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Post by agedhippie on Aug 19, 2019 12:24:36 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label. This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data. It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool. The lung safety data comes with some very specific requirements that make this approach tricky. Specifically they are looking for people who have a higher than normal probability of getting lung cancer.
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Post by boca1girl on Aug 19, 2019 12:27:40 GMT -5
If we can get a new classification (category) of “ultra rapid”, then maybe we can finally get decent coverage. I'm a fan bocagirl but can't resist a joke at your expense. (My sincerest apology in advance if I manage to genuinely offend.)
Your "If" statement reminded me of the joke, "If we had some ham we could have ham and eggs for breakfast if we had some eggs."
I 100% agree with your supposition and your conclusion, but it's the unsaid that made me want to tease.
My post last night was intended to challenge more extreme VDEX sycophants to explain clearly how VDEX can solve the Afrezza sales challenges created by the lack of "Class A or B" data to prove superiority of Afrezza as compared to the competitor RAA prandial insulins. To me, THAT lack of a first class clinical trial is Rome and all roads lead there.
Afrezza will not get the new "ultra rapid" classification and be able to put that on the label or tell it to Endos and PCPs without it.
For years I have refused to believe that there couldn't be quicker, cheaper, alternatives to achieving the sales goals such as TV DTC and on-line media campaigns, but those have and are being tried and the weekly NRx is stubbornly not making material progress. And, I continue to refuse to believe that Mannkind management or their salesforce are stupid, greedy, and lazy, and will not accept those complaints as valid reasons for the lack of new Afrezza sales success. Like nearly all of us, these people are making good faith efforts and we should respect them for it.
We have the facts and we've been told over and over what is lacking and what is required. It's time to recognize it (for me at least) and then demand a plan that acknowledges the challenge and builds in a roadmap to achieving first class clinical results that provide the A or B quality of data on the scale that is required, even if that is 5 years away.
Because of the Sanofi perfidy, like a baby Mannkind must crawl before it can walk before it can run. I believe the current roadmap being executed is sensible given where Mannkind is in it's journey, but I want to see more acknowledgement for how/when we get to being able to lay legitimate claim to superiority which is probably a longer term goal unless something happens sooner to accelerate it.
Why do you say we won’t get the “ultra” category? Because of the resistance of the ADA?
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Post by prcgorman2 on Aug 19, 2019 13:58:46 GMT -5
Bocagirl, I might misunderstand but I thought that claiming "ultra-rapid" meant FDA approval of a new category beyond "rapid acting". In fact, I thought Mannkind had already applied for that designation and been turned down. I don't know if we can ever get that approved, even if we're able to prove (to the satisfaction of the FDA, insurers, and prescribers) that Afrezza is superior to RAA prandial insulins.
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Post by harryx1 on Aug 19, 2019 14:26:08 GMT -5
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Post by ktim on Aug 19, 2019 15:40:03 GMT -5
If we can get a new classification (category) of “ultra rapid”, then maybe we can finally get decent coverage. I'm a fan bocagirl but can't resist a joke at your expense. (My sincerest apology in advance if I manage to genuinely offend.)
Your "If" statement reminded me of the joke, "If we had some ham we could have ham and eggs for breakfast if we had some eggs."
I 100% agree with your supposition and your conclusion, but it's the unsaid that made me want to tease.
My post last night was intended to challenge more extreme VDEX sycophants to explain clearly how VDEX can solve the Afrezza sales challenges created by the lack of "Class A or B" data to prove superiority of Afrezza as compared to the competitor RAA prandial insulins. To me, THAT lack of a first class clinical trial is Rome and all roads lead there.
Afrezza will not get the new "ultra rapid" classification and be able to put that on the label or tell it to Endos and PCPs without it.
