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Post by liane on Jun 27, 2014 19:50:26 GMT -5
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Post by noonen on Jun 28, 2014 1:28:17 GMT -5
what a crazy last 15 minutes. i'm asleep when the market closes over here, but wow those were some major swings.
so awesome about the approval.
one thing about this nyt and the other articles, how many times are they going to talk about the dreaded "Boxed Warning"? not a doctor, but good lawd all along we've known that copd, smokers, etc were gonna be out. come on!
hopefully we get favorably partnership soon. if it drops a couple bucks before we get some type of announcement, i think it's a buy again.
enjoy it all, have a great weekend and 4th of july week.
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Post by Chris on Jun 28, 2014 7:25:45 GMT -5
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Post by babaoriley on Jun 28, 2014 8:48:20 GMT -5
I know three nurses that are disappointed the Times didn't choose a different photo!
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Post by thekindaguyiyam on Jun 29, 2014 11:12:11 GMT -5
FDA approves Afrezza inhalable insulin for diabetics. Buh-bye needles?Insulin is conventionally delivered into a diabetic's system through injection but people who suffer from diabetes now have a new option for insulin treatment after health regulators gave the go signal for insulin that is inhaled instead of being injected. On Friday, June 28, the U.S. Food and Drug Administration announced that it has green-lighted MannKind Corporation's Afrezza, insulin in powder form that is delivered through an inhaler the size of a whistle. The drug, which needs to be administered before or within 20 minutes of each meal to improve the blood sugar level of adult diabetics, acts faster than conventional insulin that is administered via injection. Jean-Marc Guettier, from the FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products, said that the approval of Afrezza brings new option for diabetics who need mealtime insulin. "Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels," Guettier said. FDA's approval is a long-awaited decision for Connecticut-based MannKind and its 88-year old chief executive Alfred Mann who spent a big part of his personal wealth to help sustain the company through the nearly eight years of seeking approval for its inhalable diabetes therapy. The company spent approximately $1.8 billion developing the drug, about $975 million of which came from Mann's own money. "Approval of Afrezza is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," Mann said in a statement. "We thank the more than 6,500 adult patients and healthy volunteers who participated in the Afrezza clinical program." FDA cleared Afrezza for use by individuals with Type 1 and Type 2 diabetes but prior to prescribing it, physicians need to conduct physical examinations and verify if the patient has a medical history of lung disease. The drug is not advised for use by individuals with lung problem and will, in fact, come with a warning that highlights the risks for acute bronchospasm, which is marked by the inflammation of the airways of the lungs, in patients with chronic obstructive pulmonary disease and asthma. The drug is not also recommended for use by diabetics who smoke or have just stopped smoking. Adverse effects that were associated with use of Afrezza in clinical trials include cough, hypoglycemia irritation or pain in the throat. www.techtimes.com/articles/9360/20140628/fda-approves-afrezza-inhalable-insulin-for-diabetics-buh-bye-needles.htm
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Post by thekindaguyiyam on Jun 29, 2014 11:15:27 GMT -5
Inhaled Insulin: FDA Approval Of MannKind’s Afrezza Gives This Class Of Diabetes Therapies New Lease On Life Almost seven years since inhaled insulin appeared to have been an idea whose time had come -- and gone -- the MannKind Corp.’s (NASDAQ:MNKD) success in securing U.S. Food and Drug Administration marketing approval for its Afrezza Inhalation Powder has breathed new life into this class of treatments for adults with diabetes mellitus. The first inhaled-insulin offering to win FDA marketing approval did not have a happy history. Pfizer Inc.’s (NYSE:PFE) Exubera was available in the U.S. between September 2006 and October 2007, but the major drug manufacturer pulled the plug when it failed in the marketplace, where competing products historically have been administered by injection. Alfred E. Mann, MannKind’s founder, chairman and CEO, seems unlikely to follow in Pfizer’s footsteps should Afrezza’s sales falter in its first year or so on the market. Announcing its FDA approval on Friday, Mann said in a statement, “We are excited for patients, as we believe that Afrezza’s distinct profile and noninjectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated.” Afrezza is a rapid-acting inhaled insulin that is administered either at the beginning of each meal or within 20 minutes of starting it. About 29.1 million Americans, or 9.3 percent of the U.S. population, are believed to have diabetes, according to the “National Diabetes Statistics Report, 2014” prepared by the Centers for Disease Control and Prevention. Accordingly, Afrezza’s addressable market is massive. Equity investors and traders appeared to be focusing on the size of this addressable market after the close of trading on Friday, when MNKD’s share price advanced in the postmarket session to $11.00 from $10.00, a gain of $1.00, or 10 percent, following the FDA announcement of Afrezza’s approval. Animal spirits in the stock market may have been restrained -- a little or a lot -- by the FDA’s noting that Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). As a result, the agency pointed out Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD. Based in Valencia, Calif., MannKind is also being required to conduct four postmarketing studies for Afrezza. According to the FDA, the drug’s efficacy and safety were evaluated in a total of 3,017 clinical-trial participants -- 1,026 with type 1 diabetes and 1,991 with type 2 diabetes. www.ibtimes.com/inhaled-insulin-fda-approval-mannkinds-afrezza-gives-class-diabetes-therapies-new-lease-1614718 |
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Post by thekindaguyiyam on Jun 29, 2014 11:28:28 GMT -5
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Post by BD on Jun 29, 2014 12:42:29 GMT -5
We're setting up this pinned thread for posting of all post-approval media articles (including SA, Fool, etc.) about MannKind. The idea is that this will give us a convenient chronological history of such articles from here on out. And I'm guessing there are going to be a LOT of 'em  So, please post your article links (and C/P's if you like) here. Thanks! |
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Post by savzak on Jun 29, 2014 14:15:59 GMT -5
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Post by savzak on Jun 29, 2014 18:30:56 GMT -5
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Post by babaoriley on Jun 29, 2014 20:57:25 GMT -5
Not so widespread, mainly concentrated skepticism in the minds and hearts and wallets of the shorts.
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Post by chmith27 on Jun 29, 2014 21:31:19 GMT -5
it's buy time tomorrow for me! maybe someone will believe the articles that come out tomorrow. i sound like such a pumper it's kinda fun to feel like this!! xmas in almost july!!
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Post by brentie on Jun 29, 2014 22:36:26 GMT -5
I like your new avatar, BD.
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Post by BD on Jun 29, 2014 22:50:04 GMT -5
I like your new avatar, BD. I have to keep up with the Joneses, brentie... |
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Post by brentie on Jun 29, 2014 22:51:02 GMT -5
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