Interview with Mike C Part Deux

[joeypotsandpans]

www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx

Very nice follow up with Mike by Speights

[peppy]

Nov 21, 2017 6:37:00 GMT -5 joeypotsandpans said:

www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx

Very nice follow up with Mike by Speights

Relationships with managed-care organizations

Keith Speights: One of the ways, at least from an outsider looking in, that you've been more effective than Sanofi is in the effort to win over managed-care companies. But you mentioned, I think in the last conference call, that this is still something of an uphill battle. Why is that the case? Why aren't these managed-care companies recognizing the value for Afrezza to patients and being more willing to work with you?

Michael Castagna: Maybe because the healthcare system in the U.S. is disconnected from the medical claims in the U.S. What I mean by that is two PBMs [pharmacy benefit managers], Express Scripts (NASDAQ:ESRX) and CVS Health (NYSE:CVS), make up 70% of the prescriptions in the entire U.S. market. Now, they're not responsible for the medical costs. So when it comes to, for example, we think we have lower rates of hypoglycemia. They don't care about that. They don't measure that. They don't look for that. It's not their responsibility for costs. But their responsibility is for drug costs. And so when you're managing only one edge of the sword, right, they're not responsible for managing insulin pumps -- they don't care if people are on insulin pumps or not.

On the PBM side, with CVS and Express Scripts, you've got to remember two things about them. They make money off the higher-volume drugs. And they make money off drugs that increase prices frequently. Because as a PBM, they get an administration fee. If you're making 5% off of a $100 versus 5% off $500, which drug would you rather have on formulary -- the one that's going to give $25, not $5, right? So then if you're getting $25 a year, and the price is going to go up, you're going to get a raise of 20% a year, that gives you a $5 raise every single year. You don't have to do anything, other than block competition.

So today, our competition says in order to get our discount, you need to block every drug in the class, including Afrezza, and every patient must fail our drug to get to Afrezza, in order to get our rebates. So that's what happens. Novo Nordisk (NYSE:NVO) basically blocks patient access to our product. And so, if you're CVS, and you want those rebates, and you want that admin fee, and you don't want to do any work, the easier thing to do is just to say, "Sorry, I'm doing good cost of care, because Novo is giving me all these rebates for blocking everybody." And then if you say, "Well, add us to the formulary," they say, "You don't have any market share." Then we say, "We don't have any market share, because you block everything!" So how can I get market share? It's a circular argument. This is how they protect their monopoly. This is why you have all these lawsuits going on with insulin.

Speights: So how do you overcome that hurdle?
The Wall. Thanks Joey.

[boca1girl]

It’s nice to hear this information. Too bad it can’t be delivered to shareholders directly.

Why doesn’t MND GO DIRECTLY TO THE FTC TO COMPLAIN ABOUT THESE UNCOMPETITIVE PRACTICES IN THE DRUG INDUSTRY???

We will file in Canada. No target date given. Maybe US patients will be able to buy directly from Canadian pharmacies at a big discount to US prices.

[pantaloons]

Mike C. makes it out quite clear that there are insurance and formulary hurdles in prescribing Afrezza and that this is a very well established fact within the prandial insulin market space. He insinuates that providing evidence of Afrezza's clear short-term benefits for PWD will be a key factor for selling the product. Any reason why this wasn't addressed during Phase II and/or III? Had these been put in place prior to marketing the drug, then Afrezza would have had a much greater chance at success.

Granted, this is in hindsight, but if these challenges were obvious beforehand, why are they only now being used as an explanation for slow adoption and sales? In other words, why not establish superior clinical efficacy prior to selling the product?

[joeypotsandpans]

Nov 21, 2017 15:54:31 GMT -5 pantaloons said:

Mike C. makes it out quite clear that there are insurance and formulary hurdles in prescribing Afrezza and that this is a very well established fact within the prandial insulin market space. He insinuates that providing evidence of Afrezza's clear short-term benefits for PWD will be a key factor for selling the product. Any reason why this wasn't addressed during Phase II and/or III? Had these been put in place prior to marketing the drug, then Afrezza would have had a much greater chance at success.

