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HAPPY FATHER'S DAY TO ALL THE WONDERFUL HUSBANDS AND DADS OUT THERE.
Nice finish for the week. Looking forward to weeks ahead.
Enjoy your weekend!
Nice...nothing wrong with establishing a new and solid base. Today's formed base is significantly better than what it was.
When this data gets published in a peer review journal it will really explode upwards. It is still not even being noticed by institutional investor communities yet mostly because it isn’t on a major exchange. However, when things really start to happen and they take a position, it will blow past $10.
Completely agree with you!
Lots of loading at .42
George Mason researcher examining the use of Brilacidin for treatment of coronavirus infections
George Mason researcher examining the use of Brilacidin for treatment of coronavirus infections
Innovation Pharma reports more “positive” COVID-related Brilacidin data
Nano cap Innovation Pharmaceuticals (OTCQB:IPIX +28.3%) announces new results from ongoing laboratory tests evaluating Brilacidin’s effects on the SARS-CoV-2 virus in cell cultures.
In a human lung epithelial cell line, Brilacidin reduced viral load by 95% and 97%, respectively, compared to control, at two therapeutic concentrations tested while being non-toxic to the cells.
The company says the new data reinforce previous testing, in VERO cells, where Brilacidin showed inhibition of 75% against SARS-CoV-2 compared to control.
Results, when completed, will be submitted for publication. Data generated to date supported a federal grant application filed last week by RBL, the testing laboratory, in collaboration with IPIX seeking funds to finance studies evaluating Brilacidin as a pan-coronavirus therapeutic.
It is in the process of manufacturing Brilacidin for intravenous dosing and will be seeking FDA guidance on a proposed COVID-19 clinical trial.
COVID-19 cases swell in 21 states
Grabbed another 11,000.
Did you get filled in AH?
Hi Dino...any thoughts on CHAP?
Thanks Dino! Greatly appreciate it!!
dino how in the world did you call this....fabulous play!!!
Clay...don't the gaps from Friday's open and today's open have to be filled?
Thanks
3BB
Clay...don't the gaps from Friday's open and today's open have to be filled?
Thanks
3BB
“We are very pleased with the progress that has been made with our clinical strategy for Bucillamine in the potential treatment of COVID-19, specifically with our focus on a Phase 3 confirmatory study to be conducted in the U.S. and our expansion into Canada,” said Michael Frank, Revive’s Chief Executive Officer.
The Company will have its Pre-CTA meeting with Health Canada this week. A complete briefing package accompanied the meeting request to discuss Bucillamine’s Chemistry, Manufacturing and Controls, non-clinical and clinical safety information, clinical trial design, and Health Canada’s guidance regarding the possibility of including an additional exploratory arm in the proposed trial in a subset of patients from the pediatric population. Results from the Pre-CTA meeting with Health Canada will be made available and the Company expects to initiate a clinical study as soon as possible following receipt of regulatory clearance from Health Canada.
Additionally, Revive is finalizing its IND with the U.S. FDA for the proposed Phase 3 confirmatory clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection. The Company will file the IND later this month and expects final approval to proceed to the Phase 3 study shortly thereafter.
Phase 3 Study Design
The Phase 3 study will be an adaptive design titled, A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine or Placebo in Patients with Mild-Moderate COVID-19. Symptomatic patients will initially be randomized 1:1:1 to receive Bucillamine 300 mg/day, Bucillamine 600 mg/day, or placebo.
The Phase 3 study will enroll a minimum of 210 patients, then a single Bucillamine dose is selected and a go/no-go decision is made. Patients will then be randomized 2:1 to the selected Bucillamine dose and placebo. Interim analyses will occur every 100 subjects up to the maximum sample size of 800 people. An independent data safety monitoring board (“DSMB”) will actively monitor interim data for the ongoing safety of patients.
The primary objective of the Phase 3 study is to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is a 3-level ordinal scale of a patient’s worst outcome between randomization and day 28. The levels of the ordinal outcome are 1) death, 2) alive and hospitalized, and 3) alive and not hospitalized.
Secondary objectives will aim to evaluate the safety of Bucillamine therapy at low (300 mg/day) and high (600 mg/day) dose levels when administered up to 14 days; to compare disease course in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo; to evaluate time to clinical improvement in patients with COVID- 19 receiving low- and high-dose Bucillamine compared with placebo; and to assess impact of Bucillamine therapy on supplemental oxygen needs of patients with COVID-19. In addition, an exploratory objective will be to evaluate the effects of Bucillamine on viral clearance from nasal swabs in patients with COVID-19.
