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Post by lakers on Oct 3, 2016 15:27:41 GMT -5
1. Mnkd gonna conduct EpiHale clinical trial for the next 3-4 mos. After that, Mnkd will review the result w/ FDA early 1Q17. The whole process to FDA approval is ~ 10 mos. 2. Mnkd will co-market Afrezza in NFL game-day pamphlets for SD Chargers, LA Rams, Phily Eagles, Chicago Bears. These are large markets. An Ads could show up in USA Today. 3. Mnkd has been negotiating a settlement w/ Sanofi. Matt has traveled in the last 2 weeks. Mnkd will announce when there is some news. 4. BoD has plan to address delisting, extend the runway. 5. Of course Afrezza ramp-up would help pps. Afrezza story was printed in trade journals. I can't disclose my source. I recite to the best of my recollection. #2 - i have only head about MLB game day pamphlets during playoff time. Are you sure that is not what you mean here? NFL game day pamphlet is a surprise in addition to MLB playoffs. It makes sense as NFL is the largest market in U.S. Mgmt must be confident about the funding. These Mktgs are not cheap.
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Post by lakers on Oct 3, 2016 14:36:50 GMT -5
Is the ~10 months timeline to FDA approval for Epihale from today or 1Q17? Any idea when some of this info may become public? Q3 conference call? ~10 mos from early 1Q17. SH should have a need to know given delisting notice.
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Post by lakers on Oct 3, 2016 14:19:07 GMT -5
1. Mnkd gonna conduct EpiHale clinical trial for the next 3-4 mos. After that, Mnkd will review the result w/ FDA early 1Q17. The whole process to FDA approval is ~ 10 mos.
2. Mnkd will co-market Afrezza in NFL game-day pamphlets for SD Chargers, LA Rams, Phily Eagles, Chicago Bears. These are large markets. An Ads could show up in USA Today.
3. Mnkd has been negotiating a settlement w/ Sanofi. Matt has traveled in the last 2 weeks. Mnkd will announce when there is some news.
4. BoD has plan to address delisting, extend the runway.
5. Of course Afrezza ramp-up would help pps. Afrezza story was printed in trade journals.
I can't disclose my source. I recite to the best of my recollection.
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Post by lakers on Oct 2, 2016 14:17:50 GMT -5
Examples of drugs acquired at IND stage. It's time to deal the EpiHale or PAHale card from the bottom up to avoid further SH dilution and delisting. It's ironic that Mnkd spent $2.9B on Afrezza but those 2 cards might be the ones that rescue the company. NanoAntibiotics Acquires Company Developing Novel Therapies for Liver Disease Announces New Company Name -- BioVie, Inc. BEVERLY, MA--(Marketwired - Apr 18, 2016) - NanoAntibiotics Inc. (OTCQB: NNAB) (the "Company"), a development stage company focused on the discovery, development, and commercialization of novel drug therapies, is pleased to announce the acquisition of LAT Pharma LLC, of Chicago, IL, an early-stage biotechnology company developing novel medicines to treat life-threatening complications of liver cirrhosis. LAT Pharma brings a promising new therapeutic opportunity to NanoAntibiotics. Earlier this year LAT Pharma met with the FDA to discuss a submission for a novel therapy to treat ascites due to liver cirrhosis. The meeting designated as a "pre-investigational new drug (IND) meeting," provided guidance that is currently being addressed. The Company's goal is to commence a clinical trial program in human subjects upon FDA clearance of the IND application. m.marketwired.com/press-release/nanoantibiotics-acquires-company-developing-novel-therapies-for-liver-disease-otcqb-nnab-2115659.htmROCKVILLE, Md., Nov. 12, 2012 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the Company has entered into an agreement with Prev AbR LLC to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile (C. diff) infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA www.syntheticbiologics.com/news-media/press-releases/detail/82/synthetic-biologics-to-acquire-clinical-stage-c-difficile
