toronto and has substantial expertise with licensing and royalty deals." Following are excerpts from the phone interview:
To start off, could you please provide an overview of Intellipharmaceutics?
We are Nasdaq listed with 23 million shares; 31 million fully diluted. Our biggest shareholder is our Founders, Dr. Isa Odidi and Dr. Amina Odidii. They are the formulators and the reason we exist. They own 26 percent. Our cash is just short of $6 million. What makes our company interesting at this juncture is that, for the very first time, we have revenues. Trailing 12-month revenue is $7.7 million and we have analyst coverage from four firms.
So, Intellipharmaceutics is a specialty pharmaceutical company, but under that umbrella name for specialty pharmaceuticals, we are in the drug delivery space. Our drug delivery technologies are really controlled drug delivery release technologies. These controlled release technologies fit into three baskets:
The first basket is our abuse resistance drug delivery platform, which is called Rexista. We have some Phase 1 data on our Rexista oxycodone, and we'll have some additional data later on this year.
The second basket is our once-a-day formulations of drugs where once-a-day doesn't exist. We've done that with Pfizer's (NYSE:PFK) Lyrica. The generic name for Lyrica is Pregabalin, so we are working on providing Phase 1 data on that, and we should have additional data later on this year.
The third basket is our generic portfolio. We can actually create copycat generics of once-a-day formulated drugs. We do this without reverse engineering the innovator's patented XR technologies. We use our own XR technologies to create these once-a-day XR generics. Our marketed product is Focalin XR, which received approval in November 2013. We have seven other drugs filed with the FDA that are generic equivalents and are XR formulations.
So, we have quite a lot of products, and our patents surrounding our drug delivery solutions are not involved in the typical biotech companies developing novel drugs. Our patents are around our drug delivery solutions, which are our own proprietary methods of delivering drugs.
What's your overview on the future of your niche or specialization in the drug delivery industry?
Well, the specialization of drug delivery has been going in a lot of different directions. You can find drug delivery companies that are very much focused on injectables, and others which are focusing on transdermal applications. Our drug delivery solutions are all oral solid dosage forms (pills and caps). So, our controlled release formulations are really surrounding oral solid dosage forms.
The typical life cycle management strategy of Big Pharma is that they come out with a drug, such as Pfizer's Lyrica, which brings in around $2.8 billion a year in the US. Lyrica is a 2-to-3-times-a-day drug. Pfizer's patent for Lyrica is going to expire in 2017 or 2018. As a result, Pfizer is in the process of developing, filing and ultimately receiving approval for a once-a-day formulation of Lyrica. Thus, the life cycle management strategy of Big Pharma is to move patients on a more convenient dosage form (once a day) as patents expire, which actually improves compliance. For instance, think about yourself. Think about how many times you've missed a dose of a medication taken two or three times daily. But if you can take it only once a day, you're good for the entire day (and less likely to forget doses). So, people actually prefer once-a-day formulations.
Are the once-a-day drug formulations actually cheaper than the multiple-dose-per-day formulations?
Not necessarily. If it's replacing a three-times-a-day drug, it could actually cost more than the three-times-a-day drug because of the convenience factor and the compliance factor. Now, with many drugs, doctors want patients to take them multiple times a day because patients need to have certain minimum levels of the drug in their body in order to get the full therapeutic benefit of that drug. You don't want spikes in terms of the levels of that drug in your body. You want to have it in the body at certain times and certain levels. The pharmaceutical companies have developed drugs for that purpose, because when a patient starts missing doses, that's not good from a medical perspective.
What are the main challenges that the drug delivery industry faces today?
I'm going to personalize this answer to Intellipharmaceutics. So I talked about the specialty pharmaceutical umbrella, and under that we have the drug delivery companies. And under that umbrella, we are in the controlled release space. We consider that to be a niche area because there is a barrier to entry here. You have your own controlled release technologies, so we believe there is a barrier to entry, and the level of competition in the controlled release space is very different than many other spaces because when we talk about generics, for example, people think of Chinese and Indian generic pharma companies that drive down prices and have thin margins. It's all about market share, and it's good for consumers because they get really cheap products, but that's the generic space.
As I've mentioned, we are in the extended-release space; we are using our controlled-release delivery technology to create these once-a-day drugs. So what kind of competitors do we see in this space? We see Teva (NYSE:TEVA), Mylan (NASDAQ:MYL), Actavis (NYSE:ACT) and [indiscernible]. Those are the big domestic generic players because they all have their own technologies. Any of the Chinese generic makers are great at reverse engineering, but they don't have their own proprietary technologies to create these once-a-day drugs. So, when we talk a little bit later about who competes in the Focalin generic XR space, it's a very small group, and, thus, we're able to keep prices higher and margins are very healthy because of that.
