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Greed
STRONG BUY -All indicators pointing out institutional investors loading up in 13 minutes till closing . I see $1.50 closing
NEWS=BUY-BUY-BUY-=(DCTH) shares / Delcath Systems, Inc. (DCTH): What’s the Story?
By Annette Gomez - June 29, 2017
Delcath Systems, Inc. (DCTH) is an interesting player in the Healthcare space, with a focus on Drug Delivery. The stock has been active on the tape, currently trading at $0.20, down from yesterday’s close by -5.09%. Given the stock’s recent action, it seemed like a good time to take a closer look at the company’s recent data.
Fundamental Analysis
This company has been competing with others in the Healthcare space and offers its own combination of interesting factors Delcath Systems, Inc. (DCTH) currently trades with a market capitalization of $38.83 Million. That value represents a market adjusting for revenues that have been growing by 100.81 % on a quarterly year/year basis as of the company’s last quarterly report.
The balance sheet health of any company plays a key role in its ability to meet its obligations and maintain the faith of its investment base. For DCTH, the company currently has $27.14 Million of cash on the books, which is offset by $9.29 Million current liabilities. You can get a sense of how sustainable that is by a levered free cash flow of $-14.52 Million over the past twelve months. Generally speaking, earnings are expected to hold steady in coming quarters. Perhaps, that suggests something about why 1.82% of the outstanding share supply is held by institutional investors.
https://stocknewsjournal.com/2017/06/29/delcath-systems-inc-dcth-whats-the-story-4/
STRONG BUY -All indicators Green =and pointing out that a DCTH support point bottom is $0.20 now TIME to BUY every day shares will go up $0.05 without news /Cheek it out. WEEEEEEEEEEEEEEEEEEEEE
Advice - Everyone to (DCTH) players-Please do not sell shares at opening lets shares gain strengths /
My Recommendation " In order to get better price sell shares if you decided between 11-30 a,m, 01-30 p.m. I get some money so - I BUYING more -
NEWS=BUY-BUY-BUY-=(DCTH) shares / Delcath Systems, Inc. (DCTH): What’s the Story?
By Annette Gomez - June 29, 2017
Delcath Systems, Inc. (DCTH) is an interesting player in the Healthcare space, with a focus on Drug Delivery. The stock has been active on the tape, currently trading at $0.20, down from yesterday’s close by -5.09%. Given the stock’s recent action, it seemed like a good time to take a closer look at the company’s recent data.
Fundamental Analysis
This company has been competing with others in the Healthcare space and offers its own combination of interesting factors Delcath Systems, Inc. (DCTH) currently trades with a market capitalization of $38.83 Million. That value represents a market adjusting for revenues that have been growing by 100.81 % on a quarterly year/year basis as of the company’s last quarterly report.
The balance sheet health of any company plays a key role in its ability to meet its obligations and maintain the faith of its investment base. For DCTH, the company currently has $27.14 Million of cash on the books, which is offset by $9.29 Million current liabilities. You can get a sense of how sustainable that is by a levered free cash flow of $-14.52 Million over the past twelve months. Generally speaking, earnings are expected to hold steady in coming quarters. Perhaps, that suggests something about why 1.82% of the outstanding share supply is held by institutional investors.
https://stocknewsjournal.com/2017/06/29/delcath-systems-inc-dcth-whats-the-story-4/
STRONG BUY -All indicators Green =and pointing out that a DCTH support point bottom is $0.20 now TIME to BUY every day shares will go up $0.05 without news /Cheek it out. WEEEEEEEEEEEEEEEEEEEEE
SELL--SELL-SELL=DCTH)
Interpace Diagnostics Announces Coverage of Thyroid Test By Premera Blue Cross
Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced that Premera Blue Cross, the largest Regional health plan based in Mountlake Terrace, Washington, has agreed to cover Interpace’s ThyraMIR® test for all of its more than 2 million members located primarily in Washington, Oregon, and Alaska. Premera Blue Cross has a network of more than 38,000 physicians, hospitals, laboratories, and other healthcare providers across the Northwest. Interpace’s ThyraMIR assay is now covered for thyroid nodules deemed indeterminate by standard cytopathological analysis. With the addition of Premera’s members, ThyraMIR is now covered for over 250 million patients nationwide, including through Medicare, National, and Regional health plans. The Company also recently announced coverage of ThyraMIR by United Healthcare and Aetna.
The ThyGenX® - ThyraMIR® combination represents the only test in the market that includes the rule-in properties of next-generation sequencing of a patient’s DNA and RNA along with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, approximately 90% of the Company’s ThyGenX cases are reflexed to ThyraMir for additional assessment. The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 15,000 ThyraMIR tests for nearly 400 physicians and hospitals nationwide.
