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Post by rockstarrick on Aug 4, 2019 7:55:50 GMT -5
Actually they do on both counts and I’m of the opinion that VDex will succeed in growing rapidly, no thanks to MannKind’s CEO. IMO he’s made a tactical error in his treatment of VDex. VDex’s commitment is to the patient and to shareholders but no longer to MannKind’s management. I suspected that Castagna would re-launch a DTC campaign, possibly funded by new non-dilutive debt. Unfortunately the obstacles that have thwarted previous attempts remain and there is scant evidence that Castagna is working to improve Afrezza’s label, which limits what can be communicated to patients and physicians. Even if the rumored marketing partnership with Dexcom comes the fruition the non-inferiority and black box warning on the label will be a major obstacle to significant growth. I do expect some sales growth to be the result of a new DTC campaign designed to emphasize what distinguishes Afrezza from current insulin treatments with scripts possibly reaching 1,000-2,000 per week while over 250k Humalog and Novolog scripts continue to be written every week. I know that I may come across as hostile to the current CEO but I remain supportive of Afrezza and MannKind’s delivery technology. If the rumored MannKind-Dexcom alliance is true and CEO Castagna has plans for a conducting a superiority study using Dexcom CGM capability then I will be the first to commend the CEO. Removing the impediments to market acceptance is an essential first step for growth. Well if the FDA believes Afrezza is safe enough to begin trials with the youngest of Diabetics that will ever use Afrezza, then the black box is a complete contradiction. If a Ball is “Blue” and we can unanimously see it’s blue, we shouldn’t need trials to prove it just because. Our Healthcare System wastes more time and money than I ever imagined
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Post by agedhippie on Aug 4, 2019 8:24:30 GMT -5
Well if the FDA believes Afrezza is safe enough to begin trials with the youngest of Diabetics that will ever use Afrezza, then the black box is a complete contradiction. If a Ball is “Blue” and we can unanimously see it’s blue, we shouldn’t need trials to prove it just because. Our Healthcare System wastes more time and money than I ever imagined The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial.
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Post by longliner on Aug 4, 2019 11:03:38 GMT -5
Actually they do on both counts and I’m of the opinion that VDex will succeed in growing rapidly, no thanks to MannKind’s CEO. IMO he’s made a tactical error in his treatment of VDex. VDex’s commitment is to the patient and to shareholders but no longer to MannKind’s management. I suspected that Castagna would re-launch a DTC campaign, possibly funded by new non-dilutive debt. Unfortunately the obstacles that have thwarted previous attempts remain and there is scant evidence that Castagna is working to improve Afrezza’s label, which limits what can be communicated to patients and physicians. Even if the rumored marketing partnership with Dexcom comes the fruition the non-inferiority and black box warning on the label will be a major obstacle to significant growth. I do expect some sales growth to be the result of a new DTC campaign designed to emphasize what distinguishes Afrezza from current insulin treatments with scripts possibly reaching 1,000-2,000 per week while over 250k Humalog and Novolog scripts continue to be written every week. I know that I may come across as hostile to the current CEO but I remain supportive of Afrezza and MannKind’s delivery technology. If the rumored MannKind-Dexcom alliance is true and CEO Castagna has plans for a conducting a superiority study using Dexcom CGM capability then I will be the first to commend the CEO. Removing the impediments to market acceptance is an essential first step for growth. Here is to hoping you get to be the first to commend MC!
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Post by theebavarian on Aug 4, 2019 18:57:31 GMT -5
So, yea, this is more a MNKD forum than a VDEX forum, correct? What's most important then is what's best for MNKD rather more than what's best for VDEX - though itself a good and worthwhile company? If both are elevated then all the better, but it's MNKD that counts on this forum, right? Or is this a VDEX forum?
