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Post by liane on Feb 20, 2016 8:46:49 GMT -5
falconquestI see your point entirely. If I were the CEO of SNY, I would want Afrezza lock, stock, and barrel. Total BO at a price much higher than they seemed willing to pay right now. Revolutionize the treatment of diabetes. But maybe their analysis shows that they make more money just continuing with all their not-so-revolutionary old school drugs.
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Post by LosingMyBullishness on Feb 20, 2016 8:51:11 GMT -5
falcon, I appreciate your comment and what I stated is simply my perspective. I do not see a contradiction to what I stated.
You are correct that there the market for basal are very competitive. My take is that SNY is not willing to give up territory in basal and they need all sales& marketing to get the numbers as planned. Afrezza are not running by itself, they have to share the profit and SNY might even risk some sales in basal. Shorts were right when they pointed out the lack of attention in Brandicourt' presentation last year. If SNY would have been willing to shift from competitive basal to monopoly inhaled insulin they would have shown this in their presentation.
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Post by LosingMyBullishness on Feb 20, 2016 9:06:35 GMT -5
If this is the case than this threat was what all big players in the field of diabetics would have been worried about this. One of the BP would have taken the job to get it under control and I believe that a SNY has less trouble to do so than a Novo Nordisk.
So it would have taken an outsider with deep pockets, not an incumbent, but who understands the technology and the hugh implications.
Now, that there is real early adopter testimonies they might help in attracting such a partner. And this is were social media might really help.
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Post by BlueCat on Feb 20, 2016 10:08:52 GMT -5
I still believe that Sanofi wanted Afrezza but Al wouldn't agree on the price. They could have lowered the price of Afrezza, improved the insurance tier and had the most novel treatment in diabetes care to come down the road ever. But instead they deep sixed it? Not very smart in my mind and I think they still want it. I guess we'll see. Reminds me of the "Who Killed the Electric Car" film. SNY may want it - but not until they have to have it. Perhaps they are hoping to buy it at auction. Then say, "Out of our the care from our French hearts for those few diabetes patients that want it, we'll continue to offer it". They then trickle sell and mothball until another disruption comes along and its time to pivot their strategy.
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Post by BlueCat on Feb 20, 2016 11:30:14 GMT -5
I still believe that Sanofi wanted Afrezza but Al wouldn't agree on the price. They could have lowered the price of Afrezza, improved the insurance tier and had the most novel treatment in diabetes care to come down the road ever. But instead they deep sixed it? Not very smart in my mind and I think they still want it. I guess we'll see. Reminds me of the "Who Killed the Electric Car" film. SNY may want it - but not until they have to have it. Perhaps they are hoping to buy it at auction. Then say, "Out of our the care from our French hearts for those few diabetes patients that want it, we'll continue to offer it". They then trickle sell and mothball until another disruption comes along and its time to pivot their strategy. For clarification: Presented this is a Foil Hat alternative. Not subscribed to theory.
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Post by Deleted on Feb 20, 2016 11:47:42 GMT -5
@reverselo ... I think you might be assuming that "statistically significant" implies something about the clinical benefit of Afrezza, which it doesn't. These studies are not ones designed to show that Afrezza can lower A1c or reduce incidence of hypos. The only thing MNKD has indicated that might come out of this trial is that these results may allow them to get the ketoacidosis restriction removed from the label. I don't think that alone would make someone pay more for MNKD... as that restriction is never cited as a contributing factor to low sales. I think you're reading between the lines something that isn't there. There could have been results that would be bad... i.e. showing variability of the pk profile or inconsistent with previous clamp studies. I assume based on what Matt said that these new studies were successful and what was expected and that investors need not worry about any surprises from the data. Thanks for this DBC. So I sounds like I was being over optimistic about these results.
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Post by Deleted on Feb 20, 2016 11:51:51 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? JPG are you a DR? I feel like you are in the medical field. In your opinion How much would the lung safety trial cost?
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Post by Deleted on Feb 20, 2016 11:56:17 GMT -5
Falcon, Early adopters pointed out that Afrezza allowed them to use less basal insulin. I looked at the script numbers and I saw a drop in active promotion middle of last year around ADA. My hindsight is that they made a slow start to understand how much Afrezza would cannibalize their other diabetics medication esp. Toujou as this has major board attention. They figured out that is would cannibalize in the long run but that it would also need significant attention by sales&marketing AND 10 year plan for Toujou was already finalized and no middle management was eager to go to the board with a "risky change of plan". I found that it is often not the case that top management changes plans to go for the better product or the one that might offer higher margin/market shares in the long run. If it is not in the master plan and risky they avoid it. It is less organisational hassle, less personal risk and they get paid anyway. I get Sam has no skin in the game and only wants whats best for diabetics (and that is great) but he has stated you won't need the pump, less basal and recently not needing a CGM once dialed into Afrezza. These comments just turned three very different industries under the diabetes umbrella against Afrezza.
