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Post by straightly on Jul 29, 2017 18:37:10 GMT -5
At the risk of being the subject of the ire of other longs on this board, I beg to offer a different opinion of the Vdex paper than the praises being heaped upon it by virtually everyone so far. The paper's observations may well be valid, but the data presented do not support the claims made. Rather in some instances the data seem to contradict the claims. Nor are any references provided to support claims made that are not based on the "study" data. The language and writing style of the paper are not professional. For example, "Who really knows what all this stuff does or how it interacts?" The paper's author is not given, let alone one with an MD that would lend some credence to its contents. Vdex would have been better off with just a one or two page summary of their findings. As it is, the paper comes off as very amateurish. I would be embarrassed to forward this to anyone, and would certainly not send it to anyone making critical decisions that would affect Afrezza's future. Granted that there is a disclaimer at the beginning that the paper lacks "some of the rigors" of peer-reviewed articles. Still, I would hazard to say that the paper would deserve an F in any subject, whether it be English class, a technical writing class, or any hard science class. "Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Vdex should have stuck to this approach instead of attempting to explain what is going on in more detail and making general claims not supported by their observations. In the summary of safety findings the paper states: "Hypoglycemia. Our experience has been that Afrezza is extremely safe for all patients. It appears difficult to induce hypoglycemia even if you try." This is a dangerous claim. The first statement must be conditioned. You cannot disregard other medications that patients may be taking, especially when you are pretending to give advice to other practitioners. We know that taking Afrezza with metformin or basal insulin can induce hypoglycemia. Although Vdex claims that hypo's cannot be induced in patients with insulin sensitivity, I recall at least one PWD with insulin sensitivity saying the a 4-unit dose resulted in significant hypos, and wished there was a 2-unit dose available. Regarding the second statement, the paper also says, "In fact, we saw less hypoglycemia overall as patients’ blood glucose levels flattened and stabilized." So, patients did experience hypoglycemia. How many and how often? There were only 30 patients, so it cannot be that difficult to induce hypoglycemia if it occurs in the normal course of treatment. What is important, it seems to me, is how Vdex limited the hypoglycemia and flattened the BG levels. As for the data: Figures 1, 2 & 3. Where did these come from? Particularly Fig 3, BG levels on Afrezza. This chart has 7 curves plotted, one for each day of the week. Is this for one of Vdex's patients for one week? What is it supposed to show or prove? How many of Vdex's patients were able to achieve this? Was this repeatable and for how many weeks has this been achieved? The paper never provides enough information to interpret the significance of this chart. Fig 3 was certainly not the patient in study#2. "We began treatment and steadily increased dosages of Afrezza until the patient was administering 96 units of insulin each meal or almost 300 units of insulin daily. We DID NOT adjust the basal dosing." According to the clinical studies, 96 units, if taken as a single dose, is well past the point of diminishing returns for Afrezza and fasting BG levels were only reduced to 130-180. Vdex doesn't say if the 96 units were taken at one time or stacked or whatever. Vdex's conclusion, "even massive doses of Afrezza in some patients seem not to produce hypoglycemia." Is this even a meaningful statement regarding a patient with such high BG levels? My conclusion: VDEX couldn't get her BG levels under control. Not a good case study for Afrezza IMO. In case study 6, Vdex does not explain why the 8-unit dose is apparently less effective than the 4-unit dose. Clearly in 6b (4-unit) the BG is already in range before the second dose is taken. In 6c, with the 8-unit dose BG is higher and stays out of range longer than with the 4-unit dose in 6b. Seems to be counterintuitive. Maybe at this point the patient couldn't cope with yet another 6" turkey sub. "Given our extensive, direct experience with Afrezza, we have confirmed the safety of the product. " How many patients has Vdex treated with Afrezza? The paper only mentions 30. No one will accept this as extensive experience, especially in the case of a safety study. They may have treated many more, but they never say. They also never say what percentage of their patients reach goal or what the dropout rate is. Isn't this what practitioner's want to know, especially if they are being told that Vdex has found the holy grail of diabetes and to follow their example. The paper may have a useful message, but it is poorly explained and could, in reality, be counterproductive. oldfishtowner, buy a few shares of MNKD Monday and see if you can give the paper a passing grade. It is hard to resist the urge to be critical, I know.