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Post by lakers on Oct 2, 2016 11:28:25 GMT -5
Thu Sep 22, 2016 | 8:25 AM EDT UnitedHealth trims drug coverage, including Sanofi insulin www.google.com/amp/mobile.reuters.com/article/amp/idUSKCN11R2N7Photo A packet of diabetes drug Lantus SoloStar passes along the production line at a manufacturing site of French drugmaker Sanofi in Frankfurt June 5, 2013. REUTERS/RALPH ORLOWSKI (Reuters) - UnitedHealth Group (UNH.N), the largest U.S. health insurer, will stop covering several brand-name drugs as of next year, reinforcing a trend of payers steering prescriptions to lower-priced options. In a bulletin seeking client feedback by Sept. 28, UnitedHealth said it is changing reimbursement terms for long-acting insulins and will no longer cover Lantus, the main insulin drug sold by Sanofi (SASY.PA). The insurer said Basaglar, a cheaper biosimilar insulin sold by Eli Lilly (LLY.N) would be covered as "Tier 1," meaning the lowest out-of-pocket costs for members. Levemir, produced by Novo Nordisk (NOVOb.CO), will move from Tier 1 to Tier 2. CVS Health (CVS.N) made a similar move last month to drop Lantus in favor of Lilly's new biosimilar. Analysts at Jefferies said the sales impact of the United exclusion should be less than that from the CVS move, because the United plan covers around 15 million people while CVS covers 19 million. Sanofi shares fell more than 1 percent on Thursday after the news but had recovered by 1200 GMT, while Novo was down 1.3 percent. Sanofi reaffirmed its sales expectations despite the latest exclusion. A spokeswoman said the company was still targeting a decline in diabetes drug sales of 4 to 8 percent a year until 2018. "We are disappointed with the decision. For Sanofi, it is a pity not to leave doctors a choice," she said. "We had anticipated this kind of decision but we are holding discussions with other organisations in the United States to have them keep Lantus on their lists." Biosimilars are cheaper copies of protein-based biotech drugs such as Lantus, which are no longer protected by patents. They cannot be precisely replicated like conventional chemical drugs but have been shown to be equivalent in terms of efficacy and side effects. United also said it will exclude from coverage Amgen's (AMGN.O) white blood cell-boosting drug Neupogen, in favor of Zarxio, a biosimilar sold by Novartis (NOVN.S). UnitedHealth last year bought Catamaran for $12.8 billion, making it the nation's No. 3 pharmacy benefit manager after Express Scripts Holding (ESRX.O) and Caremark, which is owned by CVS. (Reporting by Deena Beasley, Ben Hirschler and Noelle Mennella; Editing by Ruth Pitchford and Elaine Hardcastle)
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Post by lakers on Oct 1, 2016 19:27:39 GMT -5
Mannkind Collaborates with JDRF on Afrezza Pediatric Trials Under the banner of Afrezza 2.0, MannKind is moving with all deliberate speed to recover the momentum built around inhalable insulin when it was introduced in 2014. That momentum dissipated after the company turned worldwide marketing rights over to Sanofi shortly after FDA clearance in June of that year. Sanofi severed ties with Mannkind in 2016 amid slow Afrezza sales. This set in motion a series of complicated transactions to settle mutual obligations between the two companies and return control of the product to Mannkind in early April 2016. Officially, MannKind has been circumspect in commenting on Sanofi’s handling of its product, although CEO Matt Pfeffer allowed in remarks at investor calls that MannKind “would have done things differently” in bringing Afrezza to market. Now, the company is working to do just that. Mannkind has been filling 55 new sales positions, negotiating arrangements with regional diabetes care practices to conduct patient education, and refocusing its physician education efforts to target specialists in diabetes care. It also is undertaking a series of new clinical trials for Afrezza in an effort to open up the marketplace