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"Would you buy a stock after the SEC tried to prevent ETFs from buying it? "
I never heard of the SEC make any such act here. Mind giving us the link from the SEC website?
Not a confirmed news.
Why?
Can any one verify the news that Tase Financing has formally been cancelled?
I bought more at $1.85 just now
Bought more at $2.24 while crossing my fingers!
Inhaler Helping Adults Living with Diabetes
Sanofi US announced the launch of an online social destination with a purpose, offering adults with diabetes an opportunity to share their experiences with Afrezza® (insulin human) Inhalation Powder.
For each photo or comment submitted to Afrezza® Hub at www.afrezza.com/afrezza-hub or shared through Facebook or Twitter, Sanofi US will make a $5 donation to Diabetes Hands Foundation, with a goal of donating $50,000.
Afrezza is an inhaled insulin, available by prescription, used to help control blood sugar in adults with type 1 and type 2 diabetes.
http://www.fox4now.com/the-morning-blend/inhaler-helping-adults-living-with-diabetes
MannKind's man with a mission
BY STUART PFEIFER
November 8, 2015, 8:00 p.m.
The gig: Hakan Edstrom, 65, is chief executive of MannKind Corp., which developed an inhaled insulin drug that could replace injections for people with diabetes. The Valencia biotech company began selling the drug, Afrezza, in February under a partnership with French pharmaceutical company Sanofi. MannKind employs about 300 people.
Swedish roots: Edstrom was born in Sweden and graduated from the Stockholm School of Economics in 1973. He worked in marketing for General Foods, designing sales strategies for its Gevalia coffee brand in Scandinavia. "I actually liked it.... You had to be quick on your feet. You had to be sure you produced the right type of advertising and in-store promotions to make sure you retained your market leadership." He later held executive positions for Pharmacia Corp. and Bausch & Lomb, where he ran the surgical equipment division.
Getting the call: In February 2001, Edstrom received a telephone call from Alfred Mann, the billionaire medical device entrepreneur and founder of MannKind. "I knew of Al, I did not know him," Edstrom said. But it didn't take long for Mann to woo him. Two months after that call, Edstrom agreed to become president of a company that was later named MannKind. He guided the company through the regulatory process that resulted in the June 2014 approval of Afrezza. He was named chief executive in January, after Mann stepped aside to serve as executive chairman.
A slow beginning: Afrezza sales have been far lower than analysts expected, in part because the Food and Drug Administration requires users to pass lung-function tests before they can be prescribed the drug. Also, insurers have required special authorization from doctors before they'll cover the drug. In its first five months, Afrezza generated just $3.3 million in sales, a disappointing result considering some analysts expected it to eventually hit $1 billion a year. Edstrom has had to draw upon years of business leadership experience to keep employees motivated while struggling with financing and attacks from short sellers on Wall Street. MannKind's stock, which closed Friday at $2.86, is down more than 45% so far this year. During the same period, the broad Nasdaq Biotechnology Index is up 9%.
Short-sellers frenzy: MannKind has faced intense pressure from short sellers, investors who are betting that the company's stock will fall. "It certainly is very frustrating," Edstrom said. "There's so much being written on the message boards. It's not reflecting the true situation, and you suspect it's being written because it can benefit them. There's not much we can do about that.... We are very much aware that you can have a conversation with the SEC and they can find a reason to look into it. I cannot talk about it because of confidentiality reasons."
Will MannKind survive?: "Yes, it will. The basis for that is Afrezza is a unique product, and I absolutely believe we will see a significant uptick over time. I know from the feedback from patients, they absolutely love the product. The second reason is our [inhaler] is a very unique vehicle; it can deliver more than insulin through a pulmonary route. We have already started developing products that eventually will go into clinical testing." One example could be pain medication, he said.
Motivating employees: "The word is communication. I think our employees know what to expect. Hopefully, we've communicated with them in a forthright and upfront manner, so they have an understanding of the product and an idea of what it will take [to succeed]. As a management team, we are transparent. I have very much an open-door policy so people can come up to me and ask questions. We try to get people together and tell them what's happening so nothing will be a complete surprise."
