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Post by ilovekauai on May 18, 2018 9:02:23 GMT -5
Hi Peppy: I cut my Glimiperide in half to 1 tab per day at Noon. (2mg). Cut down to 3 metformin per day 500 mg each, and still take the Bydureon 1x per week injection. Should I really pick up the phone and call Michael C? I kinda don't feel comfortable contacting a very busy CEO with my little problem, but if it could meana case of Afrezza I'd do it! I just took my morning BG and it's 133. I bet if I took just a 4 unit in the morning then launch into my daily exercise program of running/yoga/lap swim, like I always do, that I'd be good to go on just Afrezza. Would love to experiment around and figure out my perfect dosing of Afrezza.
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Post by ilovekauai on May 18, 2018 9:05:48 GMT -5
Just to be clear, my new endo was willing to write me a script for Afrezza but was certain I'd be denied because my my A1c is 5.2 So, I will call Mike today and see if there's anything I can do. Thank you all.
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Post by bradleysbest on May 18, 2018 9:34:49 GMT -5
New Form 4’s out and changes in beneficial ownership.... yes! Mike 534K Dr K 53.5K Rose 90K Interesting stock option numbers.
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Post by agedhippie on May 18, 2018 9:43:11 GMT -5
Just to be clear, my new endo was willing to write me a script for Afrezza but was certain I'd be denied because my my A1c is 5.2 So, I will call Mike today and see if there's anything I can do. Thank you all. You won't get denied because of your A1c, but I am surprised that they didn't take you off Glimiperide when they put you on Bydureon. With that A1c I would have thought that the Glimiperide was probably redundant. Glimiperide is a once a day treatment since it is long lasting, Afrezza is a meal time treatment that lasts a couple of hours - so if you can replace the Glimiperide with a single 4u Afrezza unit per day then you probably don't need that 4u unit either. That's going to be real obstacle I think.
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Post by mnholdem on May 18, 2018 9:51:51 GMT -5
Uvula - not even Ralph DeFronzo believes in metformin any more. He calls it the biggest waste in diabetes care. The goal of the insurance companies is to spend the least amount and get the people to medicare. 70% of PWDs using metformin are not even at a 7 A1c. Even the ones which are see increased ldl, heart disease, eye issues, peripheral neuropathy and the list goes on. An A1c of 7.0 is an average BG of 154mg/dl of which they are probably spiking to 200+. Do you still think metformin is cheap? Its costing the insurance companies a fortune and they know it. The only thing its doing is getting the new PWD out of the PCPs office in 30minutes with a script leading to a big mess. Their problem is they don't know how to fix the problem. Every big self insured company now has "health programs" to try to prevent T2. One thing they are also learning is these programs are not working and the T2 rate is rising. The medical community will likely see published results of this study by EOY.
Brief Summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur.
Official Title: Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients Actual Study Start Date: October 16, 2017 Estimated Primary Completion Date: September 15, 2018 Estimated Study Completion Date: September 15, 2018
Primary Outcome Measures: Percentage change from baseline HbA1c [ Time Frame: 3 months ]. Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications.
Sponsor: Model Clinical Research LLC
Collaborator: Mannkind Corporation
Source: clinicaltrials.gov/ct2/show/NCT03324776?recrs=abdfg&spons=MANNKIND&rank=3
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Post by agedhippie on May 18, 2018 10:01:02 GMT -5
Brief Summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
Detailed Description:
Clinical inertia in intensifying treatment of type 2 diabetes patients occurs in the range of 70% in numerous real world database assessments. The investigator proposes treating patients with Afrezza who have an index HbA1c between 7.5% and 11.5% despite being treated with diabetes medications for at least 6 months. The response to Afrezza will be assessed with Continuous Glucose Monitoring Systems (CGMS) studies and initial and follow-up HbA1cs. The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur. Isn't the response going to be that you could get the same effect with RAA? There is no comparative arm using RAA like with the STAT study. This looks like a rerun of the 175 trial.
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Post by sportsrancho on May 18, 2018 10:07:04 GMT -5
Just to be clear, my new endo was willing to write me a script for Afrezza but was certain I'd be denied because my my A1c is 5.2 So, I will call Mike today and see if there's anything I can do. Thank you all. They tend to say that because they don’t want to write the pre-authorization letter but a Mannkind rep or Mannkind Cares can do that for you if you don’t want to do it.
