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Post by careful2invest on Mar 3, 2017 17:13:58 GMT -5
They could still start advertising in a low cost, well put together, efficient and effective way until they get the label change and then build from there. The biggest problem is...No one has ever heard of AFREZZA! Yet MNKD does a reverse split "from a position of strength" no less, and we find ourselves down another 12 percent. It just does not add up! The "from strength" was simply BS. Wish they hadn't used that phrase. So don't try to add that up to anything. The price action since announcement of RS vote through today adds up quite well with what normally happens with companies forced to do RS. I'm just hoping they can do some targeted advertising... online targeted at PWD and on TV targeted at specific regions with the highest payer coverage and where extra effort has gone to educate doctors. If they could show a strong turn around in one geographic region I think that could be the foundation for a raising capital. At least it would be better than raising capital the way things stand now... if that would even be possible. I agree Dreamboat, and hopefully they can get exposure and sales where they need to sooner than later. And I realize the bs of "from a position of strength" But put it together with "Embarrassment of riches" and "Epic turnaround" and comments like those are getting old, real old.
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Post by surplusvalue on Mar 3, 2017 17:18:28 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. ' But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. The response that MNKD's hands are tied is getting a bit tired , dont you think...all the way back to when they made the deal with Sanofi. How about management actually taking some responsibility for this fiasco. Are you also going to try to convince us the financial bungling and the need to do a RS in the first place was to do with MNKD's hands being tied too. Read my post carefully, I wasnt talking about what MNKD can or cant tell the endos. Need a clue? Look at the posts before mine discussing MNKD;s not having figured this out yet. I was responding to Peppy's post about the lack of knowledge about titration, dosing and retention that still seems to be lacking on managements part. And if you think they figured all this out and are just waiting for a label change then you haven't been paying attention. Of course, there are quite a few here who never waste an opportunity, even if its necessary to misrepresent a post, to protect management from taking any responsibility for anything at all.
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Post by goyocafe on Mar 3, 2017 17:20:18 GMT -5
The "from strength" was simply BS. Wish they hadn't used that phrase. So don't try to add that up to anything. The price action since announcement of RS vote through today adds up quite well with what normally happens with companies forced to do RS. I'm just hoping they can do some targeted advertising... online targeted at PWD and on TV targeted at specific regions with the highest payer coverage and where extra effort has gone to educate doctors. If they could show a strong turn around in one geographic region I think that could be the foundation for a raising capital. At least it would be better than raising capital the way things stand now... if that would even be possible. I agree Dreamboat, and hopefully they can get exposure and sales where they need to sooner than later. And I realize the bs of "from a position of strength" But put it together with "Embarrassment of riches" and "Epic turnaround" and comments like those are getting old, real old. The deeper problem I think is that Matt actually thinks they're coming from a position of strength. Added with all of his past statements, correlated to their actions, it's clear to me that they believe these things to be true. They've showed up stunned to more than one conference in the past in disbelief of their situation.
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Post by careful2invest on Mar 3, 2017 17:41:13 GMT -5
I agree Dreamboat, and hopefully they can get exposure and sales where they need to sooner than later. And I realize the bs of "from a position of strength" But put it together with "Embarrassment of riches" and "Epic turnaround" and comments like those are getting old, real old. The deeper problem I think is that Matt actually thinks they're coming from a position of strength. Added with all of his past statements, correlated to their actions, it's clear to me that they believe these things to be true. They've showed up stunned to more than one conference in the past in disbelief of their situation. If that is the case, we desperately need a more experienced skipper at the helm! Before it is absolutely too late. Which unfortunately, it may be already! I am a reasonably long term long (7 years) but I am losing faith in this company! As well a losing six figures in this company that could have been doing something worth while elsewhere.
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Post by surplusvalue on Mar 3, 2017 18:06:17 GMT -5
But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. They could still start advertising in a low cost, well put together, efficient and effective way until they get the label change and then build from there. The biggest problem is...No one has ever heard of AFREZZA! Yet MNKD does a reverse split "from a position of strength" no less, and we find ourselves down another 12 percent. It just does not add up! Careful2, that would be the intelligent thing to do once you were aware that you are restricted in what you can say to the doctors. And MNKD has been well aware of the restrictions for a long time. We were talking about managements still apparent lack of knowledge regarding dosing titration etc. before the thread got hijacked by the "MNKD's hands are tied" comment. I wasnt talking about what could or couldnt be said but ignoring that NY lefty is 100% correct. MNKD is restricted. But you see for those that want to shield MNKD from any responsibility its ok for management to continue to bang their heads against a wall in the face of these restrictions and sit around with their thumbs up their arse instead of adding another approach like you and many others here including myself have suggested. You see as well as I do (and many others here ) that precisely because there are these restrictions that MNKD should have been pushing from the patient side instead of solely relying on educating the endos. Endos first and then DTC was the plan and they stuck to it like glue despite its failure instead of modifying the strategy. The hands are tied excuse is no excuse. They are on launch # 3 and we still havent seen advertising. But those who keep telling us that MNKD's hands are tied seem almost as clueless as management.
