Friends of MannKInd

[Cave In Temptor]

5-y restricted stock BOD retainers means great confidence as restricted stock instead of cash

Note 2.
Annual retainer received in equity in lieu of cash. Restricted Stock Units shall vest on the earlier of retirement, removal from board, death or five years from grant date.
Note 3.
Annual retainer received in equity in lieu of cash. Restricted Stock Units shall vest on the earlier of retirement or removal from board, provided that such retirement or removal occurs more than one year after grant date; death; or five years from grant date.

Kresa Form 4

[Phaeton]

I like the last line of the article on the Sanofi web site.... "new insulin therapy for people with diabetes"
wonder what that new Insulin Therapy might be?
--------------------------------------------------------------------------------------------------------------------------------
"Chancellor Merkel and Dr. Brandicourt officially inaugurated a new, high-tech manufacturing facility that is expected to supply Sanofi's new insulin to patients throughout the world. This is one of the most cutting-edge facilities for large volume manufacturing of sterile biologics and incorporates the most modern technology enabling Sanofi to achieve the highest sterility standards in the industry

Sanofi is very proud that Chancellor Merkel visited our Frankfurt site, which is Sanofi's largest, integrated site," said Dr. Olivier Brandicourt, Chief Executive Officer, Sanofi. "The Chancellor interacted with research leaders from Sanofi and the Fraunhofer Society to discuss ideas for fueling additional antibiotics research and inaugurated Sanofi's new, high-tech manufacturing facility, which is Sanofi's global production facility for its new insulin therapy for people with diabetes."

http://en.sanofi.com/NasdaQ_OMX/local/press_releases/sanofi_hosts_german_chancellor_1924322_28-05-2015!12_30_00.aspx

[Solarman]

Low float $MMMW only 62 million shares with a great new solar cost cutting product.

[Phaeton]

I wonder how many lines of Afrezza this plant can accommodate?



I guess that Sanofi has finally got the Pfizer plant up and running in Germany. Chancellor Merkel dedicated it on 5/28/2015. I wonder how many lines of Afrezza the plant is capable of handling? Will this be for lines 4,5,6 ? I am sure there is an advantage to have they lines in the same factory that is producing the insulin. The equipment to produce Afrezza is also German equipment (I believe). It would be very nice to learn that Sanofi has ordered equipment for the plant for delivery in 12 - 18 months. I remember reading that the lead time for the equipment is 12 months? Does anybody know this for sure?

[Phaeton]

Watch Pharma deals like Par Pharma / Endo --- MannKind will be like this one. Last week there was another deal just like this one with a company that doesn't even have an FDA approved product.

Every Pharma Deal has a happy ending and so does MannKind. Just this am a deal to acquire Par Pharm for 8 billion. Read the history of Par and you will see that MannKind is worth a Minimum of 15 Billion to Sanofi. Don't think that there is not an activist out there accumulating shares like What happened to Par in 2012.

The volatility of MannKind indicates that all the big players know that there blood in the water. So the HFT and Hedges know how the game is played and is playing it well. But the signs of the end game are there with the comments made at the B of A call the other day and watching the adaptation of users to the product. Sanofi will buy in to the company or be forced to do it by an activist to keep their stake from being impaired.

Something big will happen to MannKind. It will be the REGN or ALNY story as Sanofi partners well with their friends

TPG Bought Par Pharma for 1.9 Billion in 2012 and now sells it for 8.00 plus their debt. This again shows that MannKind will be an explosive deal when it happens. Mark my words it will happen SHORTLY.
. ---------------------------------------------------------------------------------------

Watch Pharma deals like Par Pharma / Endo --- MannKind will be like this one
Every Pharma Deal has a happy ending and so does MannKind. Just this am a deal to acquire Par Pharm for 8 billion. Read the history and you will see that MannKind is worth a Minimum of 15 Billion to Sanofi. Don't think that there is not an activist out there accumulating shares like What happened to Par in 2012. Something big will happen to MannKind. It will be the REGN or ALNY story as Sanofi partners well with their friends

TPG Bought Par Pharma for 1.9 Billion in 2012 and now sells it for 8.00 plus their debt. This again shows that MannKind will be an explosive deal when it happens. Mark my words it will happen SHORTLY.
. ---------------------------------------------------------------------------------------

Endo International said it would buy Par Pharmaceutical Holdings from private equity firm TPG Capital for about $8 billion, including debt.

"This is a transaction that's transformative for Endo in general, but specifically in generics, this will position us as a top-five generics player in the U.S.," Endo International CEO Rajiv De Silva said Monday on CNBC's "Squawk Box."

Par brings a diverse portfolio of existing products to Endo, as well as a product pipeline that is "arguably one of the best in the industry," the chief executive said. The deal will grow to "double digits" beginning in 2016, he added.

Dublin-based Endo's shares rose more than 1 percent in premarket trading Monday.

Endo said its offer consists of about 18 million shares and $6.5 billion in cash.

Par Pharmaceutical was acquired by TPG Capital for $1.9 billion in 2012 following pressure from activist firm Relational Investors LLC to sell itself.

The company, which filed with U.S. regulators in March for an initial public offering of common stock, had debt of $2.35 billion as of March 31.

[Phaeton]

More problems for MannKind!

Regulatory Seminar
AREIPS
March 2015


Peeling the Onion back even further. This Class at Lille University is to help train for EMA approval. This is very very troubling if you are short in MannKind.


http://pharmacie.univ-lille2.fr/etudes-pharmaceutiques/les-masters/affaires-reglementaires-europeennes-et-internationales-des-produits-de-sante.html

AREIPS, Affaires Règlementaires Européennes et Internationales des Produits de Santé, est le nouveau nom du DESS/Master réglementation des médicaments dans l’UE créé il y a 20 ans, qui, sous ses diverses formes, a fourni des débouchés à plus de 500 étudiants et procuré des collaborateurs très appréciés à l'industrie pharmaceutique, aux entreprises fournissant divers produits de santé, aux administrations et agences telles que l'ANSM,

l’EMA, la HAS, le Ministère de la santé ou encore la Commission européenne, ainsi que divers organismes professionnels et syndicaux. Cette nouvelle dénomination traduit l’évolution logique de cette formation qui n’a eu de cesse, depuis sa création, de s’adapter à son environnement, pour répondre toujours au plus prêt, aux besoins en affaires réglementaires des industries des produits de santé et des institutions.

Ce nom traduit ainsi, aujourd’hui, formellement, cette évolution. En effet, si, dès son origine, cette formation a été ouverte à l’ensemble des métiers des affaires réglementaires, consciente qu’ils ne sauraient se circonscrire à un métier d’enregistrement, elle est aujourd’hui pleinement à même de répondre aux besoins, dans un environnement mondialisé, tant de l’industrie pharmaceutique que de ceux des autres industries des produits de santé dont l’encadrement technico-réglementaire s’inspire tous les jours un peu plus de celui du médicament.


Regulatory Seminar
AREIPS
March 2015



What is AREIPS?

AREIPS , European Regulatory and International Affairs Health Products , is the new name of the DESS / Master regulation of medicines in the EU created 20 years ago , which, in its various forms , has provided opportunities for over 500 students and provided much appreciated in the pharmaceutical industry employees , companies providing various health products , public bodies and agencies such as ANSM

EMA, HAS, the Ministry of Health or the European Commission and various professional and trade union organizations. This new name reflects the natural evolution of this formation which has continued since its inception, to adapt to its environment, to always respond as loan, regulatory affairs needs of health products industries institutions.

This name thus reflects today formally this development. Indeed, if, from the outset, this training was open to all businesses of regulatory affairs, aware that they can not be confined to a record business, it is now fully able to meet the needs in a globalized world, as the pharmaceutical industry than those of other industries of health products whose technical and regulatory framework is inspired every day a little more

[Phaeton]

From a reliable person


Sometimes what you want to know is right in front of you...

