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Post by agedhippie on Sept 11, 2017 21:02:02 GMT -5
Is the label change the KEY that will unlock all doors? Let's assume the label change includes a brand new ULTRA rapid acting category of insulin for Afrezza. Mike mentioned this on the call today. Potential Impacts: Better tier 1/2 formulary coverage? Cheaper afrezza for patients, higher likelihood of prescription from docs? Are they waiting for new FDA label to submit for international markets approval? A brand new class of insulin is more likely to get fast track approval in some jurisdictions. A financial backer could be waiting to re-capitalize the company based on the new label designation? Why invest now when you can wait to see if new label is approved and makes the company more valuable? End of September we will know Ultra on label is KEY but Less Hypo opens the door! I think it's the other way around. Ultra is a feature and what will happens is doctors will ask what the impact of that speed is - the trial data says it has no impact. Reduced hypos on the other hand is a benefit, it's obvious why you want that and the data supports it. Doctors want drugs to have benefits, not features. |
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Post by zuegirdor on Sept 12, 2017 11:31:19 GMT -5
From the ADA 2017 standard of care "Hypoglycemia is the major limiting factor in the glycemic management of patients with type 1 diabetes." and "A reasonable HbA1c goal for many nonpregnant adults is less than 7% (A rating). Providers might suggest more stringent HbA1c goals (such as <6.5%) for selected individuals if this can be achieved without clinically significant hypoglycemia or other adverse effects. Appropriate patients might include those with short duration of diabetes, long life expectancy, or no clinically significant cardiovascular disease (C rating). Less stringent HbA1c goals (such as <8%) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, or long-standing diabetes, in whom the goal is difficult to achieve despite diabetes self-management education, appropriate glucose monitoring, and intensive insulin therapy " Put together with the fact that diabetes is treated in the home setting 24/7 52 weeks a year for as long as you live, and that a person likely won't spend more than two hours a year in their endo's office: Now you've got the makings of a huge market for misery and profit taking! There's basically nothing the professionals can do for you because it is more complicated than most can fathom and so depressing even for those who do fathom it that outcomes have not changed much over the last few of decades. Enter Afrezza. Just had a blood pressure check yesterday. Before my teen went on Afrezza, I tested 150 in spite of daily workouts for the prior 6 months. My doctor was very sympathetic. knowing I have a T1d son, but insisted I go on meds. I begged for some time. My best reading in years: 120/73. The difference: 9 months of Afrezzza for my son helped us both. annals.org/aim/article/2653838/treatment-type-1-diabetes-synopsis-2017-american-diabetes-association-standards |
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Post by myocat on Sept 12, 2017 12:08:26 GMT -5
Table 1 - Pharmacokinetic of Insulin Products
Insulin Type
Rapid Acting Insulins
blah
blah
blah
Inhaled Insulin (bingo)
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Post by zuegirdor on Sept 12, 2017 13:34:59 GMT -5
Well they have it on the list or Rapid actors. but not distinguished by time to peak- which hopefully they will have later this month?
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Post by sportsrancho on Sept 12, 2017 13:40:21 GMT -5
Well they have it on the list or Rapid actors. but not distinguished by time to peak- which hopefully they will have later this month? Just had a blood pressure check yesterday. Before my teen went on Afrezza, I tested 150 in spite of daily workouts for the prior 6 months. My doctor was very sympathetic. knowing I have a T1d son, but insisted I go on meds. I begged for some time. My best reading in years: 120/73. The difference: 9 months of Afrezzza for my son helped us both. Love that so much! You should tell Mike. ( The domino affect of Afrezza:-) |
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Post by zuegirdor on Sept 12, 2017 15:33:20 GMT -5
Now if I can just get my A!C below 6.0 With Afrezza my T1d son and I now have the same A1C!
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Post by kc on Sept 12, 2017 15:56:45 GMT -5
Well they have it on the list or Rapid actors. but not distinguished by time to peak- which hopefully they will have later this month? Love to see a side-by-side example posted in an advertisement format |
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Post by sellhighdrinklow on Sept 14, 2017 9:23:56 GMT -5
Did Urbanski have the majority of input in Mannkind's label change request to the FDA? I'm concerned he screwed something up and decided to leave the company because of it. I really hope my fear is 100% off base.