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Post by dreamboatcruise on Jul 29, 2017 18:55:44 GMT -5
At the risk of being the subject of the ire of other longs on this board, I beg to offer a different opinion of the Vdex paper than the praises being heaped upon it by virtually everyone so far. The paper's observations may well be valid, but the data presented do not support the claims made. Rather in some instances the data seem to contradict the claims. Nor are any references provided to support claims made that are not based on the "study" data. The language and writing style of the paper are not professional. For example, "Who really knows what all this stuff does or how it interacts?" The paper's author is not given, let alone one with an MD that would lend some credence to its contents. Vdex would have been better off with just a one or two page summary of their findings. As it is, the paper comes off as very amateurish. I would be embarrassed to forward this to anyone, and would certainly not send it to anyone making critical decisions that would affect Afrezza's future. Granted that there is a disclaimer at the beginning that the paper lacks "some of the rigors" of peer-reviewed articles. Still, I would hazard to say that the paper would deserve an F in any subject, whether it be English class, a technical writing class, or any hard science class. "Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Vdex should have stuck to this approach instead of attempting to explain what is going on in more detail and making general claims not supported by their observations. In the summary of safety findings the paper states: "Hypoglycemia. Our experience has been that Afrezza is extremely safe for all patients. It appears difficult to induce hypoglycemia even if you try." This is a dangerous claim. The first statement must be conditioned. You cannot disregard other medications that patients may be taking, especially when you are pretending to give advice to other practitioners. We know that taking Afrezza with metformin or basal insulin can induce hypoglycemia. Although Vdex claims that hypo's cannot be induced in patients with insulin sensitivity, I recall at least one PWD with insulin sensitivity saying the a 4-unit dose resulted in significant hypos, and wished there was a 2-unit dose available. Regarding the second statement, the paper also says, "In fact, we saw less hypoglycemia overall as patients’ blood glucose levels flattened and stabilized." So, patients did experience hypoglycemia. How many and how often? There were only 30 patients, so it cannot be that difficult to induce hypoglycemia if it occurs in the normal course of treatment. What is important, it seems to me, is how Vdex limited the hypoglycemia and flattened the BG levels. As for the data: Figures 1, 2 & 3. Where did these come from? Particularly Fig 3, BG levels on Afrezza. This chart has 7 curves plotted, one for each day of the week. Is this for one of Vdex's patients for one week? What is it supposed to show or prove? How many of Vdex's patients were able to achieve this? Was this repeatable and for how many weeks has this been achieved? The paper never provides enough information to interpret the significance of this chart. Fig 3 was certainly not the patient in study#2. "We began treatment and steadily increased dosages of Afrezza until the patient was administering 96 units of insulin each meal or almost 300 units of insulin daily. We DID NOT adjust the basal dosing." According to the clinical studies, 96 units, if taken as a single dose, is well past the point of diminishing returns for Afrezza and fasting BG levels were only reduced to 130-180. Vdex doesn't say if the 96 units were taken at one time or stacked or whatever. Vdex's conclusion, "even massive doses of Afrezza in some patients seem not to produce hypoglycemia." Is this even a meaningful statement regarding a patient with such high BG levels? My conclusion: VDEX couldn't get her BG levels under control. Not a good case study for Afrezza IMO. In case study 6, Vdex does not explain why the 8-unit dose is apparently less effective than the 4-unit dose. Clearly in 6b (4-unit) the BG is already in range before the second dose is taken. In 6c, with the 8-unit dose BG is higher and stays out of range longer than with the 4-unit dose in 6b. Seems to be counterintuitive. Maybe at this point the patient couldn't cope with yet another 6" turkey sub. "Given our extensive, direct experience with Afrezza, we have confirmed the safety of the product. " How many patients has Vdex treated with Afrezza? The paper only mentions 30. No one will accept this as extensive experience, especially in the case of a safety study. They may have treated many more, but they never say. They also never say what percentage of their patients reach goal or what the dropout rate is. Isn't this what practitioner's want to know, especially if they are being told that Vdex has found the holy grail of diabetes and to follow their example. The paper may have a useful message, but it is poorly explained and could, in reality, be counterproductive. Maybe you should read the paper again - as the paper says "Figures 1. – 3. below serve to make the point well. The first illustrates typical, non-diabetic glucoselevels as measured on a CGM. The second shows CGM tracings for typical insulin-dependent diabetic blood sugar levels, and the third shows what can be achieved on Afrezza. While not all