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STRONG BUY ! CAPR BUY-BUY-BUY in this price I am adding more CAPR shares =all indicators pointing out oversold --will going only UP
NEWS ALERT! Capricor Therapeutics Inc (NASDAQ:CAPR) Just Scored A Huge Potential Payday
Capricor is currently valued at just $30 million. If it gets its drug past the FDA, then, it won’t just be in line for gains based on the forward potential of its asset in the DMD market but also for a multi hundred-million-dollar windfall if it decides to sell its Voucher.
https://insiderfinancial.com/capricor-therapeutics-inc-nasdaqcapr-just-scored-a-huge-potential-payday
Buy rating, with a $10.00 price target -Maxim analyst Jason Kolbert remains positive on the long term story for the company, reiterating a Buy rating, with a $10.00 price target, which represents a potential upside of 2226% from where the stock is currently trading.
Kolbert noted, "The totality of the data combined with the investigator comments matter and suggest to us that there maybe a window for approval based on the current data set and/or a small bridging study. As a result we are not changing our rating or valuation metrics at this time. Let's sit tight and see what's next."
https://finance.yahoo.com/news/analysts-remain-buyers-2-volatile-155411871.html
SARONG BUY Attention (CYTX) have a portfolio of 102 patents issued worldwide and over 65 applications pending. /
All indicators pointing out we will close at $0.89-$0/99 and opening at $1.08
http://www.cytori.com/our-technology/
SELL ALERT- (DCTH)' shares worth $0.0000 a share according all analyst report =there is new attempt by management to get a R/S 1000 shares = to one new 1 (DCTH)' it mining (DCTH)' shares worth $0.0000
Technology Stock recommendation to Buy: Pareteum Corporation (TEUM)
By
Paul Suggs
-
July 21, 2017
Pareteum Granted Extension by NYSE MKT for Compliance with Listing Requirements
Pareteum Sets Q2 2017 Results Announcement Date and Anticipates Revenues to Exceed Expectations Bolstered by Growing $61 M Backlog
STRONG BUY =Pareteum Signs Two New UK-Based Customers Adding $1,000,000 in Revenue Backlog for TEUM Global Mobility Cloud Platform and Ho...
STRONG BUY=The Chairman Jven Capital, Llc acquired 1,875,000 shares of the company’s stock in a transaction that occurred on Tuesday, July 18th. The stock was purchased at an average cost of $0.40 per share, with a total value of $750,000.00
STRONG BUY ! We will gone get to the $6.00 a share . Europe starting request get Rare Pediatric Disease Designation from for CAP-1002 for Patients /
NEWS ALERT! Capricor Therapeutics Inc (NASDAQ:CAPR) Just Scored A Huge Potential Payday
Capricor is currently valued at just $30 million. If it gets its drug past the FDA, then, it won’t just be in line for gains based on the forward potential of its asset in the DMD market but also for a multi hundred-million-dollar windfall if it decides to sell its Voucher.
https://insiderfinancial.com/capricor-therapeutics-inc-nasdaqcapr-just-scored-a-huge-potential-payday
SELL ALERT! Board of Directors DCTH decided try 500-1 R/S =filling will go any time , due the fact 530 million DCTH shares are registered now - management get majority . SELL .
SELL-SELL-SELL
TIME TO SELL-SELL-SELL
GOOD NEWS ALERT- Delcath Systems, Inc. (DCTH) was granted new patent to sell its medications
United States Patent 9,707,331
Johnston , et al. July 18, 2017
Apparatus for removing chemotherapy compounds from blood
Abstract
A filter apparatus for removing small molecule chemotherapy agents from blood is provided. The filter apparatus comprises a housing with an extraction media comprised of polymer coated carbon cores. Also provided are methods of treating a subject with cancer of an organ or region comprising administering a chemotherapeutic agent to the organ or region, collecting blood laded with chemotherapeutic agent from the isolated organ, filtering the blood laden with chemotherapeutic agent to reduce the chemotherapeutic agent in the blood and returning the blood to the subject.
