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Post by dudley on Jun 19, 2015 11:55:46 GMT -5
"We’ve proven it here week after week with almost non-diabetic numbers and record low A1C’s that none of us could achieve on injectable insulin. You will notice this week, once again, every one in the Type 1 Group is in “normal” non-diabetic blood sugar range and in the next month, we expect a few more people to achieve A1C’s in the 5’s." afrezzauser.comPeople are probably tired of my mantra "the laws of statistics and biology do not lie" but so far it is holding true - again anybody is welcome to disprove the thesis that these results would be expected to be seen in ANY typical patient using Afrezza. The same or similar results for 4.5 million patients on the RAA's are predictable with great statistical accuracy. Why would that statistical probability change because they are now presenting a monomer human insulin into their system vs. an engineered hexamer insulin? Sam's sample group continues to grow and 100% of the time the results are the same. THAT is NOT a coincidence. |
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Post by notamnkdmillionaire on Jun 19, 2015 12:18:02 GMT -5
Still would like to see more stories from T2 diabetics. If Afrezza is going to be a blockbuster drug, it has to make major inroads in the T2 community.
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Post by patryn on Jun 19, 2015 12:28:54 GMT -5
Not that I don't hope that your claims are proven true dudley, but I have to say that if you want the data to be accepted scientifically you have to apply scientific principles to it. For a population of 2 million diabetics that we are targeting, you would need to have a sample size of 385 people to have a 5% margin of error and a 95% confidence level. (used a sample size calculator here for convenience www.raosoft.com/samplesize.html but happy to go through the statistics with you if you want). With only 20 people in the trial group my margin of error would be 21.91% which is far too high to make any assumptions of mathematical certainty. On top of that, this group of 20 people is not random! They are a self selected, highly motivated, and highly informed group of people who want to succeed. That gives us an even higher margin for error. I believe in the science, and I am confident in the marketing and sales game plan for Afrezza. But I am not willing to accept a statistical certainty that this works for everyone. Then again my investment thesis does not need it to work for everyone and indeed if it works for even 25% of the addressable market, I will be quite happy with my investment. On top of that even one person who's quality of life is significantly increased by Afrezza makes this drug a win in my book even if there are no financial benefits. |
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Post by emsnluspa on Jun 19, 2015 12:55:29 GMT -5
What bothers me about this sample group is these are not the same results from the trial phases. What has changed from trial stages to launch other than a great desire to spread the word of the benefits of the drug. I'm a believer that this drug will capture significant market share, but the miracle drug story that's being built around it seems like a concerted effort.
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Post by patryn on Jun 19, 2015 12:58:38 GMT -5
What bothers me about this sample group is these are not the same results from the trial phases. What has changed from trial stages to launch other than a great desire to spread the word of the benefits of the drug. I'm a believer that this drug will capture significant market share, but the miracle drug story that's being built around it seems like a concerted effort. The trials were designed to show noninferiority and that's what they did. The FDA had very specific guidelines on how to do the testing. From Sam's blog here are his reasons: "To Summarize here are just a few of the hold backs why Afrezza didn’t get to show how great it works: Afrezza Dosing was only changed approx. every 6 weeks, and not flexible dosing depending on meal No CGM’s allowed Time in Zone not measured Patient quality of life not measured Brand new Afrezza users vs. Very experienced Injectable users (what if it was brand new injectable users vs. experienced Afrezza users—would that be fair? No-they would stop the trial right away because it would be a TKO/referee stops contest victory for Afrezza which we are already proving by “real-world” experience.)" Just as people in the real world use products well beyond their intended purposes in controlled trials, real Afrezza users are dosing themselves to be most effective rather than to test against existing injectable insulin treatments. |
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Post by savzak on Jun 19, 2015 13:00:27 GMT -5
What bothers me about this sample group is these are not the same results from the trial phases. What has changed from trial stages to launch other than a great desire to spread the word of the benefits of the drug. I'm a believer that this drug will capture significant market share, but the miracle drug story that's being built around it seems like a concerted effort. 1. The trial protocols prevented the flexible usage that the current users are employing. It's that freedom from the trial protocols that have made all the difference. Just read Sam Finta a/k/a Afrezzaser's explanation.
2. I'm curious why it is you think Afrezza will capture significant market share if you think the social media positive buzz is a "concerted effort".