Granted, this is in hindsight, but if these challenges were obvious beforehand, why are they only now being used as an explanation for slow adoption and sales? In other words, why not establish superior clinical efficacy prior to selling the product?

You would have to ask the former corrupt FDA commissioner that question, she was directly overseeing the FDA staffers involved with how they requested the trials be set up. You can google search quite a bit on quite a bit of various angles surrounding the whole fiasco.

[peppy]

Nov 21, 2017 18:30:34 GMT -5 joeypotsandpans said:

Nov 21, 2017 15:54:31 GMT -5 pantaloons said:

Mike C. makes it out quite clear that there are insurance and formulary hurdles in prescribing Afrezza and that this is a very well established fact within the prandial insulin market space. He insinuates that providing evidence of Afrezza's clear short-term benefits for PWD will be a key factor for selling the product. Any reason why this wasn't addressed during Phase II and/or III? Had these been put in place prior to marketing the drug, then Afrezza would have had a much greater chance at success.

Granted, this is in hindsight, but if these challenges were obvious beforehand, why are they only now being used as an explanation for slow adoption and sales? In other words, why not establish superior clinical efficacy prior to selling the product?

You would have to ask the former corrupt FDA commissioner that question, she was directly overseeing the FDA staffers involved with how they requested the trials be set up. You can google search quite a bit on quite a bit of various angles surrounding the whole fiasco.

it took the new label to point it out.

sanofi had this "A euglycemic clamp study" information. Used to get the new label.

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Novo Nordisk makes Fiasp.

So today, our competition says in order to get our discount, you need to block every drug in the class, including Afrezza, and every patient must fail our drug to get to Afrezza, in order to get our rebates. So that's what happens. Novo Nordisk (NYSE:NVO) basically blocks patient access to our product. And so, if you're CVS, and you want those rebates, and you want that admin fee, and you don't want to do any work, the easier thing to do is just to say, "Sorry, I'm doing good cost of care, because Novo is giving me all these rebates for blocking everybody." And then if you say, "Well, add us to the formulary," they say, "You don't have any market share." Then we say, "We don't have any market share, because you block everything!" So how can I get market share? It's a circular argument. This is how they protect their monopoly. This is why you have all these lawsuits going on with insulin.
www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx

cheers.

[pantaloons]

Nov 21, 2017 19:12:15 GMT -5 peppy said:

Nov 21, 2017 18:30:34 GMT -5 joeypotsandpans said:

You would have to ask the former corrupt FDA commissioner that question, she was directly overseeing the FDA staffers involved with how they requested the trials be set up. You can google search quite a bit on quite a bit of various angles surrounding the whole fiasco.

it took the new label to point it out.

sanofi had this "A euglycemic clamp study" information. Used to get the new label.

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Novo Nordisk makes Fiasp.

So today, our competition says in order to get our discount, you need to block every drug in the class, including Afrezza, and every patient must fail our drug to get to Afrezza, in order to get our rebates. So that's what happens. Novo Nordisk (NYSE:NVO) basically blocks patient access to our product. And so, if you're CVS, and you want those rebates, and you want that admin fee, and you don't want to do any work, the easier thing to do is just to say, "Sorry, I'm doing good cost of care, because Novo is giving me all these rebates for blocking everybody." And then if you say, "Well, add us to the formulary," they say, "You don't have any market share." Then we say, "We don't have any market share, because you block everything!" So how can I get market share? It's a circular argument. This is how they protect their monopoly. This is why you have all these lawsuits going on with insulin.
www.fool.com/investing/2017/11/21/mannkind-ceo-michael-castagna-on-whats-ahead-for-t.aspx

cheers.

My question is, why wasn't this data and also possibly HbA1c results acquired during clinical trials prior to approval and marketing. joeypotsandpans provided some insight into the matter and I hope it is indeed the case.

It seems like Mike C is well aware of the monopolizing forces in the prandial market - these are nothing new and strongly indicates that superiority really should have been established prior to the first marketing campaign. In hindsight, everyone (including Mike C, who is and was well versed in the insulin monopoly) believe that, prior to FDA approval, Afrezza would have no problem selling without having established superiority.

I just hope that indeed the label changes and those yet to come will indeed turn the tide.