According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant, following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign. Molecular testing using ThyGenX – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “The agreement by Premera Blue Cross to cover ThyraMIR is further evidence of the clinical utility as well as clinical validity of our thyroid assays. We are pleased that Premera has joined the growing list of health plans that cover ThyraMIR and that their 2 million members will now have access to its benefits.”
About Thyroid Nodules, ThyGenX and ThyraMIR Testing
According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innov
TIME to BUY (IDXG) Revenue improved + acceptability to test incised over billion tests including US Military Army ....=STRONG BUY -I am in the game !
News Alert! Interpace Diagnostics Announces National Contract with Aetna
GlobeNewswire•June 28, 2017Comment
PARSIPPANY, N.J., June 28, 2017 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management announced today that it has signed a new national contract with Aetna for its ThyGenX ®and ThyraMIR® molecular tests for indeterminate thyroid nodules.
Aetna is the third largest health plan in the United States, with over 44.9 million members nationwide. The agreement covers many of Aetna’s products, including commercial and Medicare Advantage plans. It does not include Medicaid, auto insurance, or workman’s compensation products. The agreement goes into effect August 15, 2017. Aetna began covering ThyGenX in June 2015 and ThyraMIR in November 2016.
The agreement is the Company’s first national provider contract with a national health plan and means that Interpace will now be part of Aetna’s laboratory network for these services.
“The agreement with Aetna is another significant reimbursement milestone demonstrating our ability to convert our product coverage approvals with major insurance providers into successful contractual agreements,” said Jack E. Stover, Interpace’s President and CEO, “Coverage of our thyroid products has continued to increase and improve over the past few quarters and now totals over 250 million covered lives.”
https://finance.yahoo.com/news/interpace-diagnostics-announces-national-contract-121500877.html
News Alert !Interpace Diagnostics Announces Coverage of Thyroid Test By Premera Blue Cross
Interpace Diagnostics Group, (NASDAQ:IDXG)
Historical Stock Chart
1 Month : From May 2017 to Jun 2017
Click Here for more Interpace Diagnostics Group, Charts.
Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced that Premera Blue Cross, the largest Regional health plan based in Mountlake Terrace, Washington, has agreed to cover Interpace’s ThyraMIR® test for all of its more than 2 million members located primarily in Washington, Oregon, and Alaska. Premera Blue Cross has a network of more than 38,000 physicians, hospitals, laboratories, and other healthcare providers across the Northwest. Interpace’s ThyraMIR assay is now covered for thyroid nodules deemed indeterminate by standard cytopathological analysis. With the addition of Premera’s members, ThyraMIR is now covered for over 250 million patients nationwide, including through Medicare, National, and Regional health plans. The Company also recently announced coverage of ThyraMIR by United Healthcare and Aetna.
The ThyGenX® - ThyraMIR® combination represents the only test in the market that includes the rule-in properties of next-generation sequencing of a patient’s DNA and RNA along with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, approximately 90% of the Company’s ThyGenX cases are reflexed to ThyraMir for additional assessment. The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 15,000 ThyraMIR tests for nearly 400 physicians and hospitals nationwide.
According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant, following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign. Molecular testing using ThyGenX – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “The agreement by Premera Blue Cross to cover ThyraMIR is further evidence of the clinical utility as well as clinical validity of our thyroid assays. We are pleased that Premera has joined the growing list of health plans that cover ThyraMIR and that their 2 million members will now have access to its benefits.”
About Thyroid Nodules, ThyGenX and ThyraMIR Testing
According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
STRONG BUY =New contract will make (IDXG) share go to $2.50 a share today and tomorrow =bank my prediction .
This companies worth time over ,has money for operations for year - will get over $1.00 today and =only way up. ...
SELL-SELL-SELL-News Alert! (DCTH)cuts work force by 20%
http://www.marketwatch.com/story/delcath-cuts-work-force-by-20-2013-06-26?siteid=bigcharts&dist=bigcharts
I expecting today DCTH share massive sell as correction be reedy fox I which I was wrong yesterday it touched $0.19 I buy some shares at $0.1956 and sold at $0.24 gained little . Good luck to all !
I do not belie whit Barchart analysis state it is all wrong =and why?
For example at Barchart in June 16, 2017 week long stated Strong Sell DCTH shares went over 390% up to $0.34 from $0.05 a share
Then at Barchart in June 24 , 2017 stated Strong Buy from 0.28 share go down to $0.11 a share
To day DCTH should go down as correction all indicators red for me that is fact to sell not what Barchart / stated/
at an exercise price of $0.27 per share with a term of exercise of one year. In total, the shares of Series B convertible preferred stock are convertible into 29.6 million shares of common stock,
at May 16, 2017
Just look date of filing under
at an exercise price of $0.27 per share with a term of exercise of one year. In total, the shares of Series B convertible preferred stock are convertible into 29.6 million shares of common stock,
at May 16, 2017
Just look date of filing under
I sold all shares (DCTH) last time when share hit $0.11 from $0.28 I lost banal =I have filling this time 50/50 go down too ? I don't relay know -no news . Well good luck to all .
