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Post by tlundy on Nov 6, 2015 9:26:15 GMT -5
Unfortunately that trial appears to be for superiority versus placebo
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Post by vestful on Nov 6, 2015 9:39:43 GMT -5
Unfortunately that trial appears to be for superiority versus placebo Please explain. Wouldn't that be a benefit?
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Post by blindhog1 on Nov 6, 2015 9:42:03 GMT -5
Having just 10% penetration in 1.1 million target patients would be more than enough to get us going and get people to notice Afrezza. I give this CC a C- (compared to what I was expecting it is actually better!). And I changed my Avatar for good luck or to sail away! Nice Avatar jpg. We're on the way. Attachment Deleted
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Post by kball on Nov 6, 2015 9:47:51 GMT -5
^ Land Ho!
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Post by peppy on Nov 6, 2015 10:35:32 GMT -5
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Post by regulus on Nov 6, 2015 10:53:00 GMT -5
I think this study is significant. Like many others I have wondered why is Sanofi going so slowly with Afrezza? I have had my doubts about their commitment, even after the investor presentation today. One of my hypotheses is that Sanofi doesn't want to bury Mannkind under a load of research and marketing costs given the nature of their agreement. If they did that before enough sales develop, they could bankrupt their smaller partner easily. This is a Praluent study. Brandicourt thinks it has blockbuster potential. So why would Afrezza and Lantus be the insulin regimen in a cardiovascular study of Praluent? Because it is going to generate a lot of data and the majority of the costs associated with the study will be borne by Sanofi not Mannkind. I think this is a very firm sign that Sanofi is in for the long haul with Mannkind and they realize they need more data to successfully market the drug. I have been reading some of the comments on the board for a while but I registered because I liked this post enough that it motivated me to register so I could respond. Does any one have other links to ongoing research studies involving Afrezza? They will be much appreciated.
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Post by robsacher on Nov 6, 2015 11:14:22 GMT -5
If you're long and unimpressed with today's presentation, think how the big-time shorts must be feeling. They just had one of the biggest pillars of FUD kicked away. Now all they have is the insufficient cash argument which, while not minor, can be resolved in a number of quantifiable and verifiable ways. They will spin this hard today but I bet they're feeling pretty sick and many will be looking for the exit, especially if today's numbers continue last week's positive trend. I agree. Holding a short position now looks untenable in the under $4 range. This was the a victory for MannKind this morning. Let's all enjoy it as the p/s recovers a bit now and before the next bear raid comes.
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Post by longinvstr on Nov 6, 2015 12:18:54 GMT -5
Like many others I have wondered why is Sanofi going so slowly with Afrezza? I have had my doubts about their commitment, even after the investor presentation today. One of my hypotheses is that Sanofi doesn't want to bury Mannkind under a load of research and marketing costs given the nature of their agreement. If they did that before enough sales develop, they could bankrupt their smaller partner easily. I think the primary issue is customer acquisition cost - smart money vs. dumb money. Dumb money launches a multi-million dollar TV ad campaign. Potential consumers are excited, inquire with GP's, find it not well covered by insurance (read = expensive), get frustrated, doc's get frustrated, and stay with current treatment. Dumb money requires that additional millions be spent to repeat the process. Many prospects may never return - the once burned effect. Once burned, many doc's may never be brought back on board. The Sharktank Sharks are always drilling entrepreneurs on their cost to acquire the next customer. It is a supremely important component in the profit equation. Smart money waits for sufficient formulary improvement so that ad dollars spent are productive. SNY has the balance sheet to sustain plenty of dumb money spending right now. MNKD does not. We should be thankful for SNY's approach ... at least, a bit more empathetic to it. The frustration many of us feel should primarily be credited to the snail-paced, gov't bureaucracy-like speed that is the world of insurance co. formulary updates. Afrezza's superior and NOVEL nature is a LT asset but a ST liability. Tomorrow's good news is today's bad news. We can't be game changing and expect immediate #2 placement. The DNA of this investment requires that it be considered only as a LT proposition. I'm trying to think like an owner. WWAD? = What Would Al Do?
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Post by Deleted on Nov 6, 2015 12:32:52 GMT -5
We could use a positive article. Let's hope SA publishes it. They seem to have no problem publishing neg articles all the time.
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Post by mindovermatter on Nov 6, 2015 12:37:28 GMT -5
We could use a positive article. Let's hope SA publishes it. They seem to have no problem publishing neg articles all the time. With all due respect, I am not sure what a positive article would do. What was really needed and would have been an absolute upper cut to those trying to destroy Mannkind would have been Sanofi verbally stating their sticking with Afrezza, believe in it and will continue to support it. The ppt slide was evidence of this but it would have been more powerful if the CEO actually verbally stated it. That didn't happen and that's a shame.
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Post by rrtzmd on Nov 6, 2015 13:01:31 GMT -5
Unfortunately that trial appears to be for superiority versus placebo Please explain. Wouldn't that be a benefit? Not for afrezza. First, note that afrezza use is not mandated. It is simply one of the available therapies for managing the patients' diabetes. Oral therapies, other rapid acting insulins such as humalog, and lantus are available as well. Given the generally accepted protocol of type 2 diabetes management, orals come first, while insulin is the very last, when all else fails, option. Also, lantus is the recommended option at that point. So it's unlikely that very many of those patients will get afrezza. Type 1 diabetics are included in the study as well, but LDL/hypercholesterolemia tends not to be a big problem with type 1s as long as their glucose is controlled. Indeed, I'm not sure why SNY included them. I think they would have a better chance of success by focusing on the type 2s where the chance is higher that the drug would contribute benefits more than just glucose control. In any case, given that most patients are already managed with injectable RAAs and would unlikely change for a study unless conditions during the study warrant it, I doubt they will see much aafrezza either.
