12 U was announced by MNKD

[otherottawaguy]

 MannKind has added a news release to its Investor Relations website.
Title: MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R) Following FDA Approval

Date(s): 27-Apr-2015 9:00 AM

For a complete listing of our news releases, please click here:

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=2040304

But to save you the time here is the announcement:

Press Releases

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MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R) Following FDA Approval

VALENCIA, Calif., April 27, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that it will begin to manufacture a 12 unit cartridge strength of AFREZZA (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes. The 12 unit cartridge was approved by the U.S. Food and Drug Administration on April 17, 2015 and is expected to be launched by Sanofi in the second half of 2015.

The new dosage strength complements the existing 4 unit and 8 unit cartridges and will provide patients with another option to receive their prescribed dose.

About Afrezza®

Afrezza® (insulin human) Inhalation Powder is used to control high blood sugar in adults with type 1 and type 2 diabetes. The drug-device combination product consists of a dry formulation of human insulin delivered in a specially designed inhaler. Administered at the beginning of a meal, Afrezza® delivers insulin into the body through the lungs with peak insulin levels achieved within 12 to 15 minutes. Afrezza® is available in 4-unit and 8-unit single-use cartridges that can be combined to meet the prescribed dose. In addition, the U.S. Food and Drug Administration (FDA) recently approved a 12-unit cartridge strength of insulin powder for Afrezza®. The disposable inhaler can be used to take the cartridges for up to 15 days and does not require cleaning or maintenance.

Sanofi and MannKind have entered into a worldwide exclusive licensing agreement to develop and commercialize Afrezza®. Under the collaboration agreement, Sanofi is responsible for global commercial, regulatory and development activities.

INDICATIONS AND USAGE FOR AFREZZA® (insulin human) Inhalation Powder

Prescription Afrezza® is a man-made rapid acting inhaled insulin breathed through your lungs and is used to control high blood sugar in adults with type 1 and type 2 diabetes.

Limitations of Use:
Do not use Afrezza® in place of long-acting insulin; Afrezza® must be used with a long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza® to treat diabetic ketoacidosis.
It is not known if Afrezza® is safe and effective for use in people who smoke. Afrezza® is not for use in patients who smoke or who have recently stopped smoking (less than 6 months).
It is not known if Afrezza® is safe and effective in children under 18 years of age.

Important Safety Information for Afrezza®

WARNING: RISK OF SUDDEN LUNG PROBLEMS (BRONCHOSPASMS) IN
PATIENTS
WITH LONG-TERM (CHRONIC) LUNG DISEASE
Sudden lung problems (acute bronchospasm) have been seen in patients with asthma and COPD (chronic obstructive pulmonary disease) using Afrezza®.


Afrezza® is not to be used in patients with long-term lung disease such as asthma or COPD.


Before initiating Afrezza®, your doctor will perform a detailed medical history, physical examination, and a breathing test (called spirometry) to identify potential lung problems.

Do not use Afrezza® if you have problems with your lungs, such as asthma or COPD (chronic obstructive pulmonary disease). Do not use Afrezza® during a low blood sugar reaction (hypoglycemia). If you are allergic to regular human insulin or to any of the ingredients in Afrezza®, do not use Afrezza® as this may cause a significant and severe allergic reaction.

Before using Afrezza®, it is important to tell your doctor about all your medical conditions, including if you have a history of lung problems, if you smoke or have recently quit smoking, if you are pregnant or plan to become pregnant, or if you are breast feeding or planning to breast-feed. Tell your doctor about all other medicines and supplements you take.

Your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza®. If your doctor finds you have lung problems, use of Afrezza® may cause a severe asthma-like breathing problem. Afrezza® can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza®, and then each year after that, even if you have no lung symptoms. More frequent testing should be done if you have symptoms such as wheezing or coughing.

You must test your blood sugar levels while using insulin, such as Afrezza®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.

There are certain serious side-effects that are associated with the use of Afrezza®.

Severe allergic reaction (including whole body reaction) is one of the serious side effects. Get medical help right away if you have any signs or symptoms of a severe allergic reaction,including a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.

Low blood sugar (hypoglycemia) is one of the most common side effects of insulin, including Afrezza®, which can be serious and life-threatening. Common symptoms of hypoglycemia are dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, or hunger. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.

Lung cancer occurred in more people who were taking Afrezza® compared to other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. Tell your doctor if you currently have lung cancer, have had it in the past, or if you have an increased risk of developing lung cancer.

Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Tell your doctor if you have any new or worsening symptoms of heart failure including shortness of breath, swelling of your ankles or feet or sudden weight gain. Your treatment with Afrezza and TZDs may need to be changed or stopped if you have new or worsening heart failure.

Get emergency help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

While using Afrezza do not drive or operate heavy machinery until you know how Afrezza affects you. You should not drink alcohol or use other medicines that contain alcohol and you should not smoke.

The most common side effects of Afrezza® include low blood sugar (hypoglycemia), cough, sore throat, headache, diarrhea, tiredness, and nausea.