As it turns out, I coach the son of an Area Sales Manager for Sanofi. He covers the East Bay and West Sacramento and has a dedicated Afrezza sales rep as part of his team. He's been in pharma sales for 15 years and was a rep for Sanofi when they launched Lantus in 2001.

You can imagine my excitement and disbelief when he told me what he does for a living. I immediately started firing off questions and happy to ask him questions you may have.

The net of it was that he's very bullish on Afrezza and the stalled sales are indeed a combination of doctor habits that don't change quickly and the spirometer testing that was highlighted in the earnings call. He kept repeating that the slow start has nothing to do with the drug because the drug itself is amazing. He's launched drugs in the past and sometimes the drug is just bad. It's absolutely not the case here. I know we all know this but glad to hear that confidence coming from a SNY salesperson.

He has been laying awake at night wondering how to stimulate Afrezza sales. To him, it should be obvious to the doctor why he or she should be prescribing Afrezza. He didn't anticipate facing some of the challenge they've encountered and really thought it would just immediately sell because of all of the reasons we believed it would. You could argue that much of that responsibility falls on the shoulders of the management team at SNY and MNKD in how they prepared the field for the launch. Interestingly, he did mention that the Toujeo launch has been much smoother. He didn't think it was because SNY neglected Afrezza but rather they had been planning the launch of Toujeo for years and only months for Afrezza.

He felt the company was definitely behind Afrezza. I asked if the field was compensated enough to drive Afrezza and he responded with a definite yes. He said a rep likely makes $300 to $400 per prescription that gets written and that is definitely enough to drive mind share, even if they have Toujeo quotas to attain.

I asked if management has been coming down hard for the slow start; he said the contrary. They've been very supportive and have admitted that they missed on addressing the spirometer test. According to him, Endos are such creatures of habit that adding the need to get a FEV1 test has really thrown them for a loop as they don't want to be bothered with this detail.

The good news is that he felt this was the first week that doctors are finally starting to come around. He was just on the phone with his Afrezza rep before I saw him. He said the early adopters are absolutely blown away with the results (as supported by patients on social media). There are still doctors hesitant to prescribe because of fear of lung cancer, but he also thought there are still many doctors who just don't know about Afrezza. His thought was that when SNY goes direct to consumer (I believe he means advertising), doctors will really begin to take an interest in Afrezza as patients will come to the office seeking to know more. He thought this was coming this summer but didn't know what form or how much advertising the company was going to do.

He said his Afrezza rep got a doctor to write 4 prescriptions today because the doctor finally became more open minded. He also said the rep had a doctor who finally decided to ask the nurse whether the fear of needles was a real phobia and was surprised by the nurses response. As such, he was planning on having his teams get the nurses more involved.

He did believe Afrezza could be a blockbuster. He said to give it more time and this may take a year before the momentum really starts. They are working through the issues and things should start to pick up soon. The spirometer test will become less of an issue and the doctor will begin to understand how to get a patient one regardless of how basic that sounds.

What I felt best about the conversation is that I have validation SNY is absolutely behind it. Things do point to more a Q3/Q4 ramp as many have written on the YMB. Can you imagine if I posted the above?

Feel free to let me know if you have questions for him. For the local guys, I'll arrange a demo since he offered to show at his house.

My final comment is that he said those analysts don't know what they're talking about :) I'm still hanging on to this rocket ship!

Peter


#Afrezza $mnkd

[Phaeton]

Read this slide deck from France.

http://moodle.univ-lille2.fr/mod/resource/view.php?id=38721&redirect=1

Things are moving with Afrezza and Sanofi.

Be short all you want as time is on our side if your long.

This slide deck should be a sticky.

[Phaeton]

On Seeking Alpha there is a writer named LFD who is part of the FUD group. I just posted the following on a thread there. But it's worth posting my response here too. He was very concerned about the Convertible notes that Matt addressed yesterday at the B of A conf.

Let's fix the chokehold on MannKind shares. Here is my plan to do fix it.

Will Sanofi play along with my plan?

What if between now and the Due date of that Convertible note Sanofi drops the Ultimate bomb on the Shorts? Perhaps they might even do it before the upcoming Shareholder meeting on May 21, 2015?

What If Al welcomes everybody to the meeting and then announces that Sanofi has filed a form 13 announcement that they acquired 10% of the common stock over the last 30 day at an average price of $3.60 per share (40,900,000 shares x $3.60 = $147,240,000)

That Sanofi saw the investment as a way to show confidence in the Afrezza after hearing Matt at the at the Bank of America conference on May 13th. Game over for the shorts. Shares close that day at $25.00 after the announcement.

Is this a far fetched notion on my part or something that could actually happen either SHORTLY or later in the year. Look at the history of Sanofi with other partners? REGN where they stated with about a 10% ownership and have expanded it to about 30% since than. REGN stock was in the same condition as MannKind was prior to their investment.

or ALNY who Sanofi purchased a 10% interest in January 2014. Their share price was languishing too until the Sanofi investment. Look at its history before and after the investment.

Wall Street knows how the sausage is made and when you see all the Goldman Sachs articles and others like Jason Karp stating the value is $2.00 why are they doing this? Only to scare the small retail investor out of his shares. The street knows how to play the ultimate destructive game on the retail shareholder. That's why most are scared of individual shares and now buy Mutual funds and ETF Funds.
The Wall Street folks know there are Millions ahead by destroying the retail investor in MannKind shares.

LFD I really don't think MannKind is over a barrel any longer. As we all heard Matt state at the B of A meeting the guy on my right has plenty of cash to make sure we take care of the convertible notes. I think MannKind has a plan and that Sanofi has a plan too. SHORTLY we will know the plan.

As a long investor it would please me to no end if MannKind at the May 21, 2015 shareholders meeting broke out bottles of French champagne to toast the enhanced partnership. (fantasy today but a reality in the future). SHORTLY we will see.

[Phaeton]

The Story of Afrezza will ultimately be a viral one that is driven by users like that UNO baseball player. Adaption of Afrezza might take longer than we all want but it will be a game changer for the diabetic.

The story about the University of Omaha baseball player is a very good one as the City of Omaha is the Home of the NCAA College World Series. Omaha has a population of about 1,000,000 within about 40 miles of their downtown. But the impact of that Story on MannKind is huge. This type of story is the viral type that will hit many other stations owned by Hearst Television that has 29 different stations under their umbrella.

Hearst Television Inc. comprises of 29 television stations, and two radio stations, in geographically diverse U.S. markets. The Company's television stations reach approximately 18% of U.S. TV households, making it one of the largest U.S. television station groups

Each article, TV story, User blog will just keep adding up until Afrezza has the recognition in the Market place as the GOLD
standard of diabetes treatment.

[Phaeton]

THE PERFECT STORM! -- 100,000,000 Short shares?

What is the value of MannKind? I guess that will be determined by the market place for Afrezza.

Look at the volume Monday 5/12/ 2015 over 10 million shares traded.

Why? Are these buyers at retail or accumulation by the Wall Street boys who have scared the small trader out of their shares.

For those of us who have the ability to see the volume trading and Time & Size charts you can see that Massive big blocks of shares over 10K trading every day. The size of the Buying over 10K shares continues to go up and the size of the sales under 1000 increases. So its evident that somebody is buying the big block shares. Who? Institutional? Hedges? Sanofi or ?

This is a war of attrition in one direction or another. Why is MannKind such a battle ground stock? Is it because somebody knows what is ahead? Do they know that there is more to come? Will that more to come be a positive or a negative? Is Afrezza really a game changer drug for the diabetic or a just a dud? Have most of us retail longs been following the pied piper down the path and off the cliff.

