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Post by mango on Feb 21, 2019 18:56:12 GMT -5
sportsrancho I'm guessing she is giving us more info than what was in the article: Afrezza + OneDrop = .93% reduction vs. RAA + OneDrop = .23% which equals a .70% difference She is ex-OneDrop so she may know the full results. Failing that hopefully they give them in the results call. Her and Jeff (along with some others) have published a couple of posters last year based on this clinical trial (do not include these data disclosed today). I'm not sure if there is additional info tied to them that I am not seeing, or if more results and info will be disclosed in the near future, but anyways here they are via ADA diabetes.diabetesjournals.org/content/67/Supplement_1/890-Pdiabetes.diabetesjournals.org/content/67/Supplement_1/889-P
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Post by sayhey24 on Feb 21, 2019 19:33:31 GMT -5
sportsrancho I'm guessing she is giving us more info than what was in the article: Afrezza + OneDrop = .93% reduction vs. RAA + OneDrop = .23% which equals a .70% difference She is ex-OneDrop so she may know the full results. Failing that hopefully they give them in the results call. So now we know why Dr. Kendall called it significant. What an understatement! A .7 different between afrezza and RAA and a coaching service with experience in afrezza like VDex was not even used. What would happen if One Drop had more experience with afrezza? It looks like even a novice like One Drop can get outstanding results and they did not even use the Libre. Add the Libre, some experience and what are we talking about 1.0+ ?
Aged - I would say its time to change the SOC
1. Step 1 - take a walk; lose some weight; and take the afrezza 2. Step 2 - follow Step 1.
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Post by sellhighdrinklow on Feb 21, 2019 22:13:52 GMT -5
It must be absolute to be significant, right?? A1c going from 8 to 7.94 (0.7%) can’t be significant. 8 to 7.3 could be. The reference is to a 8.0 to 7.3. ...or similar
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Post by mango on Feb 22, 2019 0:42:55 GMT -5
The results of the only two real-life, RCTs with Afrezza have thus far been congruous with the other real-life results shared publicly online nearly everyday by both type 1 and type 2 Afrezza users.
When we remove all the smoke and mirrors, we see that Afrezza is the superior mealtime insulin, and remains to be the only insulin with a profile that matches physiologic insulin.
The A-One clinical trial involved a large, diverse participant population with T2D. All the participants had prior experience with using an injectable mealtime insulin. None of the participants had any prior experience with using Afrezza, and none the participants had any prior experience with using One Drop—no matter how the cards fall here, Afrezza has proven yet again to be the superior mealtime insulin for people living with diabetes.
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Post by longliner on Feb 22, 2019 0:55:16 GMT -5
The results of the only two real-life, RCTs with Afrezza have thus far been congruous with the other real-life results shared publicly online nearly everyday by both type 1 and type 2 Afrezza users. When we remove all the smoke and mirrors, we see that Afrezza is the superior mealtime insulin, and remains to be the only insulin with a profile that matches physiologic insulin. The A-One clinical trial involved a large, diverse participant population with T2D. All the participants had prior experience with using an injectable mealtime insulin. None of the participants had any prior experience with using Afrezza, and none the participants had any prior experience with using One Drop—no matter how the cards fall here, Afrezza has proven yet again to be the superior mealtime insulin for people living with diabetes. Even when used with a straw!! Take that FDA!!! "Oh no, that new inhaler just may not be equivalent" Thanks FDA, for caving to the felon Shkreli over Alfred Mann!!
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Post by lakers on Feb 22, 2019 4:11:30 GMT -5
You ain’t see nothing yet. “We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore. We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.” The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs for at least 6 months. Think of it as speeding up Time To A1C Target (TTT). clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1Brief 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.Afrezza Inhalant Product Patients will be instructed to follow a Weekly Treat-to-Target BG Testing Regimen and make Afrezza dose changes according to an Afrezza Titration Algorithm. 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. Secondary Outcome Measures : Percentage of patients having HbA1c under 7% [ 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. Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ] Demonstrate that the addition of mealtime Afrezza can lower blood glucose in uncontrolled type 2 diabetes patients.
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Post by sayhey24 on Feb 22, 2019 6:20:37 GMT -5
I think the ATA - "Adaptive Afrezza Titration Algorithm" should be renamed the NEW ADA - Afrezza Dosing Algorithm because it seems its now official, afrezza has obsoleted the ADA Step program.
Even Adam F. seems to be saying so.