Let's take a step back and look at the immediate-release generic space. Do you remember last year when Lipitor, the world's biggest selling drug ever went generic? Teva, the world's biggest generic pharmaceutical company, announced it would not launch a generic Lipitor. Lipitor is an immediate-release formulation, so there's no once-a-day Lipitor. The reason why Teva said it wouldn't launch is because there were too many Chinese generic companies that had approval and were going to launch and drive down prices. And as a public company, can Teva make 10 percent margins or 5 percent margins on sales of a high volume product? It doesn't make financial sense for Teva and it doesn't make financial sense for a lot of companies.
On the company website, it shows that Intellipharmaceutics has over 10 products awaiting regulatory approval, and, of course, a marketed Focalin XR generic product. Since this business aspect is of interest to investors, when can they roughly expect the next regulatory decision on any of these pipeline assets?
Biotech companies fit under a different regiment of the FDA; they fit under the Prescription Drug User Fee Act, and they receive dates when they complete a filing. They will receive a PDUFA date which the companies will publicly announce. In the generic space, however, you do not get that luxury, which is problematic as it is hurting the American population since it slows down the time that generic drugs can enter the market. So, because of that, the FDA did implement the Generic Drug User Fee Act about a year and a half ago, and it's a 5-year program. Under the Generic Drug User Fee Act, [the FDA] is collecting revenues from generic manufacturers and generic filers of drugs and they are using those funds to build up their own resources internally so they can deal with this problem.
When you file an ANDA with the FDA, you don't get a date from the FDA; it just goes into the queue. In the last 2 years, the average time for a generic drug to get approved has gotten worse and worse. In the month of June last year, the average time was 35 months, but the standard deviation around that is huge. Of those 31 drugs, the quickest one took only 17 months to get approved by the FDA. The one that took the longest took 89 months to get approved. So, we can't provide guidance since there is a problem in the generic industry and it's impossible to predict generic regulatory approval dates. Even if you look at Teva's presentations or Mylan's presentations with respect to their ANDA filings, they will estimate how many of their generic drugs will receive approvals; however, they won't tell you which ones. In terms of all that, the pipeline that you can access on our website--our Glucophage XR, Effexor XR and Protanix XR--have been awaiting approval for 4 years. Their markets have already gone generic, so we think there is a good probability that we will get a couple of these approved by the end of the year. We're hoping that they will get approved, but there are no absolutes here.
In terms of the regulatory queue, do larger pharmaceutical companies like Teva have an advantage over smaller companies like Intellipharmaceutics, or is it more in terms of whichever company is first in line?
The whole ANDA process that the FDA is triaging and the way that companies communicate with the FDA have changed significantly in the last 12 months. This is because of the Generic User Fee Act and because the FDA is trying to become much more efficient in dealing with the backlog of almost 3,000 ANDAs that have been filed with them.
As you've pointed out, there are more well financed competitors out there, so what differentiates Intellipharmaceutics in ways that you would consider advantageous?
The way I like to explain to people how we build the business is using the baseball analogy. Our ANDAs are like a bunch of singles and doubles. So we have a number of them lined up (pipeline on website), and even if a couple of them strike out, we still got a number of singles and doubles. And with that alone, we can win the game, and we'll continue to file more ANDAs as time moves on. So, if you can get 10 products that are generating $5 million a year in revenues, you actually have a nice little portfolio, and that's effectively the base of the company. But, what are the homerun potentials using the baseball analogy? Well, our Rexista oxycodone could have homerun potential because the FDA has said point blank that it wants drug abuse deterrent technology implemented in narcotics [indiscernible]. That's exactly the space that we're moving forward with. So, Rexista has homerun potential because there is a separate regulatory path that's not as simple as the ANDA path, but it's not as long and as cumbersome as the biotech path (the Phase 1-3). Our Rexista oxycodone is going down a quicker regulatory path that has pretty good reward potential.
Now that we're on the topic of Rexista, I want to bring up a comment that was recently made by Maxim Group. The firm stated that Rexista might face tough generic competition because it may only have a few advantages over other products. I want to ask you whether management shares this concern, as well as what precisely differentiates Rexista from other abuse deterrent opioids like Pain Therapeutics' (NASDAQ:PTIE) Romaxi and Pfizer's Oxecta?