for the drug. In June 2016, JDRF and MannKind announced a research and clinical trial collaboration which will focus upon Afrezza’s safety and effectiveness for pediatric use. This will help Mannkind fulfill commitments the company has made to the FDA to do more testing of the product. It also could help Mannkind expand the potential market, according to MannKind’s chief commercial officer Michael Castagna. “The next big thing that I think is critically important for those of you who know about diabetes is that a lot of Type 1 patients are diagnosed as children, and they continue to go on through their lives needing insulin. So getting our pediatric protocol off the ground and running and getting patients enrolled is one of my top priorities,” Castagna said at a July 12th investor forum. JDRF’s senior research vice president Dr. Steven Griffen said in a telephone interview that it makes sense that Mannkind would want to do pediatric clinical trials. It was unusual for the FDA to clear a new drug without evidence to establish its effectiveness for pediatric use. “New therapies typically require a pediatric program,” he said. The challenge in these studies will come with translating doses from injectible insulin to appropriate inhaled doses, according to Dr. Griffen. With pediatric patients, it will involve strict attention to variables such as mealtime carbohydrate load, timing of meals and snacks, and activity level. Clinical studies on pediatric use should be underway in the fall of 2016. When Mannkind plans to submit Afrezza for expanded use is not clear at the moment, said Dr. Griffen. “MannKind owns the timeline, and I’m sure that MannKind intends to take the time necessary to do it right,” Dr. Griffen said. insulinnation.com/research/mannkind-collaborates-with-jdrf-on-afrezza-pediatric-trials/
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Post by lakers on Oct 1, 2016 8:53:20 GMT -5
It is truly a tragedy that with three different CEOs, Mnkd has not figured out how to monetize the TS and a bunch of patents. Instead, they blindly put all eggs in one basket. With $2.6B sunk over 10 years, Mnkd could have come up with multiple ground breaking products as RLS has staked out.
It's sad that they can only come up with Afrezza and fumbled it big time.
Mnkd didn't understand the word diversification.
Dr Solomon must have disagreed with Al about putting all eggs in one basket and left Mnkd.
Ditto Andrea Leone-Bay to join RLS.
It's time for RLS's backers to pump money into Mnkd for < 50% stake, reverse merge RLS into Mnkd to fully benefit from NOL, install their own CEO and Dirs.
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Post by lakers on Oct 1, 2016 1:19:52 GMT -5
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Post by lakers on Oct 1, 2016 1:08:10 GMT -5
Ray said, "Palonosertron is in the early technical assessment phase with preclinical work expected to begin in the third quarter of 2016 followed by clinical trials beginning in second quarter of 2017. Again we are looking for a development partner for this program. Ideally, company or companies already in the oncology supportive care space.
There are many advantages to the oral inhalation while it avoids the need for IV access or having access to the patient's port, it can be used when oral agents are not practical, for example, with mucositis. It can be self-administered, for example, to prevent anticipatory nausea and vomiting. It has the potential to decrease the cost of care, nursing time, pharmacy cost, et cetera. And it can be used in multiday regimens."
There is a major adverse effect that chemotherapy has on many patients' mucous membrane that extends from their mouth to their anus.
The competition is Aloxi, a palonosertron drug for treating nausea and vomiting, is already approved by the FDA. Eisai, a large Japanese drug company has this drug in their portfolio. Eisai has the drug in both pill form and for IV delivery.
On October 13th, 2015, the FDA approved two generic versions of Aloxi for IV dosing regimens.
