is all in $AAPL $TSLA and $PMCB
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Chairman Clayton Provides Update on Review of 2016 Cyber Intrusion Involving EDGAR System
Press Release
Chairman Clayton Provides Update on Review of 2016 Cyber Intrusion Involving EDGAR System
FOR IMMEDIATE RELEASE
2017-186
Washington D.C., Oct. 2, 2017—
SEC Chairman Jay Clayton today provided an update on the status of the agency’s review and investigation of the 2016 intrusion into the EDGAR system. In addition to updating previous disclosures, today's announcement also includes additional information on the agency’s efforts to strengthen its cybersecurity risk profile going forward.
The ongoing staff investigation of the 2016 intrusion has now determined that an EDGAR test filing accessed by third parties as a result of that intrusion contained the names, dates of birth and social security numbers of two individuals. This determination is based on forensic data analysis conducted since the agency's Sept. 20th disclosure of the intrusion which relied on the latest information available at that time.
Chairman Clayton was informed by staff of this new information this past Friday, and staff are reaching out to the two individuals to notify them and offer to provide them with identity theft protection and monitoring services. Should the agency’s review uncover additional such individuals whose sensitive information may have been accessed, the staff will contact them and offer them identity protection and monitoring as well.
“The 2016 intrusion and its ramifications concern me deeply. I am focused on getting to the bottom of the matter and, importantly, lifting our cybersecurity efforts moving forward,” said Chairman Clayton. “While our review and remediation efforts are ongoing and may take substantial time to complete, I believe it is important to provide new information regarding the scope of the 2016 intrusion and provide an update on the steps we are taking to assess and improve the cybersecurity risk profile of our EDGAR system and of the agency’s systems more broadly.”
The agency’s efforts going forward are organized into five principal work streams:
1) The review of the 2016 EDGAR intrusion by the Office of Inspector General. Staff have been instructed to provide their full cooperation with this effort
2) The investigation by the Division of Enforcement into the potential illicit trading resulting from the 2016 EDGAR intrusion
3) A focused review of and, as necessary or appropriate, uplift of the EDGAR system. The EDGAR system has been undergoing modernization efforts. The agency has added, and expects to continue to add, additional resources to these efforts, which are expected to include outside consultants, and will increase the focus on cybersecurity matters
4) The more general assessment and uplift of the agency’s cybersecurity risk profile and efforts that were initiated shortly after the Chairman’s arrival at the Commission this past May, including, without limitation, the identification and review of all systems, current and planned (e.g., the Consolidated Audit Trail or CAT), that hold market sensitive data or personally identifiable information
5) The agency’s internal review of the 2016 EDGAR intrusion to determine, among other things, the procedures followed in response to the intrusion. This review is being overseen by the Office of the General Counsel and has an interdisciplinary investigative team that includes personnel from regional offices and will involve outside technology consultants
Each of these efforts is moving forward and, as is the nature of matters of this type, will require substantial time and effort to complete. Chairman Clayton has pledged to keep Congress informed of the ultimate findings and conclusions of the agency’s internal review into the 2016 intrusion.
Looking forward, and to further the efforts discussed above, Chairman Clayton has authorized the immediate hiring of additional staff and outside technology consultants to aid in the agency’s efforts to protect the security of its network, systems and data. Chairman Clayton also has directed the staff to take a number of steps designed to strengthen the agency’s cybersecurity risk profile, with an initial focus on EDGAR. This effort includes assessing the types of data the SEC takes in through the EDGAR system, and whether EDGAR is the appropriate mechanism to obtain that data. Another part of this effort includes reviewing the security systems, processes and controls in place to protect data submitted through EDGAR.
The staff also will conduct similar reviews of other systems in use at the SEC, assessing the types of data the agency keeps and the related security systems, processes and controls. The staff also will work to enhance escalation protocols for cybersecurity incidents in order to enable greater agency-wide visibility and understanding of potential cyber vulnerabilities and attacks.
More broadly, the agency is evaluating its cybersecurity risk governance structure, which has included the establishment of a senior-level cybersecurity working group and may include additional enhancements to promote the management and oversight of cybersecurity across the SEC’s divisions and offices.
Other initiatives resulting from the general cybersecurity assessment Chairman Clayton initiated in May are ongoing or will commence shortly. These include internal, Commission-level incident response exercises and continued interaction on cybersecurity efforts with other government agencies and committees, including the Department of Homeland Security, the Government Accountability Office and the Financial and Banking Information Infrastructure Committee.
