Aloha Crew: Once the CLAMP study is completed, (due anytime now!!). and the results show what we’re expecting (much fewer hypo events, large reductions in HbA1C values, etc), then the label will most certainly change for the better – allowing Sanofi to make bold, gripping claims.

A TV commercial that can make claims as bold as “significant a1c reduction” & “much less risk of going hypoglycemic” will most certainly send the patients to the doctors, as well as force doctors to do their own due diligence.

This is our future Crew; Afrezza spreading around the Globe, helping millions upon millions of diabetics. What an honor to be associated with Dr. Al Mann, founder of MNKD, and leading the world into a revolutionary new way to treat diabetes!

Sanofi is definitely ramping up their advertising efforts. They are choosing the channels that are cheapest first, and that provide a level of awareness. Since then, we’ seen advertising though banners on several sites. Finally, they have appeared in Time Magazine multiple times, as well as Good Housekeeping and others! TV ads to follow soon after Tier 2 insurance coverage is initiated.

Tic-toc, tic-toc, and soon; for whom the bell tolls? IMO it's the shorts. Remain patient Crew, our time of a rising SP is a certainty with Afrezza making a Global impact! Aloha.

I'm in agreement that these are the next 5 Steps of Sanofi's Marketing Plan for Afrezza:

1. Completion of the CLAMP Study (https://clinicaltrials.gov/ct2/show/NCT02470637)
2. Apply for a new, better label (allows them to make bold advertising claims)
3. Use the new label/clamp study results to gain Tier 2 insurance coverage
4. Gain approval in other countries
5. Once insurance mostly covers Afrezza, Sanofi will hire more sales reps and begin a "full-on" DTC campaign.

We are on our way my fellow-investors. Simply hold your shares, don't let detractors try to scare you into selling, and good tidings will be coming your way! Aloha.

It's only a matter of time RF2 and when MNKD takes off, those who aren't in agreement with this little gem of a company will be gone with the wind. You can take that to the bank my friend. Aloha.

Aloha Hypi: I believe this article dated 10/01/15 is what you'd posted earlier. Very nice! Title: Why Sanofi's Afrezza Marketing Strategy Is Brilliant: http://seekingalpha.com/article/3545846-why-sanofis-afrezza-marketing-strategy-is-brilliant

What does Dr. Al Mann have up his sleeve?
Technosphere worth billions with so many applications!
And IMO those applications are coming soon. Al didn't become who he is and come all this way for nothing.
Don't be fooled, the bashing happens for 1 reason only....
To get you to sell....don't even think about it!
They will continue to employ any shred of negativity for usage to scare you.

I'm betting on Dr. Mann to deliver! He's been in this business too long,

and way too shrewd to ever fail!

Just watch Dr. Mann and learn.

Aloha.

Heraclitus said: "the only thing that is constant is change." And so it will be with Afrezza, as the word of this incredibly effective, powdered insulin, spreads throughout the medical community, and around the entire globe. Keep the vision, and become the Visionary that Dr. Al Mann already is. You will be handsomely rewarded for your patience in MNKD. Aloha.

I concur. A most excellent article outlining current strategies & recapitulating all the great reasons why I'm invested in MNKD. Mahalo for posting AfrezzaSNY! Aloha.

Hey, hey, ho, ho... what have we here! Men's Health Magazine. Look who made the Top Ten at #10. Hey, hey, ho, ho, here we go Afrezza!!!
http://www.menshealth.com/health/best-new-drugs-2015

Finding out Afrezza works amazingly in the real world, wasn't forecasted by the short interest.
Those who bet against its success, are now more than ever forced to clouding the airways with garbage. (They have to hurry too! before ongoing studies prove superiority) If they thought Afrezza was just non-inferior, they wouldn't be wasting their time publishing article, after negative article. NOR would there be a need to be posting 24/7. They would just sit back, relax, and reap the rewards of a non-inferior, inhalable insulin. Ha-ha. Wrong!

They were right to count on insurance adoption progressing slowly, and the effect that would have on sales early on. However, they didn't count on real world users taking to the web, and telling the world Afrezza has changed their lives. No way did they forecast this. Surprise!

They have to cover 125,000,000 shares, institutions own about the same. Oh what a dilemma they're in! For whom the bells tolls. Tic-toc, tic-toc. Cheers, Crew.

Yes, that's the part that really made laugh. Like we 're supposed believe that this "writer," with a history of MNKD fud behind him, was right there; in on negotiations, at the table. Right.

These folks won't quit till MNKD is safely returned to higher SP levels which is going to happen. Oh happy day when the bell tolls for them.

