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Post by dreamboatcruise on Feb 13, 2017 14:00:40 GMT -5
So then a diabetic, due to insulin issue has more glucose floating around in their system not being used as fuel for cells vs a person without diabetes having the glucose absorbed into cells as fuel. Not a scientist as my comments indicate but does insulin allow glucose into cancer cells as well as healthy cells? Theoretically starving cancer cells via lack of insulin might slow growth but you'd be starving all other cells in the body as well and doing damage from high BG. The issue would be whether insulin (or in this case Afrezza) ever causes cancer. So far the clinical trials would suggest that it does not... i.e. there has been no statistically significant increase in cancer. MNKD did cellular studies for carcinogenicity which were negative. Things like cigarette smoke can be shown using similar studies to be carcinogenic. FDA is requiring long term safety studies of Afrezza and undoubtedly cancer incidence will be something that is monitored, but at this point it would seem very unlikely that a problem will arise. Any drug has the potential for some safety issue over the long run... but Afrezza actually has a much longer track record due to its delays in approval compared to other drugs that are just starting on their launch. At this point there have been many thousands of users and some have now probably been on Afrezza for close to a decade. |
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Post by peppy on Feb 13, 2017 14:19:09 GMT -5
Welcome to Mannkind, I am very excited to have you on our team as our hopes and future are now in your hands. Afrezza is the greatest advance in diabetes treatment since Banting and Best first used insulin in 1922, 95 years ago. You have the ability to dramatically affect the future in diabetes treatment. Research teams are currently working on methods to reduce A1c from the 9+'s to the 7's. With afrezza it should be the norm for patients to be in the 6's, 5's and even 4's. If the patients are not hitting these numbers, don't blame the product as they are either dosing improperly, holding the inhaler upside down, or the patient has other issues in addition to their diabetes. There is only one thing which can bring down high blood sugar and it is insulin. The best insulin which does this is the insulin secreted from the pancreas, monomer human insulin. No pills, DPP-4 Inhibitor, GLP-1 Agonist, SGLT-2 Inhibitor, or any Analog insulin can do what the healthy pancreas can do. If you can NOT sell afrezza don't blame the product as the product is this exact same insulin which the pancreas secretes. No other product can do what afrezza does and has the pharmakinetics afrezza does which mimics the pancreas. No other Analog is as easy to use as afrezza and there is no carb counting. If sold properly afrezza should dominate the entire diabetes space and should be used by most T1's and T2's including off label for corrections for smokers and those with COPD. It will not be easy as Big Pharma has been and will continue to throw everything at you to stop you and afrezza. They will convince doctors its too new BUT you know its human insulin and human insulin has been around since the beginning of man. You will also be armed with all the info on FDKP. BP will point the doctors to the lackluster A1c results from Studies 171 and 175 but you will be armed with the study results from that one doctor in those studies called out by the FDA because he had his patients follow the 90 minute second dose as outlined in the protocol to mimic phase 2 pancreatic release and his results blew away the Insulin Aspart results. You will explain how afrezza mimics the healthy pancreas with phase1 and phase 2 insulin release. You will also explain how import each phase is and that only afrezza can provide that ALL important phase 1 release. You will also be armed with the clamp study results and explain why A1c is really not the best way to treat diabetes but rather time in range. They will then tell you the current protocol for T2's is to first treat will pills but you will have all the latest studies which show how early insulin intervention can not only stop the progression their patients will see on those pills but in some cases reverse diabetes. For early insulin intervention there is no better choice than afrezza. Once they run out of every other excuse they will throw the cancer Red Herring at you but since you already know human insulin does not cause cancer you will smile. You will then explain that current diabetics do have a higher rate of cancer and you will be armed with the studies which point to the elongated amount of time the current analogs are in the system as one potential for increased cancer rates. You will explain how fast afrezza is in and out so this may give afrezza a big advantage