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Post by peppy on Nov 6, 2015 13:10:08 GMT -5
Please explain. Wouldn't that be a benefit? Not for afrezza. First, note that afrezza use is not mandated. It is simply one of the available therapies for managing the patients' diabetes. Oral therapies, other rapid acting insulins such as humalog, and lantus are available as well. Given the generally accepted protocol of type 2 diabetes management, orals come first, while insulin is the very last, when all else fails, option. Also, lantus is the recommended option at that point. So it's unlikely that very many of those patients will get afrezza. Type 1 diabetics are included in the study as well, but LDL/hypercholesterolemia tends not to be a big problem with type 1s as long as their glucose is controlled. Indeed, I'm not sure why SNY included them. I think they would have a better chance of success by focusing on the type 2s where the chance is higher that the drug would contribute benefits more than just glucose control. In any case, given that most patients are already managed with injectable RAAs and would unlikely change for a study unless conditions during the study warrant it, I doubt they will see much aafrezza either. When you know type 1's who have died in their early 40's of a heart attack, your words can not easily be read. Plenty of type 1 eat a bratwurst over a potato so as not to awaken the need for insulin. How many type 1's do you know that are well controlled?
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Post by blindhog1 on Nov 6, 2015 13:19:49 GMT -5
It's apparent that T2's are an underserved portion of the population. We deserve to be treated better. We deserve more recognition. Considering we are 90% of the Diabetic population you'd think we would be the target market. Next week I'll let you know.
Watch this space.
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Post by jpg on Nov 6, 2015 13:26:04 GMT -5
Not for afrezza. First, note that afrezza use is not mandated. It is simply one of the available therapies for managing the patients' diabetes. Oral therapies, other rapid acting insulins such as humalog, and lantus are available as well. Given the generally accepted protocol of type 2 diabetes management, orals come first, while insulin is the very last, when all else fails, option. Also, lantus is the recommended option at that point. So it's unlikely that very many of those patients will get afrezza. Type 1 diabetics are included in the study as well, but LDL/hypercholesterolemia tends not to be a big problem with type 1s as long as their glucose is controlled. Indeed, I'm not sure why SNY included them. I think they would have a better chance of success by focusing on the type 2s where the chance is higher that the drug would contribute benefits more than just glucose control. In any case, given that most patients are already managed with injectable RAAs and would unlikely change for a study unless conditions during the study warrant it, I doubt they will see much aafrezza either. Where did you get this info? You seem to be forgetting the opposite opinion you gave (of the same study!) a few days ago! Hmmm... Under the tread: Afrezza (insulin human) intervention in Study of Alirocumab on Oct 27, 2015 at 7:59am you said: Whatever the results, praluent will get the limelight for anything positive. Sanofi may even resort to blaming afrezza for any bad results. I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: Read more: mnkd.proboards.com/user/1944/recent#ixzz3qjkuoFYfSo which one is correct? They are or aren't using other prandial insulins? Oh yes the skin thing right? But what about lantus? And in my opinion you miss the reasons why Afrezza is being used: it's a perfect drug for 'metabolic syndrome' and for 'success by association'.
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Post by cjc04 on Nov 6, 2015 14:20:05 GMT -5
Like many others I have wondered why is Sanofi going so slowly with Afrezza? I have had my doubts about their commitment, even after the investor presentation today. One of my hypotheses is that Sanofi doesn't want to bury Mannkind under a load of research and marketing costs given the nature of their agreement. If they did that before enough sales develop, they could bankrupt their smaller partner easily. I think the primary issue is customer acquisition cost - smart money vs. dumb money. Dumb money launches a multi-million dollar TV ad campaign. Potential consumers are excited, inquire with GP's, find it not well covered by insurance (read = expensive), get frustrated, doc's get frustrated, and stay with current treatment. Dumb money requires that additional millions be spent to repeat the process. Many prospects may never return - the once burned effect. Once burned, many doc's may never be brought back on board. The Sharktank Sharks are always drilling entrepreneurs on their cost to acquire the next customer. It is a supremely important component in the profit equation. Smart money waits for sufficient formulary improvement so that ad dollars spent are productive. SNY has the balance sheet to sustain plenty of dumb money spending right now. MNKD does not. We should be thankful for SNY's approach ... at least, a bit more empathetic to it. The frustration many of us feel should primarily be credited to the snail-paced, gov't bureaucracy-like speed that is the world of insurance co. formulary updates. Afrezza's superior and NOVEL nature is a LT asset but a ST liability. Tomorrow's good news is today's bad news. We can't be game changing and expect immediate #2 placement. The DNA of this investment requires that it be considered only as a LT proposition. I'm trying to think like an owner. WWAD? = What Would Al Do? [ I completely agree,,,, and may I just add, that anytime I look for Afrezza, on a web site, magazine add or web add, I am overwhelmed with this black box warning.... This must be taken care of before any real DTC, imo. We can't have our cake and eat it too,,, I think SNY has done a great job of going slow, doing the work behind the scenes, staying as far away from the crazy Internet rumorville (which is made up of just as many psycho MNKD longs as it is Shorts trying to do harm), at the same time giving just enough to show they're not walking away. I still believe the final outcome was decided with Al long ago, and as hard as it is I'm trying to believe in that. I expect to hear the same ol on Monday, more attempts to buy time. Many will continue to call MNKD mgmt inept, but until I hear concern about the SNY relationship from them, I will continue to hold and consume as much kool-aid as I can get.
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