This update also is being included as part of Chairman Clayton’s written testimony submitted to the U.S. House of Representatives Committee on Financial Services in connection with the Committee’s upcoming hearing titled “Examining the SEC’s Agenda, Operations, and Budget.”
###
https://www.sec.gov/news/press-release/2017-186
[Pats self on back for predicting intrusion was via EDGAR]
OK, I'm putting on my tin foil hat so bear with me.
Playbook to manipulate a stock:
1. Take over social media accounts of insider.
2. Post fake news from hijacked accounts.
3. Encourage people to contact company IR via email.
4. Coordinate an Email Storm attack against IR email server.
5. Encourage people to grab virtual pitchforks and torches online, citing fake news and lack of email responses (both of which were manufactured) as proof there is something amiss.
6. Buy cheap shares.
7. Profit when company releases real news.
All the bio stocks I own make only very vague announcements regarding dates. "2017". "2nd Half of 2017". Pretty normal stuff.
So why are people trying to hold $PMCB to a different standard? Why do people believe if they bombard the company with emails they will suddenly get a date?
Timeline will be published after IND is accepted, not before.
Take a look at the recent press releases: http://ir.pharmacytebiotech.com/press-releases
Board has filled out. CMO selected. S-3 for a $50 Million debenture effective. We have movement.
There are sheepdogs here to protect and there are wolves dressed as sheep sowing chaos. Make sure you can spot the difference.
Go $SGMO! 100K+ shares purchased at 10:39 am, pushing the stock over the $16 mark.
Wow, just wow!
Aurora Cannabis Inc. (TSX: ACB) (OTCQX: ACBFF) today announced that the Company has completed the acquisition of 100% of both BC Northern Lights Enterprises Ltd. and Urban Cultivator Inc., leading companies, respectively, in the production and sale of proprietary systems for the safe, efficient and high-yield indoor cultivation of cannabis, and in state-of-the-art indoor gardening appliances for the cultivation of organic microgreens, vegetables and herbs in home kitchens.
BCNL and Urban Cultivator, which have been operating for 16 years and 7 years, respectively, are each growing strongly and, combined, are tracking to generate more than $5 million in revenues in their current fiscal year, ending October 31, 2017.
Neil Belot, Chief Global Business Development Officer said, "These transactions are an important step in Aurora's strategy to serve the home gardening market in Canada for patients who choose to grow their own medical cannabis, and ultimately for adult consumers who choose to grow their own after Canada's federal government legalizes adult usage, which is anticipated by July, 2018. For over a decade, BC Northern Lights products have been widely recognized as the gold standard for home cannabis production, and we look forward to integrating our offerings to deliver a truly unique and full service customer experience."
As at August 21, 2017 10,547 Canadians were registered to grow either their own cannabis or as designated growers for others (source: Health Canada in response to questions from Lift.co). The number of home cannabis cultivators is expected to grow as a result of continued processing of applications by Health Canada, with further expansion anticipated subsequent to legalization of cannabis for adult use, with a proposed limit of four plants per household. While the ultimate number of home growers is anticipated to be limited relative to the overall size of the market, it represents very significant upside potential for BCNL to grow its customer base and market share.
"These acquisitions add an excellent range of proprietary products to our expanding portfolio of customer offerings that meet the Aurora Standard, and position us extremely well to capitalize on the opportunity in a distinct and rapidly-growing segment of the market," said Terry Booth, CEO. "We have always advocated for people's ability to make their own choices and are very supportive of the Supreme Court's Allard decision, which confirmed patients' rights to grow their own medical cannabis. Similarly, we believe that, after implementation of consumer legalization in Canada, individuals who choose to grow their own cannabis should have access to cultivation solutions that are in controlled environments, safe, and can produce high-yielding, high quality cannabis."
Mr. Booth added, "BCNL indoor grow systems produce consistent, predictable, and repeatable yields, while at the same time reducing the labour intensity normally associated with home growing. We believe the systems' CSA-approved design, safety features, and odorless operation will generate strong resonance with our target markets, and securely address potential concerns among municipal governments. We are very pleased that both co-founders, Tarren and Linnea Wolfe, have agreed to stay on with Aurora and help drive our expansion strategy in the home grow market."