Agree with you...What the heck!!
IPIX
Innovation Pharmaceuticals Inc.
Common Stock
0.18
0.0095
5.57%
0.176 / 0.1824 (5000 x 5000)
Real-Time Best Bid & Ask: 07:20am 05/27/2020
Delayed (15 Min) Trade Data: 12:00am 05/26/2020
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OTC DISCLOSURE & NEWS SERVICE
Inhibitory Effect of Innovation Pharmaceuticals’ Brilacidin on SARS-CoV-2 (COVID-19) in Primary Human Immune Cells to be Studied at Leading Public Health Research Institute
Press Release | 05/05/2020
WAKEFIELD, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has executed a Material Transfer Agreement (MTA) with a leading U.S.-based Public Health Research Institute, with access to a Biosafety Level-3 (BSL-3) laboratory, to evaluate the immunomodulatory and antiviral properties of Brilacidin in relation to COVID-19. This new research is separate from the previously announced antiviral studies being conducted at a U.S. Regional Biocontainment Laboratory (RBL), which over the weekend informed us that the next phase of Brilacidin testing has commenced.
Scientists at the Public Health Research Institute plan to evaluate Brilacidin’s inhibitory effect on SARS-CoV-2 viral replication in primary immune mediators (peripheral blood mononuclear cells, T cells, B cells, monocytes, macrophages) obtained from both young and old donors to assess age-dependent host responses to the novel coronavirus. Brilacidin drug substance has been received by the Institute and is now available for testing.
The Company appreciates the support and interest in Brilacidin from these government-funded laboratories during the COVID-19 pandemic. A great deal of important research on the antiviral properties of Brilacidin is ongoing, which further underscores the overall therapeutic potential of our first-in-class defensin-mimetic. Based upon the data to date, the Company is hopeful that Brilacidin can become a breakthrough treatment for COVID-19 patients, exhibiting unique 3-in-1 properties—antiviral, anti-inflammatory and antimicrobial.
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in Phase 2 human trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help address the emerging worldwide coronavirus crisis. Lab testing conducted at a U.S.-based Regional Biocontainment Laboratory (RBL) supports Brilacidin’s antiviral activity in directly inhibiting SARS-CoV-2 in cellular assays, with a molecular screening study of 11,552 compounds also supporting it as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit the production of IL-6, IL-1b, TNF-a and other pro-inflammatory cytokines and chemokines (e.g., MCP-1), which have been identified as central drivers in the worsening prognoses of COVID-19 patients. Brilacidin’s antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a particularly promising and unique (3 in 1 combination: antiviral, immune/anti-inflammatory, and antimicrobial) anti-COVID-19 therapeutic candidate.
Business
Innovation Pharmaceuticals Receives Data from Public Health Research Institute Showing Brilacidin Inhibits SARS-CoV-2 (COVID-19)
May 26, 2020, 7:00 AM CDT
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Innovation Pharmaceuticals Receives Data from Public Health Research Institute
Showing Brilacidin Inhibits SARS-CoV-2 (COVID-19) in a Human Cell Line
* Brilacidin showed a dose-dependent inhibitory response in a human kidney
cell line expressing hACE2
* Data supports Brilacidin’s potential to prevent SARS-CoV-2 binding to the
hACE2 receptor, the method by which the novel coronavirus gains entry in
human cells
WAKEFIELD, Mass., May 26, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals
(OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company,
reports today receiving data from a leading Public Health Research Institute
(PHRI) showing Brilacidin inhibits SARS-CoV-2, the novel coronavirus
responsible for COVID-19, in a human cell line. Brilacidin, in comparison to
vehicle control, exhibited an inhibitory effect on SARS-CoV-2 in a
dose-dependent manner—an average 29 percent inhibition at 0.1ug/ml (the lowest
concentration) to an 85 percent inhibition at 100ug/ml (the highest
concentration).
The Brilacidin anti-SARS-CoV-2 research being conducted at the PHRI is
separate from research being performed at a U.S. Regional Biocontainment
Laboratory (RBL), both with BSL-3 testing capabilities.
“This human cell line data is highly significant, with exciting implications,”
commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals.
“We now have preliminary in vitro data from two separate independent
laboratories that, cumulatively, support Brilacidin’s ability to act directly
on the novel coronavirus, as a virucidal agent, and prevent viral binding to
host cells. Across the coming weeks, we anticipate sharing additional
anti-SARS-CoV-2 data from both research institutions as we work towards
initiating a clinical study of Brilacidin for the treatment of COVID-19.”