All longs know MNKD is going to succeed, as does the big money beginning with that corrupt G/S.

I know. It's so ridiculous isn't it.

Latest hit piece; just more of the same old song. Throwing stuff against the wall to try and make anything stick, and they just can't succeed Desperation is setting in for shorts and big money knows this. Lot's of action gonna happen with Afrezza into 2016. This "diabetic investor" is so wrong, he makes me laugh. http://www.benzinga.com/general/biotech/15/09/5873684/diabetic-investor-on-mannkind-theres-a-reason-why-so-many-people-are-s?utm_campaign=partner_feed&utm_source=marketwatch.com&utm_medium=web_click&utm_content=ticker_page

Well stated Twister! Aloha.

It must be massively disappointing that this is the best the short side can do. All the competing BP's all the corrupt analysis, all the PHD lapdogs posting away arguments against all common sense, and all the incessant retail short posters & this is the best they can muster? Aloha.

Glad to hear you're taking a break King to enjoy time in the Islands. Good for you. Here's to the Grand Alliance: MNKD/Afrezza/Sanofi/Google! Aloha.

Aloha Conix: I never stated the shorts weren't profiting. The simple reason why that's occurring is Sanofi is waiting to push Afrezza.

And, IMO it's easy to refute low scripts. As things now stand, SNY is prohibited to advertise Afrezza as being superior to existing prandial insulins. They are not allowed by FDA rules to state what all who have followed the initial adopters progress already know, that is, Afrezza is vastly superior and lowers A1c like nothing ever seen before. Hence, the CLAMP study. SNY will use these studies to change the label while at the same time forcing insurance companies to more Afrezza to tier 2 status. Then its "game on" Conix, and SNY knows it. And, so do the big boys who have been continually acquiring shares.

Mahalo for your post Conix.

Mahalo, King. The unfairness and bias of that SA article has got me fired up this morning. I also discovered that the "author" also stated during the FDA approval process, that Afrezza had; "less than a 50% chance of approval." Uh-huh, now we know for certain where this "writer" stands don't we?!! Aloha to all on the board. I'm off to the Mainland this morning for a 1-week break from Kauai.

It's inevitable to those who are invested here, the profoundly positive impact Afrezza will have in the world of diabetes therapies. Once Afrezza's absorption kinetics are understood by healthcare providers and patients, Afrezza will become the new “normal science” for treating diabetes. Afrezza will overtake basal insulin as the first course of insulin therapy for type 2 diabetics going onto insulin therapy (earlier in the treatment plan) and will replace existing RAA options for a majority of patients already on prandial insulin. When this happens, not only will Afrezza reach “mega-blockbuster” status but it could become the most valuable drug of our time. The Paradigm Shift of Afrezza is inevitable -- improving the health and Quality of Life for millions of diabetics. Help is coming soon to all who are suffering from this horrible disease!! Aloha.

I hope a rebuttal is posted to the SA article this morning trashing the Afrezza script count. And, that "writer" has indicated he will be publishing henceforth, a weekly script report on SA. Why does this person gain privileged access to a site to write weekly trash articles on MNKD? Huh? Needless to say I won't be reading any of his trash talk from this point forward.

Sanofi's Point of View
1. They know they have a very effective drug in Afrezza, but its immediate success is not financially important to Sanofi.

2. They want to negotiate the highest price possible to achieve tier II coverage and they are in no hurry to lower the price when they can wait for superior medical results to add leverage against the insurance companies.

3. Large scale advertising without full tier II coverage only creates a situation where patients are unable to get Afrezza, because they can't afford it yet under their current coverage.

4. If Sanofi wants to buy Mannkind, they may get a better price by doing what is in their financial best interest (see previous points) rather than what's in Mannkind's best interest.

5. Shorts will cover in direct proportion to insurance tier II coverage including the time delay built into the advertising / sales / prescribing process.

Both the longs and the shorts are correct, assuming there is no buyout. The shorts are correct that Mannkind's profitability is many months aways. The longs are correct that Afrezza will eventually have significant worldwide marketshare.

Great post Hypi. You helped cheer me up a bit and appreciate it. Aloha.

Good news for SNY/REG in Europe this morning! EU OK for their cholesterol drug.This bodes well for SNY/MNKD/Afrezza IMO, which is up next with the EU. Aloha. http://www.marketwatch.com/story/sanofi-regeneron-get-eu-ok-for-cholesterol-drug-2015-09-28

Mahalo RF2. Smart move adding too! Aloha.

Well stated IMO J1. I appreciate the candor on your take.

Watching, waiting, remaining hopeful, out here on the coconut telegraph for; QMC! Aloha.