Managing in Europe versus U.S.: "In San Francisco and L.A., you have so many opportunities in terms of finding new jobs if you don't like what you're doing. In places like Sweden, when you're employed with a company you tend to stay very loyal to the company, almost to a fault, because the options where you're living may not be many. In the U.S., I have to inspire, build loyalty with my employees because they always have options here to go somewhere else. Here, I'm buying their time, I'm buying their loyalty. As long as what I'm offering is good, they'll stay. If someone else comes along and offers something better, then I'm at a much bigger risk. It doesn't mean U.S. employees are less loyal, it just means they have more opportunities."
Leadership advice: "You can never be successful alone. A team can always beat you, no matter how smart you are. Choose your team with much care. Make sure you have a business culture, business philosophy and way of working that is a foundation for a strong team.... Together with your team, plan your business: What are the objectives, the strategies? You need to be a preacher and communicate with your staff; they need to understand what you're trying to accomplish."
Family man: Edstrom and his wife, Marie, have been married 40 years and have two adult sons and two grandchildren. They live in Santa Clarita.
stuart.pfeifer@latimes.com
source: http://touch.latimes.com/#section/-1/article/p2p-84945797/
Thanks again for the chart. I will take note of this.
I bought more yesterday at $0.368 and have no plan to sell today at all.
Symphony data for week ending 10/30/15
NRx = 363
TRx = 583
$TRx = $304,000
Read more: http://mnkd.proboards.com/thread/1742/afrezza-script-counts-symphony-data?page=1#ixzz3qic9YDC0
I must thank Sharpei for bringing this stock to my attention last year so that I had the chance to have bought at around $0.20 and now my average is $0.244.
GLTA!
Actually I bought also a few days ago at $0.235 & $0.289 when the stock started picking up. Today I did not buy much.
GLTA!
Bought more at $0.368. Hope I have made the right move. Wish me luck!
Shorts really need to work harder. I was expecting to test the 52 week low. Let's see if they can make it this week.
Mr. Adnan Butt is ranked #3,391 out of 3,836 analysts (#7,365 of 8,518 overall experts). Any idea why?
https://www.tipranks.com/analysts/adnan-butt
A proven technology has undoubtedly value in a company and the success of its applications and commercialization is of different kind of elements to reflect in a company's value, and thus share price.
I agree it is hard to put value to a technology that is NOT proven.
Oh well, we do have corruptions in the Wall Street, don't we?
Looks like in the eyes of RBC, MNKD only worth with Afrezza but nothing else. TS is worth less than a buck?! LOL
I actually deleted the private email.
I have not idea but this is a great story to tell and help diabetes. To increase sales is a long term goal and I do not trade this stock everyday but do buy or sell to adjust my risk tolerance.
I don't have much to talk about but to tell you I am happy with the close today.
New form of insulin helps some diabetes patients manage disease
Health Cast report: Sam Finta tells you how Afrezza can help
http://m.local10.com/health/new-form-of-insulin-helps-some-diabetes-patients-manage-disease/36238950
"Beyond-the-Pill" strategies gain a competitive edge ---- MNKD becomes the potential target?
Teva snaps up Gecko and its 'smart inhaler' to pump up respiratory meds
October 5, 2015 | By Beth Snyder Bulik
Getting patients to stick to their meds is a big problem in treating pulmonary diseases. So to boost adherence for its respiratory portfolio, Teva Pharmaceuticals ($TEVA) is turning to technology.
The Israel-based drugmaker recently snapped up "smart" inhaler company Gecko Health Innovations, and at the center of the deal is Gecko's CareTRx, a cloud-based solution for chronic respiratory disease management. The hardware and software system connects patients, caregivers and doctors through remoting monitoring and real-time adherence tools, Teva said.
"Poor adherence to treatments for chronic diseases, such as asthma and COPD, is a worldwide problem," a Teva spokesperson wrote FiercePharmaMarketing in an email interview. "CareTrx provides dose-tracking and reminder features for one of the most common types of inhalers, metered dose inhalers (MDIs), along with intuitive applications and cloud-connected technology which can be a powerful tool for improving patient adherence and enabling data-sharing between patients and their healthcare providers."