[peppy]

quote: My question is, why wasn't this data and also possibly HbA1c results acquired during clinical trials prior to approval and marketing. joeypotsandpans provided some insight into the matter and I hope it is indeed the case.

It seems like Mike C is well aware of the monopolizing forces in the prandial market - these are nothing new and strongly indicates that superiority really should have been established prior to the first marketing campaign. In hindsight, everyone (including Mike C, who is and was well versed in the insulin monopoly) believe that, prior to FDA approval, Afrezza would have no problem selling without having established superiority.

I just hope that indeed the label changes and those yet to come will indeed turn the tide.

REPLY: turns out dosing had to be figured out. Dosing, the new label change helped dosing.

dosing:
www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdf
page 22.

Comments
Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the
product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We
recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20
minutes after the start of the meal, and then another dose of the same size about 45 minutes later.
With very long meals, we have even advised patients to administer two follow-on doses, for very tight
control.

Read more: mnkd.proboards.com/thread/7878/afrezza-starting-titrating#ixzz4z7K3FZQY

[sayhey24]

Al Mann assumed afrezza would be approved on the first submission and why not all he was asking for was human insulin to be approved. Its the exact same insulin molecule released by the pancreas directly into the blood. All Al had was a way to get his external monomer human insulin into the blood so it worked like the pancreas. Heck, hexamer human insulin was already approved. It was a no-brainer, wrong. He had 50+ studies showing superiority with the original inhaler which are currently not usable with the new inhaler.

What Al did not realize was the corruption at the FDA and the power of BP. Right before MNKD's first submission Pfizer joined with the other BPs to kill afrezza by suddenly pulling Exubera from the market. This was a brilliant move because Pfizer did not want to spend the time and resources making the market only to have afrezza get approved and snatch the entire market. Bankrupt MNKD, snatch them up and restart your sales team with afrezza made perfect sense for Pfizer except MNKD never folded.

After the 2nd CRL Al got the message the cards where stacked against him and he went to the FDA and asked them to tell him what studies needed to be done and how to get his human insulin approved. The result was the 171 and 175 studies designed by the FDA. Again the FDA was ready to issue another CRL but MNKD asked for the ADCOM resulting in approval but with a bad label.

Al never thought the 171/175 would be the final studies but only the beginning, heck he did over 50 other studies with the old inhaler which already demonstrated afrezza being superior but they would need to be done with the new inhaler. He thought they could fix the label pretty quick. Then he got sick and thought he had a deal with Sanofi. Nothing got done and the rest is history. I am not sure why Matt got nothing done but thank God for Mike.

[lakers]

International plans

Castagna: We filed in Brazil. We will file by ourselves in some markets like Canada. And we'll evaluate Europe and Australia. And then we'll partner in markets like China, the Middle East, and India and Japan. And so as you look out, those are some of the ways we continue to expect to bring in revenue and royalties in the future that will create more value for our shareholders.

Let's check the competition.

New fast-acting mealtime insulin, Fiasp®, now approved and available in Canada for the treatment of diabetes

Faster absorption of insulin key for Canadians living with diabetes

www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Fiasp_Launch_PR_English.pdf

MISSISSAUGA, ON, March 27, 2017 – Today, Novo Nordisk Canada Inc. announced

that Fiasp® (insulin aspart), a faster acting mealtime insulin,is now approved and

available in Canada, giving Canadians living with diabetes a new treatment option for

achieving optimal mealtime glucose control.1,2


Approximately 11 million Canadians live with diabetes or prediabetes and that number is

set to increase to more than 13 million by 2026.3 Diabetes can lead to serious

complications if left untreated or improperly managed, including heart attack, stroke,

kidney failure, blindness and amputation.4


Achieving optimal glycemic control is recommended by Diabetes Canada to reduce the

incidence and slow the progression of diabetes-related complications.5 Yet, limiting

postprandial (post-meal) glycemic (PPG) excursions has been one of the most

challenging aspects in achieving adequate glycemic control.6


Fiasp® is an innovative formulation of insulin aspart that more closely matches the

natural physiological insulin response of a person without diabetes, after a meal,

compared with NovoRapid® (conventional insulin aspart).7 Fiasp® also has the option of a