IMO, I suspect many like me are waiting for the sureness of a bonafide contract, before adding more. I remain hopeful and patient. Aloha.

A most excellent post Hypi. Very enlightening and educational to what is really going on out there. Indeed, we are fortunate it have Al Mann in our corner! Aloha.

Aloha Robert: Yes, same old routine from these "writers" putting out hit pieces to try and crash MNKD. It's all so ridiculous and just not gonna happen. All Longs know this.

What's truly wondrous and of much more consequence IMO is; the time of just & righteous reward is nearly here for shareholders, and more importantly, for the millions upon millions of Diabetics around the world who are going to benefit from using the revolutionary new drug, Afrezza. There simply is nothing better on the market than Afrezza, and time will validate this. Once Diabetics begin to grasp the incredibly positive implications of using Afrezza, they will clamor for and demand it.

This, my fellow investors has been Dr. Alfred Mann's Grand Vision, and unyielding dedication for the past 15 years of his life. What an honor for me and I'm sure for many others here, to be associated with such a Visionary!

The Grand Alliance: MNKD/Sanofi/Afrezza/Google.

We rarely get VOG here on Kauai; usually only in winter. Go MNKD! Aloha.

Aloha FM: If your wife's Ohana is here, then you can always come back anytime if you wish! GLTY too and let's just sit back, relax, and wait this out. MNKD will succeed.

Here is how you know Googles about Afrezza.

Diabetics are far more likely to have heart attacks, they’re far more likely to have cancer, and they’re 15 times more likely to have their foot cut off because of vascular issues,” said Andy Conrad, chief executive officer of Life Sciences, to Bloomberg. “If we could prevent strong and profound fluctuations in the levels of blood sugar, we could prevent most of the problems associated with diabetes.”

And, notice he focused on fluctuations in levels of blood sugar.....Andy Conrad that is..head of Google Life Science...Dexcom has devices already..that show Afrezza eliminating fluctuations...with Google and Dexcom...they can show the world...in the cloud....and Sanofi is Afrezza distributor and marketer..so clear...Google wasn't partnering before Afrezza!

Google is very aware of glucose and how it relates to the health of diabetics. In a meeting between Dexcom and Google the question was asked to Dexcom CEO , "How do you know when a T2 patient should transition to insulin?". The real answer is not A1C it is CGM Share data analyzed by Google.
Google/Dexcom/Sanofi/Mannkind = Alphabet

Google is working on Nanoparticle technology. What is the most efficient way to deliver the nanoparticle into the bloodstream? Could it be Technosphere?
Hire a Nanoparticle Delivery Engineer to answer that question.

Google is data analytics expert. they know the total cost to healthcare and productivity due to the effects of diabetes and thats whey they chose this one first. They will use this analytics to push for aggressive treatment and new technology. My guess is that Afrezza is part of the larger strategy for the Google/Sanofi strategy. More to come! Aloha.

Wow, watch them attempt to take M down this last hour. Incredible. Aloha.

I ran across this article recently. It's just 3 weeks old, so very relevant. Enjoy!

Diabetes Care Mag: Afrezza Lowers HbA1C in Uncontrolled Type 2 Diabetes
Afrezza Lowers HbA1C in Uncontrolled Type 2 Diabetes
Rachel Lutz
Published Online: Monday, August 31, 2015
Follow Pharmacy_Times:

Adding Afrezza insulin inhalation powder to oral diabetes medications significantly reduces HbA1C in adults with poorly controlled type 2 diabetes.

To arrive at this conclusion, researchers recently examined more than 350 adults with type 2 diabetes and HbA1C levels between 7.5% and 10% who were taking metformin alone or at least 2 oral antidiabetes agents.

As an add-on to their oral regimen for 24 weeks, roughly half of the patients were randomly assigned to receive Afrezza, a prandial Technosphere inhaled insulin approved by the Food and Drug Administration (FDA) in June 2014 and launched by Sanofi and MannKind Corp in February 2015, while the remaining participants received prandial Technosphere inhaled placebo for the same time period.

Afrezza doses were titrated weekly based on glucose levels for the first 12 weeks to target 90-minute postprandial glucose levels of 110 mg/dL to 160 mg/dL. The participants could take a supplemental dose if their 90-minute postprandial glucose level was at least 180 mg/dL. For the remaining 12 weeks of the study, the researchers only adjusted doses for safety concerns.

The study results showed that Afrezza treatment reduced HbA1C by 0.8% from 8.3% at baseline, compared with the placebo’s 0.4% decrease in HbA1C from baseline. Significantly more inhaled insulin participants also achieved an HbA1C of less than or equal 7% than the placebo group.