For the experiment, the SARS-CoV-2 spike pseudotyped luciferase virus was
incubated with Brilacidin at different concentrations—from a low of 0.1ug/ml
to a high of 100ug/ml—for 1 hour before being added to HEK/293T cells (a human
kidney cell line) expressing hACE2 for 2 hours. Then, the infected cells were
cultured in media for 3 days before cells were lysed, with the inhibitory
effect measured as a function of luciferase activity. Multiple measurements
were taken to determine an average efficacy.
The primary investigator characterized the results as promising, especially
given inhibitory effects in this particular human cell line are difficult to
achieve based on the PHRI’s experience testing other defensins. The researcher
also theorizes Brilacidin’s inhibitory effect may be partially due to the
drug’s ability to prevent viral entry by blocking the SARS-CoV-2 Spike 1 (S1)
Receptor-Binding Domain (RBD) from interacting with the Angiotensin-Converting
Enzyme-2 (ACE2) receptor, the method by which the novel coronavirus gains
entry into human cells. Additional anti-SARS-CoV-2 testing in human cell lines
is underway at both the PHRI and the RBL to further elucidate Brilacidin’s
antiviral properties.
Related, the article below highlights how defensins/peptides and their
synthetic mimics, like Brilacidin, might be able to block the uptake of the
novel coronavirus into host cells via the ACE2 receptor given their unique
molecular properties. The article further points out that SARS-CoV-2 might be
losing the battle in the intestines, in contrast to the lungs, due to
defensins (present naturally) exerting a protective effect.
* “Blocking Coronavirus 19 Infection via the SARS-CoV-2 Spike Protein:
Initial Steps.” CS Med. Chem. Lett. 2020. Published online May 18, 2020.
https://pubs.acs.org/doi/10.1021/acsmedchemlett.0c00233 (pdf)
For researchers and institutions interested in collaborating on Brilacidin for
COVID-19, please send inquiries to: covid19@ipharminc.com
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in
Phase 2 human trials for other clinical indications, providing an established
safety and efficacy profile, thereby potentially enabling it to rapidly help
address the worldwide coronavirus crisis. Laboratory testing conducted at a
U.S.-based Regional Biocontainment Laboratory (RBL), and at a Public Health
Research Institute (PHRI), supports Brilacidin’s antiviral activity in
directly inhibiting SARS-CoV-2 in cellular assays, with a molecular screening
study of 11,552 compounds also supporting the drug as a promising novel
coronavirus treatment. Additional pre-clinical and clinical data support
Brilacidin’s potential to inhibit the production of IL-6, IL-1ß, TNF-a and
other pro-inflammatory cytokines and chemokines (MCP-1), which have been
identified as central drivers in the worsening prognoses of COVID-19 patients.
Brilacidin’s antimicrobial properties might also help to fight secondary
bacterial infections, which can co-present in up to 20 percent of COVID-19
patients. These data collectively support Brilacidin as a particularly
promising and unique (3 in 1 combination: antiviral, immune/anti-inflammatory,
and antimicrobial) anti-COVID-19 therapeutic candidate.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical
company developing a world-class portfolio of innovative therapies addressing
multiple areas of unmet medical need, including inflammatory diseases, cancer,
infectious disease, and dermatologic diseases. Brilacidin, a versatile
compound with broad therapeutic potential, is in a new chemical class called
defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the
prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck
Cancer, met its primary and secondary endpoints, including reducing the
incidence of SOM. The Company plans to advance Brilacidin oral rinse into
Phase 3 development, subject to available financial resources. Positive
results were also observed in a Phase 2 Proof-of-Concept trial treating
patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative
Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma
S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single
intravenous dose of the drug delivered comparable outcomes to a seven-day
dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute
Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer
drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due
to its crucial role in controlling cell mutations and has successfully
completed a Phase 2 trial in Ovarian Cancer. More information is available on
the Company website at www.IPharmInc.com.
https://www.nbc.com/mad-money/video/mad-money-may-26-2020/4170471
may 26, 2020 Jim Cramer googles for IPIX
On May 19, 2020, Innovation Pharmaceuticals Inc. issued a press release titled, Innovation Pharmaceuticals’ Brilacidin Reduces Viral Titer of SARS-CoV-2 (COVID-19) by 75 percent After Only 1 Hour of Preincubation in In Vitro Study at BSL-3 Facility; Demonstrates Potent and Rapid Virucidal Activity.
On May 21, 2020, Innovation Pharmaceuticals Inc. issued a shareholder alert titled, Pursuing the Gold Standard in the Battle Against SARS-CoV-2 (Covid-19).