Monday, 06/26/17 08:43:53 AM
Re: ice1234 post# 13691
Post #
13694
of 13888 Go
BUY Alert !Pre Market indicators all green 3 time more buyers then sellers =pointing out share DCTH will go up at list to 20% or more 35% today. Check it out .
BUY Alert !Pre Market indicators all green 3 time more buyers then sellers =pointing out share DCTH will go up at list to 20% or more 35% today. Check it out .
Buying opportunity= R/S- the reverse split is canceled officially/ =As part of the most recent vote, a little over 70 million votes were cast For the split approval and a little over 37 million votes were cast Against. /
1.5 million votes abstained.
While the for votes outnumbered those against, the proposal received fewer votes in favor than the required majority of the total number of outstanding shares as of the record date.
It is this cancellation that is really driving this company right now. It means that some sort of joint venture, a buyout or an offloading of the company’s lead development asset is probably going to be likely, each of which serves to potentially add a premium on to current share price on execution.
10Q=Market Access & Commercial Clinical Adoption
European Union
Our immediate market access and clinical adoptions efforts continue to be focused on the key target markets of Germany and the United Kingdom, which represent a majority of the total potential liver cancer market (primary and metastatic) in the EU and where progress in securing reimbursement for CHEMOSAT treatments offers the best near-term opportunities. We also continue to support clinical adoption of CHEMOSAT in the Netherlands, Spain, France and Italy. We employ a combination of direct and indirect sales channels to market and sell CHEMOSAT in these markets. Our European Headquarters is in Galway, Ireland.
Since launching CHEMOSAT in Europe, treatments have been performed at over 20 leading European cancer centers. Physicians in Europe have used CHEMOSAT to treat patients with a variety of cancers in the liver, primarily ocular melanoma liver metastases, and other tumor types, including hepatocellular carcinoma, cholangiocarcinoma, and liver metastases from colorectal cancer, breast, and cutaneous melanoma.
European Reimbursement
A critical driver of utilization growth for CHEMOSAT in Europe is the expansion of reimbursement mechanisms for the procedure in our priority markets. In Europe, there is no centralized pan-European medical device reimbursement body. Reimbursement is administered on a regional and national basis. Medical devices are typically reimbursed under Diagnosis Related Groups (DRG) as part of a procedure. Prior to obtaining permanent DRG reimbursement codes, in certain jurisdictions, the Company is actively seeking interim reimbursement from existing mechanisms that include specific interim reimbursement schemes, new technology payment programs as well as existing DRG codes. In most EU countries, the government provides healthcare and controls reimbursement levels. Since the EU has no jurisdiction over patient reimbursement or pricing matters in its member states, the methodologies for determining reimbursement rates and the actual rates may vary by country.
23
Germany
In October 2015, we announced that the Institut f?r das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, established a national Zusatzentgeld (ZE) reimbursement code for procedures performed with CHEMOSAT in Germany. The ZE diagnostic-related group (DRG) code is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created, and will replace the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. In 2016, coverage levels were negotiated between hospitals in Germany and regional sickness funds. Coverage levels determined via this process are renegotiated annually.
United Kingdom
In the United Kingdom, though Delcath and our participating cancer centers identified existing Healthcare Resource Groups (HRG) code(s), we have been advised that hospitals have not used it for coverage of CHEMOSAT related costs. We continue to work with the HRG organization that decides on new HRG codes toward receipt of a dedicated and permanent reimbursement code in the future.
Delcath expects to consult again with the Interventional Procedures Advisory Committee at the National Institute for Clinical Excellence (NICE) in England, to provide recent clinical evidence with a view to moving existing Interventional Procedural Guidance from research to specialist status. This would enable greater scope for commercialization because it would allow more use by NHS clinicians of the therapy. It might also pave the way for a full Medical Technology Assessment as a way towards longer term reimbursement with the NHS.
In May 2014, the NICE, a non-departmental public body that provides guidance and advice to improve health and social care in the UK, completed a clinical review of CHEMOSAT. The NICE review indicated that as the current body of evidence on the safety and efficacy of PHP with CHEMOSAT for primary or metastatic liver cancer is limited, the procedure should be performed within the context of research by clinicians with specific training in its use and techniques. NICE stated that this research may take the form of observational studies. With continued enrollment in the UK in our Phase 2 HCC and ICC trial in 2016, we believe the data generated from these studies will help provide supporting clinical data and address the concerns raised by NICE relative to survival, quality of life and adverse events. NICE may decide to conduct a Technology Appraisal of CHEMOSAT thereafter, the outcome of which could influence the long-term reimbursement status.
In the short term, public patients will continue to be treated in the UK through clinical trials. Private patients will continue to be treated through the established private treatment pathway such as private insurance coverage or self-pay.
