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Post by Deleted on Jun 11, 2017 9:53:40 GMT -5
peppy "The most common is a condition called insulin resistance in which some receptors in the liver and the muscle cells stop responding properly to insulin." Is there a credible scientific study to justify that statement?
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Post by peppy on Jun 11, 2017 10:04:09 GMT -5
peppy "The most common is a condition called insulin resistance in which some receptors in the liver and the muscle cells stop responding properly to insulin." Is there a credible scientific study to justify that statement? the study looks impressive. grater than 4,000 participants, multiple countries in europe. listen to him. 5 types of insulin resistance identified. the video explains why regeneron had a cardiovascular medication in trials with afrezza. Doesn't it.
The biochemical engineer is European. Since the state of affairs in the united states is physicians are obligated to not use their eyeballs, I think I may trust this speaker/study more. Look at the zoo we have running this country. hmmm
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Post by Deleted on Jun 11, 2017 10:08:31 GMT -5
peppy was this published in a respected medical journal?
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Post by peppy on Jun 11, 2017 10:10:57 GMT -5
peppy was this published in a respected medical journal? kastances, look it up. I am not your personal secretary, although I can be bought. (consider me the board Flynn.) this stops now, we can not steal the thread.
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Post by mnholdem on Jun 11, 2017 10:37:06 GMT -5
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Post by sportsrancho on Jun 14, 2017 13:18:06 GMT -5
Can anyone confirm this?
Aloha96707 Wednesday, 06/14/17 10:34:26 AM
Re: Hypi post# 24134
Post # of 24138
I heard from friend that VDEX is writing about 300 scripts a month.
With every new patient they attached a CGM for a week and monitor their BG Levels and their diet. They give them samples with strict instructions so that they can see how the patient reacts. After the first week they will adjust. It's a smart way to ease the patient on to Afrezza and for the patient to understand Afrezza.
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Post by liane on Jun 14, 2017 13:28:03 GMT -5
Hope it's true.
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Post by compound26 on Jun 14, 2017 13:40:55 GMT -5
Can anyone confirm this? Aloha96707 Wednesday, 06/14/17 10:34:26 AM Re: Hypi post# 24134 Post # of 24138 I heard from friend that VDEX is writing about 300 scripts a month. With every new patient they attached a CGM for a week and monitor their BG Levels and their diet. They give them samples with strict instructions so that they can see how the patient reacts. After the first week they will adjust. It's a smart way to ease the patient on to Afrezza and for the patient to understand Afrezza. Some of the older posts from the same author： Aloha96707 Sunday, 06/04/17 12:22:20 PM Re: nobodysbusiness post# 23872 Post # 23886 Wait until the pulmonary lung test is not required. Rumor has it with the upcoming new label it will be REMOVED. Aloha96707 Sunday, 06/04/17 12:01:43 PM Re: DownWithPumpers post# 23828 Post # 23884 A buddy of mine made an Appt for next Friday at VDEX for an assessment. His ENDO would not prescribe Afrezza. She's in for a big surprise when he goes for his next 6 month checkup. --------------------------------------------------------------------------------------------------------------- So, assuming what he posted on June 4 was true, he has a friend who had an appointment with VDEX on June 9, 2017. And he may have learned something from talking with this friend? |
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Post by peppy on Jun 14, 2017 13:44:55 GMT -5
I do not believe the pulmonary test will be removed with the up coming label change.
(Based on, I read plenty of labels, black boxes are on many, some have blue boxes.)
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Post by mnholdem on Jun 14, 2017 13:46:21 GMT -5
There is data from 40,000 prescriptions, so CDER should be able to make that determination if there have been few serious lung problems and, similar to the first inhaled insulin by Pfizer, they could change the FEV test to a recommendation vs requirement. I, too, this has a good chance of happening on the new label.
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Post by zuegirdor on Jun 14, 2017 13:59:05 GMT -5
Can anyone confirm this? Aloha96707 Wednesday, 06/14/17 10:34:26 AM Re: Hypi post# 24134 Post # of 24138 I heard from friend that VDEX is writing about 300 scripts a month. With every new patient they attached a CGM for a week and monitor their BG Levels and their diet. They give them samples with strict instructions so that they can see how the patient reacts. After the first week they will adjust. It's a smart way to ease the patient on to Afrezza and for the patient to understand Afrezza. So the obvious next question must be, why is this not showing up in the script numbers? |
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Post by scoy on Jun 14, 2017 14:06:30 GMT -5
There is data from 40,000 prescriptions, so CDER should be able to make that determination if there have been few serious lung problems and, similar to the first inhaled insulin by Pfizer, they could change the FEV test to a recommendation vs requirement. I, too, this has a good chance of happening on the new label. My understanding from reading the FDA briefing document is that Mannkind requested the spirometry test be part of the label. I do no think the FDA will go against Mannkind's recommendation since the huge safety study was never performed. Getting the safety study started, getting Mannkind approved over as much of the world as possible is all stuff that in my opinion should've happened back in 2015. The sponsor has proposed in the Afrezza labeling that Afrezza be contraindicated in patients with a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD) or other chronic lung disease. The sponsor also has proposed labeling under Warnings and Precautions that Afrezza not be recommended for current smokers and those who have smoked in the last 6 months and that prior to initiating therapy with Afrezza, all patients should be clinically evaluated with a detailed medical history, physical examination and spirometry (FEV1) to identify any potential underlying disease. |
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Post by zuegirdor on Jun 14, 2017 14:08:49 GMT -5
Is there a scientific explanation for "insulin resistance" or is this theory similar to "pancreatic phase response"? My endo told me that Insulin resistance is reversible. It is caused by inactivity. Get active. Stay active. However, your pancreas's capacity to deliver insulin is genetically pre-determined. Use it slow or use it fast by eating more or less carbs per meal. You will only have so much insulin to secrete over your lifetime. Possible exception is that there is some evidence that "starvation mimicking" diets can regenerate beta cells in the pancreas. |
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Post by seanismorris on Jun 14, 2017 14:31:45 GMT -5
Can anyone confirm this? Aloha96707 Wednesday, 06/14/17 10:34:26 AM Re: Hypi post# 24134 Post # of 24138 I heard from friend that VDEX is writing about 300 scripts a month. With every new patient they attached a CGM for a week and monitor their BG Levels and their diet. They give them samples with strict instructions so that they can see how the patient reacts. After the first week they will adjust. It's a smart way to ease the patient on to Afrezza and for the patient to understand Afrezza. Re: VDEX is writing about 300 scripts a month. I find that hard to believe... First off, our sales force would have to have had a negative impact on Afrezza's script counts. It's hard to imagine they're that incompetent... And second, I don't think 300 is physically possible with only one location. Afrezza is only targeting a relatively small portion of the diabetes population. Given that, VDEX would have to be swamped with patents.... they'd have opened another location by now. I think VDEX writing 300 Afrezza scripts total (since they opened) would be more reasonable. |
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Post by peppy on Jun 14, 2017 14:46:30 GMT -5
just throwing it out in the atmosphere, I thought I read vdex opened another location, was it @ 3 weeks ago I read it?
Am I incorrect?
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