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Post by sayhey24 on Jan 3, 2019 21:24:57 GMT -5
We seem to have some numbers - "To date, with over 200 patients treated, we have yet to observe a single, severe hypoglycemic event."
If true and I have no reason not to believe it, not a single severe hypoglycemic event is huge. I did not see a breakdown of how many T1s versus the T2s in the 200. In the affinity 2 the severe hypos were with people taking TZDs.
Has Dr. Kendall discussed their finding with them? Is there anyway he can leverage their clinical results for ADA purposes? Maybe these are question for Mike C. tomorrow Mike K. can ask.
200 PWDs in 2 years is a proof of concept. How can this be turned into a profitable business model if MNKD was a partner? Each clinical should be doing 200 PWDs per month.
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Post by mnkdfann on Jan 3, 2019 21:27:51 GMT -5
Maybe I missed it but did he explain exactly what the "AFAL protocol" consists of? I believe its "afrezza first afrezza last" as opposed to the "Treat to Fail" Four Step ADA protocol From the white paper: "We described that new paradigm as “Afrezza First, Afrezza Instead, Afrezza Always,” more easily referred to as “AFAL” (people in diabetes love to try to come up with clever acronyms). Consequently, Vdex developed its own proprietary AFAL protocols." The actual protocols are alluded to on the next pages, but not explicitly spelled out in detail AFAIK (e.g. dosing is said to be aggresive, but details are missing). Respectfully, the white paper style is a little sloppy and inconsistent. E.g., at times it says AFAL protocol (singular) and elsewhere AFAL protocols (plural). Assuming the AFAL protocols are proprietary, it makes perfect sense they are not stated in detail.
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Post by mango on Jan 3, 2019 21:43:54 GMT -5
"To date, with over 200 patients treated, we have yet to observe a single, severe hypoglycemic event."
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Post by mango on Jan 3, 2019 21:50:53 GMT -5
"In our patients, we have had a very different experience. We not only bring their HbA1cs down, we keep them down. We have one primary tool in our AFAL Protocol: Afrezza. In most cases, we see no need to augment the Afrezza dose with additional agents. In fact, we slowly titrate most patients off their other medications (see further detail on this point below)."
"As we eliminate some of the other medications, patients feel better too. One good example is metformin. Many of the poorly-controlled patients have been taking the maximum daily dose of metformin, 2000mg. At this dosage, a considerable segment of the patient population, perhaps 40-50%, have gastrointestinal problems: diarrhea, gas, nausea. At Vdex, we routinely eliminate metformin from the therapy."
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Post by boca1girl on Jan 3, 2019 21:52:51 GMT -5
Maybe I missed it but did he explain exactly what the "AFAL protocol" consists of? I believe its "afrezza first afrezza last" as opposed to the "Treat to Fail" Four Step ADA protocol “Afrezza First, Afrezza Instead, Afrezza Always,” more easily referred to as “AFAL” (people in diabetes love to try to come up with clever acronyms). Consequently, Vdex developed its own proprietary AFAL protocols.
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Post by sportsrancho on Jan 3, 2019 21:53:10 GMT -5
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Post by seanismorris on Jan 3, 2019 22:05:31 GMT -5
200 patients is peanuts. More peanuts please.
Maybe the dilution is to up the peanuts with VDEX.
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Post by boca1girl on Jan 3, 2019 22:48:38 GMT -5
I thought this section was a bit confusing...
“The problem is the tools being used.
Given the limitation of the available tools, doctors are doing the best they can. The ADA recom- mendations make sense. The technology employed in the Vdex protocols shows there’s a better way. We have better tools.”
...Afrezza is an available tool for all to use. The paper made it sound like Vdex was the only one aware of it and even made an excuse for the ADA’s recommendations.
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Post by boytroy88 on Jan 3, 2019 23:04:23 GMT -5
I thought this section was a bit confusing... “The problem is the tools being used. Given the limitation of the available tools, doctors are doing the best they can. The ADA recom- mendations make sense. The technology employed in the Vdex protocols shows there’s a better way. We have better tools.” ...Afrezza is an available tool for all to use. The paper made it sound like Vdex was the only one aware of it and even made an excuse for the ADA’s recommendations. I think it meant the tools being used that are recommended by the ADA.
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Post by boca1girl on Jan 3, 2019 23:16:44 GMT -5
I thought this section was a bit confusing... “The problem is the tools being used. Given the limitation of the available tools, doctors are doing the best they can. The ADA recom- mendations make sense. The technology employed in the Vdex protocols shows there’s a better way. We have better tools.” ...Afrezza is an available tool for all to use. The paper made it sound like Vdex was the only one aware of it and even made an excuse for the ADA’s recommendations. I think it meant the tools being used that are recommended by the ADA. Read it again. In my mind, it would have made more sense to say...if Afrezza was NOT available, then the ADA recommendations make sense...but the Vdex protocol shows there’s a better way. We have a better tool and it’s called Afrezza.
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Post by sportsrancho on Jan 4, 2019 0:05:34 GMT -5
I’m going to have to verify this but I believe what they mean by the tools is their whole approach to teaching dosing . Teaching them how to dose and not be afraid of a larger dose, and handle their own blood sugars. They stick with them until they understand it. It’s like with personal training, I give the client the tools to get results. If I just hand them two dumbbells and let them go off on their own they’re not gonna know what to do and they won’t get any results. It takes 3 to 6 weeks to teach them. If they only get one training session they won’t get the results and they’re going to think that this doesn’t work for them, then they are going to tell 10 people that weight training is for the birds:-) Yes granted some people can figure it out for themselves, but we all know of that diabetic expert that was using the inhaler upside down!
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Post by sportsrancho on Jan 4, 2019 0:12:35 GMT -5
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Post by mytakeonit on Jan 4, 2019 0:24:48 GMT -5
From what I read previously, VDEX is doing pretty good and expanding locations. It doesn't just head straight to an Afrezza remedy, but goes in all different directions to help the patient. So, 200 patients on Afrezza ... is what it is.
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Post by travis1953 on Jan 4, 2019 4:00:09 GMT -5
Maybe I missed it but did he explain exactly what the "AFAL protocol" consists of? I believe its "afrezza first afrezza last" as opposed to the "Treat to Fail" Four Step ADA protocol Yes, but what exactly is the protocol they follow? Do they go the standard diet and exercise first, etc, or do they start with afrezza straight off? Do they use CGMs on every patient?
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Post by sayhey24 on Jan 4, 2019 6:33:57 GMT -5
I think it meant the tools being used that are recommended by the ADA. Read it again. In my mind, it would have made more sense to say...if Afrezza was NOT available, then the ADA recommendations make sense...but the Vdex protocol shows there’s a better way. We have a better tool and it’s called Afrezza. Here is the current "tool" sheet doctors follow - I refer to it as the Rube Goldberg Treat to Fail protocol.
Replace that embarrassment with a simple tool, the wheel of diabetes - insulin. However the AFAL wheel is no longer made of stone. Now doctors can use afrezza as their first tool and afrezza as the last tool. You can take figure 9.1 and put it where it should be, the trash.
One thing I did note was a welcome change from when they first started - getting the PWDs off the metformin. The theory was they would have better results and it seems they are.
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