Spain
In April 2016, we announced that the General and Digestive Surgery team at HM Sanchinarro University Hospital had activated the hospital's CHEMOSAT program. The Sanchinarro team successfully performed three procedures with CHEMOSAT, using the procedure to treat patients with peripheral cholangiocarcinoma, neuroendocrine tumors and colorectal liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer CHEMOSAT treatments.
Turkey
In April 2016 we announced the activation of the Hacettepe University Clinic in Ankara, Turkey as a CHEMOSAT treatment center. Hacettepe University Clinic successfully completed its first CHEMOSAT treatments in March 2016, and the center represents the first CHEMOSAT commercial location to be activated outside of the European Union. We believe that Hacettepe University can serve as an important hub for CHEMOSAT treatment to patients in Turkey and throughout the region.
Other European Markets
Permanent reimbursement coverage in remaining EU markets will require additional time to secure. For France, Spain and the Netherlands, publication of the Phase 3 trial manuscript is a key component of the reimbursement process. The Phase 3 trial manuscript has been accepted for publication in the prestigious Annals of Surgical Oncology and will serve as the foundation for the reimbursement efforts in these countries. In the interim period, we are seeking payment through various avenues, including new technology programs.
24
Distribution Partners
As a result of the Company’s strategy to prioritize resources on the key direct markets of Germany and the United Kingdom, the Company expects that its distribution strategy will play a lesser role in its current commercial activities. In Spain, the Company has determined that there was no benefit to continuing with an indirect model and therefore terminated its relationship with its distributor in Spain and is now represented in Spain through a sales agency.
Regulatory Status
Our products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. Foreign regulatory agencies, the FDA and comparable regulatory agencies in state and local jurisdictions impose extensive requirements upon the clinical development, pre-market clearance and approval, manufacturing, labeling, marketing, advertising and promotion, pricing, storage and distribution of pharmaceutical and medical device products. Failure to comply with applicable foreign regulatory agency or FDA requirements may result in Warning Letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.
United States Regulatory Environment
In the United States, the FDA regulates drug and device products under the FFDCA, and its implementing regulations. The Delcath Melphalan/HDS is subject to regulation as a combination product, which means it is composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of its primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of the Melphalan/HDS, the primary mode of action is attributable to the drug component of the product, which means that the Center for Drug Evaluation and Research, has primary jurisdiction over its pre-market development and review.
The process required by the FDA before drug product candidates may be marketed in the United States generally involves the following:
o
submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually;
o
completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;
o
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;
o
submission to the FDA of an NDA after completion of all pivotal clinical trials;
o
a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;
o
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practice, or cGMP, regulations; and
o
FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States.
The development and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted on a timely basis, if at all.
The results of preclinical tests (which include laboratory evaluation as well as GLP studies to evaluate toxicity in animals) for a particular product candidate, together with related manufacturing information and analytical data, are submitted as part of an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. IND submissions may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive good clinical practice regulations and regulations for informed
25
consent and privacy of individually identifiable information. Similar requirements to the United States IND are required in the European Economic Area (EEA) and other jurisdictions in which we may conduct clinical trials.
In addition, shareholders of the Company also approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 170,000,000 to 500,000,000.
https://ih.advfn.com/p.php?pid=nmona&article=74536379
Buying opportunity= ClinicalTrials.gov processed this record on June 23, 2017
Buying opportunity= in other words, officially -R/S the reverse split is canceled.
As part of the most recent vote, a little over 70 million votes were cast For the split approval and a little over 37 million votes were cast Against. 1.5 million votes abstained. While the for votes outnumbered those against, the proposal received fewer votes in favor than the required majority of the total number of outstanding shares as of the record date.
It is this cancellation that is really driving this company right now. It means that some sort of joint venture, a buyout or an offloading of the company’s lead development asset is probably going to be likely, each of which serves to potentially add a premium on to current share price on execution.
ClinicalTrials.gov processed this record on June 23, 2017
Buying opportunity= in other words, officially -R/S the reverse split is canceled.
As part of the most recent vote, a little over 70 million votes were cast For the split approval and a little over 37 million votes were cast Against. 1.5 million votes abstained. While the for votes outnumbered those against, the proposal received fewer votes in favor than the required majority of the total number of outstanding shares as of the record date.
It is this cancellation that is really driving this company right now. It means that some sort of joint venture, a buyout or an offloading of the company’s lead development asset is probably going to be likely, each of which serves to potentially add a premium on to current share price on execution.
10Q=Market Access & Commercial Clinical Adoption
European Union
Our immediate market access and clinical adoptions efforts continue to be focused on the key target markets of Germany and the United Kingdom, which represent a majority of the total potential liver cancer market (primary and metastatic) in the EU and where progress in securing reimbursement for CHEMOSAT treatments offers the best near-term opportunities. We also continue to support clinical adoption of CHEMOSAT in the Netherlands, Spain, France and Italy. We employ a combination of direct and indirect sales channels to market and sell CHEMOSAT in these markets. Our European Headquarters is in Galway, Ireland.