for not promoting cancer as other analogs may do. You will also have the AspB10 report and explain that no one is quite sure of the long term effects with the analogs and work is just starting to understand if the analogs may be a reason for the higher incidents. Yes, we have been told they are safe but are they really safe for everyone? We know human insulin is safe. You will be armed with your Abbott Libre and Dexcom and explain titrating using the guide in the starter kit and explain why glucose measuring several times after eating is needed and a second and maybe even a third dose of afrezza may be needed after meals to mimic the pancreas phase 2 release. You can then explain the Libre is fully covered and by lending the new T2 a scanner for several months to do the home measurements while returning every two weeks to collect and review the measurements it is not only the best way to titrate but also fully covered for the patient and profitable for the doctor. It will also guarantee the measurements are available and correct. Ideally Mannkind will have software which can model these results and highlight adjustments which can be made to dosing. Do your homework, be prepared and be persistent. You have one of the biggest $ markets to sell into and you have the best product. You have the potential to have hundreds of $millions in sales within a few short years. You have never had such a sales opportunity as this. You have real users showing real results on youtube which researchers still can't mimic in their labs with non-insulin approaches. As additional technology products which measure and track real time glucose levels enter the market this should make selling afrezza even easier because nothing can control high blood sugar like afrezza except a healthy pancreas. Many of these things you suggest are getting out of the bounds of what is allowed by FDA. Sales people cannot market for off-label. Many drug companies get nailed for that. We cannot afford the fines nor antagonizing an FDA from whom we need to get label change and approval of needed future trial protocols. I believe sales people can provide medical literature to docs but they cannot put spin on it as you suggest. I was once in a doc office and overheard an interaction between drug sales rep and doc... it was basically to say if he was interested in some of the scientific lit the rep would have one of the pharmas scientists/docs call. Pharmas have to be careful non physician sales reps aren't playing doctor/researcher and inappropriately using scientific lit as sales prop in a way that isn't supported in the conclusions of the paper. The Libre that allows patients to see readings isn't even approved in the US. I highly doubt doctors would purchase unapproved devices and loan to patients. As far as we know MNKD isn't even working on dosing software. Further, if they were it would still be years away from coming to market. Any software that suggests dosing would need to go through clinical trials and be approved by FDA. If I could say anything, this is what I think the physician needs to know. Afrezza, technosphere insulin, an inhaled regular human insulin, www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. End of effect
• On a dose basis, the effect of Afrezza ends 2 h before Lispro
My words: Diabetes use a higher dose of afrezza then of subq fasting. this is because afrezza has two independent effects. The first effect is phase one effect, the large hit of glucose to the liver stops gluconeogenesis. *This stops blood glucose from going high in the first place* you do not get phase one with fast acting subq. www.screencast.com/t/qHsWcjqc www.screencast.com/t/pYQ4TMFaY
continuing regarding dosing I use Matt's words: In my world these are the perfect dosing instructions.
"I have previously mentioned the importance of dosage timing when taking Afrezza, but have not gone into much detail. So I thought it would be worthwhile talking about what I have learned so far about timing.
As a general rule, I dose about 10 minutes after I start eating, which is before my glucose levels start to rise from the meal. As I mention in the video, the best time to dose seems to depend on the fat content of the meal. And for some high fat meals, a follow up dose of Afrezza is neccesary.
I have found the same rule also applies if a follow-up dose is required. It is important to have the follow-up dose before the levels begin to rise out of range. If I had a CGM with alerts, I would use this to notify me as soon as it levels began to increase. That way I wouldn’t miss the optimum time for the follow-up.
It is worth remembering that much, much more Afrezza is needed to correct high glucose levels than to cover meals. As the video details, if I wait too long to dose, the dose required may be four times higher!"
afrezzadownunder.com/
Doc, "Afrezza is an insulin diabetes can take."
