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Post by agedhippie on Jan 27, 2017 8:55:15 GMT -5
Silent: you are either in denial or a fudster. If the analogues were identical to insulin, people using the analogues would not have hypos and vascular damage leading to amputation and organ failure. Enough said! Rubbish. It is entirely down to the delivery route and nothing to do with the insulin. In the old days we used to inject the same insulin that Afrezza uses and it was horrible. RAA is a huge improvement on Regular then injected - if it wasn't we would all still be on Regular and not RAA but as it is injected Regular is only used on cost grounds.
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Post by kball on Jan 27, 2017 8:56:49 GMT -5
Also...in addition to ezra's story I think he's been on this ride longer than almost all of us here if i recall.
Maybe get parents in touch with matty from down under if he's still around
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Post by silentknight on Jan 27, 2017 9:01:03 GMT -5
I understand it well enough. Other insulin has had its chemical structure changed on a molecular level while Afrezza has not. Yet it still is effective in treating the disease, despite what you suggest. That's why the standard of care is what it is currently. Perhaps you should start a world tour to stop in and educate every diabetes patient and endo on earth to inform them that they're all wrong and that Afrezza is the only real way to treat diabetes since it's not an analog. Spreading the word about Afrezza is what's needed after all... I would have thought that social media would have had a greater impact on spending the word. The current standard of care is outdated but it what is well known and understood, but less than optimal. Unfortunately, it takes time to build awareness and trust and doctors practicing defensive medicine does not help our cause but docs behave like, well people and all of us are to some extend risk averse especially those that need a medical license to make a living. A1c remains a benchmark measurement but with CGMs, the information provided by A1c is not nearly as valuable as it once was. Metformin is also a standard of care as are RAAs but as we all know, for most people with diabetes, if we wired them up to a CGM with their current regiment of care for a few months and then did the same after they went on Afrezza (with a few weeks to learn how to dose it) the numbers the patient would achieve would be significantly better with Afrezza. Its easier and loads better but its also vastly different. If the new sales team is good, given we have better samples and titration packs, the ratio of patients trying / patients using ongoing should improve in a few weeks and NRx will measure if this is the case. My expectation is that by 2-17 we should start to see consistent W/W growth in NRx. Small at first perhaps but consistent. Hopefully we get a reprieve from the delisting. At this point, if the commercialization strategy is right and properly executed, even with a smaller sales force, the Rx growth trend with an extra few months runway prior to a potential delisting would get SP > $1.00 I think your assessment is fair. The standard of care IS outdated and Afrezza IS better, but that doesn't mean it will translate to the product's success. We've seen as much over the last two years. Some people operate under the philosophy that "If better is possible, good is not enough". I tend to be one of those and I'd certainly wish more endo's would adopt that outlook and give Afrezza a try with proper titration and timing. Afrezza would be selling like hotcakes if that were true. It's simply not and I'm no longer of the belief that the standard of care will reflect Afrezza's efficacy. Endos and many diabetic patients simply don't care enough to do it. Some do, but as we've seen, they're few and far between. Personally, I like the idea that many of our new sales reps are former Sanofi employees. Hopefully many of them have sold Afrezza in the past and have some experience with it. For a while, Sanofi was selling the drug pretty well, at least looking at the trend lines and w/w growth. Perhaps they can do that for MNKD as well. Only time will tell.
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Post by silentknight on Jan 27, 2017 9:08:48 GMT -5
Silent: you are either in denial or a fudster. If the analogues were identical to insulin, people using the analogues would not have hypos and vascular damage leading to amputation and organ failure. Enough said! I never said they were identical, but let's not let the truth get in the way of you unnecessarily labeling someone a "fudster" again just because they disagree with you. I said they were effective enough in treating the disease which is why the standard of care is what it is and why endos, in large part, first prescribe those analogs over Afrezza. And honestly, the FUD thing is getting quite tiresome. I don't deny that Afrezza is better than anything on the market. I deny that it's the only treatment option available, which is what you suggested in your post.
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Post by Deleted on Jan 27, 2017 9:22:06 GMT -5
Silent: you are either in denial or a fudster. If the analogues were identical to insulin, people using the analogues would not have hypos and vascular damage leading to amputation and organ failure. Enough said! poorly managed on analogues have hypos and everything else. there are people on analogues that restrict their diet and flatline like people on Afrezza. Afrezza just makes it easier on them to be liberal and still have great control. If its the only one and only one solution - by now we would do more than 250 TRX per week.
