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Afrezza
Mar 3, 2017 14:14:01 GMT -5
Post by peppy on Mar 3, 2017 14:14:01 GMT -5
I have been doing some digging and while many of you know, I want to talk about it. So this is what the physicians are battling with. 1) number of actual delivered units through airway. 2) how to dose. 3) patients thinking it isn't working when their dosages go up after the the honeymoon period.
Afrezza.
www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000OtherActionLtrs.pdf
Page 3 second letter.
15 units of insulin in a cartridge delivers the equivalent of approximately 4 units of insulin labeled. (delivered.)
30 units of insulin in a cartridge delivers the equivalent of approximately 8 units of insulin labeled (delivered)
Additionally after the honeymoon period, the amount of insulin a diabetic needs increases until it stabilizes. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
The continuous glucose monitors tell the true story of how well Afrezza works.
Physicians, even if they decide to try it, did not know how to dose. Initially went I looked, I could see the physicians thinking regarding the amount of insulin. The amount of insulin over subq is greatly increased. Thinking it through, the "Results: The 7-point blood glucose measurements indicated that postprandial glycemic
excursions were of lesser magnitude with TI + basal insulin than with BPR 70/30. There
were more hypoglycemic events in the BPR 70/30 group than in the TI group." (page 187)
Afrezza really is the insulin you can take. phase one and phase two insulin reactions, and diabetes do not get a phase one with subq. www.screencast.com/t/qHsWcjqc www.screencast.com/t/pYQ4TMFaY
TI + basal insulin was noninferior to BPR 70/30 in terms of the primary assessment of
HbA1c change at 52 weeks. TI + basal insulin, like BPR 70/30, provided a significant
reduction in HbA1c that was sustained over 52 weeks. TI + basal insulin resulted in less
weight gain. 
There is the battle. Afrezza the insulin you can take.
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Deleted
Deleted Member
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Post by Deleted on Mar 3, 2017 14:18:20 GMT -5
holy wall of ..
u lost me there peppy
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Post by agedhippie on Mar 3, 2017 14:20:30 GMT -5
Doctors are initially concerned to prescribe because of the step sizes in dosing. They are used to the impact of a single unit in RAA and worried that this will be reflected in Afrezza. It's obviously incorrect but that is a perception. Somehow Mannkind needs to get the idea over to the doctors that Afrezza does not need to be precise. I am not sure how to do that though.
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Afrezza
Mar 3, 2017 14:24:01 GMT -5
Post by peppy on Mar 3, 2017 14:24:01 GMT -5
holy wall of .. u lost me there peppy look at the increase of TI units between week 1 and week 12, iam2. and basal for that matter.
additionally, look at how much subq insulin people take in the study.
It looks like the physicians know even with subq analogs that the initial dosing goes up. they have no clue how to dose. then they see the numbers and it is way over their comfort level? then if you know the actual units... used... 10 units to deliver 4 units
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Post by kbrion77 on Mar 3, 2017 14:35:37 GMT -5
Doctors are initially concerned to prescribe because of the step sizes in dosing. They are used to the impact of a single unit in RAA and worried that this will be reflected in Afrezza. It's obviously incorrect but that is a perception. Somehow Mannkind needs to get the idea over to the doctors that Afrezza does not need to be precise. I am not sure how to do that though.My biggest fear is that by the time MNKD and doctors figure this drug out it will either have been sold for pennies on the dollar or the company went bankrupt. I honestly have no idea if Afrezza is just to revolutionary for anyone to nail down the science in the real world but their new titration pack to me seems like its welp here is a ton of different options give it a whirl! |
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Post by peppy on Mar 3, 2017 14:37:22 GMT -5
Doctors are initially concerned to prescribe because of the step sizes in dosing. They are used to the impact of a single unit in RAA and worried that this will be reflected in Afrezza. It's obviously incorrect but that is a perception. Somehow Mannkind needs to get the idea over to the doctors that Afrezza does not need to be precise. I am not sure how to do that though.My biggest fear is that by the time MNKD and doctors figure this drug out it will either have been sold for pennies on the dollar or the company went bankrupt. I honestly have no idea if Afrezza is just to revolutionary for anyone to nail down the science in the real world but their new titration pack to me seems like its welp here is a ton of different options give it a whirl! liane will kill me. A bit like antigravity and free energy from the ether. By the time we all figure out....
Al Mann was smart as could be.