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Post by lakers on Oct 1, 2016 0:40:50 GMT -5
Ray said "The first is Treprostinil for pulmonary arterial hypertension, PAH. PAH is a sizeable market expected to reach $10 billion by 2020. Treprostinil, a prostacyclin vasodilator is currently available in several formulations. However, these often carry a significant burden. This often leads to poor compliance and poor clinical outcomes. Our Tresprostinil program is in the early technical assessment phase. Preclinical is expected to begin in the second quarter of 2016 followed by clinical trials beginning in first quarter of 2017. We are actively looking for a development partner for this program. Ideally, the partner would be companies that already are active in this space." Competitor is United Therapeutics. The first product to look at is Remodulin, where 7 out of 10 patients on continuous PAH therapy are prescribed this drug. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion. A drug they market under the name Tyvaso. And guess how Tyvaso is dosed? If you guessed that it is dosed with a United Therapeutics inhaler---BINGO! If you guessed it's treprostinil for PAH, then you get to move to the head of the class. Tyvaso has $450 M/yr run rate. Injected Remodulin has $650M/yr run rate. If the bong-like Tyvaso can sell well, why can't TS PAHale succeed if a reliable partner is found? Tyvaso had to go through the same 5-yr lung and 2-yr pediatric trials as Afrezza will. Somehow, UT marketed it well and made it a success. Mnkd needs to learn from the United Therapeutic Master. ir.unither.com/releasedetail.cfm?ReleaseID=981603Picture of the huge Tyvaso bong. www.tyvaso.com/hcp/dosage-administration/tyvaso-inhalation-system
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Post by lakers on Sept 30, 2016 10:50:27 GMT -5
www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/mannkind-path-to-afrezza-survival-involves-lower-prices-to-woo-payersMannKind: Path to Afrezza Survival Involves Lower Prices to Woo Payers Did MannKind misjudge consumer demand, or are barriers from payers to blame for Afrezza's woes? A feature outlining the misfortunes and future plans for the only inhaled insulin on the market. Published Online: March 15, 2016 Andrew Smith MannKind Corp has been racing to reinvent itself since Sanofi backed out of a deal to market its inhalable insulin.1 However, the product remains in limbo. Until the companies can complete a complex transition, Sanofi maintains control over Afrezza. MannKind cannot market the drug, negotiate coverage with insurers, file for regulatory approval in new jurisdictions, or take any other steps to turn the notorious flop into the success that MannKind’s leaders still hope it can be. Nonetheless, a flurry of announcements has kept the California-based company in the news, sometimes to the delight of investors and sometimes to their chagrin. In less than 3 months, MannKind’s founder left the board and passed away; it parted ways with 2 chief executives, attracted a class-action lawsuit, begun the hunt for a chief marketing officer, negotiated with potential international marketing partners, signed a deal that could be worth more than $100 million with a mysterious biotech, discussed potentially illegal short-selling with regulators, and announced its intention to win insurer coverage by lowering Afrezza prices. “We learned many things in 2015, and those lessons will benefit us greatly as we look forward to launching our own strategies this year,” said CEO Matthew Pfeffer during a February 3, 2016, investor conference call,2 which provided the most detailed glimpse to date of his plans for the company. Pfeffer is the fourth man to run MannKind since November, when CEO Hakan Edstrom resigned after just 11 months on the job and founder and chairman Alfred Mann stepped in on a temporary basis.3 MannKind offered the post to Duane DeSisto, the former CEO of the insulin pump maker Insulet, but Insulet protested on grounds of a noncompete agreement. MannKind withdrew the offer4 just after DeSisto had started and offered the job to Pfeffer, who had been serving as the company’s chief financial officer and now fills both roles. “The Afrezza transition is MannKind’s top priority, and it is getting the full attention it deserves,” Pfeffer told investors, noting the company’s particular focus on insuring continuity of supply for the few people who do use the drug. “The transition teams have been formed and include operations, scientific, and legal personnel from both MannKind and Sanofi. The teams have met and begun discussions about the complex process that a transfer like this involves. MannKind is targeting April 5 as the transition date for the rights to develop and commercialize Afrezza, but may request that Sanofi agree to a later date. “There are many factors that influence when the transition will occur, including a myriad of regulatory, commercial, and development activities, many of which involve third-party vendors