Please see full Prescribing Information, including Boxed WARNING, at www.afrezza.com.

Afrezza® is a registered trademark of MannKind Corporation.

About MannKind Corporation

MannKind Corporation (Nasdaq:MNKD) focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations. 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, MannKind's dependency on Sanofi for commercialization of Afrezza, manufacturing effectiveness and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
CONTACT: Company Contact:
Matthew J. Pfeffer
Chief Financial Officer
661-775-5300
[e-mail]

MannKind Corporation Logo
MannKind Corporation

[sla55]

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=2040304

[mnholdem]

Good call, liane, when you wrote last week that MannKind would have 4 days to file the FDA approval with the SEC. I wasn't sure whether that responsibility now belongs to MannKind's new Afrezza development partner, but I checked the SEC site just now and nothing has been filed about the 12-unit cartridge by Sanofi.

Although, now that I read the press release, I notice it's been 10 days since FDA approval. Perhaps neither company considers this news to be a material event and MannKind is issuing a press release simply because the 12-unit cartridge has been the talk of the town lately?

That would be encouraging, as it would indicate that management isn't turning a deaf ear to investor inquiries, n'est pas? 

[liane]

Remember, our board beat MNKD to the punchline last week. 

[mnholdem]

Yes. Kudos to many Pro Board members. Maybe if we get real good at this, we can get a jump on everyone else and load up before a major rally?

[Deleted]

Apr 27, 2015 8:15:38 GMT -5 mnholdem said:

 Although, now that I read the press release, I notice it's been 10 days since FDA approval. Perhaps neither company considers this news to be a material event and MannKind is issuing a press release simply because the 12-unit cartridge has been the talk of the town lately?

That would be encouraging, as it would indicate that management isn't turning a deaf ear to investor inquiries, n'est pas? 

The lack of Public Relations on the part of MNKD and SNY, making us dependent on message boards and early Afrezza users for information, is placing our future in the hands of the shorts and accounts for the dismal performance of the stock.

[cubonwallstreet]

Apr 27, 2015 8:53:34 GMT -5 avogadro said:

Apr 27, 2015 8:15:38 GMT -5 mnholdem said:

The lack of Public Relations on the part of MNKD and SNY, making us dependent on message boards and early Afrezza users for information, is placing our future in the hands of the shorts and accounts for the dismal performance of the stock.

Or, it is making us dependent on Afrezza's success and placing our future in Afrezza's hands. You know, the product you originally invested in. Whether our investments turn profitable or not will not be because of PR or lack thereof.  

[ezrasfund]

Question: If the 12 unit cartridge is now in production does that mean that at least one of the 2 new production lines is certified?

[Deleted]

MNKD has mastered the art of turning good news into bad news, and has been doing so for years.    

[nugjuice]

Apr 27, 2015 9:01:59 GMT -5 cubonwallstreet said:

Apr 27, 2015 8:53:34 GMT -5 avogadro said:

Or, it is making us dependent on Afrezza's success and placing our future in Afrezza's hands. You know, the product you originally invested in. Whether our investments turn profitable or not will not be because of PR or lack thereof.  

In his defense, I don't think it's totally that simple. If shorts are winning, everyone will think the stock is a dog. If they think the stock is a dog, they'll think the medicine sucks (for lack of a better word). If they think the medicine sucks, they certainly won't be talking about it in a positive light and certainly won't be recommending it to their friends.

Look at it this way - it holds true both ways. If Wall Street was getting all bulled up about this stock, lots of people would be talking about it. Positive press = positive word of mouth = positive attitudes toward the product.

Perception, unfortunately, is often reality.

Investors are voting with their shares, and the voting isn't going very well.

I think anyone who is loaning their shares out to be sold short needs to do some serious introspection. It's not as black and white as "the product will decide it all" when Doctors' and patients' perception of the product will certainly play a role in its success

[mnkdorbust]

Apr 27, 2015 9:09:49 GMT -5 ezrasfund said:

Question: If the 12 unit cartridge is now in production does that mean that at least one of the 2 new production lines is certified?

Based on the PR wording "expected to be launched by Sanofi in the second half of 2015"

That tells me that its' approved but not in production.  That being said they would need to produce it for approval so either they used the existing line or configured one of the additional lines to produce it.  

[cubonwallstreet]

Apr 27, 2015 9:12:43 GMT -5 nugjuice said:

Apr 27, 2015 9:01:59 GMT -5 cubonwallstreet said:

Or, it is making us dependent on Afrezza's success and placing our future in Afrezza's hands. You know, the product you originally invested in. Whether our investments turn profitable or not will not be because of PR or lack thereof.  

In his defense, I don't think it's totally that simple. If shorts are winning, everyone will think the stock is a dog. If they think the stock is a dog, they'll think the medicine sucks (for lack of a better word). If they think the medicine sucks, they certainly won't be talking about it in a positive light and certainly won't be recommending it to their friends.

Look at it this way - it holds true both ways. If Wall Street was getting all bulled up about this stock, lots of people would be talking about it. Positive press = positive word of mouth = positive attitudes toward the product.