Does wall Street remember the history lesson of Mini-med. What happened to that company in its infancy stage after FDA approval?

Think about it. Minimed once traded for $2 a share before Medtronic paid a split-adjusted $90.

Do the HFT Traders / institutional folks remember that company? I bet they do and know that Sanofi didn't partner with MannKind to lose their investment or reputation on a product like Afrezza if it was no good. They want it in their diabetes tool kit.

Let the big boys of Wall street tell us every day that our investment is going to go down to nothing or $2.00 per share so they can scare you out of your shares. We surely have seen this everyday over the last year. Why?

Think about the Market capital of MannKind at $3.60 per share would be $1,472 billion. Do you think some activist investor wouldn't step up and make a run to buy MannKind on the cheap. It would not surprise me if a Peltz, Ackmann , Icahn or Cooperman was not buying shares to accumulate enough to get the attention of MannKind Management to push them into making a decision on what to do to enhance shareholder value. They play this game of shareholder value everyday and know how to milk it in order to put the company in play. We all know that sooner or later the company will make some kind of transition either with a Buy In by Sanofi or somebody else. Or perhaps a selling of Afrezza to Sanofi and Technosphere goes on its own.

Would Sanofi risk losing the right to own Afrezza and let another Pharma buy MannKind on the cheap based on today's valuation? Of course not. The agreement with them gives them the right of first refusal so no matter what happens they will always be able to offer enough to make the deal happen.



So Wall Street knows that MannKind is nothing more than a ticking time bomb waiting to go off in the near future. Hopefully the drug Afrezza is the ultimate weapon that creates the bomb explosion as it has the potential to be a game changer.

In conclusion, If you were Sanofi would you be buying as many shares as they could at $3.60 before they had to disclose on a SEC rule 13 filing having accumulated more than 5% or they announce a buy out? or buy in like they have with ALYN or REGN You bet they would. So yesterday when you saw over 10 million shares traded or last Friday when 20 million traded, we know that someone (Most of us who are long) are banking on the PERFECT STORM. who will survive and who will die? the ultimate explosion when the Shorts have to cover the 100,000,000 shares they borrowed to hedge their bet.

[Cave In Temptor]

Seems counter-productive in the sense you are giving ammunitions to shorts and help them lower PPS...

Unless a sudden cancellation of loan authorization is planned on a massive scale to create a massive short-squeeze.
Would need coordination though, like the shorts do...

[Phaeton]

A different way to invest in Mannkind stock and also earn return while invested in the company.

several different broker companies have an share lending program where you can buy a certain amount of MannKind stock and put it into their lending program.

For example on a new account with a 100,000 deposit (purchase of 27,777 shares at today's close of $3.60 per share) and get a current (but it could change + or-) 20% return would you open that account with that broker? Yep you can get that annual rate of return. just go in on Friday deposit your funds into a new account and invest in MannKind shares. In turn ask them to then put your shares in their paid investor lending program. Very simple easy peasy.

Would you do it? The upside is very good. Would you agree with me on that?

I am getting a current return of 20% are there risks? Sure but being invested in MannKind is very risky as Jason Karp has stated today that he is very short in the company and see's the value going down.

the broker does loan your shares out to the shorts but at a higher rate currently about 29.25% but again that could be + or - depending on the day.

Upside very high when the shorts squeeze happens if it every happens.

So there is risk to investing in MannKind some do it with options / puts. Others do it on Margin, Some short it. Pick your situation and invest in what makes you feel the most comfortable.

[Cave In Temptor]

Getting short of negative arguments

- Afrezza will never work: FALSE
- Afrezza will never pass FDA trials: FALSE
- Afrezza will never be recommended at AdCom: FALSE
- Afrezza will never be approved: FALSE
- MNKD will never find a credible partner with global reach: FALSE
- Afrezza warning label will doom it: FALSE
- Diabetics will not try to use it: FALSE

So, what is left ?

- Charts that change with time and give positive feed-back to market manipulations,
- Fear on label warning that are found on nearly all medicines,
- Fear on a partner that knows one don't successfully create a new multi-billion $ market without spending first (recall Sanofi has created the long-lasting insulin market, and sold $1.3 billion of Lantus just in q4),
- Fear on a launch that is just started,
- Fear on management that owns 40% of MNKD,
- Fear on fear itself ?


I don't know why, but this kind of message tend to be deleted on the other Mannkind board...

[Phaeton]

WEEK 7 OF THE AFREZZA CHALLENGE.
Sam Finta blog.


http://afrezzauser.com/week-7/


What is the Afrezza “Real Life” User Challenge?

It is a group of Afrezza Users who use a Continuous Glucose Monitors (Type 1’s) seeking tighter diabetes control and measuring the time spent in each blood sugar range. Laureen uses “finger prick” measurements throughout her day to measure her blood glucose levels while the rest of us are using CGM’s (continuous glucose monitors). It is NOT a competition between T1’s and T2’s nor among any of us and was only started so people could understand and see the inherent benefit of why Afrezza provides better control and higher patient satisfaction for t1 and t2 diabetics over any our previous regimens. In essence, this is a “real-world” trial of “do your best”, and have good and bad days, but keep track of it all, and let everyone know the results. Well, the results thus far are clearly unbelievably positive.

Why are you doing this?

There has been so much discussion about the FDA Afrezza Drug trials and why I feel as a participant in the Affinity 1 trial, there were significant “hold backs” as to why we were not able to materially outperform Injectable Insulin because of the protocols on the trials. This is no longer the case!

To Summarize here are just a few of the hold backs why Afrezza didn’t get to show how great it works:
•Afrezza Dosing only changed approx. every 6 weeks, and not flexible dosing depending on meal
•No CGM’s allowed
•Time in Zone not measured
•Patient quality of life not measured
•Brand new Afrezza users vs. Very experienced Injectable users (what if it was brand new injectable users vs. experienced Afrezza users—would that be fair? No-they would stop the trial right away because it would be a TKO/referee stops contest victory for Afrezza which we are proving by real world experience.)



What surprises you most about the Week 7 data?

What is amazing this week, is that just when you think it can’t get any better, you see continued improvement, either lower average blood glucose numbers or greater “time in zone” results or both! The fact every person, if you average their numbers over the last seven weeks, has a correlated A1C in the 5’s and is experiencing a freedom like never before should be no surprise to the readers who are following our group. This week, the results will be partially certified by medical professionals as Eric and I both have doctors appointments later in the week. This week, you might notice that Eric and I both had slightly higher BG levels–He was turkey hunting in New York State, and did a ton of walking (he walked 8 miles on Sunday, almost all of it solo) and didn’t want to take any chances having a low come on quickly as he is in remote unfamiliar areas at high terrain. He purposely chose to keep his sugars a little higher than usual, and was happy to report no severe lows while hunting this year. Here is a photo he sent me –can you tell it’s him?

imagejpeg_0

As for me I was on vacation in the Dominican Republic and eating out every meal and doing some fairly extreme hikes. As a general rule for diabetics, it’s always better to be safe than sorry if away from civilization and so I adjusted my sugar alerts to 100-130 vs. the usual 85-120. I think most diabetics can relate being stranded somewhere facing a low and caught with not enough sugar. Certainly not a fun feeling. I have never experienced that panic while on Afrezza nor do I ever want to. In spite of Eric and I’s adventures, we still maintained extremely controlled blood sugars compared to our old insulins as you can very well see.

Afrezza is the paradigm shift in all our diabetes treatment–it is like nothing else anyone has seen before, and when diabetics and their doctors realize what is available to them, we all believe Afrezza will be the “first line” treatment option over current injectables. What a welcome relief this will be to both doctors and patients who won’t have to deal with the complications and anguish down the road that nobody talks about–amputations, nerve damage, kidney failure, blindness, etc. That means a “happier” practice for doctors and a better life for all diabetics.