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Post by dreamboatcruise on Mar 3, 2017 18:18:22 GMT -5
They could still start advertising in a low cost, well put together, efficient and effective way until they get the label change and then build from there. The biggest problem is...No one has ever heard of AFREZZA! Yet MNKD does a reverse split "from a position of strength" no less, and we find ourselves down another 12 percent. It just does not add up! Careful2, that would be the intelligent thing to do once you were aware that you are restricted in what you can say to the doctors. And MNKD has been well aware of the restrictions for a long time. We were talking about managements still apparent lack of knowledge regarding dosing titration etc. before the thread got hijacked by the "MNKD's hands are tied" comment. I wasnt talking about what could or couldnt be said but ignoring that NY lefty is 100% correct. MNKD is restricted. But you see for those that want to shield MNKD from any responsibility its ok for management to continue to bang their heads against a wall in the face of these restrictions and sit around with their thumbs up their arse instead of adding another approach like you and many others here including myself have suggested. You see as well as I do (and many others here ) that precisely because there are these restrictions that MNKD should have been pushing from the patient side instead of solely relying on educating the endos. Endos first and then DTC was the plan and they stuck to it like glue despite its failure instead of modifying the strategy. The hands are tied excuse is no excuse. They are on launch # 3 and we still havent seen advertising. But those who keep telling us that MNKD's hands are tied seem almost as clueless as management. At the risk of appearing a management apologist... the one potentially positive reason for delays now in roll out of adverts is if Mannkind is in serious discussions with FDA about being more aggressive in pointing out pk/pd and dare say linking that to better BG control. If the eventual ads are merely the same as the short clips generated under SNY, then this delay will be rather inexplicable. This hope on my part is probably a long shot, but perhaps evidence from various trials can justify something. Are results generated by FDA approved simulation good enough to allow a "may help you to... " sort of statement in a commercial ? ?
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Afrezza
Mar 3, 2017 19:18:56 GMT -5
Post by surplusvalue on Mar 3, 2017 19:18:56 GMT -5
Careful2, that would be the intelligent thing to do once you were aware that you are restricted in what you can say to the doctors. And MNKD has been well aware of the restrictions for a long time. We were talking about managements still apparent lack of knowledge regarding dosing titration etc. before the thread got hijacked by the "MNKD's hands are tied" comment. I wasnt talking about what could or couldnt be said but ignoring that NY lefty is 100% correct. MNKD is restricted. But you see for those that want to shield MNKD from any responsibility its ok for management to continue to bang their heads against a wall in the face of these restrictions and sit around with their thumbs up their arse instead of adding another approach like you and many others here including myself have suggested. You see as well as I do (and many others here ) that precisely because there are these restrictions that MNKD should have been pushing from the patient side instead of solely relying on educating the endos. Endos first and then DTC was the plan and they stuck to it like glue despite its failure instead of modifying the strategy. The hands are tied excuse is no excuse. They are on launch # 3 and we still havent seen advertising. But those who keep telling us that MNKD's hands are tied seem almost as clueless as management. At the risk of appearing a management apologist... the one potentially positive reason for delays now in roll out of adverts is if Mannkind is in serious discussions with FDA about being more aggressive in pointing out pk/pd and dare say linking that to better BG control. If the eventual ads are merely the same as the short clips generated under SNY, then this delay will be rather inexplicable. This hope on my part is probably a long shot, but perhaps evidence from various trials can justify something. Are results generated by FDA approved simulation good enough to allow a "may help you to... " sort of statement in a commercial ? ? This doesnt provide an explanation as to why they didnt modify the strategy earlier. Some think management cares about us, perhaps but perhaps not given their total lack of concern about the sp except when it threatens them. www.youtube.com/watch?v=KwIo9Y9iJ6A
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Post by sweedee79 on Mar 3, 2017 21:08:23 GMT -5
Our label says that Afrezza and Subq are the same dose for dose... how can it be that you need 3Xs as much Afrezza?? This is the first time Ive seen this info... how did Afrezza finish as noninferior in the trials with this much of a dose differentiation ? I knew there was some difference but I had no idea that it was this much.. when my dad was on Afrezza he was on aprox the same dose as he had been while on Novolog... his A1C dropped by 1 point..