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Post by longliner on Aug 4, 2019 20:07:07 GMT -5
Well if the FDA believes Afrezza is safe enough to begin trials with the youngest of Diabetics that will ever use Afrezza, then the black box is a complete contradiction. If a Ball is “Blue” and we can unanimously see it’s blue, we shouldn’t need trials to prove it just because. Our Healthcare System wastes more time and money than I ever imagined The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial. "The trial is not relevant".... "The ad is wrong"... You certainly have a way with words. I would hate to see what you write about technologies you want to fail! But I digress, cause you only write about Afrezza. 😉
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Post by sportsrancho on Aug 4, 2019 20:21:09 GMT -5
So, yea, this is more a MNKD forum than a VDEX forum, correct? What's most important then is what's best for MNKD rather more than what's best for VDEX - though itself a good and worthwhile company? If both are elevated then all the better, but it's MNKD that counts on this forum, right? Or is this a VDEX forum? This is a stupid Non-relevant Website. Vdex is not a public company, doesn’t have any stock that we can buy. So since Vdex promotes Afrezza as their lead product and are working around the clock keeping patients on Afrezza MNKD is the best way to invest in them also.
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Post by theebavarian on Aug 4, 2019 21:02:18 GMT -5
So, yea, this is more a MNKD forum than a VDEX forum, correct? What's most important then is what's best for MNKD rather more than what's best for VDEX - though itself a good and worthwhile company? If both are elevated then all the better, but it's MNKD that counts on this forum, right? Or is this a VDEX forum? This is a stupid Non-relevant Website. Vdex is not a public company, doesn’t have any stock that we can buy. So since Vdex promotes Afrezza as their lead product and are working around the clock keeping patients on Afrezza MNKD is the best way to invest in them also. Okay. But with VDEX not being a publicly traded company, is their hopeformannkind website stupid and non-relevant too?
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Post by sportsrancho on Aug 4, 2019 21:28:48 GMT -5
HFM is an activist movement, hoping to bring about value for shareholders of MNKD. You are either satisfied with the way things are being run or you’re not, it’s a choice to be a part of unlocking shareholder value. Some people choose to fight for change instead of selling. So they join the movement and verbalize the changes they want. Everyone has a voice. It’s irrelevant in the sense that if you choose to stay long you are along for the ride no matter what happens. What are people on this website saying no to....they don’t even know. Once you nominate different board members then you have a choice to vote yes or no.
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Post by longliner on Aug 4, 2019 21:34:57 GMT -5
Hopefully, come Wednesday, this will no longer be a talking point! Ideally both companies will be successful.
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Post by agedhippie on Aug 4, 2019 22:05:50 GMT -5
The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial. "The trial is not relevant".... "The ad is wrong"... You certainly have a way with words. I would hate to see what you write about technologies you want to fail! But I digress, cause you only write about Afrezza. 😉 You really need to read the whole post: The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial.What is your point? I don't understand if you are complaining because I said this even though it's correct (see the trial inclusion criteria), or if you believe I am incorrect in which case I would ask how. The FDA will exclude any candidate who falls into the black box group therefore the trial cannot prove that Afrezza is safe for that excluded group.
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Post by longliner on Aug 4, 2019 22:17:09 GMT -5
"The trial is not relevant".... "The ad is wrong"... You certainly have a way with words. I would hate to see what you write about technologies you want to fail! But I digress, cause you only write about Afrezza. 😉 You really need to read the whole post: The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial.What is your point? I don't understand if you are complaining because I said this even though it's correct (see the trial inclusion criteria), or if you believe I am incorrect in which case I would ask how. The FDA will exclude any candidate who falls into the black box group therefore the trial cannot prove that Afrezza is safe for that excluded group.The entire post was included. No need to act the victim. You truly have the first four to five word response dialed in. I am only using your words. To be clear, the trial is relevant as it shows that 4 to 7 year old children can safely tolerate Afrezza. The ad is correct in that it cleverly illustrates that Afrezza acts faster than RAA's. I have no doubt that you will be encouraged to continue with your (dis)information campaign.