So Week 7 actual results– another positive testimony to the power and effectiveness of Afrezza–even when on vacation or turkey hunting! Thank you to the entire Afrezza Users Group for sharing your results. Good luck to everyone this week.

What would you like to express to everyone out there considering Afrezza or to any doctors considering prescribing Afrezza for their patients?

My opinion is that Afrezza is a “life-changing” drug that is not very well understood by the diabetic community at large—both doctors and patients. This will change! It improved my life and gave me hope in treating my diabetes. I would wish the same for you or any other diabetic you know—enjoy a better and higher quality of life! Please demand to try Afrezza from your doctor, and if he/she won’t or is not able to prescribe it–go find one that will–your life and the quality of it matters!

[Phaeton]

I see the handwriting on the wall.

Just reviewing the Slides this AM while listening to the Sanofi Shareholder meeting makes me wonder if your right on target. Sanofi will pull the wool over the shareholders of MannKind like you suggested. These two slides show how they feel about MannKind and two other partners they have collaborated with on other drug products. Will they do the same with MannKind as they have with Regeneron? or Anlylam. It would really be horrible for all of us longs if they did that to MannKind.





I would appreciate hearing from others if they could live with their investment in MannKind if Sanofi took such action on Buying into the company. Or perhaps they might buy it out like Genzyme.

[Phaeton]

Keep your eyes on the advertising agency that SANOFI retained in the 3rd quarter of 2014.

Sanofi-Regeneron Alliance: Arnold (for the Alirocumab, Dupilumab and Afrezza programs)


http://www.reuters.com/article/2015/03/19/idUSnHUG1dpX39+1c4+ONE20150319

I once thought that MannKind would make a great buyout target for Regeneron since Sanofi owns about 30% of Regeneron. It would be really interesting if that occurred as REGN is a cash rich company and they would be able to fully develop the Technosphere platform that Mannkind has. No matter what happens Mannkind would fit well in Sanofi, the GENZYME division of Sanofi or Regeneron.

Long term something good will happen for MannKind shareholders.

[Phaeton]

My reason for investing in Mannkind is proven out by this 2012 CDC report card on Diabetes showing the incidence of Diabetes increasing. Read the report and then think about How Afrezza can be used as the GOLD standard of Treatment especially for Type 2 diabetics. Al Mann has stated many times that most diabetics avoid treatment for diabetes until its too late and complications set in from lack of treatment. I believe he called this the lost decade. That 10 year period where the diabetic is in denial until he has very serious life threatening health issues and than starts injection insulin. Getting a Type 2 on Afrezza will be easier than getting them started on injections. So when you read the CDC report think about how many potential users there are for early diabetes treatment with Afrezza. Afrezza will become the GOLD standard for treatment. Both in the USA and eventually Worldwide. Sanofi knows it by the early results of Users since launch. This is a ticking time bomb ready to go off on the SHORTS as more folks learn about Afrezza.

Has anybody read the CDC report card on Diabetes. It very clearly shows why Afrezza will become the GOLD standard for Diabetes treatment especially for Type 2.

Time is on $MNKD Side #Afrezza GOLD standard.T2DM 95% of diagnosed

diabetes in adults from CDC
2012 CDC report card on Diabetes.
http://www.cdc.gov/diabetes/pubs/pdf/diabetesreportcard.pdf

[Phaeton]

Anybody following the Afrezza Users Challenge? This is week six.


You can Follow Sam Finta and the others at:
http://afrezzauser.com/week-6-results/

Week 6, and what’s on everyones mind right now is our upcoming A1C tests when we visit our doctors in the next month or so. What will those numbers actually be? When all the data is downloaded from our Dexcom monitors how will the “Time in Zone” be viewed? Will it be with skepticism or applause? One thing we all agree is on is that we will all have record low A1C numbers, and the highest “time in zone” as well as highest “quality of life” we have ever experienced. We believe this will start a slow and steady tidal wave in the clinical and medical community proving once and for all the superiority of Afrezza and how great it really works in the “real world”. Will diabetics then demand Afrezza for the sake of their health and a better life with fewer complications? Will Endo’s and PCP’s adjust their “standard of care” and change their prescribing habits? We think they will when the data is actually reported, not just by us, but also the many people I talk with who you never hear about. Here are this weeks numbers!

What is the Afrezza “Real Life” User Challenge?

It is a group of Afrezza Users who use a Continuous Glucose Monitors (Type 1’s) seeking tighter diabetes control and measuring the time spent in each blood sugar range. Two weeks ago we added a new user who like most diabetics uses “finger prick” measurements throughout her day to measure her blood glucose levels. For her (Laureen) we will take an average blood glucose per day (which is an average of approximately 7 or more daily finger pricks). It is NOT a competition between T1’s and T2’s nor among any of us and was only started so people could understand and see the inherent benefit of why Afrezza provides better control and higher patient satisfaction for t1 and t2 diabetics over our previous regimens. In essence, this is a “real-world” trial of “do your best”, and have good and bad days, but keep track of it all, and let everyone know the results. Well, the results thus far are clearly unbelievably positive.

Why are you doing this?

There has been so much discussion about the FDA Afrezza Drug trials and why I feel as a participant in the Affinity 1 trial, there were significant “hold backs” as to why we were not able to materially outperform Injectable Insulin because of the protocols on the trials. This is no longer the case!

To Summarize here are just a few of the hold backs why Afrezza didn’t get to show how great it works:
•Afrezza Dosing only changed approx. every 6 weeks, and not flexible dosing depending on meal
•No CGM’s allowed
•Time in Zone not measured
•Patient quality of life not measured
•Brand new Afrezza users vs. Very experienced Injectable users (what if it was brand new injectable users vs. experienced Afrezza users—would that be fair? No-they would stop the trial right away because it would be a TKO/referee stops contest victory for Afrezza which we are proving by real world experience.)

What surprises you most about the Week 6 data?

This week what surprises me most is CONSISTENCY. Even with the “busyness” of life, new stresses and strains, and fighting the never-ending diabetic battle–what is readily apparent is that the numbers are getting very “sticky”. What I mean by that is, they just don’t change a great deal week to week, which is a tremendous advantage and a personal relief! If you look twice at the time in zone “before” Afrezza and the time in zone “with” Afrezza, it really is night and day. Add in the fantastic bottom line results and it just doesn’t get better than that short of a cure.

So Week 6 actual results were clearly another positive testimony to the effectiveness of Afrezza!

What would you like to express to everyone out there considering Afrezza or to any doctors considering prescribing Afrezza for their patients?

My opinion is that Afrezza is a “life-changing” drug that is not very well understood by the diabetic community at large—both doctors and patients. This will change! It improved my life and gave me hope in treating my diabetes. I would wish the same for you or any other diabetic you know—enjoy a better and higher quality of life! Please demand to try Afrezza from your doctor, and if he/she won’t or is not able to prescribe it–go find one that will–your life and the quality of it matters!

[Phaeton]

Cross posted from MannKind

I guess we will see what we see. Perhaps your right and perhaps I'm right . But if I'm right then I will be glad to make a nice contribution to a diabetic education organization as a way to pay it back to the diabetic community . If I lose than I hopefully will have another winner to offset my losses in MannKind. Over my 40 + years of active investing I have had far more long term winners in all types of stock be they financial, retail, technology, biotech, insurance and chemical. So I have my views of investing that is very long term and have patience to hold on for the long haul. Heck I still have my first stock that my folks gave me 10 shares of in 1961. Yep it was in dividend investment until mid 2000's. That stock was GE.

