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Post by sayhey24 on Jan 28, 2017 21:12:57 GMT -5
"There was a group of people who thought both RAA (engineered insulin) and Regular (GMO produced insulin) were unnatural and wanted to stick with porcine and bovine insulins. How did that end? Look around you..."
So, what you are saying is it is more than a Red Herring, interesting. What chance did these guy have against BP? Moreover, the RAA until afrezza did give you better control. But now you can do better and get back to a more natural approach with afrezza. Although I am not really sure it matters unless MNKD fixes their marketing approach. If they continue to push speed versus near-natural pancreatic function, afrezza may not be doomed but MNKD might very well be.
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Post by sayhey24 on Jan 28, 2017 21:20:40 GMT -5
mango - thank you for posting this graph. From graph A: the areas under each curve one can see that the activity (dynamics) of Afrezza is much smaller than Lispro; this is the reason Afrezza causes fewer hypos than analogues. Hopefully this clears up the confusion? OK - as I said above pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how the organism affects the drug. What the graph (page 15 of the label) on the left is showing is the glucose infusion rate - time curve , which is the PD. The graph on the right is the one Al carried everywhere and it shows the PK. The monomer nature of afrezza allows the profile you are seeing on the right. As they say on the label the amount of afrezza taken 4u, 8u 12u, probably does not effect the profile although they can conclude that for certain. The important take away is afrezza mimics the pancreatic release and NO RAA does. I am not sure why they didn't include the normal pancreatic insulin - odd. Al always did. |
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Post by seanismorris on Jan 28, 2017 22:37:31 GMT -5
It would be nice to see real world hospital visit comparisons. I do think "mimicking the pancreas" using "natural" insulin should resonate with docs, but it's the results that counts.
In the clinical trials, the insulin levels achieved wasn't that impressive vs. the alternatives...
Most of us are still here because we think, when used correctly, superiority is a reachable goal. (5-6)
At the end of the day, the graphs are nice but that's not going to sell docs many on prescripting Afrezza (these guys are going to be very conservative when trying something new).
Now saying "Afrezza reduced hospital visits 30%" that's REAL persuasive. MannKind doesn't just need more/better sales people, they need a better message to sell.
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Post by agedhippie on Jan 28, 2017 23:49:27 GMT -5
"There was a group of people who thought both RAA (engineered insulin) and Regular (GMO produced insulin) were unnatural and wanted to stick with porcine and bovine insulins. How did that end? Look around you..." So, what you are saying is it is more than a Red Herring, interesting. What chance did these guy have against BP? Moreover, the RAA until afrezza did give you better control. But now you can do better and get back to a more natural approach with afrezza. Although I am not really sure it matters unless MNKD fixes their marketing approach. If they continue to push speed versus near-natural pancreatic function, afrezza may not be doomed but MNKD might very well be. No pharma big or small is going to keep producing animal insulins for a handful of people. It's simply not commercial viable. Give up on the natural approach. It's natural when your pancreas releases it along with c-peptide, amylin, and glucagon and all in the right amount, it's artificial when you are breathing in encapsulated manufactured insulin. This is not a natural pancreatic function, it's a fraction of one. Endos know this and will laugh at you. |
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Post by falconquest on Jan 29, 2017 6:44:28 GMT -5
seanismorris said:
"Now saying "Afrezza reduced hospital visits 30%" that's REAL persuasive. MannKind doesn't just need more/better sales people, they need a better message to sell".
Isn't this exactly why they hired Mike? He's supposed to be the expert on marketing drugs. We know one thing quite clearly, whatever he has done to date is not working.