patients can achieve the level of control reflected in the third graph, ALL AFREZZA USERS THAT WE STUDIED SHOWED FLATTENED CURVES such as we illustrate here. This paper was done for money guys not for doctors and especially not for research types. The 3 figures were presented for illustrative purposes. VDex has no intention of explaining to the money guys how a 2 strand amino acid with a molecular weight of 5808 Da is different and acts different than an analog weighing 5825.8 Da. I suspect Mike has similar results which were done by research scientists which Al left in a file cabinet. Maybe Mike can find them. This would seem strange to me if put together primarily for money guys. It goes into a lot of details that I doubt many would be interested in or appreciate without prior detailed knowledge of BG metabolism. Further it lacks the information they would be interested in such as what percentage of patients coming in with uncontrolled BG were able to be brought within targets. Not to mention the notion that a VC would read a document that long would make many laugh out loud. I've put together pitches to VCs and reviewed quite a few others. Though certainly can't speak to what was in their minds putting this together.
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Post by mnkdfann on Jul 29, 2017 20:30:05 GMT -5
This paper was done for money guys not for doctors and especially not for research types. The 3 figures were presented for illustrative purposes. VDex has no intention of explaining to the money guys how a 2 strand amino acid with a molecular weight of 5808 Da is different and acts different than an analog weighing 5825.8 Da. Done for money guys? Where do you get that from? The introduction says the studies were soley for internal use. The line "Vdex has chosen to release this White Paper publicly due to the need for better therapies to control the exploding disease of diabetes", if anything, suggests to me that it was released for the benefit of the medical community. If you have additional information, please do share. Frankly, if the paper WAS done and released for 'money guys' then IMHO the paper becomes promotional garbage and the medical community will treat it as such. So I hope it was not.
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Post by scoy on Jul 29, 2017 21:25:57 GMT -5
I could not figure out how to edit it, but in response to: buy a few shares of MNKD Monday and see if you can give the paper a passing grade. He starts off by saying that FDA clinical data doesn't support "a claim of greater safety with Afrezza". Then the paper goes on to make the argument that we should be relying on an anonymous paper instead of relying on the FDA clinical data.
Later it says their approach sounds "irresponsible".
If only shareholders are going to like the argument, then it doesn't convince anyone who is not already a strong believer in Afrezza.
It looks to me like a lot of work went into creating the document. I think it would've been a lot more effective if they would've stopped the introduction with, "Specifically, Vdex conducted numerous studies over a 12-month period to understand various attributes of Afrezza, to help define the best use of the product, and to understand the best practices to be followed in prescribing or recommending the product.",
Then only include material that supports that statement.
It'd be a look how easy it is to achieve great results with Afrezza type of paper, rather than the establishment is messed up, don't look at clinical results, the label is misleading, troubles are exaggerated, people are emotional, type of paper.
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Post by oldfishtowner on Jul 29, 2017 21:30:00 GMT -5
At the risk of being the subject of the ire of other longs on this board, I beg to offer a different opinion of the Vdex paper than the praises being heaped upon it by virtually everyone so far. The paper's observations may well be valid, but the data presented do not support the claims made. Rather in some instances the data seem to contradict the claims. Nor are any references provided to support claims made that are not based on the "study" data. The language and writing style of the paper are not professional. For example, "Who really knows what all this stuff does or how it interacts?" ......... The paper may have a useful message, but it is poorly explained and could, in reality, be counterproductive. oldfishtowner , buy a few shares of MNKD Monday and see if you can give the paper a passing grade. It is hard to resist the urge to be critical, I know. I've been buying. Bought some on Thursday, some the week before, etc. I've doubled my holdings since the reverse split. I just don't have a high opinion of the Vdex paper. It has nothing to do with MNKD or Afrezza, other than the paper is so poorly written it could do more harm than good IMO. I like what Castagna has been doing since he came on board, and I see some reason for optimism regarding scripts. IMO there is a good chance that MNKD will beat SNY's highest script numbers by the end of this year and could do much better than that if Reversed and other DTC are effective. I am still cautious only because MNKD needs cash badly. I am not sure how that will play out, but even if there is dilution it is not clear whether it is better to buy now or wait until after the dilution. It depends on if and by how much you expect the stock price to rise between now and then.
