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Post by mnholdem on Jun 15, 2019 9:01:59 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD.
The VDex proposal offers MannKind a unique and, perhaps, rare opportunity.
For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE.
As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company.
Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO.
MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments.
MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio.
I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex.
I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure.
If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously.
As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann.
Good fortune to all.
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Post by uvula on Jun 15, 2019 10:34:22 GMT -5
If vdex already had financing lined up they would have mentioned it in the proposal. It is literally the most important thing at this point.
Without money nothing is going to happen.
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Post by harryx1 on Jun 15, 2019 10:36:28 GMT -5
I assume the BoD already knew about this, so why was it scrapped? I support VDex and believe they have done great things with Afrezza. But they must also present the data they have showing the success they have had IMO.
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Post by golfeveryday on Jun 15, 2019 11:01:21 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD. The VDex proposal offers MannKind a unique and, perhaps, rare opportunity. For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE. As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company. Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO. MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments. MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio. I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex. I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure. If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously. As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann. Good fortune to all. best post of the year I would say. Completely aligned with every syllable. Mnkd should do their due diligence on every offer presented as I presume there are few others, if any, on the table. I hope they approach a potential response to Vdex in the manner you suggest - which is an opportunity to improve the value of a potential relationship - rather than respond with a defensive posture.
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Post by awesomo on Jun 15, 2019 11:24:46 GMT -5
mnholdem, can you please be on the board of directors?
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Post by sweedee79 on Jun 15, 2019 11:28:13 GMT -5
Thank you MN.. I was waiting for you to chime in all day yesterday..
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Post by cjm18 on Jun 15, 2019 11:49:08 GMT -5
If the retention rate is that low then what a waste of money spent on commercials and no big pharmaceutical company is going to want to partner with mannkind on Afrezza.
It’s time for mannkind to at least collaborate with vdex. The status quo is failing. Mc is getting pressure to change the path. I expect changes in strategy soon. Vdex will be included in some shape or form.
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Post by mnholdem on Jun 15, 2019 11:52:54 GMT -5
I assume the BoD already knew about this, so why was it scrapped? I support VDex and believe they have done great things with Afrezza. But they must also present the data they have showing the success they have had IMO. Harry, As I recall this idea was being pushed by former CEO Matt Pfeffer. Can you confirm that? I have limited internet access at my current location.
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Post by mnholdem on Jun 15, 2019 11:56:12 GMT -5
Never mind, Harry. I found confirmation on another thread.
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Post by Thundersnow on Jun 15, 2019 13:46:31 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD. The VDex proposal offers MannKind a unique and, perhaps, rare opportunity. For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE. As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company. Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO. MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments. MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio. I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex. I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure. If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously. As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann. Good fortune to all. All of this will be MOOT if MNKD announces a new marketing partner on July 2nd. A partner with deep pockets that will take Afrezza to the next level. I feel VDEX knows about an imminent deal and are trying to get in the middle. The new partner will handle all future trials to improve the label and expand the brand. VDEX is making this move out of desperation.
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Post by rtmd on Jun 15, 2019 13:48:00 GMT -5
If vdex already had financing lined up they would have mentioned it in the proposal. It is literally the most important thing at this point. Without money nothing is going to happen. I suspect VDEX is looking to get funding for whatever its planning from Mannkind. I also suspect the reason why the "Mannkind 2.0" plan didn't come to fruition was because funding VDEX was going to be too expensive.
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Post by boca1girl on Jun 15, 2019 13:52:49 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD. The VDex proposal offers MannKind a unique and, perhaps, rare opportunity. For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE. As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company. Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO. MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments. MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio. I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex. I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure. If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously. As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann. Good fortune to all. All of this will be MOOT if MNKD announces a new marketing partner on July 2nd. A partner with deep pockets that will take Afrezza to the next level. I feel VDEX knows about an imminent deal and are trying to get in the middle. The new partner will handle all future trials to improve the label and expand the brand. VDEX is making this move out of desperation. I think you are setting unrealistic expectations for July 2, 2019. I would hate to see the stock price plummet on July 3 if there were no big announcement on July 2.
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Post by sportsrancho on Jun 15, 2019 14:28:06 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD. The VDex proposal offers MannKind a unique and, perhaps, rare opportunity. For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE. As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company. Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO. MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments. MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio. I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex. I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure. If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously. As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann. Good fortune to all. All of this will be MOOT if MNKD announces a new marketing partner on July 2nd. A partner with deep pockets that will take Afrezza to the next level. I feel VDEX knows about an imminent deal and are trying to get in the middle. The new partner will handle all future trials to improve the label and expand the brand. VDEX is making this move out of desperation. No
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Post by sportsrancho on Jun 15, 2019 14:28:54 GMT -5
If vdex already had financing lined up they would have mentioned it in the proposal. It is literally the most important thing at this point. Without money nothing is going to happen. I suspect VDEX is looking to get funding for whatever its planning from Mannkind. I also suspect the reason why the "Mannkind 2.0" plan didn't come to fruition was because funding VDEX was going to be too expensive. No, they have their own funding.
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Post by uvula on Jun 15, 2019 14:54:23 GMT -5
Simple question. If they have funding why are there no details in the so called proposal?
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