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Post by liane on Mar 8, 2017 5:25:41 GMT -5
You left out pediatric trials seem to have taken a back seat to the back seat. Never ceases to amaze me, too. Do you know how much a clinical trial costs?? Much as we need it, funding a trial right now detracts from the one immediate goal of selling more product.
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Post by sayhey24 on Mar 8, 2017 6:25:11 GMT -5
You left out pediatric trials seem to have taken a back seat to the back seat. Never ceases to amaze me, too. Do you know how much a clinical trial costs?? Much as we need it, funding a trial right now detracts from the one immediate goal of selling more product. No, I have no idea. How much? Sports keeps telling us the kids are the sweet spot. 17 years and $2.5B and we don't have the money to get over the finish line? Assuming they cost a lot, is there a way to do them cheaper with technology? How many kids do you need to prove monomer human insulin works? We know it works. Its been working since the beginning of mankind. Whats the point of this trial anyway? Is it to see if the kids can suck on the inhaler or is it an FDKP cilia sticking safety study which we know doesn't happen? Is it really the problem they need an xsmall cartridge and don't have one? Or, is something else going one which has them saving the money right now to pay the electric bill? How many kids do you need for this, 25, 100, more? We seem to have just hired a bunch of very expensive people, like the Amgen guy. Can he help out? I keep looking for some urgency but I can't find it which makes me ask the question, whats going on, things don't add up?
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Post by Deleted on Mar 8, 2017 6:44:18 GMT -5
Do you know how much a clinical trial costs?? Much as we need it, funding a trial right now detracts from the one immediate goal of selling more product. No, I have no idea. How much? Sports keeps telling us the kids are the sweet spot. 17 years and $2.5B and we don't have the money to get over the finish line? Assuming they cost a lot, is there a way to do them cheaper with technology? How many kids do you need to prove monomer human insulin works? We know it works. Its been working since the beginning of mankind. Whats the point of this trial anyway? Is it to see if the kids can suck on the inhaler or is it an FDKP cilia sticking safety study which we know doesn't happen? Is it really the problem they need an xsmall cartridge and don't have one? Or, is something else going one which has them saving the money right now to pay the electric bill? How many kids do you need for this, 25, 100, more? We seem to have just hired a bunch of very expensive people, like the Amgen guy. Can he help out? I keep looking for some urgency but I can't find it which makes me ask the question, whats going on, things don't add up? Stefan working behind the scenes. Patience I say 😜
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Post by kbrion77 on Mar 8, 2017 6:50:09 GMT -5
"Nobody knows what to do with this drug" really, nobody? Wow! Prior to real time sensors I might agree with you but between the Libre and G5, CGMs are getting cost effective and common place. There are a bunch of smart guys out there and Nobody can figure out what to do with the only treatment which works just like a healthy pancreas. Yet there are a bunch of people on this board that understand the impact afrezza could have on peoples lives and we have afrezza users who tell us it is "life changing". To quote Kevin Sayers when asked about the social media reports he said "I have never seen anything like it". Now, Kevin seems like a smart guy. He even has a deal going with the same folks as our ex-Sanofi afrezza manager. It seems odd a smart guy like Kevin who has been in the diabetes market for a while can't figure something out. Just saying, something seems odd. Yes nobody knows what to do. Sanofi didn't know what to do and we are now on what Mannkind 3.0? Our best strategy to date is the titration pack which is great but to me it feels like "hey here are a bunch of different options give it a go and see what works!" Doctors will not prescribe and PWD will not pay the money to experiment like that. Nobody is saying the drug isn't incredible or not a life changer but 2 years later and well the numbers speak for themselves.
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Post by peppy on Mar 8, 2017 6:56:08 GMT -5
"Nobody knows what to do with this drug" really, nobody? Wow! Prior to real time sensors I might agree with you but between the Libre and G5, CGMs are getting cost effective and common place. There are a bunch of smart guys out there and Nobody can figure out what to do with the only treatment which works just like a healthy pancreas. Yet there are a bunch of people on this board that understand the impact afrezza could have on peoples lives and we have afrezza users who tell us it is "life changing". To quote Kevin Sayers when asked about the social media reports he said "I have never seen anything like it". Now, Kevin seems like a smart guy. He even has a deal going with the same folks as our ex-Sanofi afrezza manager. It seems odd a smart guy like Kevin who has been in the diabetes market for a while can't figure something out. Just saying, something seems odd. Yes nobody knows what to do. Sanofi didn't know what to do and we are now on what Mannkind 3.0? Our best strategy to date is the titration pack which is great but to me it feels like "hey here are a bunch of different options give it a go and see what works!" Doctors will not prescribe and PWD will not pay the money to experiment like that. Nobody is saying the drug isn't incredible or not a life changer but 2 years later and well the numbers speak for themselves. I look at it this way. What if all fast acting insulin was afrezza, and pharm brings out the fast acting subq analogs.... No one would know what to do. The learning curve would be huge.