Inventors: Johnston; Daniel S. (Trappe, PA), Chammas; Jacques (Walpole, MA), Appling; William M. (Granville, NY), Barton; Samantha J. (Hudson Falls, NY)
Applicant:
Name City State Country Type
Delcath Systems, Inc.
New York
NY
US
Assignee: DELCATH SYSTEMS, INC. (New York, NY)
STRONG BUY ! We will gone get to the $6.00 a share . Europe starting request get Rare Pediatric Disease Designation from for CAP-1002 for Patients /
GOOD NEWS ALERT- Delcath Systems, Inc. (DCTH) was granted new patent to sell its medications
United States Patent 9,707,331
Johnston , et al. July 18, 2017
Apparatus for removing chemotherapy compounds from blood
Abstract
A filter apparatus for removing small molecule chemotherapy agents from blood is provided. The filter apparatus comprises a housing with an extraction media comprised of polymer coated carbon cores. Also provided are methods of treating a subject with cancer of an organ or region comprising administering a chemotherapeutic agent to the organ or region, collecting blood laded with chemotherapeutic agent from the isolated organ, filtering the blood laden with chemotherapeutic agent to reduce the chemotherapeutic agent in the blood and returning the blood to the subject.
Inventors: Johnston; Daniel S. (Trappe, PA), Chammas; Jacques (Walpole, MA), Appling; William M. (Granville, NY), Barton; Samantha J. (Hudson Falls, NY)
Applicant:
Name City State Country Type
Delcath Systems, Inc.
New York
NY
US
Assignee: DELCATH SYSTEMS, INC. (New York, NY)
Strong Buy ~(DCTH)' Selling it medication in Europe -expending -in US =FDA push on fast track 'Delcath Systems, Inc. (DCTH)' chemosaturation system. Its clinical trial include a Phase III multi-center study for patients with unresectable metastatic ocular or cutaneous melanoma exclusively or predominantly in the liver; and a multi-arm Phase II clinical trial of the Delcath chemosaturation system with melphalan in patients with primary and metastatic liver cancer, which comprise neuroendocrine tumors, hepatocellular carcinoma, ocular or cutaneous melanoma, and metastatic adenocarcinoma. Delcath Systems, Inc. was founded in 1988-Management getting reach salaries depreciating (DCTH shares in order get control of the beard - They Know (DCTH) worth more then $16 dollars a share/
BUY-BUY-BUY at market nothing stands between $0.13 and $0.18 shorts out only way UP!
All indicators pointing out STRONG BUY !
You are welcome Good luck/
Yes it is true- read filing page 17 on this side //
Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a)
Date : 07/12/2017 @ 4:34PM
Source : Edgar (US Regulatory)
Stock : Delcath Systems, Inc. (MM) (DCTH)
Quote : 0.139 0.0 (0.00%) @ 8:27AM
TOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING
In order for a stockholder proposal to be eligible for inclusion in our proxy statement for the 2018 annual meeting of stockholders, the proposal must be received by the Corporate Secretary not later than January 9, 2018, and must otherwise comply with the requirements of Rule 14a-8(e) of the Securities Exchange Act of 1934. In addition, in order for a stockholder to present a proposal or other matter or to nominate a person for election as a director at the 2018 annual meeting of stockholders, the stockholder must give Delcath written notice of the proposal or other matter to be presented at the meeting no later than January 9, 2018, and must otherwise comply with our amended and restated certificate of incorporation. If the date set for the 2018 annual meeting is more than 30 calendar days before or after June 5, 2018, such notice must instead be received no later than 60 calendar days before the date set for such meeting. Proposals or notices of intent to present a proposal should be addressed to the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019, and should be sent by overnight delivery or certified mail, return receipt requested. If a stockholder fails to provide timely notice of a proposal to be presented at the 2018 annual meeting, the proxies designated by the Board will have discretionary authority to vote on the proposals.
/s/ Jennifer K. Simpson
New York, New York Jennifer K. Simpson, Ph.D.