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Post by Deleted on Jan 29, 2017 6:55:30 GMT -5
"Give up on the natural approach. It's natural when your pancreas releases it along with c-peptide, amylin, and glucagon and all in the right amount, it's artificial when you are breathing in encapsulated manufactured insulin. This is not a natural pancreatic function, it's a fraction of one. Endos know this and will laugh at you." agedhippie: Afrezza functions closer to pancreatic insulin than any analogue or injected insulin; so what is your point? |
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Post by sayhey24 on Jan 29, 2017 10:48:33 GMT -5
It would be nice to see real world hospital visit comparisons. I do think "mimicking the pancreas" using "natural" insulin should resonate with docs, but it's the results that counts. In the clinical trials, the insulin levels achieved wasn't that impressive vs. the alternatives... Most of us are still here because we think, when used correctly, superiority is a reachable goal. (5-6) At the end of the day, the graphs are nice but that's not going to sell docs many on prescripting Afrezza (these guys are going to be very conservative when trying something new). Now saying "Afrezza reduced hospital visits 30%" that's REAL persuasive. MannKind doesn't just need more/better sales people, they need a better message to sell. You are absolutely correct - the results were not only "not impressive" but WORSE. Why was that? The answer is four fold; first dosing - while in the protocol to test after 90 minutes and redose, this was not done in all but one doctor who achieved such great results the FDA accused him of cheating; second - in many cases not enough afrezza was taken for phase 1 release and the basal was not adjusted enough; third - CGMs should have been used and can be now but at the time a CGM was not approved for dosing guidance; fourth - Al just wanted to get it approved and knew the pressure from BP not to approve. He thought he would be able to get label changes and other issues squared away after approval. To date 2+ years later all we have is the application in review based on the clamp studies. IMO, Mannkind has a huge marketing problem not a product problem. My use of the "Near Natural" is the best I have come up with so far. "Near Normal", "Proxy Pancreas", and a few more are other thoughts. What I do know is "Artificial Pancreas" has all the marketing buzz. Why not leverage the buzz. IMO, "Near Natural Pancreas" is much better than "Artificial Pancreas" from a marketing perspective. What we also know is the only time the "Artificial Pancreas" provides near normal meal time control is when they use afrezza with it. If it were me I would give the purple Outsulin Man a green "Near-Natural" girlfriend. As part of the "near natural" they need to explain phase 1 and phase 2 release which the GMIs don't provide. I would also start referring to the RAA as "meal time Genetic Modified Insulin" - GMIs. Not all but a lot of people given the choice between GMO and natural pick the natural. At the same time they need to get all the afrezza PWDs using some form of CGM. For the money the Libre is IMO is the way to go today. |
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Post by agedhippie on Jan 29, 2017 11:24:27 GMT -5
"Give up on the natural approach. It's natural when your pancreas releases it along with c-peptide, amylin, and glucagon and all in the right amount, it's artificial when you are breathing in encapsulated manufactured insulin. This is not a natural pancreatic function, it's a fraction of one. Endos know this and will laugh at you." agedhippie : Afrezza functions closer to pancreatic insulin than any analogue or injected insulin; so what is your point? My point is it's exactly that, closer to pancreatic insulin. What it isn't is natural, or mimicking a pancreas. Really the whole point is moot because aside from being laughed out of the office of any endo they try the pancreas line at the salesman will also get stamped on by the new CCO because it is untrue and the FDA will be after Mannkind for it. |
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Post by sayhey24 on Jan 29, 2017 13:45:01 GMT -5
"Give up on the natural approach. It's natural when your pancreas releases it along with c-peptide, amylin, and glucagon and all in the right amount, it's artificial when you are breathing in encapsulated manufactured insulin. This is not a natural pancreatic function, it's a fraction of one. Endos know this and will laugh at you." agedhippie : Afrezza functions closer to pancreatic insulin than any analogue or injected insulin; so what is your point? My point is it's exactly that, closer to pancreatic insulin. What it isn't is natural, or mimicking a pancreas. Really the whole point is moot because aside from being laughed out of the office of any endo they try the pancreas line at the salesman will also get stamped on by the new CCO because it is untrue and the FDA will be after Mannkind for it. Come on man, no one is saying its replacing the pancreas, what we are saying is it providing "Near Natural" pancreatic insulin release. No "GMI" RAA meal time insulin does that. Now about being laughed at by endo's, I just had that happen, or at least that was the plan. In fact the endo had his BP buddy who sells a meal time GMI RAA with him which I was not expecting. The endo had little understanding of phase 1 and 2 release and why these GMIs don't react with the liver as with a "normal healthy pancreas" let alone afrezza. Long story short his Buddy finally pulled the cancer card out of frustration and I pulled the AspB10 "Red Herring" and that was when I coined the term "GMI" (tm - maybe I should trademark it). The endo knew nothing about how the GMI RAAs were developed and his buddy left in a huff. After that the endo got really interested in learning more. But, you are correct, BP has and will continue to throw everything at afrezza to keep it from being subscribed and will prepare the endo to laugh at "Near Natural" pancreatic insulin release. |
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