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Post by liane on Mar 8, 2017 7:03:21 GMT -5
Cost of clinical trials can vary widely, a lot of that due to administrative and site retention costs. At the very low end, I would speculate $10M. Others can chime in with more specific info. I'm just saying that money more appropriately needs to go toward marketing and selling Afrezza now.
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Post by sayhey24 on Mar 8, 2017 7:07:40 GMT -5
"Nobody knows what to do with this drug" really, nobody? Wow! Prior to real time sensors I might agree with you but between the Libre and G5, CGMs are getting cost effective and common place. There are a bunch of smart guys out there and Nobody can figure out what to do with the only treatment which works just like a healthy pancreas. Yet there are a bunch of people on this board that understand the impact afrezza could have on peoples lives and we have afrezza users who tell us it is "life changing". To quote Kevin Sayers when asked about the social media reports he said "I have never seen anything like it". Now, Kevin seems like a smart guy. He even has a deal going with the same folks as our ex-Sanofi afrezza manager. It seems odd a smart guy like Kevin who has been in the diabetes market for a while can't figure something out. Just saying, something seems odd. Yes nobody knows what to do. Sanofi didn't know what to do and we are now on what Mannkind 3.0? Our best strategy to date is the titration pack which is great but to me it feels like "hey here are a bunch of different options give it a go and see what works!" Doctors will not prescribe and PWD will not pay the money to experiment like that. Nobody is saying the drug isn't incredible or not a life changer but 2 years later and well the numbers speak for themselves. Sanofi knew exactly what to do. They got $250M and started a new company with Google. Their plan is to go after the PCP T2 market. The question is how? What their plan? They are not going after the endos. What's the Edelman protocol?
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Post by kbrion77 on Mar 8, 2017 7:10:40 GMT -5
Yes nobody knows what to do. Sanofi didn't know what to do and we are now on what Mannkind 3.0? Our best strategy to date is the titration pack which is great but to me it feels like "hey here are a bunch of different options give it a go and see what works!" Doctors will not prescribe and PWD will not pay the money to experiment like that. Nobody is saying the drug isn't incredible or not a life changer but 2 years later and well the numbers speak for themselves. I look at it this way. What if all fast acting insulin was afrezza, and pharm brings out the fast acting subq analogs.... No one would know what to do. The learning curve would be huge.
Agreed which is why big pharma is not straying away from the methods they have built their diabetes empires on, you will only see tweaks. In all of our eyes this insulin is absolute gold, there is nothing like it on the planet but why don't any PE firms, biotech investors, small/middle pharma see that as well? Why can we get no partnerships? How are we not handing Afrezza to Dexcom on a silver platter? How are we not calling Viehbacher at Boston Pharmaceuticals every day until they strike a deal? As every day passes it continues to be a little more clearer nobody outside of MNKD wants to touch Afrezza.
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Post by sayhey24 on Mar 8, 2017 7:11:39 GMT -5
Cost of clinical trials can vary widely, a lot of that due to administrative and site retention costs. At the very low end, I would speculate $10M. Others can chime in with more specific info. I'm just saying that money more appropriately needs to go toward marketing and selling Afrezza now. $10M is round-off when we are talking $2.5B. I use to run a soccer club. Rule #1 was if I needed something done I would get the busiest Mom and some how she could always get it done faster than anyone else. We are talking about Mom's and their kids. We have Teledoc technology. We have the G5. We have the Moms. Can't Edelman do this during his lunch? Can't Matt call Bernie Sander and asked for a free coupon with the FDA?
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Post by madog365 on Mar 8, 2017 7:48:00 GMT -5
Cost of clinical trials can vary widely, a lot of that due to administrative and site retention costs. At the very low end, I would speculate $10M. Others can chime in with more specific info. I'm just saying that money more appropriately needs to go toward marketing and selling Afrezza now. $10M is round-off when we are talking $2.5B. I use to run a soccer club. Rule #1 was if I needed something done I would get the busiest Mom and some how she could always get it done faster than anyone else. We are talking about Mom's and their kids. We have Teledoc technology. We have the G5. We have the Moms. Can't Edelman do this during his lunch? Can't Matt call Bernie Sander and asked for a free coupon with the FDA? Have you been puffing on that RLS technosphere?