"We are delighted to now be part of the Aurora family," said Tarren Wolfe, co-founder of BCNL and Urban Cultivator. "This will enable us to address a much larger audience of people who have been empowered by the Allard decision to operate a home garden, and are seeking access to the equipment, genetics, and educational support services to do so. In teaming up with Aurora, we will work with an industry-leading team of cannabis branding specialists and sales and marketing professionals to bring BCNL to the next level. In addition, Aurora's Licensed Producer status means the Company will soon be able to provide a fully integrated package, including starter materials such as clones, offering one-stop shopping for people who choose to grow their own cannabis at home."
https://technical420.com/cannabis-article/aurora-cannabis-inc-acquires-bc-northern-lights-enterprises
From what I've read CBER would need to inspect and certify the cell production facility, which Austrianova has in Singapore and Thailand. Since $PMCB switched to Eurofins in June, it appears to me they switched to a lab which has already been inspected and certified by the FDA.
Pure speculation, but it's possible scheduling and waiting for the FDA inspection in Singapore/Thailand would have taken longer than just having Eurofins make the cells.
It would be nice to have some clarification here. As other has asked, is Austrianova working with Eurofins? To me that would be nice to know, but it's not that important.
I'm just happy we have Eurofins doing the cell line to be perfectly honest. They are a world class facility.
This was the cover story on Barron's two weekends ago.
Stock was $12.90 on the Friday before the Barron's article. This past Friday's close was $15.00, and there is good News this morning.
Go $SGMO!!!
With today's news, $SGMO has 6 approved Phase 1/2 FDA trials:
Hemophilia A
Hemophilia B
MPS I (Scheie, Hurler-Scheie and Hurler syndromes)
MPS II (Hunter syndrome)
Beta thalassemia
HIV (TCells)
HIV (HSCs)
RICHMOND, Calif. and WALTHAM, Mass., Oct. 2, 2017 /PRNewswire/ -- Sangamo Therapeutics, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, and Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for hemophilia and other rare blood disorders, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for ST-400, a gene-edited cell therapy candidate for people with transfusion-dependent beta-thalassemia. Sangamo and Bioverativ are developing ST-400 as part of an exclusive worldwide collaboration to develop and commercialize gene-edited cell therapies for beta-thalassemia and sickle cell disease.
"We are very pleased with the FDA's acceptance of the IND for ST-400 for the treatment of beta-thalassemia and look forward to initiating the first clinical trial," said Edward Conner, M.D., chief medical officer at Sangamo. "We believe the precision, efficiency and specificity of zinc finger nuclease gene editing technology will differentiate ST-400 among other genomic therapies in development for beta-thalassemia."
"Beta-thalassemia is a serious, lifelong blood disorder, and many children and adults with the disease require frequent and demanding blood transfusions that may lead to iron overload and long-term organ damage," said Tim Harris, Ph.D., D.Sc., executive vice president of research and development at Bioverativ. "The advancement of ST-400 demonstrates our commitment to progressing novel science that has the potential to make a meaningful, lasting difference in the lives of people with beta-thalassemia."
The IND enables Sangamo to initiate a Phase 1/2 clinical trial to assess the safety, tolerability and efficacy of ST-400 in adults with transfusion-dependent beta-thalassemia. Sangamo expects to open several clinical sites across the United States and begin enrolling patients in the first half of 2018.
Beta-thalassemia is an inherited blood disorder caused by mutations in the beta-globin gene that leads to reduced or absent production of adult hemoglobin, the protein in red blood cells that carries oxygen to cells throughout the body. The disorder causes the destruction of red blood cells, which results in severe anemia and reduced oxygen transport to various tissues in the body.
According to the World Health Organization, there are approximately 100,000 treated beta-thalassemia patients worldwide, with ~19,000 of those in the United States and Europe.1 The majority of these patients are transfusion-dependent, and their current standard of care includes a chronic regimen of red blood cell transfusions, which may lead to iron overload and organ damage even with daily iron chelation therapy. Allogeneic bone marrow transplant may be a treatment option for these patients if a suitable donor can be found, but carries substantial risks such as graft-versus-host disease and chronic morbidity.