Copies of the press release and alert are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. The information in this Current Report on Form 8-K under Item 7.01, including the accompanying press release and alert, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by reference to such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.
Description
99.1
Press release dated May 19, 2020
99.2
Shareholder alert dated May 21, 2020
*spooked...
well....ok. Not sure that we should be focusing on 2014 announcements right now...but that's GREAT if it happens. Not part of my DD though.
What happens when 16mm warrants get exercised at .05-.07 some time between now and 2023...AND I am LONG
Dude this is from 2014....imho not much in to play with what's going on today. I am long but not in to bs others.
OPKO Health Unit Providing Coronavirus Antibody Screening in New York City
Its BioReference subsidiary is rolling out testing with five locations -- one in each of NYC's boroughs -- but will quickly expand its footprint.
Eric Volkman
May 11, 2020 at 10:16AM
Author Bio
OPKO Health (NASDAQ:OPK), which is on the forefront of testing for COVID-19 and the SARS-CoV-2 coronavirus that causes it, is helping New York City get a handle on how the disease has been spreading through the five boroughs. On Friday, the company's BioReference lab testing subsidiary launched a large-scale SARS-CoV-2 antibody screening service for residents of the city, which was hit particularly hard by the pandemic.
In the opening phases of the project, 140,000 of the municipality's residents will be tested in five locations, one in each of its five boroughs. In the next few weeks, other testing sites are to be opened
livefree - I imagine most everyone if not all understand the message you convey - just remember not to judge others who don't do exactly as we ourselves do or hope that they do. There are many many reasons for people's different and individual reactions to situations. Many, many issues are in play at the moment, different intentions, goals, perceptions, etc. Personally, I worry about me, myself and my family...weigh the risk(s) of "potential" consequences and keep moving forward based on knowledge I arm myself and family with. Never judge as the information obtained is not gospel...for any of us. Everyone and everything has an alternative motive...especially when politics are involved...AND it is!
Wish all the BEST to us all!!
3BB
https://www.bioworld.com/COVID19products
Prodrug of GS-441524 that targets the viral RNA-dependent RNA polymerase in development for Ebola, Nipah virus and COVID-19; agent is formulated using Captisol technology from Ligand Pharmaceuticals Inc. and is already in clinical testing for COVID-19; key opinion leaders told SVB Leerink analysts that it had good chances of being effective and rapidly scaled but might not be available for a year-and-a-half; was available for compassionate use; Gilead rescinded its request to the FDA on March 25 for orphan drug status, following a public backlash; remdesivir is being tested in the SOLIDARITY trial sponsored by WHO; as of April 13, a cohort analysis showed most of the 53 individuals hospitalized with severe complications of COVID-19 who were treated with remdesivir on a compassionate use basis improved clinically with no new safety signals; after 28 days of follow-up, the cumulative incidence of clinical improvement was 84%; overall mortality was 13%; as of April 15, two phase III studies in China testing were halted after Chinese authorities reported a lack of eligible patients, but other studies remain ongoing
This is from the FDA site of companies and trials in progress for COVID 19
The Company is currently focused on advancing the clinical development for Bucillamine, which has a proven safety profile and has been prescribed for arthritis in Japan and South Korea for over 30 years and is being repurposed by the Company as a potential treatment of infectious diseases, including COVID-19. Revive has applied for a provisional patent with the U.S. Patent and Trademark Office entitled "Use of Bucillamine in the Treatment of Infectious Diseases" (Serial No. 62/991,996) and the Company is targeting COVID-19 as its lead indication.
We have strengthened our scientific and clinical team that will allow us to pursue the clinical development of Bucillamine in the potential treatment of not only COVID-19 but also other infectious diseases and we are seeking to advance Bucillamine for COVID-19 towards a potential U.S. FDA Phase 2 clinical study and a clinical study in one of the APAC countries," said Michael Frank, Revive's Chief Executive Officer. "Revive has built a robust product pipeline that has a particular focus on infectious diseases and rare disorders and is discovering and developing new therapeutic uses of drugs such as Bucillamine, Psilocybin and Cannabidiol. We are steadily advancing our product development programs that will unlock the potential value of Revive and we are continuing to expand our product pipeline in infectious diseases and rare disorders."
The FDA recommended that the Company proceed directly into a Phase 3 confirmatory clinical trial ("Phase 3 study") to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection in order to ensure expeditious evaluation of the safety and efficacy of Bucillamine.
Pharm-Olam - The Company is well-known for producing quality results with reduced risk, costs, and timelines in challenging international trials.