Since launching CHEMOSAT in Europe, treatments have been performed at over 20 leading European cancer centers. Physicians in Europe have used CHEMOSAT to treat patients with a variety of cancers in the liver, primarily ocular melanoma liver metastases, and other tumor types, including hepatocellular carcinoma, cholangiocarcinoma, and liver metastases from colorectal cancer, breast, and cutaneous melanoma.
European Reimbursement
A critical driver of utilization growth for CHEMOSAT in Europe is the expansion of reimbursement mechanisms for the procedure in our priority markets. In Europe, there is no centralized pan-European medical device reimbursement body. Reimbursement is administered on a regional and national basis. Medical devices are typically reimbursed under Diagnosis Related Groups (DRG) as part of a procedure. Prior to obtaining permanent DRG reimbursement codes, in certain jurisdictions, the Company is actively seeking interim reimbursement from existing mechanisms that include specific interim reimbursement schemes, new technology payment programs as well as existing DRG codes. In most EU countries, the government provides healthcare and controls reimbursement levels. Since the EU has no jurisdiction over patient reimbursement or pricing matters in its member states, the methodologies for determining reimbursement rates and the actual rates may vary by country.
23
Germany
In October 2015, we announced that the Institut f?r das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, established a national Zusatzentgeld (ZE) reimbursement code for procedures performed with CHEMOSAT in Germany. The ZE diagnostic-related group (DRG) code is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created, and will replace the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. In 2016, coverage levels were negotiated between hospitals in Germany and regional sickness funds. Coverage levels determined via this process are renegotiated annually.
United Kingdom
In the United Kingdom, though Delcath and our participating cancer centers identified existing Healthcare Resource Groups (HRG) code(s), we have been advised that hospitals have not used it for coverage of CHEMOSAT related costs. We continue to work with the HRG organization that decides on new HRG codes toward receipt of a dedicated and permanent reimbursement code in the future.
Delcath expects to consult again with the Interventional Procedures Advisory Committee at the National Institute for Clinical Excellence (NICE) in England, to provide recent clinical evidence with a view to moving existing Interventional Procedural Guidance from research to specialist status. This would enable greater scope for commercialization because it would allow more use by NHS clinicians of the therapy. It might also pave the way for a full Medical Technology Assessment as a way towards longer term reimbursement with the NHS.
In May 2014, the NICE, a non-departmental public body that provides guidance and advice to improve health and social care in the UK, completed a clinical review of CHEMOSAT. The NICE review indicated that as the current body of evidence on the safety and efficacy of PHP with CHEMOSAT for primary or metastatic liver cancer is limited, the procedure should be performed within the context of research by clinicians with specific training in its use and techniques. NICE stated that this research may take the form of observational studies. With continued enrollment in the UK in our Phase 2 HCC and ICC trial in 2016, we believe the data generated from these studies will help provide supporting clinical data and address the concerns raised by NICE relative to survival, quality of life and adverse events. NICE may decide to conduct a Technology Appraisal of CHEMOSAT thereafter, the outcome of which could influence the long-term reimbursement status.
In the short term, public patients will continue to be treated in the UK through clinical trials. Private patients will continue to be treated through the established private treatment pathway such as private insurance coverage or self-pay.
Spain
In April 2016, we announced that the General and Digestive Surgery team at HM Sanchinarro University Hospital had activated the hospital's CHEMOSAT program. The Sanchinarro team successfully performed three procedures with CHEMOSAT, using the procedure to treat patients with peripheral cholangiocarcinoma, neuroendocrine tumors and colorectal liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer CHEMOSAT treatments.
Turkey
In April 2016 we announced the activation of the Hacettepe University Clinic in Ankara, Turkey as a CHEMOSAT treatment center. Hacettepe University Clinic successfully completed its first CHEMOSAT treatments in March 2016, and the center represents the first CHEMOSAT commercial location to be activated outside of the European Union. We believe that Hacettepe University can serve as an important hub for CHEMOSAT treatment to patients in Turkey and throughout the region.
Other European Markets
Permanent reimbursement coverage in remaining EU markets will require additional time to secure. For France, Spain and the Netherlands, publication of the Phase 3 trial manuscript is a key component of the reimbursement process. The Phase 3 trial manuscript has been accepted for publication in the prestigious Annals of Surgical Oncology and will serve as the foundation for the reimbursement efforts in these countries. In the interim period, we are seeking payment through various avenues, including new technology programs.
24
Distribution Partners
As a result of the Company’s strategy to prioritize resources on the key direct markets of Germany and the United Kingdom, the Company expects that its distribution strategy will play a lesser role in its current commercial activities. In Spain, the Company has determined that there was no benefit to continuing with an indirect model and therefore terminated its relationship with its distributor in Spain and is now represented in Spain through a sales agency.