flexible dosing regimen (up to two minutes before a meal and up to 20 minutes after

starting a meal), without compromising overall glycemic control or safety.1,8


“People living with diabetes often struggle to control blood glucose around mealtimes,

which can be extremely challenging and result in debilitating diabetes-related

complications,” said Dr. Rémi Rabasa-Lhoret, endocrinologist at the Institut de

Recherches Cliniques de Montréal and onset® investigator*. “With the approval of a

faster-acting insulin, one that is closer to the natural physiological insulin response of a

person without diabetes, we can further support people in managing their blood glucose

levels around meals, which may help prevent hyperglycemia, for instance, a condition

that can cause serious complications for people living with diabetes.”


Fiasp® is absorbed faster than NovoRapid® (conventional insulin aspart), appearing twice

as fast in the bloodstream after injection,8,ix which leads to improved glycemic control

after a meal.

In clinical trials, Fiasp® demonstrated improved overall glycemic control in type 1

diabetes and comparable overall glycemic control in type 2 diabetes, versus

NovoRapid®.1,x Results also showed improved mealtime glucose control in type 1 and type

2 diabetes.1,x This was achieved without a significant difference in the overall rate of

severe or confirmed hypoglycemia compared with NovoRapid®.1,x


“Novo Nordisk is committed to helping people living with diabetes better manage their

disease, and in preventing complications that could have a detrimental impact on their

health and quality of life,” said Brian Hilberdink, President, Novo Nordisk Canada Inc.

“We are continuously researching innovative solutions to improve diabetes management

and address critical unmet needs. We are pleased to be able to offer a new solution with

the launch of Fiasp®, one that supports people with diabetes in achieving optimal

mealtime glucose control, particularly in an area that is in need of more innovative

advancements.”


About Fiasp®

Fiasp® is a new, faster acting mealtime insulin, developed by Novo Nordisk with the

objective of achieving a faster initial absorption, to improve glycemic control after a

meal, in people with type 1 and type 2 diabetes.1,2 Fiasp® is insulin aspart, a molecule

with more than 17 years of clinical experience,xi in an innovative formulation, in which

two excipients have been added, Vitamin B3 (niacinamide) to increase the speed of

absorption, and a naturally occurring Amino Acid (L-Arginine) for stability.9

The efficacy and safety profile of Fiasp® was investigated in the phase 3a onset® clinical

trial program consisting of four trials, encompassing more than 2,100 people with type 1

and type 2 diabetes.


Fiasp® was approved by Health Canada on January 6, 2017 for the treatment of adult

patients with diabetes mellitus who require mealtime insulin for the control of

hyperglycemia.2

Fiasp® received marketing authorization from the European Commission

on January 9, 2017. It is currently under regulatory review in Switzerland, Australia,

Brazil, South Africa and Argentina.

[Brazil, S Africa, Australia, Canada are also targeted by Afrezza. Fiasp was approved by EU, Can at almost the same time!

Expect Afrezza approval by Health Canada to be quick! It took almost 3 mos to make Fiasp avail in Canada since approval by Health Canada]

[gamblerjag]

Nov 21, 2017 21:18:41 GMT -5 lakers said:

International plans

Castagna: We filed in Brazil. We will file by ourselves in some markets like Canada. And we'll evaluate Europe and Australia. And then we'll partner in markets like China, the Middle East, and India and Japan. And so as you look out, those are some of the ways we continue to expect to bring in revenue and royalties in the future that will create more value for our shareholders.

Let's check the competition.

New fast-acting mealtime insulin, Fiasp®, now approved and available in Canada for the treatment of diabetes

Faster absorption of insulin key for Canadians living with diabetes

www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Fiasp_Launch_PR_English.pdf

