MannKind's Afrezza: Early Adopters’ Confirms its Advantages

[compound26]

MannKind's Afrezza: Early Adopters’ Confirms its Advantages

Summary

• Almost Six Months Have Passed Since Afrezza Became Available To Early Adopters.

• Early Adopters’ experiences have confirmed and in many respects exceeded Al Mann’s predictions and observations in the past that Afrezza is far superior (than RAAs (rapid-acting analog insulin)) in controlling blood sugar for diabetics.

Even though it took about 10 years and $1 billion personally investment from Al Mann himself for Mannkind to get Afrezza approved by FDA, Al Mann has always remained confident that Afrezza will be a paradigm-shifting product for diabetics in the prandial insulin market due to its many advantages over RAAs.

Six months after Afrezza was released into the market, the early adopters’ experiences of Afrezza have confirmed that Afrezza has plenty of advantages (over RAAs), including, among other things, the following:

• Better A1Cs

• More time-in-zone

• Peak action in 15 minutes (Fast acting in correcting BG highs)

• Action finished in 90 minutes (No worry about IOB or insulin stacking)

• Less hypos

• Precise dosing not required (and no complex Carb Counting needed)

• Spontaneousness (meaning one can enjoy more varieties of Food (and in general, life))

• Reduce risks for complications

• Reduce burden of managing diabetes

• Reduce burden of family members

• Device the size of a whistle – discreet and easy to carry around

• No needles - inhaled

• Help lose weight

• Pump Free Freedom

• Other advantages (no smell, no taste; it's real human insulin - not an modified analogue; likely lead to better compliance)

1. Better A1Cs

Look at Gustavo Basualdo’s result before and after Afrezza—from 6.5 to 5.4 in 90 days.



afrezzauser.com/week-17-afrezza-produces-non-diabetic-a1c/

In the Type 1 Afrezza Users “Real Life” Results Group as reported by Sam Finta, per Sam, “all nine of us have achieved lifetime best A1C with much less effort and a tremendously higher quality of life than we ever have before. And every single one of us have posted our official lab reports from our doctors’ offices to be fully transparent in all our results for whoever may be looking at this–doctor’s, diabetes educators, etc. Funny thing is we are all so different. We live in different parts of the country, we’re different ages, professions, backgrounds, and we all had varying starting A1C’s (from 10.2 to 6.5) before beginning Afrezza. Yet, within 3 months’ time,

ALL OF US have achieved a “Lifetime Best” A1C on Afrezza!”

afrezzauser.com/week-17-afrezza-produces-non-diabetic-a1c/

2. More time in the zone

Look at Brian Sharp’s BG level over one week. He was able to stay between 60-150 on his blood sugars for 100% of the time. He had ZERO severe or moderate lows and finished the week with an average blood sugar number of 99.

Here is what Amy Tenderich says regarding time in the zone:

“Simply put, Afrezza is helping me spend more time in range. My CGM screen now rarely shows the little dotted line going outside the borders of yellow for too-high and red for too-low. I’ve had whole days that remained in the white zone. And I’ve managed to do both a spin class and aerobics class starting at a “normal” blood sugar (100-ish) and ending there as well!”

www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

3. Peak action in 15 minutes (Fast acting in correcting BG highs)

With Afrezza, maximum concentration in blood reached within 12 to 15 minutes.




www.afrezzapro.com/afrezza-action-profile

This means Afrezza is superfast in correcting high BGs. Here is what Laura Kronen says regarding this: “Afrezza brought down a high blood sugar from 329 to 140 in 45 minutes. That would have taken me 3+ hours on [RAA] insulin.”

Think about it, if you are a diabetic and is having a high blood sugar of 329, would you prefer it to come down in 45 minutes or 3+ hours?

4. Action finished in 90 minutes (No worry about IOB or insulin stacking)

With Afrezza, maximum concentration in blood reached within 12 to 15 minutes and declined to baseline by approximately 180 minutes (see chart above).

www.afrezzapro.com/afrezza-action-profile

Because of Afrezza’s distinctive fast-in and fast-out Pharmacokinetics, one needs not to worry about insulin on board or stacking of insulin. Here is what Gustavo Basualdo says regarding this: “as with any fast acting insulin, exercise has a big impact. If I have a BG of 150, I’ll take 4 units, wait 15 minutes and do a 100 jumping jacks. My BG will drop like a rock, but Afrezza stops working so fast, by the time it gets around 100 or so it will be done and level out.”

afrezzauser.com/afrezza-journey/

“Had a post lunch spike. Is my afternoon bike session ruined due to post correcting insulin pooling? Not with #afrezza.”