About ST-400 and the Phase 1/2 Clinical Trial
ST-400 is an autologous cell therapy that involves gene editing of a patient's own hematopoietic stem cells (HSCs) using zinc finger nuclease (ZFN) technology. It is being developed with the aim of providing a one-time treatment for people with transfusion-dependent beta-thalassemia by increasing production of fetal hemoglobin, which can more effectively carry oxygen, potentially eliminating the need for chronic blood transfusions. As part of the Phase 1/2 clinical trial protocol, a patient's HSCs are isolated from the blood, and the cells then undergo ex-vivo gene editing using ZFNs to modify a specific sequence of the BCL11A gene that suppresses fetal hemoglobin production in erythrocytes. Following a conditioning regimen, patients will be infused with their own modified HSCs, with the goal of producing increased amounts of fetal hemoglobin to compensate for the decrease in functional beta-globin levels, potentially resolving the need for chronic blood transfusions and ameliorating the complications from major organ failure that frequently arise from the disease.
About the Sangamo and Bioverativ collaboration
Sangamo and Bioverativ have an exclusive worldwide collaboration to develop and commercialize ZFN-mediated gene-edited cell therapies for the treatment of beta-thalassemia and sickle cell disease. Based on the terms of the agreement, Sangamo is responsible for conducting the ST-400 Phase 1/2 clinical trial, and Bioverativ will be responsible for subsequent worldwide clinical development, manufacturing, and commercialization.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating ground-breaking science into genomic therapies that transform patients' lives using the company's industry leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. The Company has open Phase 1/2 clinical trials in Hemophilia A and Hemophilia B, and lysosomal storage disorders MPS I and MPS II. Sangamo has an exclusive, global collaboration and license agreement with Pfizer Inc. for gene therapy programs for Hemophilia A, with Bioverativ Inc. for hemoglobinopathies, including beta-thalassemia and sickle cell disease, and with Shire International GmbH to develop therapeutics for Huntington's disease. In addition, it has established strategic partnerships with companies in non-therapeutic applications of its technology, including Sigma-Aldrich Corporation and Dow AgroSciences. For more information about Sangamo, visit the Company's website at www.sangamo.com.
About Bioverativ
Bioverativ is a global biopharmaceutical company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 following separation from Biogen Inc., Bioverativ builds upon a strong heritage of scientific innovation and is committed to actively working with the blood disorders community. The company's mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit bioverativ.com or follow @bioverativ on Twitter.
Sangamo's Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the therapeutic potential of gene editing and ST-400, including the potential of ST-400 as a one-time treatment option for people with beta-thalassemia, the planned Phase 1/2 clinical trial of ST-400, including its design and Sangamo's expectations for opening clinical sites and enrolling patients and the timing thereof, as well as other statements that are not historical facts. These forward-looking statements are based on Sangamo's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: gene therapy product candidate development and the inherent uncertainty of clinical success, including the risks that Sangamo and/or Bioverativ may encounter unanticipated toxicity or adverse events in, or fail to demonstrate the efficacy of ST-400 in, clinical development and that the planned Phase 1/2 clinical trial may otherwise fail to validate and support the tolerability and efficacy of ST-400; Sangamo's substantial dependence on the clinical success of its lead therapeutic programs; the initiation, enrollment and completion of the stages of its clinical trials, including Sangamo's potential inability to enroll the planned Phase 1/2 clinical trial of ST-400 in a timely manner or at all; technological challenges; the lengthy and uncertain regulatory approval process; Sangamo's and Bioverativ's ability to develop a commercially viable ST-400 product or other products under the collaboration; technological developments by competitors and others in the genomic therapy field; and Sangamo's dependence on its collaboration with Bioverativ for the development of ST-400 and its ability to maintain its collaboration with Bioverativ. A more detailed discussion of these and other risks and uncertainties may be found under the caption "Risk Factors" and elsewhere in Sangamo's SEC filings and reports, including Sangamo's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and future filings and reports by Sangamo. Sangamo assumes no obligation to update the forward-looking information contained in this press release.
Bioverativ Safe Harbor
This press release contains forward-looking statements, including statements about the potential benefits, safety and effects of ST-400, and expected timing and enrollment of clinical trials. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on Bioverativ's current beliefs and expectations. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Factors which could cause actual results to differ materially from Bioverativ's current expectations include: uncertainties relating to the initiation, enrollment and completion of stages of clinical trials; unexpected concerns may arise from data, analysis or results obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of product candidates; risks and uncertainties relating to collaborations; Bioverativ's reliance on third parties over which it may not have control; or Bioverativ may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Bioverativ's drug development and commercialization activities, please review the Risk Factors section of Bioverativ's most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and Bioverativ assumes no obligation to update any forward-looking statements.