Obviously there is a difference in dosing... but how can we inform docs while our label says its the same dose for dose as subq .. ?? Also, docs need to be made aware that you CAN take more Afrezza with a very reduced risk of hypo and get a better A1C
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Afrezza
Mar 3, 2017 22:04:36 GMT -5
Post by agedhippie on Mar 3, 2017 22:04:36 GMT -5
Our label says that Afrezza and Subq are the same dose for dose... how can it be that you need 3Xs as much Afrezza?? This is the first time Ive seen this info... how did Afrezza finish as noninferior in the trials with this much of a dose differentiation ? I knew there was some difference but I had no idea that it was this much.. when my dad was on Afrezza he was on aprox the same dose as he had been while on Novolog... his A1C dropped by 1 point..
Obviously there is a difference in dosing... but how can we inform docs while our label says its the same dose for dose as subq .. ?? Also, docs need to be made aware that you CAN take more Afrezza with a very reduced risk of hypo and get a better A1C
In the early trials they gave the real number of units used but they swapped part way through to use the new method because it was causing confusion and it looked bad for Afrezza (you need to take 4x the insulin??) When it was released they moved to the equivalence where a 4u cartridge produced the same result as 4u of RAA. This avoids the impression that Afrezza is ineffective and makes titration easier - one of the problems with Exubera was the bizzare dosing. I was always surprised that Mannkind never got the hypo claim for Type 1 on the label. There is a clear 25% reduction and that is a positive benefit as well as a KPI for quality of life in methodologies used for product selection in the EU countries. You could not make the hypo claim for Type 2 since there was never a trial against MDI for Type 2. My suspicion is that they didn't think it was necessary since they always saw the market as Type 2 in the early days.
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Post by sweedee79 on Mar 3, 2017 23:24:46 GMT -5
Another question... how can we say the pricing is similar to Novolog and Humolog when you need 3 to 4xs as much??? How likely is it that insurance companies will want to pay for this when it is 3 to 4xs higher in price ?? .. I just get more confused by the day ... and more and more discouraged about how we can market Afrezza under these circumstances ... Management had to have been aware of these problems all along... did they think it would all just resolve itself?? I just don't understand it...
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Post by peppy on Mar 4, 2017 0:44:51 GMT -5
Another question... how can we say the pricing is similar to Novolog and Humolog when you need 3 to 4xs as much??? How likely is it that insurance companies will want to pay for this when it is 3 to 4xs higher in price ?? .. I just get more confused by the day ... and more and more discouraged about how we can market Afrezza under these circumstances ... Management had to have been aware of these problems all along... did they think it would all just resolve itself?? I just don't understand it... With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
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Post by sayhey24 on Mar 4, 2017 10:16:20 GMT -5
Another question... how can we say the pricing is similar to Novolog and Humolog when you need 3 to 4xs as much??? How likely is it that insurance companies will want to pay for this when it is 3 to 4xs higher in price ?? .. I just get more confused by the day ... and more and more discouraged about how we can market Afrezza under these circumstances ... Management had to have been aware of these problems all along... did they think it would all just resolve itself?? I just don't understand it... With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
The current 4u has 10u of insulin and the 8u has 20u. From the label - Clinical pharmacology studies showed that carrier particles are not metabolized and are eliminated unchanged in the urine following the lung absorption. Following oral inhalation of AFREZZA, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces. This is where the 4u gets its name since of the 10u you get 3.9 of the insulin in the lungs. The rest is wasted in the cartridge, inhaler and GI tract. Pricing and packaging would be OK if the PWD did not need to second dose to mimic phase 2 release. But to get the amazing BG numbers they do and unless they are actively monitoring their BG 60, 90 and 120 minutes after eating and re-dosing as needed they are going to get OK results. And, if they don't take enough up front and then try to bring down high BG they are going to need additional cartridges.
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Afrezza
Mar 4, 2017 10:35:14 GMT -5
Post by agedhippie on Mar 4, 2017 10:35:14 GMT -5
With the price increases the fast acting insulin analog makers have had, the price of the afrezza titration pack is comparable to subq fast acting these days. Afrezza uses regular insulin, not an analog. (is my understanding.)
aged. or all, correct me if I am wrong. I do not want to look it up.
The current 4u has 10u of insulin and the 8u has 20u. From the label - Clinical pharmacology studies showed that carrier particles are not metabolized and are eliminated unchanged in the urine following the lung absorption. Following oral inhalation of AFREZZA, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces. This is where the 4u gets its name since of the 10u you get 3.9 of the insulin in the lungs. The rest is wasted in the cartridge, inhaler and GI tract. Pricing and packaging would be OK if the PWD did not need to second dose to mimic phase 2 release. But to get the amazing BG numbers they do and unless they are actively monitoring their BG 60, 90 and 120 minutes after eating and re-dosing as needed they are going to get OK results. And, if they don't take enough up front and then try to bring down high BG they are going to need additional cartridges. I don't think the second dose approach it tenable. You are meant to do that today with RAA but I don't know anyone on pens who does (pumps are different because the pump can do it automatically with a square wave bolus). The problem is that while it is easy to bolus with the meal it's disruptive to have to do the follow on so people just don't. The real world results are going to reflect that which is why trial data matters and early adopters are given far less weight.