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Post by dudley on Jun 19, 2015 13:03:24 GMT -5
Not that I don't hope that your claims are proven true dudley, but I have to say that if you want the data to be accepted scientifically you have to apply scientific principles to it. For a population of 2 million diabetics that we are targeting, you would need to have a sample size of 385 people to have a 5% margin of error and a 95% confidence level. (used a sample size calculator here for convenience www.raosoft.com/samplesize.html but happy to go through the statistics with you if you want). With only 20 people in the trial group my margin of error would be 21.91% which is far too high to make any assumptions of mathematical certainty. On top of that, this group of 20 people is not random! They are a self selected, highly motivated, and highly informed group of people who want to succeed. That gives us an even higher margin for error. I believe in the science, and I am confident in the marketing and sales game plan for Afrezza. But I am not willing to accept a statistical certainty that this works for everyone. Then again my investment thesis does not need it to work for everyone and indeed if it works for even 25% of the addressable market, I will be quite happy with my investment. On top of that even one person who's quality of life is significantly increased by Afrezza makes this drug a win in my book even if there are no financial benefits. Hi patryn - I accept that premise when one is dealing with "normal' surveys like polling political preferences, product choices etc. But when dealing with biology "preferences" do not come into play. One cannot have a preference or a choice when it comes to how one's system is going to deal with a biological process - it is going to happen no matter what you choose. I would greatly prefer that my fingernails don't grow because I hate having to trim them. What sample size is required to show that fingernail growth is expected in the majority of the population? Insulin works virtually the same way in every single human body on the planet. The clinical trials had a scientifically "satisfactory" result in proving non-inferiority to the RAA's using those very biased protocols. Now that patients are free to vary timing and dosage the results are proving vastly SU-perior to the RAA's. I can't see any logical argument that these results should not be expected by ANY user given the time to get things "dialed in". It can be debated endlessly - but it is extremely telling we are seeing 100% identical results from an ever-growing group of patients. Many thanks as always to Sam Finta for his gigantic contributions toward the Afrezza cause. |
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Post by _neil on Jun 19, 2015 13:11:00 GMT -5
Thank you very much patryn. You very clearly explain why I feel uneasy quoting the success stories of the twitter users in general and Sam in particular. The drug working for a few people is great news for those particular users. Unless it is scientifically (post release journal publications and post market studies) proven to work, all the good news doesn't mean much to us investors. I appreciate Sam being a one-man salesforce but I'd rather see this trumpeting from the official channels.
As of today, the hb1ac control achieved by users is statistically insignificant. I do believe the science but for me, it's far from being able to confidently say this will be standard care practise.
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Post by emsnluspa on Jun 19, 2015 13:19:39 GMT -5
OK thank you for that explanation. I'm still a bit skeptical that self dosing can bring everyone into controlled levels like is being reported, but what you (and Afrezzaer) have outlined would be a gap from the trials, yes.
I'm bullish on the market capture primarily due to new patient compliance. I believe the true disruption of this technology in the diabetic arena will be the millions and millions of T2s who don't go back to the doctor knowing they need to start sticking themselves, or have given up with the daunting realization that they need to inject multiple times a day for the rest of their lives. IMO even if Afrezza was slightly inferior, a doctor in many, many cases will choose that option vs. knowing they'll never see the patient again. This change in mindset will take awhile to see affect, but it's the path of least resistance and an inevitability IMO. I believe had Exubera stuck around the same inevitability would have happened, but the bong was a harder sell.
Of course if Afrezza truly starts to exhibit superiority then penetration rates will increase by orders of magnitude. And if technosphere becomes applicable in other arenas then...
Either way, this is a winner long term.
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Post by joeypotsandpans on Jun 19, 2015 13:19:52 GMT -5
What bothers me about this sample group is these are not the same results from the trial phases. What has changed from trial stages to launch other than a great desire to spread the word of the benefits of the drug. I'm a believer that this drug will capture significant market share, but the miracle drug story that's being built around it seems like a concerted effort. I recommend you watch the Adcom hearing...the panel of experts literally chastised what I call the FDA "interns" and said qoute "but you were the ones that set up those parameters of the trials" when they (the panel) realized how ridiculous it was in trying to administer the treatment the same way in showing Afrezza's benefits and "non inferiority" rather than "superiority".... That combined with the testimonials after the lunch break is what swung the whole thing around and resulted in the almost unanimous votes to recommend approval for both T1 and T2... |
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Post by spiro on Jun 19, 2015 13:23:49 GMT -5
poorneil,
One thing is certain, when hundreds of different doctors keep getting significantly improved A1c results from the early Afrezza users, their eyes will open wide and Spiro doesn't think they will give a hoot about statistical significance,
Spiro here, getting bored watching those same old low BG readings happen day after day.