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Post by agedhippie on Mar 3, 2017 14:39:11 GMT -5
Doctors are initially concerned to prescribe because of the step sizes in dosing. They are used to the impact of a single unit in RAA and worried that this will be reflected in Afrezza. It's obviously incorrect but that is a perception. Somehow Mannkind needs to get the idea over to the doctors that Afrezza does not need to be precise. I am not sure how to do that though.My biggest fear is that by the time MNKD and doctors figure this drug out it will either have been sold for pennies on the dollar or the company went bankrupt. I honestly have no idea if Afrezza is just to revolutionary for anyone to nail down the science in the real world but their new titration pack to me seems like its welp here is a ton of different options give it a whirl! The problem remains the step size, not the dose size itself. In fairness I made the same mistake when I first looked at Afrezza and thought the step was to large. |
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Post by peppy on Mar 3, 2017 14:55:02 GMT -5
My biggest fear is that by the time MNKD and doctors figure this drug out it will either have been sold for pennies on the dollar or the company went bankrupt. I honestly have no idea if Afrezza is just to revolutionary for anyone to nail down the science in the real world but their new titration pack to me seems like its welp here is a ton of different options give it a whirl! The problem remains the step size, not the dose size itself. In fairness I made the same mistake when I first looked at Afrezza and thought the step was to large. Al Mann made an insulin people could take. people are afraid.
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Post by sportsrancho on Mar 3, 2017 15:00:28 GMT -5
The problem remains the step size, not the dose size itself. In fairness I made the same mistake when I first looked at Afrezza and thought the step was to large. Al Mann made an insulin people could take. people are afraid.
I think that may be right. But kids aren't afraid. They embrace it. Not that that's doing us much good at this time. |
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Post by surplusvalue on Mar 3, 2017 15:34:45 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. '
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Post by peppy on Mar 3, 2017 16:00:09 GMT -5
we have figured out the dosing for the most part. The diabetes figured it out for us. Not the physicians.
As a general rule, I dose about 10 minutes after I start eating, which is before my glucose levels start to rise from the meal. As I mention in the video, the best time to dose seems to depend on the fat content of the meal. And for some high fat meals, a follow up dose of Afrezza is neccesary.
I have found the same rule also applies if a follow-up dose is required. It is important to have the follow-up dose before the levels begin to rise out of range. If I had a CGM with alerts, I would use this to notify me as soon as it levels began to increase. That way I wouldn’t miss the optimum time for the follow-up.
It is worth remembering that much, much more Afrezza is needed to correct high glucose levels than to cover meals.
The follow up dose at 45 mins after initial dose if glucose is going up and between 120 and 130.
The titration pack. They know. They have to get the physicians and diabetes the knowledge and comfort.
Additionally corrections: one 4 u will bring glucose down 30mg/dl in 90 mins from the pharmacist and diabetic that wrote the article. Easy as pie really. Once you know.
afrezzadownunder.com/2015/10/afrezza-timing-is-everything/
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Post by nylefty on Mar 3, 2017 16:40:12 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. ' But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. |
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Post by compound26 on Mar 3, 2017 16:41:36 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. ' But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. Agree. If we get the ultra-fast classification and fewer hypo indication, that would greatly help! My understand is that Mannkind applied for both. |
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Afrezza
Mar 3, 2017 16:50:31 GMT -5
Post by careful2invest on Mar 3, 2017 16:50:31 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. ' But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. They could still start advertising in a low cost, well put together, efficient and effective way until they get the label change and then build from there. The biggest problem is...No one has ever heard of AFREZZA! Yet MNKD does a reverse split "from a position of strength" no less, and we find ourselves down another 12 percent. It just does not add up! |
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Post by dreamboatcruise on Mar 3, 2017 17:01:43 GMT -5
But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. They could still start advertising in a low cost, well put together, efficient and effective way until they get the label change and then build from there. The biggest problem is...No one has ever heard of AFREZZA! Yet MNKD does a reverse split "from a position of strength" no less, and we find ourselves down another 12 percent. It just does not add up! The "from strength" was simply BS. Wish they hadn't used that phrase. So don't try to add that up to anything. The price action since announcement of RS vote through today adds up quite well with what normally happens with companies forced to do RS. I'm just hoping they can do some targeted advertising... online targeted at PWD and on TV targeted at specific regions with the highest payer coverage and where extra effort has gone to educate doctors. If they could show a strong turn around in one geographic region I think that could be the foundation for a raising capital. At least it would be better than raising capital the way things stand now... if that would even be possible. |
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