Perception, unfortunately, is often reality.

Investors are voting with their shares, and the voting isn't going very well.

I think anyone who is loaning their shares out to be sold short needs to do some serious introspection. It's not as black and white as "the product will decide it all" when Doctors' and patients' perception of the product will certainly play a role in its success

Stockholders are not the ones buying the medicine and determining its efficacy. If the drug sells, investors will eventually follow. 

Your view seems shortsighted; seems you would rather a pump and dump stock. 

Doctors' and patients' perceptions will absolutely play a role. However, PR statements will do very little to influence this. As MNKD said, they will begin advertising to medical professionals first, followed by DTC. 

[bradleysbest]

DTC will be the catalyst for us. Once that starts everything else will follow. Press, scripts, reviews etc......

[mnholdem]

Apr 27, 2015 9:01:59 GMT -5 cubonwallstreet said:

Apr 27, 2015 8:53:34 GMT -5 avogadro said:

Or, it is making us dependent on Afrezza's success and placing our future in Afrezza's hands. You know, the product you originally invested in. Whether our investments turn profitable or not will not be because of PR or lack thereof.  

avolgadro comment was, "The lack of Public Relations on the part of MNKD and SNY, making us dependent on message boards and early Afrezza users for information, is placing our future in the hands of the shorts and accounts for the dismal performance of the stock."

----

 

Perhaps the two of you are arguing both sides of the same coin?

It's true that when, for whatever reason, MannKind or Sanofi chooses not to respond to bad press, it exposes potential investors to a negative bias regarding the stock. After all, the naysayers are the only ones doing the talking.

However, it's also very likely that share price would be totally unaffected by any PR coming out of Investor Relations where the intent is to respond to naysayers. After all, look what happened to the share price after news of FDA approval and of partnering with Sanofi. MannKind cannot win that kind of game.

-----

Success will not be determined by Wall Street. It will be determined by diabetics. Until patients speak out loud and clear, as evidenced by sales figures, share price will continue to languish. It's possible that other announcements, such as EU/Japan launches and pipeline agreements, may create a ripple. 

But, ultimately, it comes down to sales. Short interest pundits can only keep the bad press going until Afrezza sales proves them wrong.

-----

I'd luv to see MannKind Corporation take more of an active interest in its image, too. However, AND I THINK THIS IS IMPORTANT, until MannKind has some sales numbers to back up their claims, their guidance is also extremely speculative.  I highly doubt they'll risk another shareholder lawsuit and will choose, instead, to let the numbers speak for themselves.

----

So, again, you're both right and there's not a whole lot we can do about it.

I'll just try not to worry about it and keep accumulating shares of MNKD based on my DD. Time will prove me right or wrong. What else is new about investing?

[nugjuice]

Apr 27, 2015 9:29:49 GMT -5 cubonwallstreet said:

Apr 27, 2015 9:12:43 GMT -5 nugjuice said:

In his defense, I don't think it's totally that simple. If shorts are winning, everyone will think the stock is a dog. If they think the stock is a dog, they'll think the medicine sucks (for lack of a better word). If they think the medicine sucks, they certainly won't be talking about it in a positive light and certainly won't be recommending it to their friends.

Look at it this way - it holds true both ways. If Wall Street was getting all bulled up about this stock, lots of people would be talking about it. Positive press = positive word of mouth = positive attitudes toward the product.

Perception, unfortunately, is often reality.

Investors are voting with their shares, and the voting isn't going very well.

I think anyone who is loaning their shares out to be sold short needs to do some serious introspection. It's not as black and white as "the product will decide it all" when Doctors' and patients' perception of the product will certainly play a role in its success

Stockholders are not the ones buying the medicine and determining its efficacy. If the drug sells, investors will eventually follow. 

Your view seems shortsighted; seems you would rather a pump and dump stock. 

Doctors' and patients' perceptions will absolutely play a role. However, PR statements will do very little to influence this. As MNKD said, they will begin advertising to medical professionals first, followed by DTC. 

I would rather a pump and dump? Quite the opposite actually. The shortsighted view is the one that says "I'm gonna make a quick buck lending my shares out to shorts who are setting out to destroy this company" and not the other way around. My view is very much the long-term view.

In the long run, the more good press this product gets, the more people know about it, the more successful it will be in the real world.

The financial world and the 'real' world are separate, but also inexplicably intertwined. 

Why wouldn't you want the tailwind of positive press in the media? If the stock was up 100% since the launch, do you really think nobody would be talking about it? Do you really honestly believe that none of that good press would spill over into the reservoir of patient and Doctor knowledge? 

The more money shorts make on the stock, the more they're going to short it, the more vocal they're going to be in bashing the company. This is not limited to CNBC and Mad Money. These are real people, and they can absolutely have a real affect on patients' and Doctors' perceptions of the product.

Whatever, it seems like this stock has created some strange martyr-like culture where you almost want the pain, that way you can feel more right in the end and laugh at all the stupid people