The deal comes as drugmakers are increasingly looking to "beyond-the-pill" strategies to gain a competitive edge, particularly in gaining favorable reimbursement from payers. Adherence can be a big part of that: Companies are experimenting with digital devices, mobile apps, text messaging and other strategies to help keep patients on their meds.
While studies vary, experts agree that respiratory nonadherence, both intentional and unintentional, is high, with rates that range from 30% to 70%. The American Academy of Allergy, Asthma & Immunology reports that "there is a tremendous care gap in asthma due to low adherence, resulting in a preventable economic and health burden."
Teva's current portfolio of respiratory drugs includes ProAir and Qvar. In its most recent quarterly report, Teva noted that for the 6 months ending in June 2015, ProAir brought in $252 million and Qvar $181 million. For full year 2014, the branded Teva respiratory drugs totaled $957 million, with $478 million for ProAir and $286 million for Qvar.
In the competitive respiratory market, Teva's main competitors are GlaxoSmithKline ($GSK) and AstraZeneca ($AZN). In Europe, Teva is rolling out a generic of AstraZeneca's widely used Symbicort. In the U.S., Teva is developing an asthma antibody biologic called reslizumab, although GSK and AZ are also well along in developing their own versions.
While not offering any details about how it will use the Gecko technology, Teva did say that the acquisition is "directly in-line" with its respiratory growth strategy. "The technology and expertise gained as a result of this acquisition provide Teva with a solid platform to develop and deliver truly patient-centered solutions by utilizing eConnected, data-driven technology to improve the management of respiratory diseases," Teva said.
http://www.fiercepharmamarketing.com/story/teva-snaps-gecko-and-its-smart-inhaler-pump-respiratory-meds/2015-10-05
Afrezza: An inhaled approach to insulin delivery.
Fleming LW1, Fleming JW1, Davis CS1.
Author information
Abstract
PURPOSE:
The purpose of this article is to educate nurse practitioners about Afrezza.
DATA SOURCES:
A comprehensive literature search was conducted using MEDLINE for clinical trial data. Information from the Centers of Disease Control and Prevention, World Health Organization, clinical guidelines, Food and Drug Administration labeling, briefings, and press releases was also utilized.
CONCLUSIONS:
Afrezza represents a promising noninjectable insulin delivery option for type 1 and type 2 diabetes mellitus. According to clinical trial evidence, it appears to be efficacious and comparable to currently available prandial insulin options, and based on current data, it appears to be a safe alternative to injectable insulin with high treatment satisfaction.
IMPLICATIONS FOR PRACTICE:
Afrezza may offer an alternative for insulin naïve patients who are hesitant about initiating traditional insulin. It may cause less weight gain when compared to subcutaneous mealtime insulin with a more rapid absorption and elimination profile, but more long-term studies are needed. Afrezza is limited in type 1 diabetes to use in combination with basal insulin. It is not recommended in the treatment of diabetic ketoacidosis or for patients who smoke. It is contraindicated during hypoglycemic episodes, in chronic lung diseases, or in those with hypersensitivity to regular human insulin or any of the excipients in Afrezza.
©2015 American Association of Nurse Practitioners.
http://www.ncbi.nlm.nih.gov/pubmed/25764151
Well I just wish I could be like them cos I just cannot make a living doing things like regularly. I mean, no investment interest in a stock but giving board members great advice to NOT hold any position of the stock on daily basis (almost). They are in my opinion very caring people!
Sounds like Afrezza is still struggling at the stage of product awareness?
Not only I agree that "If Sanofi dumps Afrezza it will be their failure not Mannkinds.", but also it will be the failure on part of the new CEO of Sanofi who has indeed been the one mainly responsible for the EXECUTION decisions. Thus far we have only seen some ads in the market and there are other actions being taken behind the scene. We'll have to wait and see.
Opening Bell Ceremony with MannKind Corporation
This morning, (28.10.15), MannKind Corporation celebrated its Dual Listing at the Tel Aviv Stock Exchange by taking part in the "Opening Bell Ceremony".