An investor buys good quality companies and watch them go through cycles. Good and bad cycles. MannKind is a young company and is just getting ready to start their cycle. Mannkind will have a bull run in the future. The product first has to have its official launch. We are in a soft launch.

Let's check back in January 2016 and we will see who is right or wrong.

MAHALO!

[Phaeton]

I would encourage any of you who are SHORT OR LONG to go to this web site and watch the 23 minute long video by Dr. Edelman which is directed toward the medical professional - Doctors, Nurses and others who are in the Diabetes field. Then go and review the 24 slides that again are geared toward the professional on how and why Afrezza works. After reviewing this material than you can make up your own mind. The question you need to ask and answer after watching reviewing this material is Sanofi committed to Afrezza. Only you can make that determination for yourself.

http://www.medscape.org/viewarticle/840611
You will have to sign in to watch the video and see the slides.

Here is a basic review:
This activity is intended for primary care physicians, diabetologists, endocrinologists, pulmonologists, nurses, and pharmacists who manage patients with diabetes.

The goal of this activity is to review the need for advances in rapid-acting insulin therapy and appreciate the unique mechanism of action and pharmacokinetics/pharmacodynamics of inhaled insulin compared with other currently available insulin products.

Upon completion of this activity, participants will be able to:

Review the limitations of available rapid-acting insulin products
Examine the mechanism of action of the inhaled insulin products recently approved
Compare the pharmacokinetics and pharmacodynamics of inhaled insulin with those of other currently available prandial insulin products
Differentiate new inhaled insulins from past products

[Phaeton]

New 12U package approved, now they need to finish up with a 2U package. Then they have the spectrum covered. You have to think that as the pieces fall into place you will read many more stories like this guy on YMB posted yesterday. GAVE UP THE PUMP! WOW! now that is a good Afrezza headline or story.

Will Afrezza be a game changer for some diabetics? You bet it will be. The results of early adapters will drive the sales in the next 12 months and then Doctors will really start feeling very comfortable and prescribing it to patients. Today its the risk-takers who want to get off injects or reduce them. Uptake might seem very slow to all of us since its about the investment/money we have invested in MannKind. But you don't go from a crawl to running a marathon overnight. Just sit back and watch this unfold over the next 12 months. Sanofi is just beginning and second guessing a product that has only been on the market for 80 days is a foolish mistake.



Another posting this Morning by JDRF South Florida. With 1005 followers at just that chapter. Think about their nationwide audience (chapters)

Amazing Afrezza – Non-Invasive Insulin That Works! via Healthline RSS Feed - I can't wait to get ... http://t.co/IZNKyNSjX7

— JDRF South Florida (@JDRFSouthFL) April 22, 2015

[mc67]

A martind18 post I saved... Q. was where do you see the PPS a year from now ? (share-holders only)

The question was to someone who owns shares and is not short.

First... Let me address a few things:

1. Mr Mann... The insider that knows what he has more than any other insider... Has not sold a single share.

2. The people who were involved with the trials were begging the committee to approve this.

3. Sanifi are no dummies... They partnered in this to make money.... And they will.

4. Here we are still above $5.00 even after the vicious attacks and even the silly $3.00 price target. That ought to tell you something about the huge battle being waged by the insulin and pump companies.

No way to project the PPS a year from now.... But I am glad I own shares. I sleep good at night... And I understand who and what the attack on MNKD is all about.
-----------------

afrezzas-ultimate-potential

..also read an article on yahoo today that projected numbers a few years out.. and a DR, replied that we're still in the (soft launch) phase that was planned.. ?? so I'm assuming the real party hasn't even started..?

[Phaeton]

BS free zone here.

[COO2002COO]

Hi guys. I guess this is a much better place without BS here, right?

[Phaeton]

Oh My 200,000 shares in AH. Now that is a hungry buyer at $5.28 per share. now that is a big $1,056.000 of shares. must have been one of us on this board?

[Phaeton]

Why Afrezza will be a blockbuster drug? Because diabetics need a better solution. Today on Twitter there was a feed #Dayofdiabetes go read the comments by the users who have diabetes. Most of them don't know or have not heard about Afrezza yet as its in a soft launch mode until the additional lines are up in Danbury.

Take a few moments and read the comments being posted today on a twitter feed Day of Diabetes #dayofdiabetes You can read from the posters why Afrezza will be a winner. Most of the posters have had diabetes for ever and have various issues from the ailment. But the comment theme is what Afrezza is all about. With reading today

Some comments
Testing my sugar 10X/day, these test strips are EVERYWHERE EXCEPT the trash. Tricky little things! #dayofdiabetes
Today is really showing me as well just how many of my decisions are based around diabetes. #dayofdiabetes
Saw new endo yesterday...looking for new endo today....#dayofdiabetes

BG's all over the place! My son just wants to not worry about type 1 for once. Teen yrs..Wish I could trade places with him??.#DayOfDiabetes
Tried to ride that low line on my Dexcom and fell off. Skinned my pancreas. Some days I can, others I can't. #dayofdiabetes
Sex and low bs? a limp situation and confusion 4 a woman who doesnt understand my T1D. "all will be ok after this oj break" #dayofdiabetes
Waiting is one of the worst parts of living with diabetes. Wait to eat. Wait for corrections. Wait for a cure. #dayofdiabetes
Ever wonder what your fingers would look like after 5+ pricks per day? #dayofdiabetes
Anyone who needs to borrow a pen at work always leaves confused. #dayofdiabetes
I almost forgot to bolus for lunch. 40 grams of carbs #dayofdiabetes

Have a lunch meeting so carb counting is going to be more difficult than usual #dayofdiabetes

#DayOfDiabetes #CGM check
Slow rise cause?
Too many #carbs?
Too little #insulin?
#TooManyPuzzlePieces #diabetes
Baby boy woke up 240, ate breakfast, 3 units of insulin, 3 hrs later 54 after 2 juice boxes!!!! Stupid non working pancreas #dayofdiabetes
BG check. Not enough blood. Dang. Another stick. higher than I like 154. I check on heel of hand. #dayofdiabetes

AmyDBMine: A good start to my #dayofdiabetes - thank you #Afrezza !
No calls from the school or texts from the nurse yet today. No news is good news. #dayofdiabetes
Having a hard time getting going today. Months of illness = incredible fatigue, but I've got stuff that needs doing! #dayofdiabetes
Another hourly alert for high blood sugar. Currently 219 and rising. Headache starting to set in from extended high #dayofdiabetes

There are thousands of comments that were posted just today on that link. So you tell me if we will have a blockbuster drug or not? I bet within 12 months this will be a very big seller as a new way to really get BS under control. Today the USA and the future is in 120 nations worldwide. Sanofi knows what they are partnered with in MannKind. Al Mann knew what the drug was capable of doing in regards to BS.

[yosemite47]

I'm with you, but I'm partial to Blue Label. One neat shot a year.

[Phaeton]

Had Breakfast this AM with a friend who is going to go on Afrezza



Had Breakfast this morning this AM with a Friend who is a 65 Year old diabetic. He has been on once a day Lantus injections. His Endo has recommended that he start taking Meal time insulin injections. This friend who has invested in MannKind asked his Endo about Afrezza. vs mealtime injections. The Endo Smiled at him and asked him what he knew about the product and he told the Endo. Seems that the Endo knew about Afrezza but was not going to put patients on it unless they asked for it as its too new. Once the friend indicated that he wanted it the Doctor stated he had no issue with it and would prescribe it to him. That in fact it would be his first patient on it and that he was excited to do it. The Dr. Did not have the ability to do the Testing and my friend will go back to see him next week to get the prescription after he takes the pulmonary test.

As I have stated before that Afrezza will be a viral product that Doctor's will prescribe only when the demand is there and not before that time. So don't look at weekly script counts but look at the viral nature of patients who learn about Afrezza from friends and sources like blogs. Long term we will have a great increase in PPS as diabetics learn about Afrezza.