As for changes in weight, the inhaled insulin group gained an average of 0.5 kg, while the placebo group lost an average of 1.1 kg.

Both participant groups experienced respiratory adverse events, the most common of which was a mild, dry cough (23.7% in the insulin group and 19.9% in the placebo group) that caused 1.1% of the insulin group and 3.4% of the placebo group to discontinue treatment in the study.

This treatment discontinuation resolved the slightly larger decline in forced expiratory volume in 1s that was seen in the Afrezza group compared with the placebo participants.
See more at: pharmacytimesDOTcom/news/afrezza-lowers-hba1c-inuncontrolled-type-2-diabetes#sthash.iH1dBypu.TzYZ5T8R.dpuf

IMO: The Bought and Paid-For Cartel:
Motley Fool, The Street, 24/7 Wall St, Benzinga, Forbes, Goldman Sachs, BP, etc, etc. are "COLLUDING" to do the bidding of Hedge Fund Managers, and Short Interest. This is collision at its finest. These people are clearly bought and paid for, by Hedge Funds/Shorts, BP, to fabricate, or as some put it: "cheat and get ahead”.

Well, we know they get paid to post these horrendous messages to scare people out of their MNKD holding. The question is simple; why would any of them even bother spending their lives everyday posting negative comments to a bunch of strangers? Are they that pathetic? Do they live a life of nonexistence? The TRUTH is they get paid, and most just sit at home. Aloha.

Play with this one
By most accounts SNY has only been "selling" to small group of known high prescribing endos and some PCP's. Over 11k prescriptions have been written and assuming AU compilation of current prescribers is in the ballpark at 83, that works out to just over 130 scripts per provider.
If Afrezza 1.0 was truly controlled to gauge acceptance of the product then I would assert that it has been successful. If Afrezza 2.0 is now sanctioned to inform, educate and sell to all known providers what could scripts numbers amount to in another 8 months? If we happen to see any uptick in numbers 1-2 months from today buckle up.
Many good things are visible on the horizon! Aloha.

Be ready soon for Afrezza published studies and physician education with a strong DTC campaign, and Longs will be sitting in Dress Circle with champagne glasses!!

Right now shorts are controlling the PPS, but are in a perilous position; soon they will get the door shut in their face and IMO we will witness an epic bull run. IMO it will be in stages and who knows where the PPS lands. So relax and enjoy the music until then; and buy all the shares you can at this ridiculously low price! Aloha.

Aloha Crew: Don’t sell into a manufactured downturn.
All this attention for our little, supposedly worthless MNKD shares? Great humanitarians offering advice? More likely it's shorts trying to implement the big finish to their plan: pitch the borrowed shares back and forth to create selling sentiment. Same losers; same old Market game. Don't fall for it! This big finale is how short sellers anticipate getting out. Only sell if you need a kidney, and only if you don't have the other kidney!

Appreciate that King and hope you're well. Always nice to hear from you! Aloha.

Aloha Crew: Here is an analogy:

They're just like envelope stuffer's pumping out hundreds of envelopes filled with useless ads that most toss in the garbage after we pull them out of the mailbox...sending paid ads for their bosses via USPS. This is exactly the same thing except the messages are sent to dozens of sources via the most popular form of communication, the Internet.


Yes, sales are not rolling in yet but it's very early in the process and they are just hitting the next round of payer negotiations to get better tier status. But for Sanofi you just don't go in and cut your price to get the right tier position or you give up your profits. So getting to a tier 2 status takes months and perhaps a year or two. The product works and will eventually take off. Until then its going to be tough sailing unless Sanofi Buys In or Buys out MannKind or an Activist investor plays his hand of cards. It's the ultimate poker game.

So, while you read these posts filled with messages designed to play on your emotions by invoking images of fear that you'll somehow lose your money by remaining in MNKD, (yes, pick any company from GOOG to a penny stock and you'll see them working at every level), remind yourself why you bought shares in the first place.

If it was to 'get rich quick' you are the easiest target because you have the most to lose as that is surely a sign of a poor investment decision. But, what made you think you would get rich quick? It was something that was highly attractive! Nothing changed except as you became more involved or experienced, you began to read things you thought you had learned, but your 'get rich quick' mentality faltered and the realization came that not only are you not getting rich, you can't stomach the color red.

LOL. This is your weakest emotional moment and fear grips you. Sell if you must, but you are selling right into the hands of far more experienced and much wiser players. The very same people who very tactfully delivering those nasty messages are backed by billion dollar wall street manipulators and they just took your shares. My advice, if you don't have money to gamble you shouldn't be investing in biotechs.