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Post by straightly on Sept 14, 2017 9:41:30 GMT -5
Did Urbanski have the majority of input in Mannkind's label change request to the FDA? I'm concerned he screwed something up and decided to leave the company because of it. I really hope my fear is 100% off base. R u selling or buying? Just curious. |
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Post by madog365 on Sept 14, 2017 9:45:08 GMT -5
Did Urbanski have the majority of input in Mannkind's label change request to the FDA? I'm concerned he screwed something up and decided to leave the company because of it. I really hope my fear is 100% off base. the actual work for submission is done by a group of scientist worker bees so if something was screwed up, it was a group effort. Either way Mike and team knows what was submitted and they would not continue pushing the label change narrative if they didn't expect to receive an approval. |
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Post by sellhighdrinklow on Sept 14, 2017 10:19:37 GMT -5
Did Urbanski have the majority of input in Mannkind's label change request to the FDA? I'm concerned he screwed something up and decided to leave the company because of it. I really hope my fear is 100% off base. R u selling or buying? Just curious. I've been buying all the way down and haven't sold any on the uptrend. I've been buying because I'm an Afrezza user for the past 27-months (Type 1 for almost 40-years) and Afrezza has absolutely changed my life beyond what I hoped for before starting Afrezza. I posted my comment because it's been on my mind. |
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Post by ghochr on Sept 14, 2017 10:20:38 GMT -5
Did Urbanski have the majority of input in Mannkind's label change request to the FDA? I'm concerned he screwed something up and decided to leave the company because of it. I really hope my fear is 100% off base. the actual work for submission is done by a group of scientist worker bees so if something was screwed up, it was a group effort. Either way Mike and team knows what was submitted and they would not continue pushing the label change narrative if they didn't expect to receive an approval. In general and not particularly related to label change... If they did screw up something, do u think they will change the narrative now? Or will they wait out until FDA decision and keep pushing the narrative until then. I would think the later. Remember the dilution announcement in may 2016. |
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Post by hammer on Sept 15, 2017 7:00:42 GMT -5
A new label with new designation as ultra rapid clears the future for Afrezza. So why does my gut expect expect approval for Fiasp and denial of Afrezza? Sorry I don't put anything past the FDA. If that were to happen they may expose their relation with BP. Content in their ways they may see fit to deny both a new designation. Resting upon previous determinations that neither drug acts faster while completely disregarding the evidence that Afrezza reaches peak action faster and is out of the system faster than anything available.
After watching the FDA in action during the public panel, they are stuck in a time warp and dependent upon looking at statistics from poorly administered trials designed to provide comparison to two distinct different acting drugs. In essence they compared Usain Bolt and a Wheelchair athlete in the 100 meter, but made Bolt use a wheel chair as well. Definitive proof that Bolt is not faster!
I hope I am wrong!
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Post by radgray68 on Sept 15, 2017 17:02:39 GMT -5
"In essence they compared Usain Bolt and a Wheelchair athlete in the 100 meter, but made Bolt use a wheel chair as well.
"
Great analogy for the FDA's contribution to the studies. I recall a GS analyst downgrading Mannkind soon after approval because of the crummy label it was saddled with. I HATED to hear that back then. I didn't believe it was possible. Just more FUD and stuff. I didn't think to save the report but he said something to the effect that "with the current label, Mannkind wouldn't be profitable until 2019" I'm loosely quoting here, but those GS guys have been doing this for a lot longer than I have and they were actually correct in their summation. The label is an anchor for Afrezza. Thanks FDA. Thanks.
Here's to hoping they do right by us this time around.
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Post by afrezza on Sept 18, 2017 5:43:15 GMT -5
That would be great to get a label designation that no other Insulin has. But you can expect that the Big Pharma boys will lobby the FDA to try and prevent that from happening. This is a war and they are in it to destroy the little company MannKind. All the talk about BP wants to destroy MNKD..... If they really are afraid of our success then why they just don't buy the company and own the product ? They can get it right now at a super discount price. Truth is they don't believe in the product and are not interested at all until our scripts reach levels worth talking about. |
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