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Post by johntherancher on Feb 13, 2017 15:15:37 GMT -5
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Post by buyitonsale on Feb 13, 2017 18:30:36 GMT -5
This is the first attempt to promote Afrezza using Mannkind's own sales force. It's not the last of anything. Mannkind has been around through many obstacles and it's here to stay. This is MNKD 3.0. If this doesn't work, how long do they continue until they decide that despite its efficacy, the market for the product just might not be there? Do they launch MNKD 4.0, 5.0. 6.0? Trial and error indefinitely, at the expense of millions of dollars and more shareholder deficit? If MNKD can't market the drug with their own sales force, common sense tells you that they can't market the drug at all. If 3.0 fails, they will likely try to sell the product or company outright. Successful companies don't operate at a loss indefinitely and expect to keep stringing shareholders along. People may not like to believe it, but this is Afrezza greatest, and likely last chance for success under MNKD, especially given financial runway and past experience. Those are working against MNKD here, not for them. Try watching any professional men's tennis 5 set match or even the last Super Bowl game from beginning to end... Winners never quit and quitters never win! |
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Post by sayhey24 on Feb 13, 2017 20:28:20 GMT -5
Welcome to Mannkind, I am very excited to have you on our team as our hopes and future are now in your hands. Afrezza is the greatest advance in diabetes treatment since Banting and Best first used insulin in 1922, 95 years ago. You have the ability to dramatically affect the future in diabetes treatment. Research teams are currently working on methods to reduce A1c from the 9+'s to the 7's. With afrezza it should be the norm for patients to be in the 6's, 5's and even 4's. If the patients are not hitting these numbers, don't blame the product as they are either dosing improperly, holding the inhaler upside down, or the patient has other issues in addition to their diabetes. There is only one thing which can bring down high blood sugar and it is insulin. The best insulin which does this is the insulin secreted from the pancreas, monomer human insulin. No pills, DPP-4 Inhibitor, GLP-1 Agonist, SGLT-2 Inhibitor, or any Analog insulin can do what the healthy pancreas can do. If you can NOT sell afrezza don't blame the product as the product is this exact same insulin which the pancreas secretes. No other product can do what afrezza does and has the pharmakinetics afrezza does which mimics the pancreas. No other Analog is as easy to use as afrezza and there is no carb counting. If sold properly afrezza should dominate the entire diabetes space and should be used by most T1's and T2's including off label for corrections for smokers and those with COPD. It will not be easy as Big Pharma has been and will continue to throw everything at you to stop you and afrezza. They will convince doctors its too new BUT you know its human insulin and human insulin has been around since the beginning of man. You will also be armed with all the info on FDKP. BP will point the doctors to the lackluster A1c results from Studies 171 and 175 but you will be armed with the study results from that one doctor in those studies called out by the FDA because he had his patients follow the 90 minute second dose as outlined in the protocol to mimic phase 2 pancreatic release and his results blew away the Insulin Aspart results. You will explain how afrezza mimics the healthy pancreas with phase1 and phase 2 insulin release. You will also explain how import each phase is and that only afrezza can provide that ALL important phase 1 release. You will also be armed with the clamp study results and explain why A1c is really not the best way to treat diabetes but rather time in range. They will then tell you the current protocol for T2's is to first treat will pills but you will have all the latest studies which show how early insulin intervention can not only stop the progression their patients will see on those pills but in some cases reverse diabetes. For early insulin intervention there is no better choice than afrezza. Once they run out of every other excuse they will throw the cancer Red Herring at you but since you already know human insulin does not cause cancer you will smile. You will then explain that current diabetics do have a higher rate of cancer and you will be armed with the studies which point to the elongated amount of time the current analogs are in the system as one potential for increased cancer rates. You will explain how fast afrezza is in and out so this may give afrezza a big advantage for not promoting cancer as other analogs may do. You will also have the AspB10 report and explain that no one is quite sure of the long term effects with the analogs and work is just starting to understand if the analogs may be a reason for the higher incidents. Yes, we have been told they are safe but are they really safe for everyone? We know human insulin is safe. You will be armed with your Abbott Libre and Dexcom and explain titrating using