|
Post by mango on Jul 29, 2017 12:29:21 GMT -5
Couple of highlights.
|
|
|
Post by sayhey24 on Jul 29, 2017 13:58:31 GMT -5
Mango - the paper raises an interesting question of which I have never seen a study on. Have you seen a study showing what normal BG levels are in a 24/7 profile? Bernstein says 83 is non-diabetic fasting BG and 66 for a woman who is pregnant.
In this paper they show the 56 yr male who they say is non-diabetic but his BG sure seems higher than 83. Does fasting BG increase by age? Or would a 90 yr non-diabetic test 83? Got study?
The question in my head is, is BG directly tied to being able to predict longevity? In other words, if afrezza is as safe as VDex says it is, and BG is a good predictor of longevity, could a case be made to pro-actively prescribe afrezza to everyone going beyond a very tight "non-diabetic" range. Its the same discussion they had with statins and LDL but now we know the problem with LDL is not the LDL but rather the sugar attached to the LDL from high BG.
|
|
|
Post by mango on Jul 29, 2017 14:36:14 GMT -5
Mango - the paper raises an interesting question of which I have never seen a study on. Have you seen a study showing what normal BG levels are in a 24/7 profile? Bernstein says 83 is non-diabetic fasting BG and 66 for a woman who is pregnant. In this paper they show the 56 yr male who they say is non-diabetic but his BG sure seems higher than 83. Does fasting BG increase by age? Or would a 90 yr non-diabetic test 83? Got study? The question in my head is, is BG directly tied to being able to predict longevity? In other words, if afrezza is as safe as VDex says it is, and BG is a good predictor of longevity, could a case be made to pro-actively prescribe afrezza to everyone going beyond a very tight "non-diabetic" range. Its the same discussion they had with statins and LDL but now we know the problem with LDL is not the LDL but rather the sugar attached to the LDL from high BG. Dude I was thinking along the same line of thought as you when I was reading through some of this. Might very well be common place in the future. Afrezza for all.
|
|
|
Post by peppy on Jul 29, 2017 14:41:12 GMT -5
Mango - the paper raises an interesting question of which I have never seen a study on. Have you seen a study showing what normal BG levels are in a 24/7 profile? Bernstein says 83 is non-diabetic fasting BG and 66 for a woman who is pregnant. In this paper they show the 56 yr male who they say is non-diabetic but his BG sure seems higher than 83. Does fasting BG increase by age? Or would a 90 yr non-diabetic test 83? Got study? The question in my head is, is BG directly tied to being able to predict longevity? In other words, if afrezza is as safe as VDex says it is, and BG is a good predictor of longevity, could a case be made to pro-actively prescribe afrezza to everyone going beyond a very tight "non-diabetic" range. Its the same discussion they had with statins and LDL but now we know the problem with LDL is not the LDL but rather the sugar attached to the LDL from high BG.
www.slideshare.net/StephenPonder/sugar-surfing-with-a-cgm-copyright-tlc-advanced-diabetes-retreat-april-26-2014 page 3
|
|
|
Post by lakers on Jul 29, 2017 14:42:48 GMT -5
The seminal observational study link is even more important than the short term Sept label improvement rounding out the collateral making life much easier for sale reps. Powerful indeed! Gratefully.
|
|
|
Post by lennymnkd on Jul 29, 2017 14:55:44 GMT -5
Lakers / would love to give you a thumbs up .. but what do you mean ?
|
|
|
Post by nylefty on Jul 29, 2017 15:12:57 GMT -5
But could MannKind use this observational study in its marketing? Wouldn't the FDA object?
|
|
|
Post by peppy on Jul 29, 2017 15:27:39 GMT -5
But could MannKind use this observational study in its marketing? Wouldn't the FDA object? My gut feeling from what I think I understand is, Marketing is limited to label. Matt has gone over this.
This observational study could be published. This observational study could be looked at in conjunction with other studies in an multiple study analysis or meta-analysis.
me: I have not finished reading every word. I find the study fascinating and reassuring. Here is what I envision, correctly or incorrectly. I envision Mannmade, (who knows everything there is to know about afrezza and opened Vdex,) The CGM on. the donuts, the regular Coca-Cola. The clock. Afrezza 4 unit cartridge. Extra Coca-Cola if needed as rescue. A blood glucose monitor. He wanted to test it. He is selling it. He wanted to know. He checked it out and is telling us. Smart man. I think I love you by the Partridge Family with lyrics www.youtube.com/watch?v=slSXX7r_9hs
|
|
|
Post by dreamboatcruise on Jul 29, 2017 15:50:46 GMT -5
Nice. I've often, and recently, stated that I hoped they would do this.
