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Post by mnkdfann on Apr 12, 2019 11:17:45 GMT -5
I am not advocating for either the sale of Afrezza or the company. And for the record, I never thought TV ads wuld be the answer. They are necessary to a degree for reasons I have previouslu posted. And you statement is really apples to oranges when you compare the past Sanofi rights payments for a then new Afrezza to the valuation of the whole company today. Nonetheless, in answer to your question a lot has changed since Sanofi bought and then terminated their deal with mnkd. Consider the following has happened since mnkd received back the rights to Afrezza: 1. Rev has increased over Sanofi peak many times over on less marketing spend I guess it depends what you mean by 'many times over' and whether or not you adjust for the Afrezza price increases since then. For instance, Sanofi did a week with 627 TRx and $371K. That week's TRx is better than what we saw this week (582), and presumably at today's prices the revenue would have beaten this week's as well.
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Post by mannmade on Apr 12, 2019 11:18:52 GMT -5
Yes but they did not adjust nor did they understand how to titrate.
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Post by joeypotsandpans on Apr 12, 2019 11:50:54 GMT -5
I am not advocating for either the sale of Afrezza or the company. And for the record, I never thought TV ads would be the answer. They are necessary to a degree for reasons I have previously posted. And you statement is really apples to oranges when you compare the past Sanofi rights payments for a then new Afrezza to the valuation of the whole company today. Nonetheless, in answer to your question a lot has changed since Sanofi bought and then terminated their deal with mnkd. Consider the following has happened since mnkd received back the rights to Afrezza: 1. Rev has increased over Sanofi peak many times over on less marketing spend 2. ADA/SOC has become slightly more positive towards Afrezza 3. The Stat Study proves the benefits of Afrezza 4. Tresiba was launched and when paired with Afrezza appears to give significantly better than normal results 5. CGM's have become much more main stream with much more room for growth, showing the beneifts of Afrezza in real time and for TIR 6. The Facebook page and other social media adopters are growing 7. The tritation issues and lung test issues are no longer issues 8. Vdex has emerged to support what everyone knows about Afrezza's effectiveness. 9. Peds study is well underway 10. Dr. K was hired 11. JDRF, diatribe and other major diabetes orgs have come out in support of Afrezza, no longer in doubt by them 12. One drop partnership 13. People on Afrezza have dropped the pump in favor of a cgm As for the company: 1. Debt has been significantly reduced 2. Company now has a sales force (effectiveness is up for debate to be candid) 3. Uthr deal with first milestone validating TS and the deal itself 4. UTHR has said Trep T will replace current Tyvaso 5. RLS is progressing 6. Second Uthr moecule on the horizon 7. Hundreds of patents good into the 2030's 8. State of the art production facility Am sure there is more but all more than enough to justify moving forward with either Afrezza and/or the company. I personally would like to wait on judgement about Afrezza until after approved and on the market for peds to see the reaction on sales 12 months out from that. The "great" Steve Balmer (I say great with my tounge firmly planted in my cheek) once said about the iPhone upon its introduction, "No one will ever want or buy one of those." And so we go with Afrezza, early adopters continue to use it while new adopters continue to on board.... GLTAL's!!! Excellent reply MM, the problem is you're thinking on a logical macro level, some investors personally cannot wait and need their returns sooner than later so they are looking for the "quick fix" solution rather than continue to have patience with their investment. I've said it many times, if one has a personal situation whereby they cannot wait for fruit to ripen they should part ways, in the meantime as you have so eloquently laid it out, let the CEO continue to execute his game plan. Going it alone against the insulin cartel and those behind them was never going to an easy endeavor, that wall has to be taken down brick by brick. I look at the longer term view, just like a fine wine over the years...and as stated before the anecdotal evidence from new testimonials everyday only reinforces that mindset
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Post by compound26 on Apr 12, 2019 12:00:03 GMT -5
I am not advocating for either the sale of Afrezza or the company. And for the record, I never thought TV ads would be the answer. They are necessary to a degree for reasons I have previously posted. And you statement is really apples to oranges when you compare the past Sanofi rights payments for a then new Afrezza to the valuation of the whole company today. Nonetheless, in answer to your question a lot has changed since Sanofi bought and then terminated their deal with mnkd. Consider the following has happened since mnkd received back the rights to Afrezza: 1. Rev has increased over Sanofi peak many times over on less marketing spend 2. ADA/SOC has become slightly more positive towards Afrezza 3. The Stat Study proves the benefits of Afrezza 4. Tresiba was launched and when paired with Afrezza appears to give significantly better than normal results 5. CGM's have become much more main stream with much more room for growth, showing the beneifts of Afrezza in real time and for TIR 6. The Facebook page and other social media adopters are growing 7. The tritation issues and lung test issues are no longer issues 8. Vdex has emerged to support what everyone knows about Afrezza's effectiveness. 9. Peds study is well underway 10. Dr. K was hired 11. JDRF, diatribe and other major diabetes orgs have come out in support of Afrezza, no longer in doubt by them 12. One drop partnership 13. People on Afrezza have dropped the pump in favor of a cgm As for the company: 1. Debt has been significantly reduced 2. Company now has a sales force (effectiveness is up for debate to be candid) 3. Uthr deal with first milestone validating TS and the deal itself 4. UTHR has said Trep T will replace current Tyvaso 5. RLS is progressing 6. Second Uthr moecule on the horizon 7. Hundreds of patents good into the 2030's 8. State of the art production facility Am sure there is more but all more than enough to justify moving forward with either Afrezza and/or the company. I personally would like to wait on judgement about Afrezza until after approved and on the market for peds to see the reaction on sales 12 months out from that. The "great" Steve Balmer (I say great with my tounge firmly planted in my cheek) once said about the iPhone upon its introduction, "No one will ever want or buy one of those." And so we go with Afrezza, early adopters continue to use it while new adopters continue to on board.... GLTAL's!!! mannmade great summary! Recall Mike also mentioned in his last presentation a few days ago at the H.C. Wainwright Global Life Sciences Conference that preliminary data from the Philip Levin study on Afrezza ( clinicaltrials.gov/ct2/show/NCT03324776) will be presented in the coming ADA. Mike said it is pretty significant because it will try to standardize the titration for T2s.