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Post by spiro on Jul 29, 2017 22:12:49 GMT -5
This green paper statement by Spiro has been put together for money. If only that were true, Spiro would be a happy camper. It continues to amaze Spiro, how anyone can remotely think that Afrezza could not be an effective treatment for both type 1 and type 2 diabetes. Good grief it's rapid acting human insulin,. Why in the world shouldn't it work well if delivered properly? Spiro has been taking Afreezza for over 2 years now and it has effectively stalled his Type 2 Diabetes from progressing. Spiro's A1c has been stable at around 6.2 during that time. Spiro's highest BG reading in 2 years has been 214 after he stupidly forgot to puff his Afrezza after a large dinner one night. Actually that was only a couple of weeks ago, It kind of reminded Spiro that he is still a diabetic. Spiro takes 4 units after every meal. If he overindulges in carbs (Baklava), he adds an additional 4 units. Spiro will also take 4 units with in-between meal snacks. Good grief, it can't get any easier than that, for a type 2 diabetic not on any of those toxic diabetes medications. It's sad that most doctors and/or in particular the stubborn and stupid Endocrinologists have been unwilling to take the time and effort to figure out how to prescribe Afrezza.
Spiro here, I am done again, now back into my MNKD investor depression
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Post by scoy on Jul 29, 2017 23:21:00 GMT -5
This green paper statement by Spiro has been put together for money. If only that were true, Spiro would be a happy camper. It continues to amaze Spiro, how anyone can remotely think that Afrezza could not be an effective treatment for both type 1 and type 2 diabetes. Good grief it's rapid acting human insulin,. Why in the world shouldn't it work well if delivered properly? Spiro has been taking Afreezza for over 2 years now and it has effectively stalled his Type 2 Diabetes from progressing. Spiro's A1c has been stable at around 6.2 during that time. Spiro's highest BG reading in 2 years has been 214 after he stupidly forgot to puff his Afrezza after a large dinner one night. Actually that was only a couple of weeks ago, It kind of reminded Spiro that he is still a diabetic. Spiro takes 4 units after every meal. If he overindulges in carbs (Baklava), he adds an additional 4 units. Spiro will also take 4 units with in-between meal snacks. Good grief, it can't get any easier than that, for a type 2 diabetic not on any of those toxic diabetes medications. It's sad that most doctors and/or in particular the stubborn and stupid Endocrinologists have been unwilling to take the time and effort to figure out how to prescribe Afrezza. Spiro here, I am done again, now back into my MNKD investor depression I believe you of course, though for every bit that you believe that, I wonder how you can believe it and not want to be involved in a conversation about how to communicate better. My personality is to want to fix things, not to say good grief, and forget about it. But I will.
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Post by itellthefuture777 on Jul 29, 2017 23:42:20 GMT -5
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Post by slugworth008 on Jul 29, 2017 23:59:15 GMT -5
All I can say is ... I'm transferring $$$ into my account to load up before the Aug. 7th conference call. If I had any dry powder - I'd def be buying.