the guide in the starter kit and explain why glucose measuring several times after eating is needed and a second and maybe even a third dose of afrezza may be needed after meals to mimic the pancreas phase 2 release. You can then explain the Libre is fully covered and by lending the new T2 a scanner for several months to do the home measurements while returning every two weeks to collect and review the measurements it is not only the best way to titrate but also fully covered for the patient and profitable for the doctor. It will also guarantee the measurements are available and correct. Ideally Mannkind will have software which can model these results and highlight adjustments which can be made to dosing. Do your homework, be prepared and be persistent. You have one of the biggest $ markets to sell into and you have the best product. You have the potential to have hundreds of $millions in sales within a few short years. You have never had such a sales opportunity as this. You have real users showing real results on youtube which researchers still can't mimic in their labs with non-insulin approaches. As additional technology products which measure and track real time glucose levels enter the market this should make selling afrezza even easier because nothing can control high blood sugar like afrezza except a healthy pancreas. Many of these things you suggest are getting out of the bounds of what is allowed by FDA. Sales people cannot market for off-label. Many drug companies get nailed for that. We cannot afford the fines nor antagonizing an FDA from whom we need to get label change and approval of needed future trial protocols. I believe sales people can provide medical literature to docs but they cannot put spin on it as you suggest. I was once in a doc office and overheard an interaction between drug sales rep and doc... it was basically to say if he was interested in some of the scientific lit the rep would have one of the pharmas scientists/docs call. Pharmas have to be careful non physician sales reps aren't playing doctor/researcher and inappropriately using scientific lit as sales prop in a way that isn't supported in the conclusions of the paper. The Libre that allows patients to see readings isn't even approved in the US. I highly doubt doctors would purchase unapproved devices and loan to patients. As far as we know MNKD isn't even working on dosing software. Further, if they were it would still be years away from coming to market. Any software that suggests dosing would need to go through clinical trials and be approved by FDA. No, I do not think anything I said was out of bounds. Without a doubt afrezza should be used by those able smokers and COPDers for corrections and I think the sales guys should be demanding MNKD create a new box configuration for corrections with a new name "afrezza for corrections" and apply to remove the black box and spirometry test. This product should also be sold over the counter - OTC, as other human insulins. Neither the smoker restriction nor the spirometry is warranted for the occasional user. Now who ever said the sales team should tell the doctors they should prescribe off label? Not me. Some things are better not said. Even Edelman likes using afrezza for corrections then again Edelman seems to be liking afrezza a lot lately youtu.be/Xtg1ESeqAQw?t=8The restriction on the Libre is "readings are only available to patients through consultation". How I setup a consultant would be up to me. If I show the patient how to fill out the afrezza log in the starter kit and record measurements and the food they ate and return every two weeks where I also scan the sensor, compare my results to the patients log, and then suggest dosing adjustments - all aspects would be consider part of the consultation protocol. The restriction does not say "in office only". Additionally, some of these doctors are getting pretty creative and creating their own "Teledoc like" services where they are consulting over the net if the patient has questions or concerns when logging the information. There is also nothing restricting the doctor from selling a scanner to the patient as long as the patient is using it in consultation with the doctor. For about $100, I suspect many would want their own. Its a lot better than finger pokes and the test strip cost for 10 strips a day is more than the sensors. Providing study information is perfectly fine. Discussing the studies is also fine. There is no spin needed, just stick to the facts in the paper. afrezza is nothing more than the exact same insulin secreted by the pancreas. In Edelman's youtube I had to laugh when he said "if afrezza does not work for you". If the same insulin the pancreas makes does not work for you and you are dosing properly you have bigger issues. Now, do the BPs want to talk about any Analog safety concerns, no way. They are perfectly safe, trust them. However, some studies are now questioning that, I suspect more to come as it will take 20-30 years for cancer issues. What we do know is human insulin does not cause cancer and we know in AspB10 they killed the rats. No spin, no need, just the facts. You are correct MNKD does not currently have dosing software. They should and I have told them more than once. IMO, only technology will save afrezza as the patients need that real time feedback to hit their targets. Onduo is working overly complicated models buts for now LibreView is free and the doctors and patients can use it for tracking now www2.libreview.com/ and our Sales Guys need to sell now, not next month and not next year. With afrezza dosing is easy - its really hard to overdose as the liver will kick in and recover from the over dose just like when the pancreas over doses. Unlike the Analogs which hang around afrezza is gone just like pancreatic insulin. Most of the issues with afrezza is under dosing and not second dosing to mimic pancreatic phase 2 release. It often takes two puffs as Edleman mentioned. |