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Post by liane on Mar 8, 2017 7:54:41 GMT -5
Cost of clinical trials can vary widely, a lot of that due to administrative and site retention costs. At the very low end, I would speculate $10M. Others can chime in with more specific info. I'm just saying that money more appropriately needs to go toward marketing and selling Afrezza now. And 1 other thing - money spent on a trial will have no effect on sales for well over a year due to the time the trial takes and then getting the FDA approval. I've always been a person thinking of the long term, but this is one case where the short term need far outweighs the long term goal.
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Post by sportsrancho on Mar 8, 2017 8:15:11 GMT -5
It seems to me that already about 25% of the people on Afrezza are kids.
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Post by derek2 on Mar 8, 2017 8:24:09 GMT -5
Cost of clinical trials can vary widely, a lot of that due to administrative and site retention costs. At the very low end, I would speculate $10M. Others can chime in with more specific info. I'm just saying that money more appropriately needs to go toward marketing and selling Afrezza now. And 1 other thing - money spent on a trial will have no effect on sales for well over a year due to the time the trial takes and then getting the FDA approval. I've always been a person thinking of the long term, but this is one case where the short term need far outweighs the long term goal. My estimate for pediatric: Two years recruitment (500 children) and trial at a cost of $120M (similat to Affinity 2 with 400 participants). And no approval until late 2021. MNKD has an agreed-to schedule with the FDA: This required study is listed below. www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdfMNKD has used pandering language around children but has actively argued against pediatric trials, then argued against safety and efficacy testing for children under 12. There seems to be a common belief that the FDA has requested that Mannkind test Afrezza on 4-year-olds and that this shows just how safe and awesome Afrezza is. TL/DR version: 1. Around the time of their phase 2 trials, Mannkind submitted a Pediatric Study Plan proposing to study 12-18 year olds, and stating that results for 4-12 year olds (who I bet are really difficult to recruit) could be extrapolated from the teen results. 2. FDA says "No way - if you want 'em on the label you have to test with them" 3. MNKD has neither the time nor money to do this, so requests a deferral for after approval. 4. FDA says "alright, but in order to get any pediatric indication on the label you'll have to sponsor a big trial - 500 children from 4 to 18 years of age." 5. MNKD says "sure thing. We'll fund it with revenues from sales." 6. Feb 2011 PR 7. MNKD investors say "hey look, they're thinking of the children, and so safe a 4-year-old can use it" 8. Pediatric use delayed until 2022. Let's take a look at this. 1. How do we know that the FDA requested this? 2. What exactly did they ask? 3. What does it imply? So what are "the facts" regarding the FDA's pediatric testing request, or suggestion, or whatever it is? The basis for much of this is a single press release from January 2010, which talked about the approval delay due to Oraganon facility inspection, but also included the following: Hey, the FDA wants MNKD to test on children! well, wait a minute. This talks about MNKD obtaining a waiver and deferral to delay pediatric testing, not about being asked to undertake studies on children. www.pharmtech.com/pharmtech/Article/Waivers-and-Deferrals-Under-the-Pediatric-Research/ArticleStandard/Article/detail/615511 gives great backgrounder: Basically, you're mandated to test on children unless there's a good reason _not_ to. A deferral is available as if: So it looks like the FDA said "okay, you can stall pediatric testing until after approval, but then you have to do a study on 500 children". So what does this imply? I believe that it means that for everyone saying "do it for the children", at MNKD's request, Afrezza will be off-label for pediatric use for several years, until the phase 4 study is complete. Think about this. It took 2 years since the last CRL to get the bridging studies done, followed by re-submission. _that's_ where MNKD sits vis a vis kids. The bar for reaching agreement with FDA regarding a deferral appears relatively low. This provision makes sense because the issue is not if the studies will be performed, but when.
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Post by peppy on Mar 8, 2017 8:49:53 GMT -5
Derek2 are these quote regarding the 1st Generation inhaler (name escaping me) or second generation, the dreamboat? just asking? Pep Please provide the links. Thanks
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Post by agedhippie on Mar 8, 2017 10:26:09 GMT -5
Derek2 are these quote regarding the 1st Generation inhaler (name escaping me) or second generation, the dreamboat? just asking? Pep Please provide the links. Thanks
That looks like the letter that was issued with the approvals as it gives the post-approval testing that is required. The unit sizes references are Dreamboat units (the adjusted unit cartridges) so given the timing and the units I would say that it's the Dreamboat.
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