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Post by emsnluspa on Jun 19, 2015 13:30:53 GMT -5
All that being said, I'm certainly glad to see the BG and A1 numbers being reported. Had they been showing no effect (or increase) I'd be less bullish.
I came to this venue to see the Friday script numbers, but as I look around I see the rational conversations going on. Think I'll stick around for awhile.
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Post by EveningOfTheDay on Jun 19, 2015 13:35:14 GMT -5
One cannot have a preference or a choice when it comes to how one's system is going to deal with a biological process - it is going to happen no matter what you choose. I would greatly prefer that my fingernails don't grow because I hate having to trim them. What sample size is required to show that fingernail growth is expected in the majority of the population? Insulin works virtually the same way in every single human body on the planet. The clinical trials had a scientifically "satisfactory" result in proving non-inferiority to the RAA's using those very biased protocols. Now that patients are free to vary timing and dosage the results are proving vastly SU-perior to the RAA's. I can't see any logical argument that these results should not be expected by ANY user given the time to get things "dialed in". It can be debated endlessly - but it is extremely telling we are seeing 100% identical results from an ever-growing group of patients. Many thanks as always to Sam Finta for his gigantic contributions toward the Afrezza cause. Dudley, I believe your argument will eventually be proven correct. Of course, it could take quite some time still. That is where Sanofi comes in with his commercial effort. Will see how that goes. |
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Post by EveningOfTheDay on Jun 19, 2015 14:00:48 GMT -5
OK thank you for that explanation. I'm still a bit skeptical that self dosing can bring everyone into controlled levels like is being reported, but what you (and Afrezzaer) have outlined would be a gap from the trials, yes. I'm bullish on the market capture primarily due to new patient compliance. I believe the true disruption of this technology in the diabetic arena will be the millions and millions of T2s who don't go back to the doctor knowing they need to start sticking themselves, or have given up with the daunting realization that they need to inject multiple times a day for the rest of their lives. IMO even if Afrezza was slightly inferior, a doctor in many, many cases will choose that option vs. knowing they'll never see the patient again. This change in mindset will take awhile to see affect, but it's the path of least resistance and an inevitability IMO. I believe had Exubera stuck around the same inevitability would have happened, but the bong was a harder sell. Of course if Afrezza truly starts to exhibit superiority then penetration rates will increase by orders of magnitude. And if technosphere becomes applicable in other arenas then... Either way, this is a winner long term. Welcome to the only rational, almost always civil MNKD forum on the net. In my opinion, any independent thinker would have a tendency to skepticism, in part because how the results are presented. However, I believe Dudley is completely right when he states, "...when dealing with biology "preferences" do not come into play. One cannot have a preference or a choice when it comes to how one's system is going to deal with a biological process - it is going to happen no matter what you choose." If you have not, I would also recommend that you try to read on the pharmacokinetics of Afrezza and why its formulation turns it into a completely different tool than any other RAA in the market today. I believe most of the skepticism surrounding Afrezza is because of a difficulty separating the idea of how Afrezza works from how subcutaneous insulin works. Of course here we also have in play the idea of inhaling insulin, which could be off putting for some, and one of the obstacles to overcome. At the end of the day, physiology is the same for all of us, and although Afrezza's impact could be affected by other conditions in the patient, other medications in the mix or diet patterns, for most of us should work in a very similar way, as I firmly believe time will prove. |
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Post by dreamboatcruise on Jun 19, 2015 14:07:28 GMT -5
I think it may boil down to ones definition of typical. I would view that the results are very encouraging for two types of patients... 1) people on GCM or willing to blood test frequently or 2) early types 2's for whom a baseline 4u at start of meal is enough to match the level of disease progression (and hopefully stop or even reverse the progression). The extent that such patients are "typical" or the ability to extrapolate to others that don't fall within those categories is something I will still eagerly await more results for.
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