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Post by peppy on Feb 14, 2017 6:38:30 GMT -5
What I meant by this, is that with afrezza, the diabetic can take enough insulin to get phase one and phase two/or glucose control, with out fear of dying. The amazing thing about afrezza, A Matt quote, "Afrezza keeps your glucose from going high in the first place." then it brings glucose down gently and leaves the body. We see it on the continuous glucose monitors. Users, Sam, sweedee's dad say they feel better. "Insulin you can take", perhaps needs to be improved as tag line. yikes. So what I meant, is insulin that you can take a small medium or large dose and live to talk about it. yikes, I seem to be going down the rabbit hole. or whole.
www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf afrezzadownunder.com/ www.screencast.com/t/qHsWcjqc www.screencast.com/t/pYQ4TMFaY
Matt b is so smart. It is my belief he runs with physicians and is an artist.
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Post by johntherancher on Feb 14, 2017 11:59:33 GMT -5
"Insulin you can take" I really like it. It is concise, easily remembered, and stimulates a question in my mind to find out what it means. The followup would lead to a list of the advantages of Afrezza. The Afrezza logo would appear alongside "Insulin you can take" in a pictorial ad.
Thanks Peppy, for putting up with my quibbling, although you did manage to improve the message, IMO. John
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Post by agedhippie on Feb 14, 2017 14:53:51 GMT -5
The Libre device likely hasn't been approved in the US for general use because it has serious problems with hypos. From the Abbott Press Release:
In other words you cannot dose using the Libre, and there is a good chance that if you think you are hypo and gulping down glucose you are not low at all and about to go high from the glucose you just took for a non-existent low. That is going to prevent it ever getting approved for general release - it fails the accuracy requirements. However in trends accuracy is not so important which is why the FDA approved it the way they did.
Also if you take acetaminophen you are going to knock out your sensor for 8 hours while it recovers from being poisoned. Dexcom has this problem as well but I thought Abbott had changed the reagent - seems not.
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Post by sayhey24 on Feb 14, 2017 16:21:39 GMT -5
The Libre device likely hasn't been approved in the US for general use because it has serious problems with hypos. From the Abbott Press Release: In other words you cannot dose using the Libre, and there is a good chance that if you think you are hypo and gulping down glucose you are not low at all and about to go high from the glucose you just took for a non-existent low. That is going to prevent it ever getting approved for general release - it fails the accuracy requirements. However in trends accuracy is not so important which is why the FDA approved it the way they did. Also if you take acetaminophen you are going to knock out your sensor for 8 hours while it recovers from being poisoned. Dexcom has this problem as well but I thought Abbott had changed the reagent - seems not. My understanding is it was a marketing decision. The same device using the mmol scale is approved in Europe. The thinking was they could develop a new profit center for the doctors by requiring the sensor to be replaced by the doctor every two weeks and readings are only allowed in consultation with the doctor. It seems they may have been right as it really seems to be catching on with the endos. For afrezza this 2 week consultation period is perfect during the titration period. As the patient and doctor should be working closely by having the PWD document daily readings and then have the doctor verify those same readings at the 2 week mark when they replace the sensor. At that point they can review trends, meals and current dosing and make dosing adjustments. The beauty with afrezza is its like the pancreas and dosing does not have to be precise as long as follow up dosing is done when needed. The liver for the most part will take care of over dosing. If they are getting wacky lows or highs with the Libre they will need to double check with their old school meter. The Libre is not a dosing CGM its a trending device giving 15 minute readings which is plenty good enough for afrezza. If Dexcom was selling the G5 for $100 I would take the G5 but at $1100, its over kill for T2s. What Abbotts next move is in the CGM space is not clear. Rumor has it they had been looking to license the San Meditech device but Beyer was doing the same. Whatever it is its not here today and the new sales team needs devices they can leverage today for afrezza titration. |