[Phaeton]

Great reply to the Rob Sacher article on SA if you read the entire article you will see this message from a poster. Read some of the links to understand how Afrezza view the product.

http://seekingalpha.com/article/3020586-early-adopters-embrace-afrezza-as-new-inhaled-insulin-enters-market

----------------------------------------------------------------
Some early Afrezza adopters' discussion links. You can forward these links to your diabetic friends, but please do not jump into any of these diabetic discussions if you are non-diabetic.

http://bit.ly/1wbHHKD

http://bit.ly/1FdaUaq

http://bit.ly/1x2srkJ

http://bit.ly/17V1vqR

http://bit.ly/1x2stcj

http://bit.ly/1x2srkT

http://bit.ly/1x2DwCj

http://bit.ly/1x2DwCl

http://bit.ly/1DpB9eI

http://bit.ly/1DpB9eK

http://bit.ly/1BK3oBI

http://bit.ly/1BK3oBM

http://bit.ly/1xLr9VW

http://bit.ly/1xLr9VY

Al Mann's interview and talks in John Hopkins.

http://bit.ly/1BrNsU4

http://bit.ly/1zJBAh6

Why these early adopters can achieve such spectacular success?
Answer: Afrezza mimics the first phase insulin in our body. None of any regular insulin did it before.

How important is the first phase insulin?
It's well known that insulin is lost in type 1 diabetes, so type 1 has no first phase insulin at all. For type 2 diabetes, the lack of first phase insulin is a hallmark. In patients with impaired glucose tolerance or in the early stages of type 2 diabetes, first-phase insulin release is almost invariably lost. Both animal and human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.

Metformin is the popular first drug in early Type 2 diabetics. Metformin improves insulin sensitivity, but does not change first phase insulin, or can compensate the missing of first phase insulin. Therefore, supplementing Afrezza for patients who are deficient in first phase insulin should not only be a good practice but also the first choice in the future. If necessary, Afrezza and metformin can be used together. They very likely could be complementary to each other.

Afrezza's fast kinetics and mimicry of first phase insulin is the reason that "some key opinion leaders are saying that Afrezza therapy in early stage type 2 diabetes should slow, probably stop and maybe even reverse type 2 diabetes" (from Al Mann interview article).

For more understanding, please go to medline, and do the research about first phase insulin by yourself. You'll understand why Afrezza will be a paradigm shift in diabetic treatment.

[Phaeton]

Jez Moulding the President of Sanofi NA on Afrezza


He is also a diabetics expert.


http://blog.sanofi.us/2015/02/25/one-giant-leap-for-mannkind-sanofi/


One Giant Leap for MannKind [& Sanofi]

In October, I arrived in the U.S. from my former post as head of Sanofi’s Japan/Pacific region, which includes Japan, Australia, New Zealand and South Korea. Since that time, I’ve spent a lot of time listening and asking questions, and in the process, I’m beginning to learn more about our teams in America and Canada.

What I’ve learned in that time is that we have a dynamic, talented team in Sanofi US. We have the potential to launch seven new products in the U.S. by 2017. With this opportunity to reach millions of patients with our medicines, I find myself more energized now than at other point in my career.

Earlier this month, our team celebrated an especially significant milestone, launching the first of those seven new products. Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in the U.S. Click here for Full Prescribing Information for Afrezza® including Boxed WARNING.

To me, the launch of Afrezza embodies the type of innovation we strive for – not only bringing a new treatment option to market, but doing so with a treatment that can address challenges people living with diabetes face.

When we announced our global licensing agreement with MannKind Corporation last summer, we knew there was a great deal to be done in a short period of time. This launch would not have been possible without the hard work of our dedicated colleagues and the collaboration of our counterparts at MannKind.

We’re ready for a promising year ahead, and this is an exciting start.

www.Afrezza.com.

Regards,
Jez Moulding
President, North America Pharmaceuticals

[Phaeton]

There was some great action today. Buyers or Sellers look at the big blocks traded. Somebody knows what will happen in the future. my bet is on the Bulls.

8000 to 12,999 shares


over 13,000 shares


ticking time bomb for the Shorts?

[kugel]

Long and will be in for a few years have a ton in my account and a few in my wife's .

[Phaeton]

My bad today. I didn't listen to the advice of Board members who warned me about investing in MannKind. Like a drunk! I couldn't help myself from buying more cheap share today. Oh woe is me as I got them for $5.33 per share. Now as a drunk that is like buying your favorite bottle of Glenfiddich 50 year old single malt scotch at 50% off the retail value. Just too good of a opportunity to pass up.


Here is toasting to the future of MannKind. I will remain long and strong and see where we are this time next year.

Need a roll call of longs. Who are ready to raise a glass and toast MannKind.

[Phaeton]

Read below why Afrezza works.

http://afrezzauser.com/afrezza-confirmed-by-doctor-as-real-deal/

Afrezza Confirmed by Doc–it is the “Real Deal”

? Mar 13, 2015 ? Posted by afrezzauser

This past week I went for my first doctors visit since going on Afrezza. I noticed that 2 weeks into my treatment that my requirements for insulin dropped significantly even as a type 1 . The only explanation I had is that I was more insulin sensitive. From my own research I have learned that any abnormal levels of sugar can build up insulin resistance in type 1 and type 2. For someone who has had horrible A1C readings it can definitely cause insulin resistance. On my trials I dropped my A1c to 6.8 and finished at 7.1 from a start of 8.5. An A1c of 6.8 is definitely “diabetic” so I really did not notice anything drastic about my insulin use dropping my A1c levels to around 7 on my trials. As I mentioned before we were held back and limited in dosing and in what we could do for our insulin use which does not match a true “real world” experience. When I take Afrezza, I can easily and painlessly take an initial dose and then a follow up dose later and visually see the “control” and where my sugars will land, and the control seems to last for hours and hours. This is something completely counterintuitive to anyone who is taking injectable insulin where the name of that game is the half-court “one-shot” deal and it typically means spending the next few hours hoping you hit it about right–and then seeing the shot didn’t make it far enough or it went over the backboard (at least for me)–and I think that’s why so many people get “hung-up” on the exact # of units of injectable insulin needed to reach the basketball hoop when that is not the case with Afrezza. My experience on Afrezza is that the ball knows where to go, and I only have to gently guide it there and I can adjust it along the way–and the “inhalation” which is barely noticeable goes as expected and that the result is quick and predictable—yes very different, it’s a “whole new game” and something you will have to experience for yourself!

How does that contrast with how Afrezza works? Since I had 6 months of experience I was off to a great start from day 1. I was running average blood sugars of of around 125 the first week and 112 the 2nd week. Those readings include large meals (and snacking) and are truly non-diabetic numbers. In the 2nd week i noticed that my requirements for insulin went down not only on my Afrezza but with Lantus as well. The only explanation was an insulin resistance reversal.

At the doctors office Dr. Bode examined my data and numbers and said the word “unbelievable ” eight times. Here is some of the data discussed:

30 day average blood sugar 112 mg which would equal to an A1C of 5.52
18 day average blood sugar 103 mg which would equal to an A1C of 5.21
5 day average blood sugar 95 mg which would equal to an A1C of 4.9

Time in range
70-130 mg 75%
60-140 mg 86%
50-150 mg 96%

Those results are certainly incredible. The dexcom CGM takes a measure of my glucose every 5 minutes 24 hours a day, 7 days a week. The readings are stored and they cannot be altered or deleted or changed. The data is downloaded at the doctor’s office where they can examine and get an exact picture of what is going on with my blood sugars. Now I am running what equals to a non diabetic blood sugar level–hence “unbelievable”. The difference between a 7 A1c and a 5.5 A1c is the” night vs. day” or “diabetic vs. non-diabetic” reality and it’s proof that my body has been responding very well to Afrezza without all the higher toxic blood sugars running through it. To me, this is earth-shattering, not only for my treatment, but also for diabetics everywhere trying to control their glucose levels.