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Post by ktim on Apr 12, 2019 12:06:06 GMT -5
mannmade I see that children would likely prefer a no needles solution, but it also seems doctors may well be even more concerned about long term lung issues with use by children whose lungs aren't even fully developed, given the long term safety study has still not been undertaken. It may well be that many doctors have overblown the risk (a risk likely to be proved to not exist at all if the trials are done), but I'm less optimistic than you that doctors will for some reason be way more accepting of Afrezza for peds than for adults. In any case, that's a long ways off.
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Post by mannmade on Apr 12, 2019 12:18:06 GMT -5
mannmadeI see that children would likely prefer a no needles solution, but it also seems doctors may well be even more concerned about long term lung issues with use by children whose lungs aren't even fully developed, given the long term safety study has still not been undertaken. It may well be that many doctors have overblown the risk (a risk likely to be proved to not exist all if the trials are done), but I'm less optimistic than you that doctors will for some reason be way more accepting of Afrezza for peds than for adults. In any case, that's a long ways off. Imho it’s not primarily about the doctors. My brother was diagnosed w t1 at the age of 8. He put my parents thru “hell” with the needles and also their fear of his hypos, which made compliance tougher. Both of which afrezza will likely improve in peds. A mother fighting for her child will trump a doctor every time imho!
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Post by ktim on Apr 12, 2019 12:58:07 GMT -5
mannmade I see that children would likely prefer a no needles solution, but it also seems doctors may well be even more concerned about long term lung issues with use by children whose lungs aren't even fully developed, given the long term safety study has still not been undertaken. It may well be that many doctors have overblown the risk (a risk likely to be proved to not exist all if the trials are done), but I'm less optimistic than you that doctors will for some reason be way more accepting of Afrezza for peds than for adults. In any case, that's a long ways off. Imho it’s not primarily about the doctors. My brother was diagnosed w t1 at the age of 8. He put my parents thru “hell” with the needles and also their fear of his hypos, which made compliance tougher. Both of which afrezza will likely improve in peds. A mother fighting for her child will trump a doctor every time imho! Hopefully the hypo benefit will be much clearer in peds trial outcomes. That would undoubtedly help change doctors' views. I'm not saying you can't be right, but parents make some strange decisions in my views, such as vaccines. That's a case where parents are making up a risk that doesn't exist and putting their children in harms way. So isn't clear to me that parents would be way out ahead of doctors in setting aside concerns over long term lung effects. It could be pitting a parents fears against their children's fears (of needles). Quite frankly I don't know what I'd do as a parent (assuming I hadn't read all the Afrezza clinical trials as I have) if my doctor were warning me about potential long term effects but knowing my child feared needles. Granted if less hypos are so evident and meaningful in the data, that would likely sway me, but that would likely sway the doctors as well.
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Post by mannmade on Apr 12, 2019 13:11:47 GMT -5
I respect your opinion. I have personally met with five parents who have children with diabetes and not one of them had any issues with putting their child on afrezza with the current info available. Four were successful the fifth tried but did not follow thru for some reason. We should know soon enough.
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Post by ktim on Apr 12, 2019 13:23:16 GMT -5
I respect your opinion. I have personally met with five parents who have children with diabetes and not one of them had any issues with putting their child on afrezza with the current info available. Four were successful the fifth tried but did not follow thru for some reason. We should know soon enough. Seems you are very successful. Dr. Kendall just needs to figure out how to clone you so that you can meet with all parents with newly diagnosed T1 children I suspect you may be making information available to them that they would not get from a physician, also likely information that MNKD couldn't convey directly to parents because of drug marketing restrictions. I hope you're right and my skepticism is unfounded.