Regulatory Status
Our products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. Foreign regulatory agencies, the FDA and comparable regulatory agencies in state and local jurisdictions impose extensive requirements upon the clinical development, pre-market clearance and approval, manufacturing, labeling, marketing, advertising and promotion, pricing, storage and distribution of pharmaceutical and medical device products. Failure to comply with applicable foreign regulatory agency or FDA requirements may result in Warning Letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.
United States Regulatory Environment
In the United States, the FDA regulates drug and device products under the FFDCA, and its implementing regulations. The Delcath Melphalan/HDS is subject to regulation as a combination product, which means it is composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of its primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of the Melphalan/HDS, the primary mode of action is attributable to the drug component of the product, which means that the Center for Drug Evaluation and Research, has primary jurisdiction over its pre-market development and review.
The process required by the FDA before drug product candidates may be marketed in the United States generally involves the following:
o
submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually;
o
completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;
o
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;
o
submission to the FDA of an NDA after completion of all pivotal clinical trials;
o
a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;
o
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practice, or cGMP, regulations; and
o
FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States.
The development and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted on a timely basis, if at all.
The results of preclinical tests (which include laboratory evaluation as well as GLP studies to evaluate toxicity in animals) for a particular product candidate, together with related manufacturing information and analytical data, are submitted as part of an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. IND submissions may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive good clinical practice regulations and regulations for informed
25
consent and privacy of individually identifiable information. Similar requirements to the United States IND are required in the European Economic Area (EEA) and other jurisdictions in which we may conduct clinical trials.
In addition, shareholders of the Company also approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 170,000,000 to 500,000,000.
https://ih.advfn.com/p.php?pid=nmona&article=74536379
DCTH)' just took the heat off after week gaining upwards =lilt correction was expected /
=I expecting for shares of DCTH only way up -over $0.70= then a news coming soon re” new contracts or joint partnership assuming shares go over $1.15 . This is only my sought and reasons I shared with you . But you all make your own investment =we all here to make sum money not to talk regarding wether-right. Good luck to all /
The Final Word: Although there is a lot of uncertainty whether PHP will turn out to be a success, if it is then DCTH will be severely undervalued. This is a risky investment with massive upside that is finally starting to generate bullish sentiment for the first time in years.
1/ Regarding R/S = copay issue new 500,000,000 shares which has no power to R/S =which shareholders declined to approve to R/S =NO issue is closed .
2. Company has 4 proposals on its table (Buyout 100% ) $0.60.00 a share =500,000,000
3. Company take proposal to sell 40 % $1.28 a share in order to ho;d the FDA approval then management get hold on patents rights , same time shares will go up over $5.00 a share or more /
4. if Delusion and R/S then management will be personalty responsible for loss .
Just economics which management will chose =I believe 3. Company take proposal to sell 40 % $1.28 a share
10Q=Market Access & Commercial Clinical Adoption
European Union
Our immediate market access and clinical adoptions efforts continue to be focused on the key target markets of Germany and the United Kingdom, which represent a majority of the total potential liver cancer market (primary and metastatic) in the EU and where progress in securing reimbursement for CHEMOSAT treatments offers the best near-term opportunities. We also continue to support clinical adoption of CHEMOSAT in the Netherlands, Spain, France and Italy. We employ a combination of direct and indirect sales channels to market and sell CHEMOSAT in these markets. Our European Headquarters is in Galway, Ireland.
Since launching CHEMOSAT in Europe, treatments have been performed at over 20 leading European cancer centers. Physicians in Europe have used CHEMOSAT to treat patients with a variety of cancers in the liver, primarily ocular melanoma liver metastases, and other tumor types, including hepatocellular carcinoma, cholangiocarcinoma, and liver metastases from colorectal cancer, breast, and cutaneous melanoma.
European Reimbursement
A critical driver of utilization growth for CHEMOSAT in Europe is the expansion of reimbursement mechanisms for the procedure in our priority markets. In Europe, there is no centralized pan-European medical device reimbursement body. Reimbursement is administered on a regional and national basis. Medical devices are typically reimbursed under Diagnosis Related Groups (DRG) as part of a procedure. Prior to obtaining permanent DRG reimbursement codes, in certain jurisdictions, the Company is actively seeking interim reimbursement from existing mechanisms that include specific interim reimbursement schemes, new technology payment programs as well as existing DRG codes. In most EU countries, the government provides healthcare and controls reimbursement levels. Since the EU has no jurisdiction over patient reimbursement or pricing matters in its member states, the methodologies for determining reimbursement rates and the actual rates may vary by country.
23
Germany
In October 2015, we announced that the Institut f?r das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, established a national Zusatzentgeld (ZE) reimbursement code for procedures performed with CHEMOSAT in Germany. The ZE diagnostic-related group (DRG) code is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created, and will replace the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. In 2016, coverage levels were negotiated between hospitals in Germany and regional sickness funds. Coverage levels determined via this process are renegotiated annually.