[?], 2017 President, Director and Executive Officer
1https://ih.advfn.com/p.php?pid=nmona&article=75225988#D397812DPRE14A_HTM_ROM397812_4
Under the rules management request ones a year R/S on general shareholders meeting (in order to approve R/S mast 2/3 of the register shareholders before the notice must agree to such split = But DCTH shareholders stated NO in June 2017 /
So management DCTH have a right to call General shareholders meeting after year end Q4 December 31,2017, on new R/S only after Year past , which is March 2018 a 60 days prier a June 27, 2018, but shareholders mite change this management so should not be warty for another proposal for R/S June 2018 . Shares DCTH in 2Q if show income will rise over the $1.15 a share even more =depend sells in Europe / Good luck to all of you/
STRONG BUY ! Opening at $0.165 -$0.185 by 10-11 am will trade $0.265
NEWS~16 institutional holders increased their position in Delcath Systems, Inc. (NASDAQ:DCTH)
July 14, 2017
DELCATH SYSTEMS, INC. (DCTH) ADDED TO 8 NEW PORTFOLIOS
Delcath Systems, Inc. 13F Filings
At the end of Mar reporting period, 16 institutional holders increased their position in Delcath Systems, Inc. (NASDAQ:DCTH) by some 2,187,497 shares, 4 decreased positions by 94,645 and 6 held positions by 240,704. That puts total institutional holdings at 2,522,846 shares, according to SEC filings. The stock grabbed 8 new institutional investments totaling 393,840 shares while 2 institutional investors sold out their entire positions totaling 46,164 shares.
http://postanalyst.com/2017/07/14/delcath-systems-inc-dcth-added-to-8-new-portfolios/
Analysts have a mean recommendation of $2.00 on this stock (A rating of less than 2 means buy) . (DCTH), By Annette Gomez - July 13, 2017
Lookout for Price Target? Delcath Systems, Inc. (DCTH), Advanced Micro Devices, Inc. (AMD)
https://stocknewsjournal.com/2017/07/13/lookout-for-price-target-delcath-systems-inc-dcth-advanced-micro-devices-inc-amd/
STRONG BUY ! Opening at $0.165 -$0.185 by 10-11 am will trade $0.265
STRONG BUY ! NO R/S = STOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING -page 17 explanation and warning regarding R/Sat meeting year 2018 =because the R/S was rejected in 2017 by majority shareholders /
Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) look at this side
Date : 07/12/2017 @ 4:34PM
Source : Edgar (US Regulatory)
Stock : Delcath Systems, Inc. (MM) (DCTH)
Quote : 0.139 0.0 (0.00%) @ 4:00AM
UNDER -STOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING
In order for a stockholder proposal to be eligible for inclusion in our proxy statement for the 2018 annual meeting of stockholders, the proposal must be received by the Corporate Secretary not later than January 9, 2018, and must otherwise comply with the requirements of Rule 14a-8(e) of the Securities Exchange Act of 1934. In addition, in order for a stockholder to present a proposal or other matter or to nominate a person for election as a director at the 2018 annual meeting of stockholders, the stockholder must give Delcath written notice of the proposal or other matter to be presented at the meeting no later than January 9, 2018, and must otherwise comply with our amended and restated certificate of incorporation. If the date set for the 2018 annual meeting is more than 30 calendar days before or after June 5, 2018, such notice must instead be received no later than 60 calendar days before the date set for such meeting. Proposals or notices of intent to present a proposal should be addressed to the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019, and should be sent by overnight delivery or certified mail, return receipt requested. If a stockholder fails to provide timely notice of a proposal to be presented at the 2018 annual meeting, the proxies designated by the Board will have discretionary authority to vote on the proposals.
/s/ Jennifer K. Simpson
New York, New York Jennifer K. Simpson, Ph.D.
[?], 2017 President, Director and Executive Officer
18
http://ih.advfn.com/p.php?pid=nmona&article=75225988#D397812DPRE14A_HTM_ROM397812_4
In August DCTH will amply for complacency to the Nasdaq board to grant an extension for 180 days to stay at Nasdaq, until then DCTH shares could reach over $1.15 .
No date because R/S was consoled did not get votes so directors reschedule general shareholders meeting for year 2018 until then no R/S .