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Post by mnholdem on May 18, 2018 10:13:40 GMT -5
agedhippie
Your factoid about RAA comparators matters little, IMHO. What's more important is that the person responsible for providing information about the STAT study at the 2018 ADA Scientific Sessions is Satish K. Garg MD, University of Colorado Denver School of Medicine Barbara Davis Center, who ALSO happens to be the Editor-in-Chief of Diabetes Technology & Therapeutics. www.liebertpub.com/loi/dia
CMO David Kendall MD stated at the ASM that MannKind is also preparing Afrezza study data for multiple publications to be released out into the medical community.
As centralcoastinvestor posted:
4. Dr. Kendall said that when he was first investigating what was out there in terms of publications for Afrezza he came across 13 publications on pubmed. He said that is not nearly enough. He stated that MannKind now has approximately 16 additional publications that will be coming out in the months ahead. This practice of constantly putting the science of Afrezza out in front of the medical community will be intentional and ongoing.
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Post by ilovekauai on May 18, 2018 10:33:40 GMT -5
It all seems so backwards to me after hearing Dr. Kendall speak at the ASM. What an eye-opener that was for me.
My current endo said I would need to go thru certain steps by my insurance before being approved for Afrezza and that would include using liquid insulin first to see how I respond, before being put on Afrezza if I did not respond well. She's locked into that standard of care stuff that needs to change. A healthy diabetic like me, does not need that stuff. Afrezza should be my very first, No. 1 option, but she fails to see that, and is old school even though she's young!
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Post by sportsrancho on May 18, 2018 10:56:51 GMT -5
Sadly I believe you have to say you have an aversion to needles or shots.
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Post by buyitonsale on May 18, 2018 11:12:44 GMT -5
Step 1 - get Afrezza prescription
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Post by boca1girl on May 18, 2018 11:12:52 GMT -5
New Form 4’s out and changes in beneficial ownership.... yes! Mike 534K Dr K 53.5K Rose 90K Interesting stock option numbers. It will be nice to see out right stock purchases by executives in the near future. I think many shareholders on this board own more shares than the executives. Dr. K said he was ready to buy as soon as he was allowed. Hopefully the other executives step up too. Mike said he was under water on the shares he purchased out right a while ago, but he owns far fewer shares than many of us here.
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Post by peppy on May 18, 2018 11:25:51 GMT -5
It all seems so backwards to me after hearing Dr. Kendall speak at the ASM. What an eye-opener that was for me. My current endo said I would need to go thru certain steps by my insurance before being approved for Afrezza and that would include using liquid insulin first to see how I respond, before being put on Afrezza if I did not respond well. She's locked into that standard of care stuff that needs to change. A healthy diabetic like me, does not need that stuff. Afrezza should be my very first, No. 1 option, but she fails to see that, and is old school even though she's young! Every physician is locked into the standards care. Look at them closely. The set up. Mealtime Insulin if you flunk triple therapy. OR GLP-1. Prior to afrezza the only mealtime insulin choice was RAA, considered dangerous secondary to hypoglycemia. Mealtime insulin is on there. Your physician is following the standards and has your hbA1c under control.
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Post by alethea on May 18, 2018 11:35:33 GMT -5
Just to be clear, my new endo was willing to write me a script for Afrezza but was certain I'd be denied because my my A1c is 5.2 So, I will call Mike today and see if there's anything I can do. Thank you all. I'm under the impression from your past posts that you seem to be relatively well off financially. Why don't you simply purchase the Afrezza Out-of-Pocket? If you have the script you can easily do that even though your insurance will not cover it. That's what I have had to do for more than a dozen boxes during the last two years........ and I don't have much money.
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Post by centralcoastinvestor on May 18, 2018 11:46:10 GMT -5
I just thought of another question and answer that I don’t think has been posted. Unfortunately this is how my mind works, not too efficiently. I remember things at odd times. Full disclosure, I am paraphrasing as I remember. Anyway, here goes:
Question: Have you thought about what break even looks like for the company?
Answer from Mike C.: Yes we are definitely thinking and working on that issue. And you deserve an answer to that question. So my hope is to have that out to you soon.
My take on this topic is that there are a lot of moving parts that make up the answer to that question. It was a good question and it appeared that Mike wants to put something out soon. My guess is that they need to see what happens to script growth in the next couple of months and the reaction to the STAT and hypoglycemia publications at the ADA.
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