We're trying to deal with dose dumping. Dose dumping is when you manipulate a product to release its full payload in 1-2 hours, so you get really high levels. With regards to narcotics, you get that euphoric state, but the risk is that you can have increased toxicity and side effects and possibly deaths. We've seen people dying of overdoses with various drugs when they tamper with it. Heath Ledger from Batman died of an overdose of Oxycontin in conjunction with red wine. That's all they found in his hotel room. So, that's what we're trying to deal with here.
What does our Rexista oxycodone do? Well, the main thing that all these products must have is some kind of crush resistance formulation. Rexista has that too, and we have a patent application that recently got published. The reality is all products that are out there can be crushed. If you can go buy a $20 coffee grinder, throw a pill in it, and you are left with some flakes and powder. If you snort our product in the presence of moisture, it's going to get very gummy and pasty and clog up your navel cavities. If you try and pop it in your mouth and inhale it into your lungs like a dry powder inhaler, it will, once again, get clogged up in your throat and you will have to cough it out. If you try to dilute our product in water, it will get very viscous and it's not syringable, so you can't inject it.
If you take that same powder and free base it, which is when you put a powder on a spoon and place a flame underneath it to inhale the vapors, it will spontaneously combust. And if you extract the vapors that come off that burning, there's not much of the oxycodone left, so you will have essentially destroyed our product. If you try to take our once-a-day product with alcohol, that full payload will dump into your body in 1-2 hours, which is very toxic to you. So we see the opposite of dose dumping happening with our product. We've tapered it in such a way that it will release less of the payload in a normal situation, so it actually penalizes patients who try to mix our drug with alcohol. Another way drug addicts are abusing oxycodone is by microwaving it. If you took oxycodone and put it in a microwave for 3 minutes to heat it up, and then let it cool off and proceed to pop it in your mouth, you would get dose dumping. You will have destroyed the abuse deterrent technology in oxycodone. If you do that with our product, however, it doesn't induce dose dumping when you microwave it; it operates completely normal. Furthermore, a way that recreational users abuse oxycodone is by dropping it into a can of Coca Cola, which leads to dose dumping. We don't know what it is about it, but this is one of the ways that drug addicts are abusing it. But again, if you do that with our product, we don't see dose dumping happening.
So, the takeaway here is that we're dealing with a number of different mechanisms of abuse, more so than many different players. We believe that we have the best in class here because we are dealing with abuse deterrents through multiple mechanisms of abuse. We're not aware of anyone that has quite the robustness of abuse deterrent technology in one technology platform and in one product. Sure, Teva is ahead of us, and so is Pain Therapeutics, but it doesn't matter. At the end of the day, even if you get out there 2 years after these guys hit the market, what's a doctor going to prescribe? If the efficacy of the drug works exactly the same as oxycodone, the doctor will likely prescribe the drug that is very difficult to abuse (Rexista) rather than one that is only crush resistant.
Lets shift back to Focalin. Where are you with sales?
So with Focalin for ADHD, we got approval in November on the 15 mg and 30 mg, and we got tentative approval on the other doses. Our trailing 12 months of revenue is $7.7 million. Our commercial partner is Par Pharmaceuticals. Right now, we're selling into 31 percent of the market. Teva was first to file on the 5 mg, 10 mg, 20 mg and 40 mg. I don't know why it hasn't launched on the 5 mg, 10 mg and 20 mg. Does it make sense that Teva hasn't launched? No, it doesn't make sense. But, the takeaway here is that on the lion share of the Focalin market, we haven't been able to sell to it yet, which is not bad with the sales we've had so far. So on the 15 mg and 30 mg for the month of June (the most recent record), we're still doing pretty good, considering that we lost exclusivity on the 15 mg in May. On the 15 mg we still have 43 percent of the scripts. Novartis (NYSE:NVS) and Teva are sharing the other 57 percent. On the 30 mg, no one received first-to-file exclusivity, so there are a number of competitors out there and we're still a quarter of the 30 mg market. We're doing okay just on two dosages.
Now let's look at the bigger landscape. On the tentative dosages, we can't provide guidance. It's as simple as that. So, when you look at our revenues, we only have 3/4 of our revenues recorded, which is where we get the $7.7 million from as I mentioned earlier.
What part of the business do you think is being ignored that has more upside potential than Wall Street is giving it?