PRE 14A STOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING
DELCATH SYSTEMS, INC. filed this Form PRE 14A on 07/12/2017
STOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING
In order for a stockholder proposal to be eligible for inclusion in our proxy statement for the 2018 annual meeting of stockholders, the proposal must be received by the Corporate Secretary not later than January 9, 2018, and must otherwise comply with the requirements of Rule 14a-8(e) of the Securities Exchange Act of 1934. In addition, in order for a stockholder to present a proposal or other matter or to nominate a person for election as a director at the 2018 annual meeting of stockholders, the stockholder must give Delcath written notice of the proposal or other matter to be presented at the meeting no later than January 9, 2018, and must otherwise comply with our amended and restated certificate of incorporation. If the date set for the 2018 annual meeting is more than 30 calendar days before or after June 5, 2018, such notice must instead be received no later than 60 calendar days before the date set for such meeting. Proposals or notices of intent to present a proposal should be addressed to the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019, and should be sent by overnight delivery or certified mail, return receipt requested. If a stockholder fails to provide timely notice of a proposal to be presented at the 2018 annual meeting, the proxies designated by the Board will have discretionary authority to vote on the proposals.
/s/ Jennifer K. Simpson
New York, New York Jennifer K. Simpson, Ph.D.
[?], 2017 President, Director and Executive Officer
http://phx.corporate-ir.net/phoenix.zhtml?c=123840&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTExNjk1MTA2JkRTRVE9MSZTRVE9MjEmU1FERVNDPVNFQ1RJT05fUEFHRSZleHA9JnN1YnNpZD01Nw%3d%3d
PRE 14A
DELCATH SYSTEMS, INC. filed this Form PRE 14A on 07/12/2017
STOCKHOLDER PROPOSALS FOR THE 2018 ANNUAL MEETING
In order for a stockholder proposal to be eligible for inclusion in our proxy statement for the 2018 annual meeting of stockholders, the proposal must be received by the Corporate Secretary not later than January 9, 2018, and must otherwise comply with the requirements of Rule 14a-8(e) of the Securities Exchange Act of 1934. In addition, in order for a stockholder to present a proposal or other matter or to nominate a person for election as a director at the 2018 annual meeting of stockholders, the stockholder must give Delcath written notice of the proposal or other matter to be presented at the meeting no later than January 9, 2018, and must otherwise comply with our amended and restated certificate of incorporation. If the date set for the 2018 annual meeting is more than 30 calendar days before or after June 5, 2018, such notice must instead be received no later than 60 calendar days before the date set for such meeting. Proposals or notices of intent to present a proposal should be addressed to the Corporate Secretary, Delcath Systems, Inc., 1633 Broadway, Suite 22C, New York, New York 10019, and should be sent by overnight delivery or certified mail, return receipt requested. If a stockholder fails to provide timely notice of a proposal to be presented at the 2018 annual meeting, the proxies designated by the Board will have discretionary authority to vote on the proposals.
/s/ Jennifer K. Simpson
New York, New York Jennifer K. Simpson, Ph.D.
[?], 2017 President, Director and Executive Officer
http://phx.corporate-ir.net/phoenix.zhtml?c=123840&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTExNjk1MTA2JkRTRVE9MSZTRVE9MjEmU1FERVNDPVNFQ1RJT05fUEFHRSZleHA9JnN1YnNpZD01Nw%3d%3d
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.
© 2017 InvestorsHub.Com, Inc.
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.
https://ih.advfn.com/p.php?pid=nmona&article=74536379
GOOD NEWS ALERT (SPI) files annual reports under cover of Form 20-F to the
SECURITIES AND EXCHANGE COMMISSION Report of Foreign Issuer (6-k)
Date : 07/13/2017 @ 11:05AM
http://ih.advfn.com/p.php?pid=nmona&article=75230171&symbol=SPI
STRONG BUY = (SPI) will go to $2.90 a week. The sale is expected to close in July 2017.$167 million dollars getting a SPI Energy Co., Ltd.