Here is what Brian Sharp says regarding this: “I am also an avid scuba diver and underwater photographer. With Afrezza, I don’t have to dive with high BG levels or be in fear of crashing. I don’t need to take Afrezza three hours prior to a dive to assure that it’s all gone from my system before I get in the water. I am an experienced deep water diver, cold water, high-altitude, cave diver, wrecks, and night dives. Getting low on any of those types of dives could be fatal and endanger others, so control is paramount.”

www.healthline.com/diabetesmine/how-afrezza-changing-life-type-1-diabetic-pilot#3

5. Less hypos

Study indicates that Afrezza causes less hypos than RAAs do. In the phase III trial (Trial 171), the Afrezza arm has 30% less hypos and 43% less severe hypos.

www.medscape.org/viewarticle/845829?src=sttwit

The experience of early adopters of Afrezza confirms this. Here is what Howard says regarding this: “Still zero severe hypos which is a huge stress relief. Huge spikes in the 200s are a thing of the past. I will never see a 300 again.”

Here are what Ana Ortiz and Bill Kinder say regarding this:

“ALEX: Have you seen any effects of Afrezza on hypoglycemia?

BILL (T2): I set a good lower limit of 70 mg/dl on my CGM and I’ve never had any hypoglycemic issues. I’m lower than I used to be and that’s a good thing, but it’s a little different because I’m used to having higher blood sugar.

ANA (T1): It’s definitely helped with the hyperglycemia. Sometimes I’ll have low blood sugars with Afrezza, but it’s not as extreme – it’s not in the 50’s [mg/dl] anymore. With Afrezza, the lowest I’ve seen is 68 mg/dl or somewhere in the 70s, and it's not as frequent.”

diatribe.org/inhaled-insulin-afrezza-real-deal#sthash.vkBZ1tmL.dpuf

6. Precise dosing not required (and no Carb Counting)

Here is what Amy Tenderich says on this issue: “In this 2009 interview I did with Al Mann (http://www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann#2), Al Mann explained that Afrezza essentially "turns off glucogenesis" so no glucose is secreted from the liver in reaction to food. For that reason, people with type 2 can use a set dose of Afrezza for meals and run essentially zero risk of lows no matter what the meal size, whereas type 1s “will still have the issue (of lows) if they dose and don't eat anything… and if they eat a large meal, they'll need a larger dose.”

“The advantage for all patients is that they won't have to do carb counting or anything, because Afrezza does not have to be so precisely matched to food intake,” he adds.

This, my friends, has proven 100% true for me, and it’s a HUGE life improvement to be relieved of all that math (and S.W.A.G. guessing).”

www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

Here is what Brian Sharp says regarding this: “I don’t count carbs…. I don’t fixate much of my day controlling my diabetes.”

afrezzauser.com/afrezza-delivers-low-a1c/

Here is what Jackie says this: “Larger meals, I take an 8u, smaller meals I take a 4u. Its that easy. Every now and then a follow up dose.”

afrezzauser.com/afrezza-journey/

7. Spontaneousness (meaning one can enjoy more varieties of Food (and in general, life))

Because of the fast-in and fast-out and less hypo prone features of Afrezza, Afrezza has enable users to eat more spontaneously and enjoy greater varieties of food.

Here what Gustavo says regarding this: “First impromptu frozen yogurt ever. EVER.”

Here is what a user (of Afrezza) on Tudiabetes.org says regarding this: “Got my first A1C since using afrezza as my primary bolus insulin--- 5.3. I'll take it. …. My previous a1c was 5.2, so essentially no change with afrezza... But I tried about 10% as hard and very much expanded the types of foods I was willing to eat.”

www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/239

8. Reduce Risks for Complications

High sugar level can lead to many undesirable complications. Per the DCCT (The Diabetes Control and Complications Trial) study and the EDIC (The Epidemiology of Diabetes Interventions and Complications) study, intensive blood glucose control significantly reduces risk of many complications.

DCCT Study Findings

Intensive blood glucose control reduces risk of

eye disease 76% reduced risk

kidney disease 50% reduced risk

nerve disease 60% reduced risk

EDIC Study Findings

Intensive blood glucose control reduces risk of

any cardiovascular disease event 42% reduced risk

nonfatal heart attack, stroke, or death from cardiovascular causes 57% reduced risk

diabetes.niddk.nih.gov/dm/pubs/control/

Here is what Jackie says regarding: “Just got back from my Ophthalmologist who has been treating me for early stages of diabetic retinopathy. I have had several laser surgeries there to repair leaky blood vessels in my retina. Scary. Very scary. Today’s visit was quite different I had the full dye test today and the doctor was amazed at how great my eyes looked. No more laser surgeries for me! I am the first patient he knew taking Afrezza and was so excited to hear of my A1C drop to 6.7 and my very realistic goal to get to the mid-5s by year end. He was sad however that I wouldn’t need to come and see him anymore. Who knows, maybe we can go out for a beer sometime.”

afrezzauser.com/afrezza-delivers-results-week-18/

9. Reduce burden of managing diabetes

Because of the fast-in and fast-out and less hypo prone features of Afrezza, Afrezza has made management of one’s blood sugar level much easier.