For years I have refused to believe that there couldn't be quicker, cheaper, alternatives to achieving the sales goals such as TV DTC and on-line media campaigns, but those have and are being tried and the weekly NRx is stubbornly not making material progress. And, I continue to refuse to believe that Mannkind management or their salesforce are stupid, greedy, and lazy, and will not accept those complaints as valid reasons for the lack of new Afrezza sales success. Like nearly all of us, these people are making good faith efforts and we should respect them for it.
We have the facts and we've been told over and over what is lacking and what is required. It's time to recognize it (for me at least) and then demand a plan that acknowledges the challenge and builds in a roadmap to achieving first class clinical results that provide the A or B quality of data on the scale that is required, even if that is 5 years away.
Because of the Sanofi perfidy, like a baby Mannkind must crawl before it can walk before it can run. I believe the current roadmap being executed is sensible given where Mannkind is in it's journey, but I want to see more acknowledgement for how/when we get to being able to lay legitimate claim to superiority which is probably a longer term goal unless something happens sooner to accelerate it.
I wouldn't think it's impossible the FDA might create a new designation separate from any particular company doing trials. Though I've always thought many here are attaching some magical properties to an extra adjective that would probably not be terribly meaningful in the end. As you point out, regardless of what it is called, the trial data proving superiority is what would really move the needle. Decisions about formularies aren't based on adjectives. Kaiser still forces some patients to use Humulin. Just because some prandials have "rapid" as a descriptor doesn't mean Kaiser can't have barriers to their use based on the added expense (one example that I happen to know of). I'm not saying zero marketing value to "ultra", but I doubt a game changer. The pk/pd profile is in the prescribing lit and that certainly is being presented to doctors already. It's just that MNKD can't claim that results in better A1c. Same would hold even if FDA were to allow Afrezza, and perhaps Fiasp, to be called "ultra rapid".
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Post by prcgorman2 on Aug 19, 2019 15:51:11 GMT -5
Well, bocagirl did say "decent coverage", not "preferred" (the Holy Grail of coverage classifications).
I think even "preferred" is possible, not because of ultra-rapid designation which I assume has great value as easy to remember marketing language, but because of presumed ability to prove significant reductions in comorbidity using ultra-fast acting insulin to improve TIR.
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Post by agedhippie on Aug 19, 2019 17:21:21 GMT -5
Well, bocagirl did say "decent coverage", not "preferred" (the Holy Grail of coverage classifications). I think even "preferred" is possible, not because of ultra-rapid designation which I assume has great value as easy to remember marketing language, but because of presumed ability to prove significant reductions in comorbidity using ultra-fast acting insulin to improve TIR. The problem is that word presumed. This circles back to your original point about needing trials to prove and not presume. Even TIR itself is not on rock solid ground. There are trials and surveys going on into that now. There is a presumption that TIR leads to better results, but it's not yet proven. Happily Mannkind will not be the ones bearing the cost on that one, and Lilly and Novo both have an interest in getting that data.
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Post by sayhey24 on Aug 19, 2019 19:09:56 GMT -5
Aged - how many trials do we need to show that BG over 140 for 2+hours causes vascular degeneration? How many trials do we need to show nothing can bring post meal BG's down as fast as afrezza?
Stop the post meal 140+ spike, get it back to a fasting under 140 and do you think you will see improved cardiovascular health? Talk about Jardiance and Victoza. I will say afrezza will win that trail hands down and with out the thyroid cancer.
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Post by brotherm1 on Aug 19, 2019 21:49:37 GMT -5
Well, bocagirl did say "decent coverage", not "preferred" (the Holy Grail of coverage classifications). I think even "preferred" is possible, not because of ultra-rapid designation which I assume has great value as easy to remember marketing language, but because of presumed ability to prove significant reductions in comorbidity using ultra-fast acting insulin to improve TIR. The problem is that word presumed. This circles back to your original point about needing trials to prove and not presume. Even TIR itself is not on rock solid ground. There are trials and surveys going on into that now. There is a presumption that TIR leads to better results, but it's not yet proven. Happily Mannkind will not be the ones bearing the cost on that one, and Lilly and Novo both have an interest in getting that data. So the ADA added TIR recommendations to their SOC based upon presumptions? I'm not doubting what you said though it just seems odd to me as I was under the impression that they base the SOC on large clinical studies?