or regulatory authorities, and all of which need to be transferred in a smooth and coordinated fashion,” Pfeffer said. BRINGING PAYERS ON BOARD MannKind’s basic plan for boosting Afrezza sales in the United States is to lower prices enough to get insurers to cover the product on favorable terms and then market it in unconventional ways rather than sending an army of sales representatives to doctors. Sanofi failed to get any major payer to include Afrezza on its standard formulary in 2015, even though the drug became available as a fast-acting prandial insulin for patients with type 1 diabetes (T1D) early in the year. Thus, nearly all would-be users needed to secure prior authorization from their doctors before they could get any coverage for the drug. Both MannKind and outsiders who believe Afrezza can still be a big seller agree that securing widespread coverage is a necessary first step to success. Of course, lowering prices will hurt margins on existing sales, but Pfeffer hopes to offset the damage by launching Afrezza in some of the many foreign markets that will rapidly approve drugs that already have FDA approval. MannKind reports that it is already in talks with potential partners from a number of countries that could approve Afrezza without any additional trials. These partners would use their knowledge of the local market not only to shepherd Afrezza onto pharmacy shelves, but also to market it to doctors and patients. Thanks to the potential for fast approval, such partnerships could begin boosting Afrezza sales just months after they start, said Pfeffer, who noted that any substantial increase in sales volume would mitigate the effect of domestic price cuts on margins by allowing MannKind factories to operate more efficiently, thus reducing unit costs. “Much of Afrezza’s future hinges on what kind of deals MannKind signs with companies in foreign markets,” Keith Markey, PhD, who follows MannKind for Griffin Securities, said in an interview with Evidence-Based Diabetes Management (EBDM). “If MannKind only signs a couple low-dollar deals, then it will struggle to offer Afrezza at competitive prices here and it will struggle to escape its current situation. If MannKind can generate significant near-term revenues from foreign deals, though, it will have a real chance of turning things around. Any real cash flow would ease fears about the company’s financial position and increase its ability to market Afrezza in the US. Significant extra sales would also create the sort of economies of scale that would allow MannKind to price Afrezza competitively and still profit on its US business.” - See more at: www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/mannkind-path-to-afrezza-survival-involves-lower-prices-to-woo-payers#sthash.H9rpjub3.dpuf
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Post by lakers on Sept 29, 2016 1:20:46 GMT -5
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Post by lakers on Sept 29, 2016 0:36:12 GMT -5
www.post-gazette.com/business/healthcare-business/2016/09/27/Allegheny-Health-Network-doctors-patients-to-have-role-in-diabetic-device-development/stories/201609260157September 27, 2016 12:00 AM By Kris B. Mamula / Pittsburgh Post-Gazette People with diabetes could soon get more help managing the disease, thanks to a $500 million joint venture involving Allegheny Health Network, drugmaker Sanofi and Verily Life Sciences LLC, a unit of Google parent Alphabet. French pharmaceutical giant Sanofi partnered with software and miniature electronics company Verily of Mountain View, Calif., to create Cambridge, Mass.-based Onduo, a company that will use new medical devices to help people with diabetes better care for the chronic disease. Meanwhile, feedback from doctors and patients at Allegheny Health Network’s Premier Medical Associates and Sacramento, Calif.-based medical system Sutter Health will be incorporated into the final design of the devices. “The purpose is to come up with a way to better self-manage diabetes,” said internist Frank Colangelo, Premier Medical Associates’s chief quality officer, who is leading the collaboration on behalf of AHN. “We do a great job of helping patients with diabetes.” Monroeville-based Premier, which was formed in 1993, is among the biggest multispecialty medical practices in the region. Highmark owned the practice until 2004, when it was spun off as an independent organization, but re-acquired by the insurer in 2010 as part of Highmark’s plans to develop an integrated medical delivery network. Diabetes is a chronic disease characterized by inefficient or inadequate production of insulin. Including lost productivity, the cost of treating diabetes was $245 billion in 2012, up 41 percent from $174 billion in 2007, according to the American Diabetes Association. Among the biggest hurdles to diabetes management is patient compliance with glucose testing and taking medications, Dr. Colangelo said. “There are a lot of issues, even some psycho-social issues” that can make patients fearful