Here is what a user (of Afrezza) on Tudiabetes.org says on this: “Got my first A1C since using afrezza as my primary bolus insulin--- 5.3. I'll take it. …. My previous a1c was 5.2, so essentially no change with afrezza... But I tried about 10% as hard and very much expanded the types of foods I was willing to eat.”

www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/239

Here is what Amy Tenderich says on this: “This, my friends, has proven 100% true for me, and it’s a HUGE life improvement to be relieved of all that math (and S.W.A.G. guessing).”

www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

Here is what Laura Kronen says on this: “Checking my blood sugar is getting boring now. It's always perfect on #Afrezza. I feel like I just won a 22 year long race with #diabetes.”

10. Reduce burden of family members

Afrezza not only helps relieve the burden from the diabetics, but also their family members.

Here is what Gustavo says on this: “Before, my family had to follow my crazy diabetes agenda. Now we can all just go with the flow. Thank you #afrezza”.

Here is that Sam’s son wrote on this:

“Before Afrezza, diabetes was a frequent issue in our lives. Whether it was worrying about his safety when I am not with him, or making sure he has some source of sugar when we go somewhere in case of emergencies, it was a commonly spoken about topic. My dad used to, what I call, “freak out” sometimes. This is when his blood sugar runs too low and he begins to act unnatural due to his need for sugar. This was very scary for me and it happened a good amount of time when he was not on Afrezza.

During my dad’s time using Afrezza, everything changed. Diabetes was no longer a nuisance, it was not talked about at home, and it was almost as if his case of diabetes had disappeared from my life. I did not worry about him when I was not with him. It was a relief and neither of us felt stressed out any more about his case of diabetes. Not to mention the way you inhale insulin made my dad happier because he did not have to give himself shots every day. We also no longer had to calculate beforehand how long before his insulin would kick in so what he should eat before insulin and after and how much to take. From what I understand, Afrezza acts much quicker than normal insulin and this was very noticeable throughout watching my dad on this trial.

Now that my dad is back to normal insulin, all the previous problems are frequent issues in our lives again. I hope that my dad will be able to take Afrezza again as it makes our lives less stressful and I do not have to worry about him as much.”

afrezzauser.com/fda-testimony/

11. Device the size of a whistle – discreet and easy to carry around

Afrezza (the device) is the size of whistle and very discreet and easy to carry out.

Here is what Sam says on tihs: “You will see there are lots of travel advantages with Afrezza–you can use it discretely on an airplane, and not have to fly with high blood sugars and go to the bathroom every 30 minutes. And how about not freaking out the person sitting next to you if you pulled out an injectable? Traveling is a breeze with Afrezza.”

afrezzauser.com/afrezza-journey/

Here is what Bill says on this: “I’ve found the inhaler to be extremely discreet, small, and well functioning.”

diatribe.org/inhaled-insulin-afrezza-real-deal#sthash.rbk98r8p.dpuf

12. No needles - inhaled

Afrezza is inhaled insulin and therefore, no needles. Imagine how many shots one can save over a life time by using Afrezza over RAAs.

Here is what a user on tudiabetes.org says on this: “I have been a Type 1 diabetic for 58 years. After 52 years of thousands of injections, I became needle-phobic. The OUCH you think is minor to you is not minor to millions of others. ….Spent 5 1/2 years in a research study trial using AFREZZA inhaled insulin. I have not had to take an insulin injection during those 5 1/2 years. Believe me, I know that is not a cure. But for now it is the best out there for those of us struggling physically and emotionally with injections.”

www.tudiabetes.org/forum/t/insulin-independence-revolutionary-phase-3-trial-giving-type-1-diabetics-the-promise-of-a-needle-free-life/46721/15

13. Help lose weight

Study indicates that Afrezza helps to control weight. In the phase III trial (Trial 171), the Afrezza arm patients have a slight drop of weight whereas the RAA arm patients have a slight weight gain.

www.medscape.org/viewarticle/845829?src=sttwit

The experience of early adopters of Afrezza confirms this.