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Post by peppy on Jul 30, 2017 0:04:21 GMT -5
This green paper statement by Spiro has been put together for money. If only that were true, Spiro would be a happy camper. It continues to amaze Spiro, how anyone can remotely think that Afrezza could not be an effective treatment for both type 1 and type 2 diabetes. Good grief it's rapid acting human insulin,. Why in the world shouldn't it work well if delivered properly? Spiro has been taking Afreezza for over 2 years now and it has effectively stalled his Type 2 Diabetes from progressing. Spiro's A1c has been stable at around 6.2 during that time. Spiro's highest BG reading in 2 years has been 214 after he stupidly forgot to puff his Afrezza after a large dinner one night. Actually that was only a couple of weeks ago, It kind of reminded Spiro that he is still a diabetic. Spiro takes 4 units after every meal. If he overindulges in carbs (Baklava), he adds an additional 4 units. Spiro will also take 4 units with in-between meal snacks. Good grief, it can't get any easier than that, for a type 2 diabetic not on any of those toxic diabetes medications. It's sad that most doctors and/or in particular the stubborn and stupid Endocrinologists have been unwilling to take the time and effort to figure out how to prescribe Afrezza. Spiro here, I am done again, now back into my MNKD investor depression I believe you of course, though for every bit that you believe that, I wonder how you can believe it and not want to be involved in a conversation about how to communicate better. My personality is to want to fix things, not to say good grief, and forget about it. But I will.
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Post by straightly on Jul 30, 2017 0:38:22 GMT -5
This green paper statement by Spiro has been put together for money. If only that were true, Spiro would be a happy camper. It continues to amaze Spiro, how anyone can remotely think that Afrezza could not be an effective treatment for both type 1 and type 2 diabetes. Good grief it's rapid acting human insulin,. Why in the world shouldn't it work well if delivered properly? Spiro has been taking Afreezza for over 2 years now and it has effectively stalled his Type 2 Diabetes from progressing. Spiro's A1c has been stable at around 6.2 during that time. Spiro's highest BG reading in 2 years has been 214 after he stupidly forgot to puff his Afrezza after a large dinner one night. Actually that was only a couple of weeks ago, It kind of reminded Spiro that he is still a diabetic. Spiro takes 4 units after every meal. If he overindulges in carbs (Baklava), he adds an additional 4 units. Spiro will also take 4 units with in-between meal snacks. Good grief, it can't get any easier than that, for a type 2 diabetic not on any of those toxic diabetes medications. It's sad that most doctors and/or in particular the stubborn and stupid Endocrinologists have been unwilling to take the time and effort to figure out how to prescribe Afrezza. Spiro here, I am done again, now back into my MNKD investor depression F. Actually, what I meant was "thanks for the confirmation of my investments", whatever the grade you got.
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Post by straightly on Jul 30, 2017 0:42:39 GMT -5
This green paper statement by Spiro has been put together for money. If only that were true, Spiro would be a happy camper. It continues to amaze Spiro, how anyone can remotely think that Afrezza could not be an effective treatment for both type 1 and type 2 diabetes. Good grief it's rapid acting human insulin,. Why in the world shouldn't it work well if delivered properly? Spiro has been taking Afreezza for over 2 years now and it has effectively stalled his Type 2 Diabetes from progressing. Spiro's A1c has been stable at around 6.2 during that time. Spiro's highest BG reading in 2 years has been 214 after he stupidly forgot to puff his Afrezza after a large dinner one night. Actually that was only a couple of weeks ago, It kind of reminded Spiro that he is still a diabetic. Spiro takes 4 units after every meal. If he overindulges in carbs (Baklava), he adds an additional 4 units. Spiro will also take 4 units with in-between meal snacks. Good grief, it can't get any easier than that, for a type 2 diabetic not on any of those toxic diabetes medications. It's sad that most doctors and/or in particular the stubborn and stupid Endocrinologists have been unwilling to take the time and effort to figure out how to prescribe Afrezza. Spiro here, I am done again, now back into my MNKD investor depression I believe you of course, though for every bit that you believe that, I wonder how you can believe it and not want to be involved in a conversation about how to communicate better. My personality is to want to fix things, not to say good grief, and forget about it. But I will. "communicate better." If you can, please do. "want to fix things": don't you want to identify what is broken first? Nothing broken in this post, IMHO. Good grief!