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Post by agedhippie on Aug 4, 2019 23:35:49 GMT -5
You really need to read the whole post: The trial is not relevant in that sense because the pediatrics groups will exclude children where the black box warning applies. The FDA view would be that outside the contraindicated group Afrezza is safe to trial.What is your point? I don't understand if you are complaining because I said this even though it's correct (see the trial inclusion criteria), or if you believe I am incorrect in which case I would ask how. The FDA will exclude any candidate who falls into the black box group therefore the trial cannot prove that Afrezza is safe for that excluded group.The entire post was included. No need to act the victim. You truly have the first four to five word response dialed in. I am only using your words. To be clear, the trial is relevant as it shows that 4 to 7 year old children can safely tolerate Afrezza. The ad is correct in that it cleverly illustrates that Afrezza acts faster than RAA's. I have no doubt that you will be encouraged to continue with your disinformation campaign. I agree, the trial will show that 4 to 7 year olds can safely tolerate Afrezza since it excludes any child who is subject to the black box warning. That is why to go back to the original post I replied to the fact that Afrezza carries a black box warning is irrelevant to the trial group. The ad is clever but I think it's off target for diabetics for reasons discussed elsewhere. It's out there now so let's wait and see what happens.
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Post by longliner on Aug 4, 2019 23:47:50 GMT -5
The entire post was included. No need to act the victim. You truly have the first four to five word response dialed in. I am only using your words. To be clear, the trial is relevant as it shows that 4 to 7 year old children can safely tolerate Afrezza. The ad is correct in that it cleverly illustrates that Afrezza acts faster than RAA's. I have no doubt that you will be encouraged to continue with your disinformation campaign. I agree, the trial will show that 4 to 7 year olds can safely tolerate Afrezza since it excludes any child who is subject to the black box warning. That is why to go back to the original post I replied to the fact that Afrezza carries a black box warning is irrelevant to the trial group. The ad is clever but I think it's off target for diabetics for reasons discussed elsewhere. It's out there now so let's wait and see what happens. It's nice to see you now find the trial relevant! I agree that ad was indeed a clever way to illustrate that Afrezza is faster than RAA's!
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Post by matt on Aug 5, 2019 8:05:01 GMT -5
Well if the FDA believes Afrezza is safe enough to begin trials with the youngest of Diabetics that will ever use Afrezza, then the black box is a complete contradiction. If a Ball is “Blue” and we can unanimously see it’s blue, we shouldn’t need trials to prove it just because. Our Healthcare System wastes more time and money than I ever imagined FDA allowing a trial to proceed is not equivalent to a conclusion that the medication is safe for children. Ultimately the question of how safe a medication really is can only be determined by administering it to real patients of the intended age group and monitoring them closely for signs of adverse events. In order to conduct a trial all known risks must be mitigated to the extent possible, but the trial itself will identify risk that are, at the moment, unknown. Some of those unknown risks may be trivial inconveniences and some may be seriously life-threatening, but neither the FDA nor Mannkind can determine that without data.
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Post by rockstarrick on Aug 5, 2019 11:54:59 GMT -5
Well if the FDA believes Afrezza is safe enough to begin trials with the youngest of Diabetics that will ever use Afrezza, then the black box is a complete contradiction. If a Ball is “Blue” and we can unanimously see it’s blue, we shouldn’t need trials to prove it just because. Our Healthcare System wastes more time and money than I ever imagined FDA allowing a trial to proceed is not equivalent to a conclusion that the medication is safe for children. Ultimately the question of how safe a medication really is can only be determined by administering it to real patients of the intended age group and monitoring them closely for signs of adverse events. In order to conduct a trial all known risks must be mitigated to the extent possible, but the trial itself will identify risk that are, at the moment, unknown. Some of those unknown risks may be trivial inconveniences and some may be seriously life-threatening, but neither the FDA nor Mannkind can determine that without data. Thanks Matt, at least now I know why I’m the Bass Player. 😎
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