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Post by mannmade on Apr 12, 2019 15:23:24 GMT -5
You may be right that I am able to say things that most sales reps for mnkd cannot say.
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Post by nadathing on Apr 12, 2019 18:12:11 GMT -5
Lots of comments on children disliking shots and how Afrezza would do wonders for juveniles with T1. It would. The concern is, if Endos are reluctant to prescribe Afrezza for an adult how likely are they to prescribe for a child?
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johny
Researcher
Posts: 87
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Post by johny on Apr 12, 2019 23:00:46 GMT -5
Lots of comments on children disliking shots and how Afrezza would do wonders for juveniles with T1. It would. The concern is, if Endos are reluctant to prescribe Afrezza for an adult how likely are they to prescribe for a children? Good question, I'd like to add to that. Adults who are diabetic have been so for years, that being said, they have most likely tried more than one alternative to treating their diabetes and therefore are able to FIGHT for a prescription. A problem that we face today is, standard-operating-procedure (maybe that's the wrong phrase.) Before someone can try Afrezza, they need to have tried other insulin therapies first.. will it be this way for children?..
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Post by mango on Apr 12, 2019 23:41:22 GMT -5
Imho it’s not primarily about the doctors. My brother was diagnosed w t1 at the age of 8. He put my parents thru “hell” with the needles and also their fear of his hypos, which made compliance tougher. Both of which afrezza will likely improve in peds. A mother fighting for her child will trump a doctor every time imho! Hopefully the hypo benefit will be much clearer in peds trial outcomes. That would undoubtedly help change doctors' views. I'm not saying you can't be right, but parents make some strange decisions in my views, such as vaccines. That's a case where parents are making up a risk that doesn't exist and putting their children in harms way. So isn't clear to me that parents would be way out ahead of doctors in setting aside concerns over long term lung effects. It could be pitting a parents fears against their children's fears (of needles). Quite frankly I don't know what I'd do as a parent (assuming I hadn't read all the Afrezza clinical trials as I have) if my doctor were warning me about potential long term effects but knowing my child feared needles. Granted if less hypos are so evident and meaningful in the data, that would likely sway me, but that would likely sway the doctors as well. There is not a single piece of evidence which supports Afrezza may be associated with pulmonary malignancy. But, the long-term clinical trial is specifically for T2D, so it would not even apply here since the Peds approval will be for T1D.
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Post by ktim on Apr 13, 2019 14:53:52 GMT -5
Hopefully the hypo benefit will be much clearer in peds trial outcomes. That would undoubtedly help change doctors' views. I'm not saying you can't be right, but parents make some strange decisions in my views, such as vaccines. That's a case where parents are making up a risk that doesn't exist and putting their children in harms way. So isn't clear to me that parents would be way out ahead of doctors in setting aside concerns over long term lung effects. It could be pitting a parents fears against their children's fears (of needles). Quite frankly I don't know what I'd do as a parent (assuming I hadn't read all the Afrezza clinical trials as I have) if my doctor were warning me about potential long term effects but knowing my child feared needles. Granted if less hypos are so evident and meaningful in the data, that would likely sway me, but that would likely sway the doctors as well. There is not a single piece of evidence which supports Afrezza may be associated with pulmonary malignancy. But, the long-term clinical trial is specifically for T2D, so it would not even apply here since the Peds approval will be for T1D. Would be nice if docs viewed it as you do, but I think many do not. Personally I've never understood why the long term safety study is limited to T2. One component of the study is cardiovascular events. Hopefully the study can show benefit compared to RAA, and in that case hopefully docs would view it as applicable to T1, not merely T2.
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Post by agedhippie on Apr 13, 2019 20:15:05 GMT -5
There is not a single piece of evidence which supports Afrezza may be associated with pulmonary malignancy. But, the long-term clinical trial is specifically for T2D, so it would not even apply here since the Peds approval will be for T1D. Would be nice if docs viewed it as you do, but I think many do not. Personally I've never understood why the long term safety study is limited to T2. One component of the study is cardiovascular events. Hopefully the study can show benefit compared to RAA, and in that case hopefully docs would view it as applicable to T1, not merely T2. There are links between high insulin levels and cancer. Since Type 2 diabetics are usually insulin resistant by the time they get to insulin this is a problem. The same issue exists in Type 1 but to a far lesser extent. I suspect the lung study selected Type 2 because of that risk since they were trying to pick the worst case candidates (see the rest of the selection criteria). The aim is to pick a particularly bad combination so if there is a risk it will show. Before anyone says this is unfair I have to say it is standard practice in this sort of risk analysis - it's the equivalent of accelerating the aging of components through stressing them. If you have a sample set of 8,000 people and the chance of an event is 1:10,000 then you may not see any events at all - however when the drug scales up to a couple of million people that 1:10,000 is going to hand you 200 events and probably a lawsuit. To avoid this you pick a specific set where the odds may be 1:2,000 in which case your 8,000 people will return 4 events which would be a red flag. You now know there is a risk and you can do more work to find out who should and shouldn't take it.
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