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Afrezza
Mar 4, 2017 11:21:28 GMT -5
Post by sayhey24 on Mar 4, 2017 11:21:28 GMT -5
The current 4u has 10u of insulin and the 8u has 20u. From the label - Clinical pharmacology studies showed that carrier particles are not metabolized and are eliminated unchanged in the urine following the lung absorption. Following oral inhalation of AFREZZA, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces. This is where the 4u gets its name since of the 10u you get 3.9 of the insulin in the lungs. The rest is wasted in the cartridge, inhaler and GI tract. Pricing and packaging would be OK if the PWD did not need to second dose to mimic phase 2 release. But to get the amazing BG numbers they do and unless they are actively monitoring their BG 60, 90 and 120 minutes after eating and re-dosing as needed they are going to get OK results. And, if they don't take enough up front and then try to bring down high BG they are going to need additional cartridges. I don't think the second dose approach it tenable. You are meant to do that today with RAA but I don't know anyone on pens who does (pumps are different because the pump can do it automatically with a square wave bolus). The problem is that while it is easy to bolus with the meal it's disruptive to have to do the follow on so people just don't. The real world results are going to reflect that which is why trial data matters and early adopters are given far less weight. You very well could be right. Second dosing may not happen. I really have no idea how this is going to play out. I have mentioned before about "that one doctor" who did have his patients in the trials do follow-up dosing and their results were outstanding and along the lines of what the early adopters report. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients". Where Onduo lands with what they are doing is anyone's guess - except guys like Steve Edelman. But they keep talking about T2s, Primary Care Physicians, early insulin use, time in range leveraging CGMs and the cloud. Will they succeed, I have no idea. Will text alerts to remind the PWDs be enough, maybe. Will a text to their spouse help, probably. Can they really change how diabetes is currently treated, maybe. Who is going to pay for this service? Google clearly has the money to disrupt the healthcare market and I really think they would like a win for Verily. Do they need afrezza to do this? I think the time in range study says they do. Do they need MNKD, probably not but they do need the afrezza PK and its easy to use. The RAAs are not good enough. Thats the lesson learned with the Artificial Pancreas and why Al developed afrezza. Additionally, if they really do plan on early insulin intervention and changing the step program, inhaling for 3-6 months is a much better option for most new T2s aside from the PK. Is anything happening between Onduo and MNKD, I have no idea. What we do know is Mike is targeting the Endos, not PCPs and current scripts are all but nothing.
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Post by peppy on Mar 4, 2017 11:27:44 GMT -5
I don't think the second dose approach it tenable. You are meant to do that today with RAA but I don't know anyone on pens who does (pumps are different because the pump can do it automatically with a square wave bolus). The problem is that while it is easy to bolus with the meal it's disruptive to have to do the follow on so people just don't. The real world results are going to reflect that which is why trial data matters and early adopters are given far less weight. You very well could be right. Second dosing may not happen. I really have no idea how this is going to play out. I have mentioned before about "that one doctor" who did have his patients in the trials do follow-up dosing and their results were outstanding and along the lines of what the early adopters report. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients".
Where Onduo lands with what they are doing is anyone's guess - except guys like Steve Edelman. But they keep talking about T2s, Primary Care Physicians, early insulin use, time in range leveraging CGMs and the cloud. Will they succeed, I have no idea. Will text alerts to remind the PWDs be enough, maybe. Will a text to their spouse help, probably. Can they really change how diabetes is currently treated, maybe. Who is going to pay for this service? Google clearly has the money to disrupt the healthcare market and I really think they would like a win for Verily. Do they need afrezza to do this? I think the time in range study says they do. Do they need MNKD, probably not but they do need the afrezza PK and its easy to use. The RAAs are not good enough. Thats the lesson learned with the Artificial Pancreas and why Al developed afrezza. Additionally, if they really do plan on early insulin intervention and changing the step program, inhaling for 3-6 months is a much better option for most new T2s aside from the PK. Is anything happening between Onduo and MNKD, I have no idea. What we do know is Mike is targeting the Endos, not PCPs and current scripts are all but nothing. Quote: "that one doctor" who did have his patients in the trials do follow-up dosing and their results were outstanding and along the lines of what the early adopters report. He also said when questioned by the FDA why he did not do this with Novolog , he said " I would have killed my patients".
Reply: Afrezza, the insulin you can take.
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