So how does this all make me feel? Well, I finally feel like I have a new future ahead of me. Not one filled with diabetes complications, rollercoaster rides and babysitting all day, but a future with less worry, less uncertainty and more freedom.

There have been numerous people that have been able to duplicate my success – one is Brian Sharp who is/was doing that without a continuous glucose monitor. A CGM is certainly not necessary for outstanding results but it makes things much easier for a type 1 diabetic. Another Afrezza user is Jackie from Buffalo, NY and she is having the same life changing experience that I did when I first started in 2012! John George who goes by Afrezza Spiro is a type 2 diabetic also experiencing great results. His fasting blood sugars have dropped into non-diabetic ranges as well. His last 5 days he has recorded 99, 106,94,100,and 93 fasting blood sugar levels. Is this just some sort of great “once in a lifetime” coincidence that we are all approaching non-diabetic numbers-I think not.

I have attached the response from Dr. Bruce Bode who received an email from a Kyle Daniels who is a type 1 Diabetic asking about the comments I made on twitter about how my insulin resistance has been reversed. I have included Dr. Bodes response which speaks for itself.

Here is the profoundly simple email that I believe will mark a new diabetes treatment paradigm shift as doctors and diabetics understand and know more about Afrezza. No longer will we have to take “half-court” shots and hope for the best. If it worked for me, I can only imagine how well it will perform for diabetics with A1C’s less than 10 (my previous embarrassing # before starting on Afrezza)!



From: Kyle Daniels
Date: Wednesday, March 11, 2015 at 12:13 AM
To: Bruce Bode
Subject: Re: Afrezza

Dear Dr. Bode,

I just finished read Sim Finta’s twitter account and he mentions that his built-up insulin resistance has been reversed. He has been back on Afrezza for 2 weeks and stated that this was confirmed at his Doctors appointment.

Is this true? How can this be possible for a Type 1 diabetic? I have never heard of something like this being one myself. Is Afrezza really the real deal?

Thank you!
Kyle.

———————————————————————————–

From: “Bruce Bode”

Date: Mar 12, 2015 12:22 AM
Subject: Re: Afrezza
To: “Kyle Daniels” (and several others)

Glucose and lipotoxicity occurs regardless of the type of diabetes; glucose does not know if the patient is type 1 or type 2. High Glucose and High FFA and other factors impair insulin action as well as insulin release.

We see this phenomena all the time in new onset type 1 diabetes; They go into a honeymoon upon treatment of insulin due to breaking both glucose and lipo toxicity. This may last months or longer.

Sam’s A1c was above 10% with marked variability with now a mean glucose of 95 mg/dl with a SD <35; Amazing; his C-peptide was < 0.3 checked last month. Afrezza is the real deal for individuals like Sam who failed on MDI and are motivated to improve their control. Afrezza allows him to be aggressive with pre meal insulin with low risk of hypoglycemia.

Bruce

Bruce W. Bode, MD FACE



The sentence that stood out to me–AFREZZA IS THE REAL DEAL. Well said Dr. Bode! I believed that when on the trials years ago and posting online, and I feel even stronger about it today as I have “figured out” how it best works for me in real life. Lastly, I wanted to stress for new Afrezza users that as with any new insulin treatment it can take a little time for the body to get used to the new process, and I have received the most questions about this on my website–so let me tell you what I do and perhaps it will help the way you “dial it in”–here goes:

The biggest difference for myself as a type 1 is that I usually take a follow up dose 1-2 hours after a meal depending upon where my sugars are. I am not too worried to get it exactly right on a meal as long as I check my sugar 1 hour after the meal and know where it is heading. Looking at my results so far I am happy with what I found the best way to proceed with my treatment. I do check regularly to make sure I nip any post meal rises “in the bud” depending upon my carb intake. It is no different than checking your sugar on injectables 2 to 3 hours later except the difference is that with Afrezza the peak time is so quick that I dont have to wait 2-4 hours to take another injection or stack insulin guessing where I will land 3 to 4 hours from now. In a way it’s like doing a couple easy “layups” instead of the long shot. I have always said Afrezza is a “real-time” insulin as it mimics the speed of the pancreas. As Dr Bode quoted to me a few weeks ago describing why our fasting blood sugars are so good while taking Afrezza (ie. I wake up most mornings with fasting sugars of 75-85):

Dr. Bode: “I think you have normalized your glucose which improves insulin sensitivity. Afrezza also delivers first phase insulin, meaning insulin in the first 15 minutes of delivery which in turn suppresses hepatic glucose production lowering fasting glucose in the am and also post meal glucose”.

Hope this article is encouraging to everyone using or considering Afrezza! And Kyle, many thanks to you as you seek to improve your treatment results and I hope you have even greater success on Afrezza–it’s the real deal.

[Phaeton]

2nd board for MannKind

Seems very silly or stupid to make comments like that when they have a very defined product, marketing plan and partner. I just tend to ignore a person like that who makes wild and stupid remarks as one can see that there is an agenda. Its fun to read a view that is 180 from my own on MannKind. As a long term investor in the Market and this stock one can see the TRUTH from the falsehoods that many put out there. I am glad for the most part that most investors are in the game for the long haul and are not DAYTRADERS. Folks making comments like the one your referring to are just dumpers and have some agenda for their own reasons. my guess is that they are very short and have that small man syndrome.

MannKind has a very bright future if you remain long and watch the milestones get checked off over they next couple of Months and years. Today its the USA and tomorrow its the UK and EMA. Watch over the next years the Viral nature of the bloggers/users of Afrezza. This will drive eventual labeling changes to include the term Rapid or Fast acting which the FDA had denied to MannKind in June 2014. I bet the label in the UK - EMA has that on it. As patients read the blogs and see the results you don't have to be a MD to know that users will know that its a FAST ACTING OR RAPID acting Insulin. The Medical Community will view and learn from the users that the product if fast acting will prescribe it that way. Al Mann is a very smart guy as he knew all along how Afrezza would work.

[Phaeton]

This is the really a great read.

Today, a total of 77 block trades were recorded, typically at least 10,000 shares of stock or more represent a single block unit. Further examination shows that the bought value of the shares was $21,014,836 versus the sold value of $4,730,487. The positive cash flow of $16,284,348 into the stock shows that investors have bullish sentiment.




http://www.avafin.com/articles/1037452.html

[KingDMC]

Feels good to have a lot of the pressure off of our shoulders. All I see is upside from here and we are witnessing it! Way to hang in there man!

[Phaeton]

Feel much better today.

[KingDMC]

Back over $7!!

[Phaeton]

That is a Game changer. Its there for all to see.

NOTICE THAT ACTIVE DUTY MEMBERS GET IT FOR $0.00 (thanks for serving the USA)

TriCare US DOD has Afrezza 4 unit (30)/8 unit (60) for $13.00 thru Express Scripts for mail order and $17.00 for retail

I think the Short's on MNKD are in trouble. The DOD sees the benefits of Afrezza for Diabetic care. You can bet that the other government health formulary programs will be picking up Afrezza.

Eventually all plans will have it and the Tier pricing will be in the Tier 2 or 3 range.


Link for formulary- enter medication name

[Phaeton]

This is not your Pfizer bong or your college bong from the 1970's era.....

our time has come for the launch of Afrezza and for those of us who are long in this stock. Best of luck to us all.









There is a lot in a box 0f 90 units.



Cartridge size shown with a dime

[Phaeton]

Great news. I also added more shares in the 5.00 range.