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Post by mnholdem on Feb 20, 2016 13:20:44 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? It was the FDA themselves who said it. Source: www.accessdata.fda.gov/scripts/cder/pmc/index.cfm Note: You may have to type in "Afrezza" in the product field after using this link.
This is the information posted by the FDA under the section Requirement/Commitment Number: 2
"Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza."
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I seem to recall that there was some issue discussed at ADCOM about more information needed about Afrezza's dose-response curves at higher dosages. Real-world data has already confirmed that some Type II diabetics have initially under-dosed (perhaps they or their endos feared hypos) and that this also occurred during the trials, which could lead to hyperglycemic excursions.
Ketoacidosis is typically the result of BG levels of 350+ and the FDA may simply want to confirm that Afrezza performs in a dose-proportionate manner at large doses, which are typically used as an emergency treatment for ketoacidosis.
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Regardless, the FDA apparently does believe that the Afrezza post-market trial data may have an impact on the ketoacidosis issue or they wouldn't have written it into the trial description.
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Post by agedhippie on Feb 20, 2016 16:59:53 GMT -5
What they are looking at is the risk of DKA rather than treating DKA. If you are in DKA you will be in hospital on several lines while they simultaneously try and drop your blood sugar with an insulin IV, rehydrate you, rebalance your electrolytes, and get your blood pH down to a reasonable level before your organs starts shutting down. I've done it, it's not fun!
As your glucose levels rise you become more insulin resistant and you need more insulin. Because of the higher DKA incidence with Afrezza what the FDA want to see is that dosing at the higher levels works and doesn't plateau. Right now the trial data means there is a warning but if they can understand why that happened they may be able to remove the warning if there is a mitigation.
DKA is almost entirely a Type 1 issue (there are some Type 2 cases but they are extremely rare). In Type 2 you have HHNS instead which is far nastier but that is not a concern with the label or data.
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Post by jpg on Feb 21, 2016 1:19:32 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? JPG are you a DR? I feel like you are in the medical field. In your opinion How much would the lung safety trial cost? Depends how many patients obviously. They aren't cheap. 10-20 thousand per patient probably. 50-100 million at the low end if done in cheaper jurisdictions (not in the US...).
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Post by jpg on Feb 21, 2016 1:27:06 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? It was the FDA themselves who said it. Source: www.accessdata.fda.gov/scripts/cder/pmc/index.cfm Note: You may have to type in "Afrezza" in the product field after using this link.
This is the information posted by the FDA under the section Requirement/Commitment Number: 2
"Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza."
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I seem to recall that there was some issue discussed at ADCOM about more information needed about Afrezza's dose-response curves at higher dosages. Real-world data has already confirmed that some Type II diabetics have initially under-dosed (perhaps they or their endos feared hypos) and that this also occurred during the trials, which could lead to hyperglycemic excursions.
Ketoacidosis is typically the result of BG levels of 350+ and the FDA may simply want to confirm that Afrezza performs in a dose-proportionate manner at large doses, which are typically used as an emergency treatment for ketoacidosis.
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Regardless, the FDA apparently does believe that the Afrezza post-market trial data may have an impact on the ketoacidosis issue or they wouldn't have written it into the trial description.
Like DBC already pointed out: they want to understand why Afrezza has more leto. Not change the label. They couldn't do that unless they ran a trial with proper dosing and showed that with proper dosing there wasn't more keto. The clamp study is the simply to understand dosing to be able to then run a big clinical trial... No free lunch here. Again the clamp studies are minor and relatively insignificant (and relatively uninteresting) studies. Few clinicians really care about these things. Sorry but you guys are putting way to much emphasis (and hope) on these types of trials. The important trials were never done and like I said above that was my first of many big 'hmmm' moments. Thjey should have started with these types of trials relatively quickly. That was one of the FDAs many poison pills...
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Post by Deleted on Feb 22, 2016 13:32:03 GMT -5
JPG are you a DR? I feel like you are in the medical field. In your opinion How much would the lung safety trial cost? Depends how many patients obviously. They aren't cheap. 10-20 thousand per patient probably. 50-100 million at the low end if done in cheaper jurisdictions (not in the US...). Hence, why Matt refuses to answer the question.
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Post by jpg on Feb 22, 2016 14:08:45 GMT -5
Depends how many patients obviously. They aren't cheap. 10-20 thousand per patient probably. 50-100 million at the low end if done in cheaper jurisdictions (not in the US...). Hence, why Matt refuses to answer the question. Keeping shareholders uninformed seems to be the MNKD way... Then again none of this stuff is beyond a simple Google.
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