Here is Brian Sharp comment on this: “I lost 10 pounds since I started using #Afrezza I feel great! I'm In great shape! I can eat whatever I want when I want! Afrezza is awesome!”

Here is comment from a user of Afrezza from diabetesdaily.com on this: “I have another thread which I need to update regarding my experience with Afrezza but I'm happy to report that my a1c dropped after 7 weeks on Afrezza from 6.5 to 6.2. Now on 6th day in a row where my FBG is under 130. When I get time, I will update the other thread with more details. Oh and I lost 11 lbs.”

www.diabetesdaily.com/forum/multiple-daily-injections-mdi/82173-afrezza-20

14. Pump Free Freedom

Afrezza makes it easier to get a pump free life for diabetics.

Here is what Gustavo says: “3rd day pump free! Finally stabilizing. Turns out #afrezza+glargine=easier basal control than pump for me #incredible”.

Conclusion

Peter Thiel, in his book "Zero to One: Notes on Startups, or How to Build the Future", describes companies that create a monopoly on a market (like Google to search engine and Apple to tablet market). The book describes some companies win market share via a "Creative Monopoly" (i.e., you create a new product that is at least 10 times better than the existing completing product and therefore creates a dominant market position). For example, it can be argued IPAD is at least 10 times better than the other existing tablets (there were some attempts at that time) and that Google's search engine and Apple's iPhone were similarly at least 10 times better than the other existing products.

This is what Peter Thiel called "Creative Monopoly" and "Zero to One" (you create something totally new or vastly better) phenomena.

Looking at Afrezza from that angle and thinking about the advantages of Afrezza that Al Mann has envisioned, and Sam and other earlier adopters of Afrezza have experienced, including, among other things, the following:

• Better A1Cs

• More time-in-zone

• Peak action in 15 minutes (Fast acting in correcting BG highs)

• Action finished in 90 minutes (No worry about IOB or insulin stacking)

• Less hypos

• Precise dosing not required (and no Carb Counting)

• Spontaneousness (meaning one can enjoy more varieties of Food (and in general, life))

• Reduce Risks for Complications

• Reduce burden of managing diabetes

• Reduce burden of family members

• Device the size of a whistle – discreet and easy to carry around

• No needles - inhaled

• Help lose weight

• Pump Free Freedom

• Other advantages (no smell, no taste; it's real human insulin - not an modified analogue; likely lead to better compliance)

A strong argument can be made that Afrezza is at least 10 times better (to other RAAs) and therefore is comparable to iPhone (to other early smart phones) and IPAD (to other early tablets) and therefore a "zero to one" product and that Mannkind is in the early stage of dominating the prandial insulin market through a "creative monopoly".

[compound26]

Hi, fellow members, good morning. I wrote the above article summarizing the many advantages Afrezza is showing in the early adopters' reports. I think even though almost all of the members of this board probably can recount all of these advantages of Afrezza in our sleep, the sad truth is that most people (including the diabetics in general) do not know them yet.  If you think the above article is to some degree helpful to the general public and the diabetics in general in understanding Afrezza or to a minimum degree helpful to counterbalance the FUD' negative coverage of Mannkind and Afrezza, can someone (I am thinking of Rob or others who have been writing articles frequently) post the above article to Seeking Alpha or any other website you think are helpful? You can edit the article as much as you want to and post the article under your name.  I do not know how to publish an article in Seeking Alpha or to that effect any other website (other than this dear one   .

For your convenience, I have attached hereto the word version of this article for your editing and publishing. 


Attachment Deleted

[coco]

Good summarization of all the good things Afrezza is capable of providing it's users. Nice to see it all in one place.

Coco

[babaoriley]

Coco, get to the islands, if you're not already there. And for goodness sakes, do not post any selfies here - just send them to my email!!

And have a great time (how can you miss)!

[suebeeee1]

Thank you for all your hard work. I, for one, plan to send this to the doctor that refused to prescribe Afrezza to muy husband and to a number of diabetics I know personally who have not made the change yet.

This should be one of those articles we all commit to sending everywhere.

Fantastic work!

[Deleted]

Jul 27, 2015 0:25:11 GMT -5 compound26 said:

Hi, fellow members, good morning. I wrote the above article summarizing the many advantages Afrezza is showing in the early adopters' reports. I think even though almost all of the members of this board probably can recount all of these advantages of Afrezza in our sleep, the sad truth is that most people (including the diabetics in general) do not know them yet.  If you think the above article is to some degree helpful to the general public and the diabetics in general in understanding Afrezza or to a minimum degree helpful to counterbalance the FUD' negative coverage of Mannkind and Afrezza, can someone (I am thinking of Rob or others who have been writing articles frequently) post the above article to Seeking Alpha or any other website you think are helpful? You can edit the article as much as you want to and post the article under your name.  I do not know how to publish an article in Seeking Alpha or to that effect any other website (other than this dear one :)  :).