[KingDMC]

Big gap up longs!

MannKind Earns $50 Million in Milestone Payments From Sanofi

Source: GlobeNewswire Inc.

MannKind Corporation (Nasdaq:MNKD) today announced that it has earned a total of $50 million in milestone payments in connection with the satisfaction of manufacturing milestones specified in its collaboration and licensing agreement with Sanofi. Pursuant to the agreement, MannKind previously received a $150 million upfront payment and is eligible to earn up to $725 million in further development, regulatory and sales milestones, and is also eligible to receive a share of profits on sales of Afrezza.

[Phaeton]

Another MannKind Update from Nate's Notes

After intentionally not talking about MannKind in the most recent Inter-Issue Commentary, I was quickly reminded by a number of you that until the stock finally kicks into gear for us, you would appreciate updates and pep-talks as frequently as possible… and though I can’t promise I will write about it every month, the current situation certainly represents a good time to step back and look at the big picture to make sure everyone understands the possible outcomes from here (based on your emails, I worry that some of you may have forgotten that there is still some risk in owning the stock).

Starting with the optimistic side of things (before heading to pessimism and back to optimism again), it is my belief (and it is a point that I think gets overlooked far too often in discussions about “inhalable insulin”) that Afrezza is quite a bit more than just a clever repackaging of the existing insulins that are on the market, and while “no needles” is a benefit in and of itself, the fact of the matter is that what really sets Afrezza apart from the competition is the that it represents a significant step forward in the goal to develop “ideal” insulin (i.e. insulin that behaves as if it were produced naturally in the body).

This is a big deal because it allows patients to more easily monitor and control their blood sugar levels, and this, in turn, should lead to better patient outcomes… and, while each of them has a different motivation for achieving that goal, what patients, doctors, and insurance companies are all looking for is patient well-being.

Since I often get asked “why would insurance companies care if a patient is happy – all they want is money, right?,” I wanted to take a moment to point out to those of you who may not have thought about it before that whereas the cost of providing insulin to a patient pool can be estimated with a very high degree of accuracy, the costs associated with treating the complications of poorly-managed diabetes are a) much harder to predict, and b) much more expensive than simply providing insulin and hoping it gets used correctly.

If I am right about Afrezza, I believe it has the potential to become the mealtime insulin of choice over the next several years… and if it manages to do so, the product would likely be considered a “blockbuster” by even the most reluctant of skeptics.

Of course, there is a chance that I am wrong and Afrezza will end up struggling to gain traction in the highly competitive world of diabetes drugs (please read that sentence again, and keep re-reading until you really believe it… then you may proceed).

Working against the company are:

• the fact that its partner for the product, Sanofi (SNY – $45.16), is currently struggling with personnel and PR issues;

• the last inhalable insulin that was introduced to the market (Exubera) flopped big-time;

• there is a very significant short interest in the stock that a) is keeping a lid on the share price (which, in turn, makes it more difficult for the company to raise capital on favorable terms if/when it needs to), and b) may turn out to be right (though, ironically, when all of those shorts start to cover, it may end up causing a higher floor to be put under the stock than many of them are counting on – i.e. their upside may not be as big as they think it is);

• while the company has expressed confidence that it will be able to meet all of its cash flow needs going forward, there are still a lot of variables in play that might make this a challenge;

• as it stands, the labeling for Afrezza is less favorable than the company would like (though this variable can change over time as more studies are done);

• and, finally, while there have not been any flags raised based on the studies that have been done so far, the possibility of Afrezza being a lung cancer risk still gets a lot of airtime and may cause a number of potential users to hold off trying Afrezza (and, of course, there is a chance that lung cancer might actually be identified as a risk after more studies are done).

All of that being said, if you had told me in January that the stock was going to finish the year basically right where it started after having the uncertainty regarding both approval and a partnership removed from the equation, I would not have believed you… however, that’s exactly what we’re looking at today.

Given the nature of the products being developed, the biotech sector is notorious for having “market inefficiencies” in which stocks become radically mis-priced based on what turns out to be a misinterpretation of the data that is available to investors… and in my 26 years of following the sector, I believe this may represent one of the most inefficient markets I have ever seen for a stock.

While I do not claim to know for sure what has been going through their minds (and I freely acknowledge that a portion of the large short position may simply be a hedge put on by folks who own MannKind’s convertible debt), the initial batch of short sales were put in place based on the idea that Afrezza was going to fail its clinical trials.

When that investment thesis didn’t work out, it appeared that instead taking a step back and wondering if perhaps they were wrong, many of those shorts simply doubled-down on their position and changed their mantra to “despite passing clinical trials, it will never be approved… and I’ll cash in when that event occurs.

Given human nature, it should come as no surprise that this same group of people did the same thing again after the product was, in fact, approved, and they started pinning their hopes on the idea that “they’ll never find a partner.”

Of course, not only did MannKind find a partner, they found a great partner (assuming Sanofi can weather the PR storm that erupted a few months after they signed up with MannKind)… and they got a great deal to boot.

To be sure, the shorts may still prevail if Afrezza fails to sell (I will be the first to admit that the old adage “Q. What do you call a man who is right for all the wrong reasons? A. Right.” could come into play here), but the situation sure looks to me like a case in which a group of investors have fallen in love with an idea (“MannKind is going to $0 because _____”), and they’ve stuck with it despite the fact that MannKind has – on a number of occasions now – managed to clear the hurdles they were planning on seeing the company stumble over.

Please note that MannKind is still just a moderately-sized position in the Model Portfolio (and thus it should be around that size too in your own portfolio if you are more risk-averse), but is definitely one of our largest positions in the aptly named Aggressive Portfolio. This is on purpose, but I want you to notice that our MannKind position (my favorite speculative stock) is being matched by an equally large position in Apple (one of my favorite conservative ideas), and if you are also “going big” on MannKind with me, you are encouraged to make sure a sizable chunk of your other money is parked in some of the less risky stocks as well.


Read more: http://mnkd.proboards.com/thread/970/articles-media-spots-on-mnkd?page=36#ixzz3MBUrUwEI

[Phaeton]

Sanofi to continue diversification, eyes acquisitions. What could they acquire?

FRANKFURT Wed Dec 10, 2014 3:51am EST

Sanofi's new CEO will continue its strategy of diversifying beyond new drug development, possibly through acquisitions, the French drugmaker's interim chief executive said.

"We want to have businesses like consumer healthcare, veterinary medicine and vaccines that are less strongly driven by innovation but grow continuously and are more stable," German daily Handelsblatt quoted Serge Weinberg as saying in an interview published on Wednesday.

He said if there were opportunities, Sanofi would be "prepared and able" to make acquisitions in those areas, without being more specific.
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What could Sanofi acquire? Hmmm have to to think LONG and hard about that! I will get back to you SHORTLY on what that Acquistion might be .
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Think about the investment SNY made in REGN or ALNY. Makes me all warm and fuzzy thinking about what the future might bring for shareholders.


http://www.reuters.com/article/2014/12/10/us-sanofi-sa-strategy-idUSKBN0JO0P620141210

[Phaeton]

I hope it proves to be helpful for you and all diabetics. This is about making a diabetics life easier. I fit the age of a type 2. Don't have issues today but if I did I would try Afrezza first. Like victor Kiam said. Liked the company so much that I bought the company. ..

[TREND1]

VERY SIMPLE
I will try Afrezza , if my doctor agrees.

[Phaeton]

Why were you following if you didn't have a position? Seem lots of folks loved bashing it. Lots of low fly frauds like F10 retarded. Now what a phony he has been on the MannKind board. Pretty comical .

[TREND1]

HA ! HA !
I never traded MNDK.
Since I never short a stock, giving up on MNKD
means it will never be a long either.

Good luck with MNKD
You will need it.