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Post by prcgorman2 on Feb 22, 2019 7:23:59 GMT -5
sayhey - I hate reading AF, but you piqued my interest. I loathe asking this, but can you provide a link to what you’re referencing? (I want to read it to see if there are hints of sarcasm.)
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Post by therealisaching on Feb 22, 2019 7:59:21 GMT -5
sayhey - I hate reading AF, but you piqued my interest. I loathe asking this, but can you provide a link to what you’re referencing? (I want to read it to see if there are hints of sarcasm.)
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Post by Deleted on Feb 22, 2019 8:22:29 GMT -5
sayhey - I hate reading AF, but you piqued my interest. I loathe asking this, but can you provide a link to what you’re referencing? (I want to read it to see if there are hints of sarcasm.) The One Drop information is good news. The challenge is to turn that news into accelerated Afrezza sales. Afrezza revenue, Major Afrezza partnership, UTH milestone payments, cash & royalties from additional partnerships and major Mannkind product announcements are what will move the needle. Everything else for the most part is noise. One Drop, Peds study and the like enhance the value of Mankind and make for a better negotiating position. One question would be how quickly other trial / study data becomes available and when it does, how much patent runway remains as this data helps suitors calculate NPV, CF, etc etc... As far as AF, he will never be a fan of Mannkind for a variety of reasons... below is the Twitter stream and below the stream is a bio of the new Leerink analyst following Mannkind. /photo/1?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed&ref_url=http%3A%2F%2Fmnkd.proboards.com%2Fthread%2F10604%2Fmnkd-onedrop%3Fpage%3D4 www.businesswire.com/news/home/20180509005033/en/Pasha-Sarraf-M.D.-Ph.D.-Joins-Leerink-PartnersKeep in mind, Afrezza still remains the biggest threat there is to the DIC (Diabetes Industrial Complex) and while there are those who are in healthcare for noble reasons like helping people, others are in it for the money and some are so driven by the later, they do not care who they harm, how much pain or suffering their greed inflicts and what the costs are to society.
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Post by prcgorman2 on Feb 22, 2019 9:40:56 GMT -5
Thank you Scotta and Therealisaching. That answers that. The leopard did not change his spots.
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Post by sportsrancho on Feb 22, 2019 10:20:32 GMT -5
I can’t wait to tweet him.. Boy this IS fun😂
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Post by agedhippie on Feb 22, 2019 10:37:14 GMT -5
You ain’t see nothing yet. “We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore. We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.” The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs for at least 6 months. Think of it as speeding up Time To A1C Target (TTT). clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1Brief 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. ... This is the sort of thing that is immensely frustrating. This is a pointless trial. It has absolutely nothing to do with why endos should use Afrezza rather than other RAA insulins. The trial specifically excludes T2 who are using RAA ( Exclusion criteria: ... Currently using rapid acting insulins - Novolog, Humalog, Apidra), and there is no comparator arm using RAA to show Afrezza outperform RAA options. In the end all you can say is that adding meal time insulin for people who are failing on earlier steps will reduce their A1c. Sorry, but that's already established and covered in the SOC. This is effectively a small scale (40 patients!) rerun of the T2 phase 3 trial, but with CGMs. Stop doing this and have a proper large scale STAT trial that will provide the data to make a difference. Ok - I feel better for that rant.
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Post by harryx1 on Feb 22, 2019 10:44:53 GMT -5
You ain’t see nothing yet. “We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore. We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.” The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs for at least 6 months. Think of it as speeding up Time To A1C Target (TTT). clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1Brief 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. ... This is the sort of thing that is immensely frustrating. This is a pointless trial. It has absolutely nothing to do with why endos should use Afrezza rather than other RAA insulins. The trial specifically excludes T2 who are using RAA ( Exclusion criteria: ... Currently using rapid acting insulins - Novolog, Humalog, Apidra), and there is no comparator arm using RAA to show Afrezza outperform RAA options. In the end all you can say is that adding meal time insulin for people who are failing on earlier steps will reduce their A1c. Sorry, but that's already established and covered in the SOC. This is effectively a small scale (40 patients!) rerun of the T2 phase 3 trial, but with CGMs. Stop doing this and have a proper large scale STAT trial that will provide the data to make a difference. Ok - I feel better for that rant. You're full of B.....t None of the results from any of the trials or real world are good enough for you. But that's fine because it will be for the other millions of pwd out there. Straight from the trial site... Estimated Enrollment : 400 participants clinicaltrials.gov/ct2/show/NCT03313960
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Post by brotherm1 on Feb 22, 2019 10:47:54 GMT -5
I think Aged is referring to the Levine clinical out of Maryland
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