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Post by agedhippie on Feb 14, 2017 17:29:07 GMT -5
My understanding is it was a marketing decision. The same device using the mmol scale is approved in Europe. The thinking was they could develop a new profit center for the doctors by requiring the sensor to be replaced by the doctor every two weeks and readings are only allowed in consultation with the doctor. It seems they may have been right as it really seems to be catching on with the endos. For afrezza this 2 week consultation period is perfect during the titration period. As the patient and doctor should be working closely by having the PWD document daily readings and then have the doctor verify those same readings at the 2 week mark when they replace the sensor. At that point they can review trends, meals and current dosing and make dosing adjustments. The beauty with afrezza is its like the pancreas and dosing does not have to be precise as long as follow up dosing is done when needed. The liver for the most part will take care of over dosing. If they are getting wacky lows or highs with the Libre they will need to double check with their old school meter. The Libre is not a dosing CGM its a trending device giving 15 minute readings which is plenty good enough for afrezza. If Dexcom was selling the G5 for $100 I would take the G5 but at $1100, its over kill for T2s. What Abbotts next move is in the CGM space is not clear. Rumor has it they had been looking to license the San Meditech device but Beyer was doing the same. Whatever it is its not here today and the new sales team needs devices they can leverage today for afrezza titration. You may well be right about it being a marketing decision, but I think that is more because they couldn't get it passed for dosing because of inaccuracy and so redefined it's role. By making it a trend only device it becomes an adjunct device but in the setting of a doctor's office that is workable. It does mean that getting extended use could be problematic as the doctor has to write a results and actions report for every sensor (I guess that is an exercise in how little you can put). Abbott still produce the Navigator in the EU. They withdrew it in the US because the FDA restrictions were so tight. The EU is more permissive about changes and features than the FDA. The Dexcom sensor insertion is horrible. With my needle phobia it takes me a while to pluck up the courage to press the plunger. The new sensor should fix that hopefully. |
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Post by dreamboatcruise on Feb 15, 2017 11:06:16 GMT -5
agedhippie ... doesn't the Dexcom also have issues with being less accurate in the hypo range? I'm basing that on memory, but it might have been something I read about the upcoming G6 which doesn't require calibration. But I guess you're saying the G5 is significantly better than Libra for hypo range? I read that Abbott is in process of getting the full version with patient access to readings approved in U.S., though I don't know where to confirm that on FDA site.
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Post by agedhippie on Feb 15, 2017 12:18:16 GMT -5
agedhippie ... doesn't the Dexcom also have issues with being less accurate in the hypo range? I'm basing that on memory, but it might have been something I read about the upcoming G6 which doesn't require calibration. But I guess you're saying the G5 is significantly better than Libra for hypo range? The Dexcom still has problems with sensor poisoning if you take acetaminophen but any accuracy issues were fixed in the 505 firmware release for the G4 (it came with the G5). If it had the Libre's performance they would not allow it to be used unmasked either, and definitely not for treating. The fact it is approved to treat means this is not an issue for the G5. |
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Post by peppy on Feb 15, 2017 13:10:09 GMT -5
agedhippie ... doesn't the Dexcom also have issues with being less accurate in the hypo range? I'm basing that on memory, but it might have been something I read about the upcoming G6 which doesn't require calibration. But I guess you're saying the G5 is significantly better than Libra for hypo range? The Dexcom still has problems with sensor poisoning if you take acetaminophen but any accuracy issues were fixed in the 505 firmware release for the G4 (it came with the G5). If it had the Libre's performance they would not allow it to be used unmasked either, and definitely not for treating. The fact it is approved to treat means this is not an issue for the G5. care.diabetesjournals.org/content/38/10/e158 In amperometric glucose biosensors, particularly those measuring hydrogen peroxide, acetaminophen’s phenolic moiety is oxidized at the sensing electrode, producing an electrochemical signal not related to glucose (1).
so H2O2 kills it?