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Post by sportsrancho on Jul 30, 2017 4:59:12 GMT -5
Nate's thoughts on the paper; Jul. 29 at 7:51 PM NatesNotes @epicjuan lars1551 yep - a few docs probably at the 15-20 stage now, more in the 5-8 range, and many getting started with their first pts Jul. 29 at 7:40 PM NatesNotes $MNKD lars1551 "1-2 patients at first... then 5-8... then 15-20... then, if results are still consistent, THE REST OF THE PRACTICE" :-) Jul. 29 at 5:29 PM NatesNotes @bad_ass_investor it's a great collection of data & observations; should only help to accelerate trends already in place for $MNKD Afrezza
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Post by peppy on Jul 30, 2017 8:00:24 GMT -5
Nate's thoughts on the paper; Jul. 29 at 7:51 PM NatesNotes @epicjuan lars1551 yep - a few docs probably at the 15-20 stage now, more in the 5-8 range, and many getting started with their first pts Jul. 29 at 7:40 PM NatesNotes $MNKD lars1551 "1-2 patients at first... then 5-8... then 15-20... then, if results are still consistent, THE REST OF THE PRACTICE" :-) Jul. 29 at 5:29 PM NatesNotes @bad_ass_investor it's a great collection of data & observations; should only help to accelerate trends already in place for $MNKD Afrezza quote: a few docs probably at the 15-20 stage now, more in the 5-8 range, and many getting started with their first pts
reply: we know this to be true. @ 6 months ago, aged's endo group: identified their first candidate. Perhaps they got one. (Bastids) Anyway, yes.
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Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
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Post by Tinkerbell on Jul 30, 2017 9:58:04 GMT -5
At the risk of being the subject of the ire of other longs on this board, I beg to offer a different opinion of the Vdex paper than the praises being heaped upon it by virtually everyone so far. The paper's observations may well be valid, but the data presented do not support the claims made. Rather in some instances the data seem to contradict the claims. Nor are any references provided to support claims made that are not based on the "study" data. The language and writing style of the paper are not professional. For example, "Who really knows what all this stuff does or how it interacts?" The paper's author is not given, let alone one with an MD that would lend some credence to its contents. Vdex would have been better off with just a one or two page summary of their findings. As it is, the paper comes off as very amateurish. I would be embarrassed to forward this to anyone, and would certainly not send it to anyone making critical decisions that would affect Afrezza's future. Granted that there is a disclaimer at the beginning that the paper lacks "some of the rigors" of peer-reviewed articles. Still, I would hazard to say that the paper would deserve an F in any subject, whether it be English class, a technical writing class, or any hard science class. "Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Some of our studies were purely observational. We prescribed the drug and monitored the results that patients achieved. From those initial observations, we designed tests to further understand various aspects of the product. We DO NOT attempt here to fully explain how this drug works. It is for others to detail the precise mechanism of action. We sought to understand WHAT the drug does, not necessarily HOW it does it. We will hypothesize about the HOW to the extent we feel comfortable, but we encourage further study by others to completely explain our observations." Vdex should have stuck to this approach instead of attempting to explain what is going on in more detail and making general claims not supported by their observations. In the summary of safety findings the paper states: "Hypoglycemia. Our experience has been that Afrezza is extremely safe for all patients. It appears difficult to induce hypoglycemia even if you try." This is a dangerous claim. The first statement must be conditioned. You cannot disregard other medications that patients may be taking, especially when you are pretending to give advice to other practitioners. We know that taking Afrezza with metformin or basal insulin can induce hypoglycemia. Although Vdex claims that hypo's cannot be induced in patients with insulin sensitivity, I recall at least one PWD with insulin sensitivity saying the a 4-unit dose resulted in significant hypos, and wished there was a 2-unit dose available. Regarding the second statement, the paper also says, "In fact, we saw less hypoglycemia overall as patients’ blood glucose levels flattened and stabilized." So, patients did experience hypoglycemia. How many and how often? There were only 30 patients, so it cannot be that difficult to induce hypoglycemia if it occurs in the normal course of treatment. What is important, it seems to me, is how Vdex limited the hypoglycemia and flattened the BG levels.As for the data: Figures 1, 2 & 3. Where did these come from? Particularly Fig 3, BG levels on Afrezza. This chart has 7 curves plotted, one for each day of the week. Is this for one of Vdex's patients for one week? What is it supposed to show or prove? How many of Vdex's patients were able to achieve this? Was this repeatable and for how many weeks has this been achieved? The paper never provides enough information to interpret