Learn more about their full-service solutions, data protection services, and expertise in oncology, infectious diseases and vaccines, rare and orphan diseases, pediatrics, and general medicine at pharm-olam.com.
Dr. Onesmo Mpanju, PhD has over 28 years of experience in bio-pharmaceutical R&D, including 18 years as a regulatory scientist. Previously, Dr. Mpanju was a Reviewer at the U.S. FDA, Center for Biologics Evaluation & Research. His consulting experience includes non-commercial entities such as the U.S. National Institutes of Health, US Army Medical Materiel Development Activity (USAMMDA), the Bill & Melinda Gates Foundation, and others. Dr. Mpanju holds a Ph.D. in Experimental Medicine (Infectious Diseases) from the University of British Columbia, Vancouver, Canada.
When in a quiet period, ie: prior to earnings announcements buying/selling is restricted. If eminent deal that either strongly benefits or knowingly hurts the company and insiders are able to buy/sell strategically giving them a leg up on regular investors that too is prohibited. I'm not sure about placing future buys at quarter end....if any of the above circumstances are in play.
IMHO if key employees aren't motivated to buy company shares in which they are accountable for running effectively, then they are being paid to high of a salary and don't have any skin in the game or they simply do not believe in the longevity of company opportunities. If they can't hold long term and come out on top pps and tax advantage wise then they sit on the sidelines. This appears to be the case with IMSC.
Today's article appears to be nothing more than a meek attempt at appeasing retail investors.
Still a LT holder though. No point in selling at this level.
Good luck to us all!
3BB
What the "f" is going on?
Retrophin founder Martin Shkreli, replaced last year as chief executive officer of the biopharmaceutical company, is under investigation by U.S. prosecutors in Brooklyn, New York, for possible securities law violations, according to a person familiar with the matter.
Shkreli, a one-time short-seller who started New York-based Retrophin at 28, left his CEO post in September. Investors claimed in later lawsuits against him and the company that he distributed stock without the consent of shareholders.
Shkreli said in an interview today that he’s unaware of the probe and denied wrongdoing, including allegations in the lawsuits. Shkreli said he had a “difference of opinion” with his board over investing capital and stock options.
A prolific user of social media, Shkreli said on Twitter today that claims reported by Bloomberg News were “misleading and confused on an old situation that is no longer relevant.”
Shkreli also faces a probe by the U.S. Securities and Exchange Commission, according to the person, who requested anonymity because the investigation isn’t public.
Nellin McIntosh, a spokeswoman for U.S. Attorney Loretta Lynch in Brooklyn; Judith Burns, a spokeswoman for the SEC; and Tom Fernandez, a spokesman for Retrophin, declined to comment on the investigations.
Martin Shkreli under securities fraud investigation:
Article published 1/8/15
http://www.bloomberg.com/news/2015-01-07/retrophin-founder-said-probed-on-possible-securities-violation.html
Shkreli, who previously managed hedge fund MSMB Capital Management LLC, has faced criticism of his trading. In 2012, Citizens for Responsibility and Ethics in Washington, a watchdog group, asked U.S. Attorney Preet Bharara in Manhattan to investigate whether Shkreli manipulated shares of biotechnology and pharmaceutical companies by badmouthing them in order to drive down prices.
The group claimed Shkreli made postings on the website SeekingAlpha.com that spread “unfounded and inaccurate rumors about drugs owned by companies he was shorting,” and that he “inserted himself” into the Food and Drug Administration approval process for pending pharmaceuticals.
Betsy Feuerstein, a spokeswoman for Bharara, declined to comment on whether Shkreli was investigated. Stephen Santulli, a spokesman for the watchdog group, said in an e-mail that the group didn’t hear back after making the request.
According to an April 2014 profile in Bloomberg Businessweek, Shkreli, the child of working-class immigrants from Albania and Croatia, grew up in the Sheepshead Bay section of Brooklyn. As a college intern at a hedge fund formerly managed by Jim Cramer, the host of CNBC’s Mad Money, he made a name for himself by successfully recommending the short-sale of a biotech stock, according to Businessweek.
Retrophin focuses on the development, acquisition and sales of therapies for treating rare and serious diseases. It transitioned into a publicly traded company through a reverse merger with Desert Gateway Inc. in 2012. The company acquired Manchester Pharmaceuticals LLC for a total of $62.5 million last year.
To contact the reporter on this story: Christie Smythe in Brooklyn at csmythe1@bloomberg.net
To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net David Glovin, Andrew Dunn
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