MISSISSAUGA, ON, March 27, 2017 – Today, Novo Nordisk Canada Inc. announced

that Fiasp® (insulin aspart), a faster acting mealtime insulin,is now approved and

available in Canada, giving Canadians living with diabetes a new treatment option for

achieving optimal mealtime glucose control.1,2


Approximately 11 million Canadians live with diabetes or prediabetes and that number is

set to increase to more than 13 million by 2026.3 Diabetes can lead to serious

complications if left untreated or improperly managed, including heart attack, stroke,

kidney failure, blindness and amputation.4


Achieving optimal glycemic control is recommended by Diabetes Canada to reduce the

incidence and slow the progression of diabetes-related complications.5 Yet, limiting

postprandial (post-meal) glycemic (PPG) excursions has been one of the most

challenging aspects in achieving adequate glycemic control.6


Fiasp® is an innovative formulation of insulin aspart that more closely matches the

natural physiological insulin response of a person without diabetes, after a meal,

compared with NovoRapid® (conventional insulin aspart).7 Fiasp® also has the option of a

flexible dosing regimen (up to two minutes before a meal and up to 20 minutes after

starting a meal), without compromising overall glycemic control or safety.1,8


“People living with diabetes often struggle to control blood glucose around mealtimes,

which can be extremely challenging and result in debilitating diabetes-related

complications,” said Dr. Rémi Rabasa-Lhoret, endocrinologist at the Institut de

Recherches Cliniques de Montréal and onset® investigator*. “With the approval of a

faster-acting insulin, one that is closer to the natural physiological insulin response of a

person without diabetes, we can further support people in managing their blood glucose

levels around meals, which may help prevent hyperglycemia, for instance, a condition

that can cause serious complications for people living with diabetes.”


Fiasp® is absorbed faster than NovoRapid® (conventional insulin aspart), appearing twice

as fast in the bloodstream after injection,8,ix which leads to improved glycemic control

after a meal.

In clinical trials, Fiasp® demonstrated improved overall glycemic control in type 1

diabetes and comparable overall glycemic control in type 2 diabetes, versus

NovoRapid®.1,x Results also showed improved mealtime glucose control in type 1 and type

2 diabetes.1,x This was achieved without a significant difference in the overall rate of

severe or confirmed hypoglycemia compared with NovoRapid®.1,x


“Novo Nordisk is committed to helping people living with diabetes better manage their

disease, and in preventing complications that could have a detrimental impact on their

health and quality of life,” said Brian Hilberdink, President, Novo Nordisk Canada Inc.

“We are continuously researching innovative solutions to improve diabetes management

and address critical unmet needs. We are pleased to be able to offer a new solution with

the launch of Fiasp®, one that supports people with diabetes in achieving optimal

mealtime glucose control, particularly in an area that is in need of more innovative

advancements.”


About Fiasp®

Fiasp® is a new, faster acting mealtime insulin, developed by Novo Nordisk with the

objective of achieving a faster initial absorption, to improve glycemic control after a

meal, in people with type 1 and type 2 diabetes.1,2 Fiasp® is insulin aspart, a molecule

with more than 17 years of clinical experience,xi in an innovative formulation, in which

two excipients have been added, Vitamin B3 (niacinamide) to increase the speed of

absorption, and a naturally occurring Amino Acid (L-Arginine) for stability.9

The efficacy and safety profile of Fiasp® was investigated in the phase 3a onset® clinical

trial program consisting of four trials, encompassing more than 2,100 people with type 1

and type 2 diabetes.


Fiasp® was approved by Health Canada on January 6, 2017 for the treatment of adult

patients with diabetes mellitus who require mealtime insulin for the control of

hyperglycemia.2

Fiasp® received marketing authorization from the European Commission

on January 9, 2017. It is currently under regulatory review in Switzerland, Australia,

Brazil, South Africa and Argentina.

[Brazil, S Africa, Australia, Canada are also targeted by Afrezza. Fiasp was approved by EU, Can at almost the same time!

Expect Afrezza approval by Health Canada to be quick! It took almost 3 mos to make Fiasp avail in Canada since approval by Health Canada]

just noticed Mexico was not mentioned do you think just an oversight?

[lakers]

Mex should be part of North America expansion. A and Outsulin have been trademarked in Can and Mex. It would be negligent not to consider a NAFTA country due to no tariff, low shipping cost to a neighbor, and approval would be quick. Distributorship should be considered there as Mnkd will file on its own.

I remember MC cited low level of refrigeration requirement lends itself well to A in Mex.