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company focused on the discovery and development of therapeutic products for diseases such as diabetes. Our only approved product, AFREZZA, (insulin human [rDNA origin]) inhalation powder, is a rapid-acting inhaled insulin that was approved by the U.S. Food and Drug Administration on June 27, 2014 to improve glycemic control in adult patients with diabetes.
Yossi Beinart, TASE CEO said: "Israel as a Start Up Nation, is the home of Technology and Biomed Industries and The Tel Aviv Stock Exchange make various steps to encourage public companies in this sector. MannKind Corporation has a long lasting Israeli relationship along with Mr. Alfred Mann, ( Founder and Chief Executive of MannKind), who stands behind some of the Israeli breakthrough's in the medical device developements. I hope and believe that Mannkind Corporation's dual listing is another step in its relations with Israel and the Israeli Biomed community, which will broaden their presence here".
Matthew Pepper, Vice president and CFO of MannKind, who took the stage and rang the TASE opening bell added, "I am proud and excited to be in Israel to list Mannkind for trade on the TASE. This is the first step of the company in Israel which reflects our intention to maintain a long term relationship with the Israeli capital market and the local biomedical industry. MannKind managed to promote a product throughout all stages of development to marketing approval and to market. Our ability to deliver insulin through an inhaler involves a revolutionary technology and I hope that our collaboration with Sanofi will help the inhaler also enter the Israeli hospitals soon. We are going to continue to develop the unique technology also for additional medical indications. "
Source: http://www.tase.co.il/Eng/NewsandEvents/PRArchive/2015/Pages/PR_20151028.aspx
FDA ought to take ELTP's NDA seriously when it is submitted by the end of 2015.
http://www.msn.com/en-us/news/crime/california-doctor-convicted-in-overdose-deaths-of-3-patients/ar-BBmDD4N?li=AAa0dzB&ocid=mailsignoutmd
True. I have always reservation the mutual trust between the two companies, especially after the sudden departure of SNY's CEO.
I think it would be better to find out why Afrezza was under performed before drawing any final conclusion about the potential of it. Was it because SNY had pulled the planned resources out from Afrezza in order to save the lower than expected sales of Toujeo and thus led to lower sales of the drug? I do not know but it could possible as Toujeo is supposed to be the driver.
I bought back at $3.28 and $3.31.
Did you not see " .... as more patients turned to new oral alternatives"? Is that why SNY is not putting more resources on promoting Afrezza? Just wonder...
It becomes hard for me to understand the French business culture. I actually sold some shares at $3.72 & $3.73 this morning to reduce my risk.
I got back in with average $3.55 during the past 3 days and will buy more tomorrow.
I expect the rally to continue in the next 5 trading days. My short term target is $5.00.
Issued shares as of Jun 30, 2015: 412,316,619
(http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001193125%2D15%2D285056%2Etxt&FilePath=%5C2015%5C08%5C10%5C&CoName=MANNKIND+CORP&FormType=10%2DQ&RcvdDate=8%2F10%2F2015&pdf=)
Amount to be listed for trade per Registration Document with Tel-AVIV: 418,275,412
(http://maya.tase.co.il/bursa/report.asp?report_cd=997588&CompCd=1652)
Does that mean MNKD has issued 5.9 million shares during the current quarter?
Market Data of MNKD on Tel-Aviv Stock exchange
Symbol: MNKD
ISIN: IL0011366395
Security Type : Share
As of 28/10/2015 12:05
Data is delayed by 20 min
Last Price
(0.01 NIS)
1,395
Change(%) + 1.68%
Turnover (NIS)
1,318,321
Trans.
157
Base Price
1,372
Opening Price
1,416
High
1,426
Low
1,310
Yield MTD (%) 0.0%
Yield YTD (%) 0.0%
Click the following link for quick reference (20 minute delay)
http://www.tase.co.il/Eng/General/Company/Pages/companyMainData.aspx?ShareID=01136639&CompanyID=001652&subDataType=0&
Dual Listing
The TASE offers companies traded in the U.S.A. and U.K. an attractive way to dual-list their shares on the TASE. Companies whose shares are traded on the NASDAQ, the New York Stock Exchange (NYSE), the NYSE MKT(formerly AMEX), or the London Stock Exchange (LSE) Main Market can dual-list on the TASE. Dual-listing is easy and simple, does not impose any additional regulatory burden, and does not entail significant costs.