Announces Sale of Two Solar Projects in Japan
SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (NASDAQ:SPI), a global clean energy market place for business, residential, government and utility customers and investors, today announced that its wholly owned subsidiary, SPI Solar Japan GK (“SPI Japan”), has entered into a definitive agreement to sell all of its interest in the land and project development rights in its two solar PV projects with total capacity of 4.8 megawatt (MW) in Shibayama city, Chiba. SPI Japan will also provide engineering, procurement and construction (“EPC”) service to complete the projects.
The solar plants are located approximately 50 kilometres east of Tokyo in Chiba and each with capacity of 2.4 MW and with an estimated total capacity of 5,200,000 kWh annually.
The sale is subject to closing conditions, and is expected to close in July 2017.
SPI Energy Co., Ltd has a Billion dollars Portfolio .
The sale to close in July 2017.is subject to closing conditions, BUY Alert! $167 million dollars getting a SPI Energy Co., Ltd.
Announces Sale of Two Solar Projects in Japan
SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (NASDAQ:SPI), a global clean energy market place for business, residential, government and utility customers and investors, today announced that its wholly owned subsidiary, SPI Solar Japan GK (“SPI Japan”), has entered into a definitive agreement to sell all of its interest in the land and project development rights in its two solar PV projects with total capacity of 4.8 megawatt (MW) in Shibayama city, Chiba. SPI Japan will also provide engineering, procurement and construction (“EPC”) service to complete the projects.
The solar plants are located approximately 50 kilometres east of Tokyo in Chiba and each with capacity of 2.4 MW and with an estimated total capacity of 5,200,000 kWh annually.
The sale is subject to closing conditions, and is expected to close in July 2017.
BUY Alert! $167 million dollars getting a SPI Energy Co., Ltd.
Announces Sale of Two Solar Projects in Japan
SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (NASDAQ:SPI), a global clean energy market place for business, residential, government and utility customers and investors, today announced that its wholly owned subsidiary, SPI Solar Japan GK (“SPI Japan”), has entered into a definitive agreement to sell all of its interest in the land and project development rights in its two solar PV projects with total capacity of 4.8 megawatt (MW) in Shibayama city, Chiba. SPI Japan will also provide engineering, procurement and construction (“EPC”) service to complete the projects.
The solar plants are located approximately 50 kilometres east of Tokyo in Chiba and each with capacity of 2.4 MW and with an estimated total capacity of 5,200,000 kWh annually.
The sale is subject to closing conditions, and is expected to close in July 2017.
Now you can see too
News Alert!
??????????Print
July 10, 2017 08:00 ET | Source: SPI Energy Co., Ltd.
HONG KONG, July 10, 2017 (GLOBE NEWSWIRE) -- SPI Energy Co., Ltd. (“SPI Energy” or the “Company”) (Nasdaq:SPI), a global clean energy market place for business, residential, government and utility customers and investors, today announced that on July 7, 2017, it received a hearings letter from The Nasdaq Stock Market LLC (“Nasdaq”).
As previously reported, on June 30, 2017, the Company was notified by the Nasdaq Listing Qualification Staff (the “Staff”) that the Company's securities were subject to delisting as a result of the Company's noncompliance with Nasdaq Listing Rule 5250(c). On July 7, 2017, the Company timely submitted a request for a hearing before the Nasdaq Listing Qualifications Panel (the "Panel") and a stay of the delisting. Nasdaq has confirmed that a hearing has been set for August 10, 2017, at which hearing the Company will demonstrate its ability to regain compliance with the particular deficiencies cited by the Staff as well as its ability to sustain long-term compliance with all applicable maintenance criteria. In addition, the delisting action referenced in the Nasdaq Staff’s determination letter has been stayed for 15 calendar days, or until July 22, 2017. Upon expiration of the stay period, the Company's securities will be suspended from trading unless the Panel grants an extension of the stay pending the hearing. The Company will be notified of the Panel’s determination before the expiration of the 15-day stay period.
STRONG BUY - Today SPI Energy Co., Ltd (SPI) filed a Form 20-F for the year ended December 31, 2016 and with its SPI Energy Co filed realistic plane in order to regain compliance with the Nasdaq listing rules in order to continued listing a (SPI) on The Nasdaq Global Select Market.
The filing can be seen late Friday July 7 ,2017 after market closing or Monday morning at July 10, 2017.
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