References
1World Health Organization. Global Epidemiology of Haemoglobin Disorders and Derived Service Indicators. Available at: www.who.int/bulletin/volumes/86/6/06-036673-table-T3.html. Accessed on: September 28, 2017.
from Facebook:
Question: "Is Pharmacyte still planning on following through with their statement of starting pivotal clinical trial for pancreatic cancer in q4 of this year?"
Answer: "We have no new updates regarding this. We are working on all the items the FDA requires from us to include in the IND. The rate-limiting factor, as mentioned in our published interview with Sarah DeMare of Facet Life Sciences (http://pharmacyte.com/pharmacyte-biotech-updates-ind.../), is the growth of the cells. We have no way of predicting how long this will take and thus can only say that we're working on all of the items that the FDA requires from us to include in the IND. We will submit the IND when we have all of the required information. Once we submit the IND and have FDA approval to proceed with the clinical trial, then we will be able to develop and release a timeline to the public. Thank you for your patience throughout this process!"
https://www.facebook.com/pharmacytebiotech/
Not long after I created this iHub account someone tried to take control of both the account and the associated email address. They would have succeeded if not for 2 factor authentication.
I'm sure it happens every minute of every day.
What prevents a competitor from staging their own CIAB trials, getting FDA market approval, and getting orphan drug exclusivity?
The competitor's legal team. No one is going to pursue a CiaB type trial only to be sued for IP infringement.
No. CIAB contains no new chemical entity.
This is a biologic and it will be evaluated by CBER.
You can't just keep re-filing new patents to replace old patents expired. PMCB would have to file some new way to manufacturer CIAB. Or some new enhancement to CIAB. Else the USPO will reject it.
PMCB has filed a provisional on the full CiaB pancreatic cancer treatment. That is not a refiling. The Austrianova patents that have lapsed were for the old encapsulation process. The latest Austrianova filing is for a new encapsulation process that can withstand stomach acid. Seems to me a smart IP law firm is using the fact that CiaB can now withstand stomach acids as the basis for a new patent. For sake of argument, assume the old CiaB process was a 20 step process and assume the new CiaB process is a 25 step process. This is done all the time to protect IP and they are literally called Improvement Patents.
Which isn't worth squat, unless: IND --> clinical trial(s) --> NDA
The market is placing a value on $PMCB of $50+ Million. Further, based on the new S-3, someone is considering a new $50 Million investment. That would be a rather epic vote of confidence.
Finally, I completely fail to see how a renown doctor such as Dr. Manuel Hidalgo would waste his valuable time with PMCB if everything were as gloomy and futile as you suggest.
I fully expect Kerr to make an announcement that his social media accounts were hacked and that any and all recent posts were not his own.
I'll do my best!
ACBFF currently has 343.69M shares outstanding, with a float of 333.52M.
https://finance.yahoo.com/quote/ACBFF/key-statistics?p=ACBFF
Options (the right to buy stock for a specific price after a certain period of time) for 1,900,000 shares were given to current Aurora employees at a price of CAD $2.76. So, say a random Aurora Manager was awarded 10,000 Stock Options. Those options expire in 5 years, so the company is saying "for your hard work today, in several years when our stock price is higher, you'll be able to buy shares for CAD $2.76". So say the ACBFF is trading at $6.00 in 2019. These employees will be able to get shares by paying the company $2.76 per share.
Not sure when that happened, so I don't know if these extra 1.9M shares are already included in OS or not.
Back to our example Manager. In the next 12 months, she will have the option of buying 3,333 shares at CAD $2.76. In 24 months, she will have the option of another 3,333 shares. Ditto in 36 months. Regardless of when those vest- 12, 24, 36 months- they all must be used within 60 months.
The second part is about Restricted Stock Units. 2,007,110 special options will be issued subject to a shareholder vote at the upcoming annual meeting (you will get to vote on this via the proxy package).
RSUs are like regular Options, but they have to be held for a longer period of time and they have additional restrictions like you have to still be with the company to exercise them and/or you can't have been fired. This is to entice employees to stay on for longer periods of time.
I'll be voting for the RSUs when I get my proxy pack. I think it's great for moral and in my experience people work harder when they have a piece of the action.
Thanks, I'll clean up my notes and repost.
$PMCB's IP currently will be covered for 7 years via Orphan Drug Designation:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=457014
7 years with the clock starting on approval of course.