the significance of this chart.Fig 3 was certainly not the patient in study#2. "We began treatment and steadily increased dosages of Afrezza until the patient was administering 96 units of insulin each meal or almost 300 units of insulin daily. We DID NOT adjust the basal dosing." According to the clinical studies, 96 units, if taken as a single dose, is well past the point of diminishing returns for Afrezza and fasting BG levels were only reduced to 130-180. Vdex doesn't say if the 96 units were taken at one time or stacked or whatever. Vdex's conclusion, "even massive doses of Afrezza in some patients seem not to produce hypoglycemia." Is this even a meaningful statement regarding a patient with such high BG levels? My conclusion: VDEX couldn't get her BG levels under control. Not a good case study for Afrezza IMO. In case study 6, Vdex does not explain why the 8-unit dose is apparently less effective than the 4-unit dose. Clearly in 6b (4-unit) the BG is already in range before the second dose is taken. In 6c, with the 8-unit dose BG is higher and stays out of range longer than with the 4-unit dose in 6b. Seems to be counterintuitive. Maybe at this point the patient couldn't cope with yet another 6" turkey sub. "Given our extensive, direct experience with Afrezza, we have confirmed the safety of the product. " How many patients has Vdex treated with Afrezza? The paper only mentions 30. No one will accept this as extensive experience, especially in the case of a safety study. They may have treated many more, but they never say. They also never say what percentage of their patients reach goal or what the dropout rate is. Isn't this what practitioner's want to know, especially if they are being told that Vdex has found the holy grail of diabetes and to follow their example. The paper may have a useful message, but it is poorly explained and could, in reality, be counterproductive. While I agree that this white paper has ‘layperson’ written all over it, I’ve underlined key statements you’ve made above and have taken the liberty of rewriting your observations and included some of my own. I hope to provide a similar point of view with a few caveats. Here goes: The recently released white paper by VDEX while far from what I would call ‘of scientific grade or merit’, nonetheless warrants some attention even if it contains errors, omissions and sloppily generated answers leading to additional questions. In fact, the definition of a white paper is: an authoritative report or guide that informs readers concisely about a complex issue and presents the issuing body's philosophy on the matter. It is meant to help readers understand an issue, solve a problem, or make a decision. That said, anyone in an institution or a business entity can write a white paper and thus I am not surprised that the quality of such doesn't alway meet the rigors of the medical/scientific community nor business practices nor the standards of an English professor. Clearly, this business entity has taken it upon themselves to attempt to shoot an arrow (albeit a crooked one) across the bow of MD indifference and that of big Pharma as it pertains to developing life changing innovation for the treatment of both Type 1 and Type 2 diabetes similar to those we've seen in the treatment of HIV and cancer. To VDEX’s credit, they are attempting to serve as a beacon (nevermind the quantity or quality of lumens they shed) in order to cast some attention to the use of Afrezza and the paradigm shift they believe it can offer. For that very reason alone, one cannot deny noble intent even if there is a potential monetary reward in the long run for what they've taken upon themselves to do. In fact, they deserve any reward they may achieve on account of the work they've attempted to do in this paper. I will be the first to admit that this white paper could never be presented in any formal setting and in my veiw (for all intents and purposes), they’ve attempted to run a quasi-phase 4 study all by themselves. As unorthodox as this may seem at first, clearly what VDEX has done begs a larger question amongst physicians treating diabetics: Just what does a CGM’s recordings look like over a short period of time? Is it out of the realm of possibility that any endocrinologist or diabetic educator request a diabetic on Afrezza to record each meal or snack for one week and bring that diary in along with their CGM recordings for a thorough review? Does such request require IRB approval? Not for a white paper it doesn't. The above then begs the secondary question. What should be the correct response to those who would snicker or make snide remarks about VDEX's white paper? I know. "Put Up or Shut Up." Finally, in light of this white paper, MDs should realize that patients are lay people too when it comes to medicine and they are getting smarter about their health care choices by the minute. Patients will choose their MDs in future whether they are in private practice or part of a medical team located at a business entity. The choice will be the patient's to make. Finally, one does not need to have a degree in rocket science to comprehend what is about to happen. Investors are not the only ones doing their due diligence. One's own health care garners an entirely different kind of due diligence and it's way more indepth than most MDs are even aware of.
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