Dual-listing has many advantages for the company and its employees, as well as for investors and for the securities industry in Israel.
The advantages of dual-listing have led more than 35 companies to list on the TASE under the terms of the Dual-Listing Law.
Why Should Companies Dual-List?
· The “home market effect” – these companies are renowned in Israel.
· More Israeli investors, both institutional and private.
· Index linked Notes and Mutual funds invest in companies that are included in all of the TASE’s major indices.
· For TA-25 companies – investors who trade in options on this index.
· Capital can be raised on the TASE through convertible securities (convertible bonds, and warrants). The minimum required capital raised is lower than abroad.
· Continuous trading from 9:45 AM to 11:00 PM (Israeli time), for companies listed in the U.S.
· The Israeli Market can be beneficial during unfavorable sentiments for a specific company in foreign markets.
· Exercising options by employees is convenient and at a low-cost.
· The dual-listing procedure is easy and simple.
Why is Dual-Listing Good for Israeli Investors?
· Transaction costs are very low compared to fees in stock markets abroad – fewer middlemen, no need for currency conversions.
· Convenient trading hours, suited to business hours in Israel (trading in the U.S. only begins at 4:30 PM, Israeli time). Trading on the TASE continues on Sundays and other global stock market holidays.
· Diverse investment possibilities on the TASE.
Who can Dual-List?
· Companies traded on the U.S. stock exchanges NYSE, NASDAQ, or NYSE MKT, or on the LSE Main Market, for at least one year. Companies traded on these markets for less than one year may dual-list, under the Dual-Listing Law, provided their market capitalization is greater than $150 million. Companies on the NASDAQ Market Capital list that have traded for at least one year are additionally required to have a minimum market capitalization of approx. $30 million at the listing date.
· All companies are required to have one type of share in their issued capital.
How to Dual-List on the TASE
· Publish a registration form, including only technical information about the company and its issued securities.
For companies listed on U.S. stock exchanges – enclose the most recent periodic financial report submitted in the U.S., and a copy of disclosures published since the periodic report. (If the company has not yet been required to publish a periodic report, it should attach the prospectus used for the IPO in the U.S.). If a prospectus was published during the year preceding the year of the periodic report, or after the date of the periodic report, it should be enclosed as well.
For companies listed on the LSE – enclose the most recent periodic report published in the UK and the most recent prospectus approved by the UK Listing Authority (or a later report that includes disclosures that are identical in essence to the disclosures in the prospectus approved by the UK Listing Authority). Also enclose a copy of disclosures published since the publication of the most recent periodic report.
· No translation into Hebrew is required for documents submitted abroad.
· Open an account with one of the four banks’ Nominee Companies.
· Trading begins three trading days after publication of the registration document.
· Exemption from listing fees and annual fees for the first year.
After Listing – What are the Reporting Requirements?
· Financial statements and all other disclosures submitted abroad are also submitted in Israel, in exactly the same format (no translation into Hebrew required).
· Financial statements are submitted according to the schedule that applies abroad. Immediate reports required abroad are submitted in Israel according to the schedule specified in Israeli regulations.
· A copy of reports, received by the company, concerning changes in holdings of interested parties must be submitted in Israel as well.
Private Placements to Employees and Others
· For employees – the rules applicable abroad apply.
· In other private placements, if a disclosure was published abroad, it must be submitted in Israel as well.
· Exemption from TASE requirements regarding private placements.
Delisting - Company’s Initiative
Shares can be delisted from the TASE with a three months notice.
Listing of Companies not Incorporated in Israel
The Israel Securities Authority (ISA) can allow companies incorporated abroad to list under the dual-listing procedure.
source: http://www.tase.co.il/Eng/Listings/DualListing/Pages/DualListing.aspx
Margin call? Fluctuation was not even 10%. I doubt it was a margin call, if I understand correctly.