For your convenience, I have attached hereto the word version of this article for your editing and publishing. 

Thanks for taking time to put this together and for sharing the Word file.  Appreciate your hard work.  

[compound26]

Jul 27, 2015 8:30:27 GMT -5 suebeeee1 said:

Thank you for all your hard work. I, for one, plan to send this to the doctor that refused to prescribe Afrezza to muy husband and to a number of diabetics I know personally who have not made the change yet.

This should be one of those articles we all commit to sending everywhere.

Fantastic work!

suebeeee1, thank you! That will be great!

[compound26]

Jul 27, 2015 9:03:49 GMT -5 @scotta said:

Jul 27, 2015 0:25:11 GMT -5 compound26 said:

Hi, fellow members, good morning. I wrote the above article summarizing the many advantages Afrezza is showing in the early adopters' reports. I think even though almost all of the members of this board probably can recount all of these advantages of Afrezza in our sleep, the sad truth is that most people (including the diabetics in general) do not know them yet.  If you think the above article is to some degree helpful to the general public and the diabetics in general in understanding Afrezza or to a minimum degree helpful to counterbalance the FUD' negative coverage of Mannkind and Afrezza, can someone (I am thinking of Rob or others who have been writing articles frequently) post the above article to Seeking Alpha or any other website you think are helpful? You can edit the article as much as you want to and post the article under your name.  I do not know how to publish an article in Seeking Alpha or to that effect any other website (other than this dear one   .

For your convenience, I have attached hereto the word version of this article for your editing and publishing. 

Thanks for taking time to put this together and for sharing the Word file.  Appreciate your hard work.  

scotta, you are welcome! Please feel free to send anywhere you want to and feel free to edit it as you would like!

[compound26]

I just fumbled through the article submitting process of Seeking Alpha and submitted the article to Seeking Alpha. Will let you guys know if it is accepted by Seeking Alpha.

[ezrasfund]

Jul 27, 2015 10:00:27 GMT -5 compound26 said:

I just fumbled through the article submitting process of Seeking Alpha and submitted the article to Seeking Alpha. Will let you guys know if it is accepted by Seeking Alpha.

I think the article will be rejected because the focus is medical not financial. It is a fantastic job and strongly supports the investment thesis, and I think it is a great article to send to diabetics and medical professionals, maybe with a slightly tweaked lead-in.

[mannmade]

Might also help with the revisions to Wikipedia

[compound26]

Jul 27, 2015 10:46:05 GMT -5 ezrasfund said:

Jul 27, 2015 10:00:27 GMT -5 compound26 said:

I just fumbled through the article submitting process of Seeking Alpha and submitted the article to Seeking Alpha. Will let you guys know if it is accepted by Seeking Alpha.

I think the article will be rejected because the focus is medical not financial. It is a fantastic job and strongly supports the investment thesis, and I think it is a great article to send to diabetics and medical professionals, maybe with a slightly tweaked lead-in.

ezrasfund, you are spot on. Here is what I received from Seeking Alpha.

"Thank you for your recent submission to Seeking Alpha. Your article "MannKind's Afrezza: Early Adopters' Confirms Its Advantages" has been declined by our editorial team. Our editors had the following feedback:

Thanks very much. This article reads as aggregation more than as an original investment thesis. Please look at some of our published articles to get a better sense of what we're looking for. Please do not assemble quotes one after the other, but rather synthesize and analyze the material in your own words to provide unique commentary. We tend to steer away from social media-based, anecdotal evidence. Please embed your links. You can do this with the help of the globe tool, next to the underline button on the editing toolbar. Copy the source URL, highlight the text you want linked, click the globe, paste in the URL, and click OK. Thanks very much."

[BD]

I think compound's article would actually make for a great web site, all by itself. Let's see if we can come up with a good domain name for a board-sponsored pro-Afrezza web site. I'll personally take care of the domain registration, and perhaps if there are any members who are web developers and are willing to program the site pro-bono, we can get something going really fast! At the low end of the "effort spectrum", Word can save the document in HTML format and that can just go up on the site as the home page...

[mannmade]

How about the following:

AfrezzaTheRealDeal.com

Afrezzajustbreath.com

freedomwithAfrezza.com

Afrezzaworks.com (or Afrezzareallyworks.com)

Afrezzaisamazing.com

Afrezzaislifechanging.com

[BD]

afrezzajustbreathe, you mean?