United Kingdom
In the United Kingdom, though Delcath and our participating cancer centers identified existing Healthcare Resource Groups (HRG) code(s), we have been advised that hospitals have not used it for coverage of CHEMOSAT related costs. We continue to work with the HRG organization that decides on new HRG codes toward receipt of a dedicated and permanent reimbursement code in the future.
Delcath expects to consult again with the Interventional Procedures Advisory Committee at the National Institute for Clinical Excellence (NICE) in England, to provide recent clinical evidence with a view to moving existing Interventional Procedural Guidance from research to specialist status. This would enable greater scope for commercialization because it would allow more use by NHS clinicians of the therapy. It might also pave the way for a full Medical Technology Assessment as a way towards longer term reimbursement with the NHS.
In May 2014, the NICE, a non-departmental public body that provides guidance and advice to improve health and social care in the UK, completed a clinical review of CHEMOSAT. The NICE review indicated that as the current body of evidence on the safety and efficacy of PHP with CHEMOSAT for primary or metastatic liver cancer is limited, the procedure should be performed within the context of research by clinicians with specific training in its use and techniques. NICE stated that this research may take the form of observational studies. With continued enrollment in the UK in our Phase 2 HCC and ICC trial in 2016, we believe the data generated from these studies will help provide supporting clinical data and address the concerns raised by NICE relative to survival, quality of life and adverse events. NICE may decide to conduct a Technology Appraisal of CHEMOSAT thereafter, the outcome of which could influence the long-term reimbursement status.
In the short term, public patients will continue to be treated in the UK through clinical trials. Private patients will continue to be treated through the established private treatment pathway such as private insurance coverage or self-pay.
Spain
In April 2016, we announced that the General and Digestive Surgery team at HM Sanchinarro University Hospital had activated the hospital's CHEMOSAT program. The Sanchinarro team successfully performed three procedures with CHEMOSAT, using the procedure to treat patients with peripheral cholangiocarcinoma, neuroendocrine tumors and colorectal liver metastases. HM Sanchinarro University Hospital is the second center in Spain to offer CHEMOSAT treatments.
Turkey
In April 2016 we announced the activation of the Hacettepe University Clinic in Ankara, Turkey as a CHEMOSAT treatment center. Hacettepe University Clinic successfully completed its first CHEMOSAT treatments in March 2016, and the center represents the first CHEMOSAT commercial location to be activated outside of the European Union. We believe that Hacettepe University can serve as an important hub for CHEMOSAT treatment to patients in Turkey and throughout the region.
Other European Markets
Permanent reimbursement coverage in remaining EU markets will require additional time to secure. For France, Spain and the Netherlands, publication of the Phase 3 trial manuscript is a key component of the reimbursement process. The Phase 3 trial manuscript has been accepted for publication in the prestigious Annals of Surgical Oncology and will serve as the foundation for the reimbursement efforts in these countries. In the interim period, we are seeking payment through various avenues, including new technology programs.
24
Distribution Partners
As a result of the Company’s strategy to prioritize resources on the key direct markets of Germany and the United Kingdom, the Company expects that its distribution strategy will play a lesser role in its current commercial activities. In Spain, the Company has determined that there was no benefit to continuing with an indirect model and therefore terminated its relationship with its distributor in Spain and is now represented in Spain through a sales agency.
Regulatory Status
Our products are subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA. Foreign regulatory agencies, the FDA and comparable regulatory agencies in state and local jurisdictions impose extensive requirements upon the clinical development, pre-market clearance and approval, manufacturing, labeling, marketing, advertising and promotion, pricing, storage and distribution of pharmaceutical and medical device products. Failure to comply with applicable foreign regulatory agency or FDA requirements may result in Warning Letters, fines, civil or criminal penalties, suspension or delays in clinical development, recall or seizure of products, partial or total suspension of production or withdrawal of a product from the market.
United States Regulatory Environment
In the United States, the FDA regulates drug and device products under the FFDCA, and its implementing regulations. The Delcath Melphalan/HDS is subject to regulation as a combination product, which means it is composed of both a drug product and device product. If marketed individually, each component would therefore be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of its primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of the Melphalan/HDS, the primary mode of action is attributable to the drug component of the product, which means that the Center for Drug Evaluation and Research, has primary jurisdiction over its pre-market development and review.
The process required by the FDA before drug product candidates may be marketed in the United States generally involves the following:
o
submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually;
o
completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;
o
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;
o
submission to the FDA of an NDA after completion of all pivotal clinical trials;
o
a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;
o
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practice, or cGMP, regulations; and
o
FDA review and approval of an NDA prior to any commercial marketing or sale of the drug in the United States.