[mnholdem]

Nov 21, 2017 19:28:18 GMT -5 pantaloons said:

Nov 21, 2017 19:12:15 GMT -5 peppy said:

[clipped].

My question is, why wasn't this data and also possibly HbA1c results acquired during clinical trials prior to approval and marketing. joeypotsandpans provided some insight into the matter and I hope it is indeed the case.
[clipped]

From an old post:

Actually it was on the FDA and they took quite a bit of heat at the April 1, 2014 ADCOM hearing because of their decision to NOT demonstrate superiority. @reverselo since you state that some trial info "was before my time" here is part of the transcript where the FDA's logic for not setting up superiority studies was questioned:

1 DR. CALHOUN: Thanks. Bill Calhoun. I
2 have two questions for Dr. Yanoff and one for Dr.
3 Paterniti. First question for Dr. Yanoff. You
4 also commented on your Slide 22 that this was an
5 unblended study. It's a non-inferiority, and so
6 errors in -- or limitations in the execution of
7 this study will bias toward no difference, which,
8 in fact, as we heard this morning, then favors
9 finding a non- inferiority finding as opposed to a
10 superiority study, in which the bias toward the
11 null is a conservative approach.
12 The question is the FDA's been working
13 with the company for five years, by my count, in
14 pulling this product to market. And so the
15 question is was the agency responsible for
16 recommending a non- inferiority, unblended design
17 for the primary efficacy study?
18 DR. YANOFF: Yes, FDA was involved, me
19 personally, after the first submission, in
20 recommending the trial designs for the two studies
21 that they -- we wanted them to come in with the --
22 with the two new devices. And since we wanted to
Meeting 04-01-2014
(866) 448 - DEPO
www.CapitalReportingCompany.com © 2014
203
1 try to limit it to two studies, one in type 1 and
2 type 2, because we already had some data with the
3 MedTone device, we really had to go for what would
4 be the best trial for each type of diabetes. And
5 in type 1, a placebo-controlled trial would be
6 non-ethical, so
7 DR. CALHOUN: And explain to me why that
8 is? Because that would be an injection -- the only
9 thing it would add would be an injection of
10 placebo in those people who are randomized to
11 active inhaled drug, and the addition --
12 DR. YANOFF: Right.
13 DR. CALHOUN: -- of a dummy inhaler to
14 those who were getting injected -- and that's
15 certainly not -- in my view, that's certainly not
16 unethical. We have trials that are far more
17 invasive than that --
18 DR. YANOFF: Uh-huh.
19 DR. CALHOUN: -- in other therapeutic
20 areas, so I don't think that's unethical at all.
21 DR. YANOFF: I appreciate your view. In
22 general, in the Division of -- in DMEP, we've
Page 204
1 approached all -- tried to be fair to all the
2 programs, and in general, our approach has been to
3 not require blinded studies for type 1 --
4 DR. CALHOUN: Okay.
5 DR. YANOFF: -- to require dummy
6 injections.


Read more: mnkd.proboards.com/user/407/recent#ixzz4z845mei7

[brotherm1]

In relaltion to our share price, these two interviews with Motley Fool took the air out of our tires. Before the interviews there were hopes of a partner, a surprise international deal, a surprise from RLS, etc...
Now it appears we have nothing to look forward to in the short term except perhaps the hope for better scripts. Sounds to me these interviews were desigined to lay it all on the table the way it is so that shareholders now realize the importance of voting for the increase in shares. With the mystique gone, share price is taking a beating.

[peppy]

Nov 22, 2017 11:32:17 GMT -5 brotherm1 said:

In relaltion to our share price, these two interviews with Motley Fool took the air out of our tires. Before the interviews there were hopes of a partner, a surprise international deal, a surprise from RLS, etc...
Now it appears we have nothing to look forward to in the short term except perhaps the hope for better scripts. Sounds to me these interviews were desigined to lay it all on the table the way it is so that shareholders now realize the importance of voting for the increase in shares. With the mystique gone, share price is taking a beating.

yep, the game now, new label, and insurance coverage talks.

If insurance, our competition says in order to get our discount, you need to block every drug in the class, including Afrezza, and every patient must fail our drug to get to Afrezza, in order to get our rebates.
Then is afrezza a different class?