of a diabetes diagnosis and therefore noncompliant with doctor’s advice, he said. “From monitoring food intake to testing glucose levels to actively seeking medical care, the challenges both on the physical and mental well being of a person living with diabetes are incredibly difficult,” Onduo CEO and emergency medicine physician Joshua Riff said in a prepared statement. The devices envisioned by Onduo are still in the exploratory stage, so no further information is available, Verily spokeswoman Carolyn Wang said. Sanofi is putting up $248 million as part of the deal and Verily has committed an equal amount in equity capital and resources. A development timeline for the devices was not disclosed. In Pennsylvania, Bedford, Jefferson and Fayette counties have among the highest rates of diabetes, with rates exceeding 13 percent of the population, according to the state Department of Health. Amputation of toes and limbs is among the most serious complications of poorly managed diabetes, but Premier, which treats about 6,500 people with the disease, uses internally developed protocols, which have resulted in fewer diabetes-related amputations among its patients. Data were not immediately available, but in the past 10 years, Dr. Colangelo said he could recall only one patient with a diabetes-related amputation — a toe. “It’s a very rare complication,” he said. Onduo will focus first on better patient management of Type 2 or adult onset diabetes, which has been increasing because of the obesity epidemic, before moving to Type 1 diabetes and prediabetes. The collaboration and anticipated medical devices may help tamp down escalating health care costs, Premier CEO Mark DeRubeis said. The Monroeville-based physician practice has about 60,000 active patients, who are seen at offices throughout the eastern suburbs. “Everybody is trying to reduce health care costs and the number one area to look is diabetes,” Mr. DeRubeis said. [Where is VDEX?]
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Post by lakers on Sept 28, 2016 23:44:55 GMT -5
MannKind Corparation Stock Surges On Double-Digit Prescription Growth www.valuewalk.comMannKind has reported a more than 30% increase in new prescriptions for Afrezza, the inhaled insulin product it has been failing to get into the hands of patients for quite some time now. That’s off a base that’s quite tiny, so much more work needs to be done; nonetheless, it’s a win the drug maker is in desperate need of–especially since it is now in danger of having its stock delisted from the NASDAQ. MannKind sees surge in new Afrezza scripts The company said last week there were 156 new prescriptions written for Afrezza, marking a 34% increase from 116 the week before, reports Seeking Alpha contributor Trent Welsh. Unfortunately, patients who had received prescriptions for the insulin previously didn’t refill last week, as refills declined 5% to 140 from 147. However, the growth in new prescriptions was strong enough to more than offset the decline in refills, leaving a 12.5% increase in total prescriptions last week, bringing it up from 263 to 296. Welsh believes that MannKind is putting some “cost-effective and smart” plans designed to spur sales into action. He feels that the label change request coming next month and the possibility of partnerships in Technosphere products might make the drug maker a “buy low” candidate. The company has had a tough go of things, although it appears that the number of Afrezza prescriptions finally bottomed out within the last year. The marketing deal with Sanofi fizzled as the competitor failed to convince doctors to prescribe the inhaled insulin. For now, it appears as if management’s efforts to turn things around are working, as the downward spiral in prescription numbers has been halted. MannKind may be delisted from the NASDAQ What investors want to see next is whether they will be able to spur growth that’s fast enough to alleviate the cash concerns, and now there’s yet another clock ticking on MannKind’s ability to access investor money. A new fuse lasting less than six months has been lit. The drug maker stands on the brink of being delisted from the NASDAQ; it said last week that it received a delisting warning from the stock exchange earlier this month. Its shares have been in penny stock territory for too long, and if it can’t get its stock price back up so that it closes over $1 for at least ten days in a row within the next 180 calendar days, it will be delisted. The stock surged by nearly 7% on Tuesday, but thus far it hasn’t been enough to carry it over the $1 mark, as the highest level on Tuesday is 62 cents, as of this writing. Not only does MannKind stand the risk of being delisted, but it also failed to comply with a rule requiring it to disclose the delisting warning letter to investors within four business days of its receipt.
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Post by lakers on Sept 28, 2016 17:33:46 GMT -5
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