Additionally, since it's a biologic, it would be granted market exclusivity for 12 years, again, on approval.
The original Austrianova patent did expire. The original process for CiaB being to manufacture encapsulated cells and immediately inject them. Since it wouldn't be possible to produce a master cell bank I don't think anyone else would consider pursuing that path.
The new technique is to make the encapsulated cells and to freeze them. Applications are pending for that process at Austrianova. I don't see how a MCB or WCB could be developed by any competitor without freezing.
Finally, PMCB has filed a provisional placeholder for the entire pancreatic cancer treatment process.
Yes, 20 year patent protection would be nicer. But PMCB owns the Orphan drug designation and that's good enough for me.
Oh dear, can someone please tell the folks on $OWCP that not only wasn't this patent issued:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135023803
The entire application is in jeopardy because of non-payment of fees:
EP Master file: https://register.epo.org/application?number=EP15872095&lng=en&tab=doclist
Application deemed to be withdrawn: https://register.epo.org/application?documentId=E0TT4EUM0893DSU&number=EP15872095&lng=en&npl=false
Thanks for the info!
Any speculation on the S-3 to share here? $50 Million debenture is a lot of capital.
"We have been provided errant posts by Kenn Kerr this week and plan to speak to him about it shortly.
His recent comments are not official PharmaCyte statements.
Regarding the IND and clinical trials: We have no information to believe that the FDA will require us to conduct a a phase 1 clinical trial before conducting our planned pivotal trial.
Please email us at investorrelations@pharmacyte.com if you have concerns or questions you would like to bring to our attention."
https://www.facebook.com/pharmacytebiotech/
Why $GWPH was down today:
GW Pharma slips 15% premarket on Zogenix's successful late-stage study of ZX008 in Dravet
Sep. 29, 2017 7:48 AM ET|About: GW Pharmaceuticals plc (GWPH)|By: Douglas W. House, SA News Editor
GW Pharmaceuticals (NASDAQ:GWPH) is down 15% premarket, albeit on only 779 shares, in apparent response to Zogenix's announcement of positive Phase 3 results for Dravet syndrome candidate ZX008.
GW's late-stage candidate for Dravet is Epidiolex (cannabidiol).
Previously: Zogenix's lead candidate ZX008 successful in late-stage Dravet study (Sept. 29)
Previously: GW Pharma initiates second Phase 3 study of Epidiolex in Dravet syndrome (April 21, 2015)
https://seekingalpha.com/news/3298365-gw-pharma-slips-15-percent-premarket-zogenixs-successful-late-stage-study-zx008-dravet
I dislike linking Seeking Alpha articles but this one seems to be dead on.
For $PMCB DD please take a look at some of these recent posts:
Factual Posts:
Medical and scientific personnel currently associated with $PMCB
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134711479
Principal Investigator will be Dr. Hidalgo, MD, PhD
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134723048
Master Cell Bank being produced by Eurofins
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134794043
Austrianova's IP
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134787469
$PMCB's new corporate law firm
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134622365
$PMCB has four institutional investors with small, "placeholder" positions
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134474894
Recent $PMCB Events
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134528572
Speculative Posts:
Why would a large pharma company want anything to do with $PMCB?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134833898
Regarding the S-3 law firm
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134711413
Pattern related to S-3 Filings and partnerships
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134711743
Another interesting week for $PMCB. : )
Hope everyone has a great weekend!
Protocols for Phase 1 aka Safety Studies for Oncology are to test on people who actually have the cancer. $PMCB's upcoming trial is targeting people who are no longer responding to regular chemotherapy.
So, again, the FDA is going to tell PMCB to inject these people with CiaB, but not to activate it? Man, that seems really cold.
The studies were published in 2014: http://www.mdpi.com/1999-4923/6/3/447/htm
Moreover, there was a recent study in China 2016: http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0179279. Why wouldn't the FDA accept data from that?
Yes, 4 letter ticker automatically means Nasdaq.
GWPH is an ADR though.
How about OTC $NMUS? It is the only US company that has permission from the DEA to legally do cannabis research via U of Mississippi. There was a study started for PTSD in Veterans, but the cannabis they received from U of Mississippi had mold and looked like ditch weed: https://www.leafly.com/news/politics/photos-prove-government-grown-cannabis-basically-ditch-weed so probably not a great investment.
$KSHB Kush Bottles is another OTC that seems to be a completely legitimate company. They just sell marketing/packaging for MJ.