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Post by Deleted on Jan 27, 2017 9:28:22 GMT -5
Refer to the pharmacodynamics thread for a better understanding of analogues and insulin.
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Post by sophie on Jan 27, 2017 9:42:17 GMT -5
Refer to the pharmacodynamics thread for a better understanding of analogues and insulin. See Humulin R as just one example. There are others. As agedhippie said, it's about delivery, not about insulin. Subq/hexameric human insulin metabolizes more slowly than does inhaled monomeric human insulin. Again, as agedhippie stated, insulin analogues have proven to be far superior than injected regular human insulin. Analogs are simply genetically engineered insulin-like molecules that still bind to the insulin receptor but have changed properties to be absorbed, metabolized, and excreted more quickly (or more slowly for basal) than human insulin.
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Post by mnholdem on Jan 27, 2017 9:57:01 GMT -5
Refer to the pharmacodynamics thread for a better understanding of analogues and insulin. I suggest that you clarify that you are talking about TI (Technosphere insulin) inhalation powder. Regular human insulin is much slower and more dangerous in its injected form than the rapid-acting analog (RAA) insulin brands.
This is only one example comparing Novolog 70/30 with Human Insulin. (NOTE: 70/30 stands for 70% insulin aspart protamine crystals and 30% soluble insulin aspart).
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Post by Deleted on Jan 27, 2017 10:02:01 GMT -5
mn: thanks for pointing that out. Yes, my posts are in regards to inhaled insulin (Afrezza) versus analogues in regards to dynamics not kinetics.
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Post by ezrasfund on Jan 27, 2017 10:23:41 GMT -5
Scientists and doctors are skeptics. They were rigorously and painfully trained, and they generally think that what they learned is the best available knowledge, and anyone who thinks differently is ill informed at best. The most important words in the history of science; not "eureka!", but "what's that?" A good example from a good book , "The Sixth Extinction" is the discovery of the iridium sediment layer which lead to the discovery of the meteor that crashed into the Yucatan Peninsula and caused the extinction of the dinosaurs and almost all life on earth. Way back in 1975 the reaction of experts was "poppycock" as the discoverer was a geologist not a paleontologist, clearly a no-nothing. Never mind that what the experts knew to be true was all completely wrong. And this was not in the Dark Ages. Back then, as in 1800, the very idea of "extinction" was new and generally dismissed. So much for the infallibility of science. Biology and other complex systems just do not yield to the same scientific techniques that work in physics and chemistry. And so "proving" that Afrezza is the best insulin is a long road.
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Post by mnholdem on Jan 27, 2017 11:46:00 GMT -5
A Phase IV clinical trial that proves Afrezza to be superior to RAA insulin, both in A1c and for tighter control (aka Time-in-Zone) would go a long ways toward convincing those research scientists and doctors, IMHO.
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Post by Deleted on Jan 27, 2017 11:48:45 GMT -5
A Phase IV clinical trial that proves Afrezza to be superior to RAA insulin, both in A1c and for tighter control (aka Time-in-Zone) would go a long ways toward convincing those research scientists and doctors, IMHO. If Mnkd management doesn't consider this as a top priority and just continue to train reps and medical community, they better step aside for Al's sake and let new blood come in and change things
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Post by mnholdem on Jan 27, 2017 11:52:19 GMT -5
It's my hope that the protocols in the pediatric trial will do this very thing. This is a huge opportunity for MannKind. The very last thing we want is another non-inferior label for kids.
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Post by BlueCat on Jan 27, 2017 12:22:04 GMT -5
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Post by zuegirdor on Jan 27, 2017 12:39:53 GMT -5
It will be all about the protocol and strict adherence to it.
I have been giving my teen instructions to take 8u puff simultaneously with 3 or 4 unit shot of RAA. This knocks down his usual (on humalog alone) breakfast spike completely. He'd rather do a follow up 4u Afrezza puff but can't remember. But today I said its OK to go back to just Afrezza Just 5 minutes ago his CGM went off (on my remote mobile app). I realized he forgot the follow up puff or did not hear his cgm alert that I HOPE he had set for 120. Had to call the nurse to send him a note.
So, yeah, it works like nothing else IF you stay with the protocol. I think that is the benefit of a controlled trial. I just hope they have a way of separating the variability due to behavior from other sources when comparing a1C across user/non-user groups.
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