The development and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product will be granted on a timely basis, if at all.
The results of preclinical tests (which include laboratory evaluation as well as GLP studies to evaluate toxicity in animals) for a particular product candidate, together with related manufacturing information and analytical data, are submitted as part of an IND to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. IND submissions may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive good clinical practice regulations and regulations for informed
25
consent and privacy of individually identifiable information. Similar requirements to the United States IND are required in the European Economic Area (EEA) and other jurisdictions in which we may conduct clinical trials.
In addition, shareholders of the Company also approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 170,000,000 to 500,000,000.
https://ih.advfn.com/p.php?pid=nmona&article=74536379
DCTH)' just took the heat off after week gaining upwards =lilt correction was expected /
=I expecting for shares of DCTH only way up -over $0.70= then a news coming soon re” new contracts or joint partnership assuming shares go over $1.15 . This is only my sought and reasons I shared with you . But you all make your own investment =we all here to make sum money not to talk regarding wether-right. Good luck to all /
The Final Word: Although there is a lot of uncertainty whether PHP will turn out to be a success, if it is then DCTH will be severely undervalued. This is a risky investment with massive upside that is finally starting to generate bullish sentiment for the first time in years.
FACTS=Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential Of Delcath Investigational PHP Therapy
https://www.barchart.com/stocks/quotes/DCTH#/news/598395/analysis-from-two-institutions-shows-strong-tumor-response-overall-survival-potential-of-delcath-investigational-php-therapy
STRONG BUY=Barchart Technical Opinion
Delcath Systems Inc (DCTH)
0.24 -0.03 (-11.11%) 06/22/17 [NASDAQ]
for Thu, Jun 22nd, 2017
The Barchart Technical Opinion rating is a 72% Buy with a Strengthening short term outlook on maintaining the current direction.
Longer term, the trend strength is Strong. Long term indicators mostly agree with the trend.
https://www.barchart.com/stocks/quotes/DCTH/opinion
STRONG BUY=Barchart Technical Opinion
Delcath Systems Inc (DCTH)
0.24 -0.03 (-11.11%) 06/22/17 [NASDAQ]
for Thu, Jun 22nd, 2017
The Barchart Technical Opinion rating is a 72% Buy with a Strengthening short term outlook on maintaining the current direction.
Longer term, the trend strength is Strong. Long term indicators mostly agree with the trend.
https://www.barchart.com/stocks/quotes/DCTH/opinion
FACTS=Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential Of Delcath Investigational PHP Therapy
https://www.barchart.com/stocks/quotes/DCTH#/news/598395/analysis-from-two-institutions-shows-strong-tumor-response-overall-survival-potential-of-delcath-investigational-php-therapy
FACTS=Published Review Shows Delcath Investigational PHP Doubles Overall Survival Over Other Targeted Liver Therapies
https://www.barchart.com/stocks/quotes/DCTH#/news/622888/published-review-shows-delcath-investigational-php-doubles-overall-survival-over-other-targeted-liver-therapies
NEWS=Spire Southampton Hospital In UK Celebrating Over 100 CHEMOSAT Treatments
https://www.barchart.com/stocks/quotes/DCTH#/news/1689200/spire-southampton-hospital-in-uk-celebrating-over-100-chemosat-treatments
THIS IS REASONS AND FACTS TO BUY=Delcath Systems, Inc. (DCTH)
The R/S was voted down, the have until august 17th to get to one dollar and can still have a 6 month extension following that to stay listed.
They are earning revenue from CHEMOSAT in Europe which is also in an expedited phase 3 trail here in the USA(not to mention another phase 2 drug here in the USA).
Delcath Systems, Inc. (DCTH) Not a scam, not getting delisted any time soon, and certainly not a scam.
STRONG BUY! $0.39-$0.49 =for June, 22,2017 THIS IS REASONS AND FACTS TO BUY=Delcath Systems, Inc. (DCTH)
The R/S was voted down, the have until august 17th to get to one dollar and can still have a 6 month extension following that to stay listed.
They are earning revenue from CHEMOSAT in Europe which is also in an expedited phase 3 trail here in the USA(not to mention another phase 2 drug here in the USA).
Delcath Systems, Inc. (DCTH) Not a scam, not getting delisted any time soon, and certainly not a scam.
STRONG BUY! $0.39-$0.49 =for June, 22,2017 THIS IS REASONS AND FACTS TO BUY=Delcath Systems, Inc. (DCTH)
The R/S was voted down, the have until august 17th to get to one dollar and can still have a 6 month extension following that to stay listed.
They are earning revenue from CHEMOSAT in Europe which is also in an expedited phase 3 trail here in the USA(not to mention another phase 2 drug here in the USA).
Delcath Systems, Inc. (DCTH) Not a scam, not getting delisted any time soon, and certainly not a scam.
$0.22-$0.26 will pull back to mach selling blocks shares . I hop I am wrong .