Who owns the group?
This is your post on $PMCB yesterday:
Kenn has recently said he thinks it is not possible ( at this point for PMCB to complete the MCB / WCB along with testing of cells ) for us to complete the steps reqd to actually file the IND in 2017 ...... He also said he expects the trial ( noting that FDA may requite a P1 before allowing us to run a pivotal trial ) will not happen until end of 2018
you all should know I am a Long , and a supporter of PMCB , but my patience is running thin . That does not mean I am selling my shs , I am not . none of them . Patience is going to be required .
BarChart showing $SGMO as a 96% Strong Buy
https://www.barchart.com/stocks/quotes/SGMO
BarChart showing $EARS as a 72% Strong Buy
https://www.barchart.com/stocks/quotes/EARS
Based on the tape, some people panic sold on her post. I don't applaud fear-based trading.
SEC accepted the S-3.
$SGMO hitting the investor circuits hard, first Cantor Fitzgerald and now
"RICHMOND, Calif., Sept. 28, 2017 /PRNewswire/ -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced today that Sandy Macrae, M.B., Ch.B., Ph.D., Sangamo's chief executive officer, will participate in the following conferences in October.
2017 Cell & Gene Meeting on the Mesa, La Jolla, CA, October 4-6, 2017
Dr. Macrae will participate in a panel discussion on gene editing at 9:15 a.m. PT on Thursday, October 5th, and is scheduled to present a company overview later that afternoon during the annual Partnering Forum at 2:15 p.m. PT.
Jefferies Gene Technology Investor Summit, New York, NY, October 12, 2017
Dr. Macrae is scheduled to present a company overview at 2:50 p.m. ET on Tuesday, October 12th.
The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A replay of the presentations will be archived on the Sangamo website for two weeks after the event."
Nice IPO! Congrats to everyone who got shares early yesterday!
China just shut down all North Korean businesses on Chinese soil.
NK has had the same playbook for years: Launch missiles until US gives $$$. That's not working anymore. All the sabre rattling, missiles and marches, is really just an elaborate extortion play.
The latest UN action is actually working, so who knows what NK is going to do next.
I know a lot of people like $WEED ($TWMJF), but I like Aurora more. The deal in Germany is huge and the license for oils is crucial.
However, revenues are going to need to grow rapidly in 2018 to justify these lofty market caps.
Safe US MJ play is $SMG - Scotts Miracle-Gro.
Safe but speculative MMJ plays are $GWPH (ouch today), $ZYNE (nice yesterday), and $CARA as they all use synthetic cannabinoids. All have current FDA Phase 2 or Phase 3 trials. ZYNE and CARA tend to follow GWPH, so expect pull back across the board here.
If you want the companies that touch the plant you have to go to Canada, so OTC ADR land:
$TWMJF - $900 million US dollar market cap
$ACBFF - $800 million US market cap
$APHQF - $700 million US market cap
ACB is Aurora and that is my favorite company. Most people in Canada seem to love TWMJF, which has the cool Canadian ticker of WEED.
I'm banned from the OWCP board, but if I wasn't I'd tell them to watch out. The former COO, Ziv, was selling stock that was supposed to be held in trust AND he didn't notify the SEC, their accountant found out about it, and Ziv was terminated. How on Earth there haven't been lawsuits is beyond me. Crickets from the SEC as well.
"Just as long as they don't dilute any more than necessary."
I've read the S-3 and the latest prospectus and as it is filed it's for a debenture. As far as I can tell $PMCB has never issued a debenture.
Yeah, that's the part of this very weird post that really stood out as blatant BS.
Cellulose has been approved by the FDA since the 1970s. In food. Artificial tears. KY gels. Fiber powders. Plastic surgery gels.
FDA is suddenly going to ask for a safety study on cellulose?!?
A partnership would be sooooooooooo nice. But, yes, IND or we riot!
So the S3 didn't get an Underwriting Agreement. Thought that was interesting.
Hummm the SEC Whistleblower tip function is offline until Oct 2nd for "scheduled maintenance".
Possibly to incorporate tip reporting to the new Cyber Division. : )
https://www.sec.gov/tcr-system-upgrade
DUN DUN!
IF we have some positive news tomorrow, the people who were *scared* into selling those million shares today are going to have a bad weekend.
Amazing. Just amazing. I really underestimated how many people get info from this board.