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Post by ktim on Aug 19, 2019 23:27:08 GMT -5
Aged - how many trials do we need to show that BG over 140 for 2+hours causes vascular degeneration? How many trials do we need to show nothing can bring post meal BG's down as fast as afrezza? Stop the post meal 140+ spike, get it back to a fasting under 140 and do you think you will see improved cardiovascular health? Talk about Jardiance and Victoza. I will say afrezza will win that trail hands down and with out the thyroid cancer. I think you've mentioned that 2 hour and 140 threshold many times. What is the study that concluded that? Was it a large trial and using CGM? I wasn't aware there was some settled science on precise numbers, though obviously there is a known strong correlation with hyperglycemia and cardiovascular disease.
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Post by mnholdem on Aug 20, 2019 7:48:39 GMT -5
Good points. While I am far from being a “sycophant” about VDex, their business plan seems to rely heavily on results. As you point out, without empirical evidence, MannKind’s sales strategy cannot include results that are not supported by the label. This is one reason why I believe the former CEO wanted to collaborate with VDex to gather real-world clinical evidence which the FDA now accepts for label upgrades, provided scientific rigors are met in gathering and presenting the clinical data. It seems by now that much of the required lung safety data could have been gathered by ALL clinics that are prescribing Afrezza. It all comes down to management to devise a viable approach to gathering a data pool. You refer to "required lung safety data." What kind of data is required? www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf
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Post by prcgorman2 on Aug 20, 2019 8:32:45 GMT -5
When the FDA approved Afrezza, in addition to requiring lung safety tests using FEV equipment to avoid prescribing to folks with chronic lung disease, they also required a long-term safety study (or studies). I think it may be shown on the Mannkind slides from 2Q.
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Post by dh4mizzou on Aug 20, 2019 8:54:12 GMT -5
When the FDA approved Afrezza, in addition to requiring lung safety tests using FEV equipment to avoid prescribing to folks with chronic lung disease, they also required a long-term safety study (or studies). I think it may be shown on the Mannkind slides from 2Q. I could be wrong but I recall that the FDA waived the study about 12-18 months ago.
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Post by prcgorman2 on Aug 20, 2019 8:58:37 GMT -5
Thanks dh4mizzou. I remember there was a waiver of some sort, but wasn't sure if it was only to delay the study so I didn't speculate. You may be right.
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Post by matt on Aug 20, 2019 9:07:34 GMT -5
Aged - how many trials do we need to show that BG over 140 for 2+hours causes vascular degeneration? How many trials do we need to show nothing can bring post meal BG's down as fast as afrezza? I don't think there is going to be a lot of argument that reducing excessive BG levels has attendant health benefits. Most physicians will take it as a given that properly regulated glucose levels are highly desirable. The implied benefit from your second sentence is not so easy accepted. While perhaps Afrezza does work faster than other alternatives, what has not been demonstrated is how fast is fast enough? If Afrezza can act within 20 minutes while another drug takes 40 minutes, does that difference translate into long-term health benefits and, if so, what is the magnitude of those benefits. That is not merely a debate about semantics given that Afrezza is also the most expensive insulin product on the market by an order of magnitude. If MNKD wants to charge what it charges for its drug, then there had better be some really solid economic data that justifies the additional expense over competitive products because we already know that the arguments about patient convenience and aversion to needle sticks are not sufficient to obtain preferred placement on formularies. Medical decisions and formulary coverage are based on data, not assumptions, and the data is lacking. Running a head to head trial against the other insulins claiming ultra-rapid action (like FIASP for example) are the only way to get a better label and have credibility in the market. This has been talked about for years, but until the company actually starts such a trial the results will remain years away from completion.
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