Well, one of the things that we haven't really been talking about-- because of the limited information that we have released--is surrounding our Rexista platform technology. We've done lab based studies on other narcotics (e.g., hydrocodone, hydromorphone and morphine), and we've found that Rexista works just as well with those narcotics as with oxycodone. So, once we get oxycodone moved into a Phase 3 study or partnered off, there are other products that we can bring forward.
Could you please discuss management's latest efforts to license Rexista?
I can't give you a definitive answer, but please take a look at our management. The responsibilities of one of our latest hires, Christian Akyempon, Vice President of Commercial Operations, are twofold: to potentially license our products, but to also build our own commercializaton at an appropriate time. With respect to Rexista, if we don't get the right economics down, we will just wait until more Phase 1 data is available and disclose that to a potential licensing partner. And if we still don't get the right economics, we will have to conduct an analysis to see whether we should fund a Phase 3 trial ourselves and license Rexista after Phase 3. Rexista oxycodone would have to be licensed at some time because it would need to be [advertised] to doctors.
With regards to earnings, another concern of investors is the exponential increase in R&D expenses YOY. Could you please provide some clarity on this potential issue?
Sure. What happened in Q2 2014 was that our R&D expenses were significantly higher. Why? We clearly disclosed a $1 million one-time performance option paid to our Founders. This was based on performance criteria (filings and approvals). This performance option will expire in September 2014. It went to shareholders and we asked shareholders to approve the extension of the filing of that performance option by 2 years. So, it expires now in September 2016. Shareholders voted on it and they approved it. On the back of the approval, we now have to recognize the actual value increase in that performance option in our books immediately. That was a one-time $1 million hit to R&D. So, it would make no sense to put the one-time non-cash option expense line in an extrapolated-out financial model.
You touched on this already, but I just want to make sure to get this on record. Are you planning to process new ANDAs?
So, we are planning additional ANDA fillings. These are not new indications because they are copy-cat generics. However, we are using our own technologies so we're not infringing on the innovators' patents. That's why if you look at our financials, we have no outstanding litigation. In the past we've had litigation which we've settled, but that's not to say that we don't foresee future litigation because this is the industry we operate in.
Do you think future litigation would significantly impact business operations?
That's always a risk, but if you look at our historical financial statements, if it was a material amount in terms of our patent and litigation expenses, it would be a separate line item, but it isn't and it never has been.
I now want to ask you about IPCI stock performance. It has relatively low liquidity, so is management making efforts to increase awareness and attract more retail investors?
Absolutely, but if you and I were talking a year ago, IPCI was trading at 20,000 shares a day. Today, we are trading around 200,000 shares a day. Nevertheless, you're right, so we're attempting to increase the momentum behind IPCI stock, and, thus, improve liquidity.
So to wrap things up, and this is basically the takeaway from this interview, that at any point--whether that be tomorrow, next week or next year--the generics awaiting regulatory decision could receive approval without any prior notice from the FDA?
Correct.
Thank you so much for your time.
Looking very promising here!!
Hashbrown $GRDO, I mean
Hashish $GRDO, or is it
#$GRDO
My account may get
GORDO with GRDO!!!!
It was sure a good week here!!! My 5's are looking sweet!!!
Yes yes...he did say tomorrow...so maybe he's getting a head start. Go AASP!!!!
NITE wanting 10k at $1.29 hmm...he doesn't usually show his hand like that...
The Company is a development stage enterprise that is developing safe social networking websites for pre-teenage the teenage children. On April 25, 2014, the Company acquired In-Flight Publications Group, Inc. (See Note 8) for 25,000,000 shares of common stock. In-Flight is. a multi-media advertising company specializing in providing Hotels, Spas, Resorts, Cruise Lines, and strategic Consumer Product and Service companies with the ability to target their products to select, affluent audiences via Internet and world-class print publications, including more than 60 US and global airline in-flight magazines. As a result the Company recorded Goodwill in the amount of $16,108.
Nice volume today!!! Woohoo!!!
I'm thinking things will change. That news tells us something is happening.
Got me a couple cheapies
What just happened?
I've thought the same thing! Our ticker symbol would be a good one for an erectile disfunction company! I'm not liking this disfunction right now though!!!!
That's a MM signal that means "I'm thirsty for a Big Gulp!" Lol!!
Go AASP, ASAP!!!
Htds and Agel have ties?
@BrianLevineGCE: The SEC had confirmed receipt of GCE form 10 filing a major milestone. GCE is a fully reporting company and will be up listed in 60 days
While I must agree this stinks--I'm really not worried!!
Hmmm maybe I'll buy some of this soon--something must be goin on????