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Post by liane on Feb 15, 2017 13:19:45 GMT -5
peppy, You're speaking my language! 
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Post by Deleted on Feb 15, 2017 14:22:59 GMT -5
The Libre device likely hasn't been approved in the US for general use because it has serious problems with hypos. From the Abbott Press Release: In other words you cannot dose using the Libre, and there is a good chance that if you think you are hypo and gulping down glucose you are not low at all and about to go high from the glucose you just took for a non-existent low. That is going to prevent it ever getting approved for general release - it fails the accuracy requirements. However in trends accuracy is not so important which is why the FDA approved it the way they did. Also if you take acetaminophen you are going to knock out your sensor for 8 hours while it recovers from being poisoned. Dexcom has this problem as well but I thought Abbott had changed the reagent - seems not. My understanding is it was a marketing decision. The same device using the mmol scale is approved in Europe. The thinking was they could develop a new profit center for the doctors by requiring the sensor to be replaced by the doctor every two weeks and readings are only allowed in consultation with the doctor. It seems they may have been right as it really seems to be catching on with the endos. For afrezza this 2 week consultation period is perfect during the titration period. As the patient and doctor should be working closely by having the PWD document daily readings and then have the doctor verify those same readings at the 2 week mark when they replace the sensor. At that point they can review trends, meals and current dosing and make dosing adjustments. The beauty with afrezza is its like the pancreas and dosing does not have to be precise as long as follow up dosing is done when needed. The liver for the most part will take care of over dosing. If they are getting wacky lows or highs with the Libre they will need to double check with their old school meter. The Libre is not a dosing CGM its a trending device giving 15 minute readings which is plenty good enough for afrezza. If Dexcom was selling the G5 for $100 I would take the G5 but at $1100, its over kill for T2s. What Abbotts next move is in the CGM space is not clear. Rumor has it they had been looking to license the San Meditech device but Beyer was doing the same. Whatever it is its not here today and the new sales team needs devices they can leverage today for afrezza titration. Pitching the patient coming back every two weeks will have appeal to docs. Their admin can scan, print out and have the doc look at it with minimal time for doc in front of patient, good $ROI on that one. Any of you remember the GlucoWatch? Novel idea but it did not work. I am skeptical of San Meditech. Later this year, Dexcom is supposed to come out with their low priced sensor and sell it I believe in the retail pharmacy channel and most of their business today is at DME or mail order. Not sure if the forthcoming Dexcom sensor can send data to a smart phone vs receiver but I assume it will given Dexcoms relationship with Google. Once the new Dex sensor comes out, it will be tough to compete against. The data will automatically get sent to the Google / Verily database through patient smartphone. Once this happens, the lights will go off brighter than ever in support of Afrezza (assuming we get that far). Verily will be able to analyze vast amounts of patient data and when they see one patient population with vastly superior control of glucose levels with few if any hypos, they are going to try to figure out what that patient population is doing to achieve so much better results than the other patient populations and the common thread in a word will be Afrezza. Once this happens, the label won't be so critical as patient outcomes will scream from the mountaintop. We just need to hope there is enough cash to run this ship in its current format hard through the end of 2017. That should be enough time to gain critical mass. There has to be some big players, Pharma, financial or otherwise who are occasionally looking out of the corner of their eyes to see what if any progress Mannkind is making. The stakes are too high not to. PS - when I say new Dex sensor, I am referring to the one in current development which will be far smaller and less expensive. |
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