Though I am really curious why they didn't include A1c results over time for study participants. I would think that would be the most powerful data to convince doctors to take a serious look at Afrezza... plus time in range data for the subset on CGM.
|
|
|
Post by dreamboatcruise on Jul 29, 2017 15:57:25 GMT -5
But could MannKind use this observational study in its marketing? Wouldn't the FDA object? No for marketing to patients. Marketing to doctors is different, but I don't claim to know exactly what is allowed. Quite frankly I don't think there really are clear boundaries. FDA sometimes takes steps that are then overturned in court. Companies have to make judgement calls about how far out on the limb they are willing to go.
|
|
|
Post by sportsrancho on Jul 29, 2017 16:10:35 GMT -5
A Final Word... We shouldn’t be surprised that this product is the outgrowth of Alfred Mann’s genius. He was innovative, brilliant, and more than a touch stubborn, qualities of all successful entrepreneurs. He counseled, “take care of the patient and the business will take care of itself.” For him, success was a byproduct of delivering value to others. He brought the world the insulin pump for Type I diabetic patients, understanding the need for a better solution to the multiple daily injections that preceded the pump. Decades ago Al saw the ravages of Type 2 diabetes as well. He felt compelled to turn his prodigious talents toward finding a solution. He saw the development of many treatments and the glaring deficiency that remained: a truly physiologic prandial insulin. The pharmaceutical industry saw the problems with insulin and developed a myriad of drugs to circumvent the use of insulin. Al Mann saw the problems with insulins and said, “We need to develop a better insulin.” Of course he did. And, he gave us Afrezza. To all medical providers in diabetes: you should heed Al Mann’s advice, “take care of patients...” In fact, that is your duty, your ethical and moral obligation. With that as your guide, you simply cannot ignore the facts presented herein, safe in the knowledge that consensus currently supports you. Current care is substandard. Afrezza is a quantum leap forward. Of course, we encourage others to conduct their own studies. Develop the data for yourselves. Challenge our conclusions. We are quite confident what you will find. We know our protocol sounds revolutionary, some might even say irresponsible. But those who say such things do so without the benefit of the facts. They are responding to emotion not data, habit not science. Our interest is in the facts, and the best possible care for diabetics, not fealty to precedence, consensus opinion, or political or economic pressure. Doctors considering our recommendations might benefit from the advice of the renowned, German mathematician, Carl Jacobi, who counseled in trying to solve a difficult dilemma, “Invert, always invert.” So, imagine, if Afrezza had been developed first, would anyone bother with all the other medications currently in use?
At this writing, Vdex is one of the largest prescribers of Afrezza.
|
|
|
Post by dreamboatcruise on Jul 29, 2017 16:12:30 GMT -5
I just did, actually before I read your comment. Rock - did you also send this to every Big Pharma President? I have been saying for a while afrezza has been living in their heads "Rent Free" since ADA 2017. It would also be nice to send it to every money manager in the diabetes space AFTER everyone here finalizes their positions on Monday. What Mike now needs to deal with is direct to consumer distribution and pricing which I suspect he has a plan for. I thought your position was that all of these people are thinking about Afrezza daily, talking to Mike and following all things MNKD as they are putting final touches on their acquisition offers... yet they need someone from proboards to inform them of a major new study about Afrezza. I guess the rent free space isn't in a very desirable neighborhood of their head... maybe in one of the sinus cavities.
|
|
|
Post by goyocafe on Jul 29, 2017 16:15:13 GMT -5
Rock - did you also send this to every Big Pharma President? I have been saying for a while afrezza has been living in their heads "Rent Free" since ADA 2017. It would also be nice to send it to every money manager in the diabetes space AFTER everyone here finalizes their positions on Monday. What Mike now needs to deal with is direct to consumer distribution and pricing which I suspect he has a plan for. I thought your position was that all of these people are thinking about Afrezza daily, talking to Mike and following all things MNKD as they are putting final touches on their acquisition offers... yet they need someone from proboards to inform them of a major new study about Afrezza. I guess the rent free space isn't in a very desirable neighborhood of their head... maybe in one of the sinus cavities. Location, location, location...
|
|
|
Post by dreamboatcruise on Jul 29, 2017 16:29:20 GMT -5
While MNKD may have constraints on using this in their sales activities (I don't know), patients certainly would be free to present this to their docs. Hopefully some will start doing that. Some docs simply aren't open to receiving info from patients but others are. Of those that are actually willing to read it, it would be very interesting as to whether it ends up being persuasive. Hard to assess the impact of this without getting some feedback about how real world practicing physicians view it. I still think a chart or graph showing how A1c drops over period of months for the cohort would have been powerful (especially with the note "no serious hypos"). Perhaps breaking into subgroups as well... those previously using prandial subq and uncontrolled vs new to prandial, those with and without CGM. Maybe they still don't have enough patient months of data to make that look conclusive. Hopefully it is coming.
|
|
|
Post by sportsrancho on Jul 29, 2017 16:32:20 GMT -5
|
|