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Post by agedhippie on Jan 14, 2018 11:18:39 GMT -5
Do doctors largely get their medical information from reps? Exclusively - no, are they a source - yes. If they aren't we are wasting a lot of money having a sales force. Do they read articles on their own - the ones I know do. Then we get to the assertions you are making. If you want to be taken seriously then you need to have data to back the assertions that is gathered in a clear and transparent way. That is the whole reason for trials, and why the standards of care assign such weight to them. Does Afrezza mimic the first phase response? Superficially it looks like it, but does it really is a question you need scientific evidence to support and a hunch is not good enough. Does the fact that peak serum levels are reached in less than 15 minutes provide a sufficient copy of the first phase response or are there other components beyond the simple release of insulin? Again - trial data to show that Afrezza really does mimic the full first phase response. If you don't produce the data then don't be surprised when assertions are ignored. In the world of engineering we do not have "trials". We built prototypes and we model. The reason for this is we can measure and develop algorithms and have predictive results. ... If you are now arguing there is some other "magic" fluid the pancreas is releasing which is having the direct impact on lowering BG that insulin has I would suggest you are in "afrezza denial". I can cheerfully say that I will never take a drug that's testing is limited to prototypes and models but not tested in a trial. The history of diabetes is littered with models that failed to translate into real life. There is absolutely no way the FDA moves away from trials, their current direction is to require more and not less. The magic fluid is called amylin, a peptide produced in the beta cells. I only know that one because they make an artificial version of it called Symlin. There may well be others, I have never really looked.
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Post by dreamboatcruise on Jan 14, 2018 14:20:57 GMT -5
sayhey24... even in engineering trials are often used. The military has several large field trial programs for various types of equipment. They are deemed important to show whether real world soldiers can easily use the equipment, whether the equipment holds up to real world soldiers in a field situation and whether the new stuff integrates well with older equipment in real world scenarios. Not to mention that a lot of consumer gear (and software) goes through various stages of trials including often fairly large "beta testing" trials where a broad user population is involved. In medicine we are not even close to having a physiological model of humans that can take the place of trials. The body is simply too complicated and interactions too numerous. The medical research field (and FDA) are only at the very beginning of accepting modeling as a valid adjunct to trials, but certainly not replacing them.
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Post by sportsrancho on Jan 14, 2018 16:38:24 GMT -5
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Post by sayhey24 on Jan 14, 2018 17:15:33 GMT -5
In the world of engineering we do not have "trials". We built prototypes and we model. The reason for this is we can measure and develop algorithms and have predictive results. ... If you are now arguing there is some other "magic" fluid the pancreas is releasing which is having the direct impact on lowering BG that insulin has I would suggest you are in "afrezza denial". I can cheerfully say that I will never take a drug that's testing is limited to prototypes and models but not tested in a trial. The history of diabetes is littered with models that failed to translate into real life. There is absolutely no way the FDA moves away from trials, their current direction is to require more and not less. The magic fluid is called amylin, a peptide produced in the beta cells. I only know that one because they make an artificial version of it called Symlin. There may well be others, I have never really looked. If you want to fix the amylin, fix the beta cells and the amylin will fix itself. Now there may not be a great answer for those under an active immune attack or for those that have had massive beta cell damage but for the "T2s" who have not spent too much time on the Step program the answer for them is easier; get on the afrezza; keep non-diabetic numbers; and the beta cells in many cases will start to heal. Fix the beta cells and amylin secretion will fix itself too.
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Post by sayhey24 on Jan 14, 2018 17:43:04 GMT -5
sayhey24 ... even in engineering trials are often used. The military has several large field trial programs for various types of equipment. They are deemed important to show whether real world soldiers can easily use the equipment, whether the equipment holds up to real world soldiers in a field situation and whether the new stuff integrates well with older equipment in real world scenarios. Not to mention that a lot of consumer gear (and software) goes through various stages of trials including often fairly large "beta testing" trials where a broad user population is involved. In medicine we are not even close to having a physiological model of humans that can take the place of trials. The body is simply too complicated and interactions too numerous. The medical research field (and FDA) are only at the very beginning of accepting modeling as a valid adjunct to trials, but certainly not replacing them. There is a huge difference between human and field operability and whether the device itself works. I spent many years working "advanced technology" for the government and some for the special ops. I knew if I developed something for those guys and it did not work they were not coming home. However, there is a lot of bad engineering out there and the good engineers can always tell you why the bad stuff will not work. By the time you get to field trials it should not be for the engineers but for the client and in many cases that Colonel's promotion depends on his contractor performing well. The engineers already know if things are going to work. I worked at Grumman 10 years after Apollo 13 and they still had the back-up LEM sitting there. The engineers in that case hoped that crazy idea would work but it was not engineered for what they did with it. Now, how many more studies do we need on human insulin? The issue is how fast can you get it into the blood. This is why Al Mann was floored with the first CRL. All he was asking the FDA to approve was the exact same human insulin which is already used by the body. By CRL two he figured out afrezza was never being approved without some sunshine. As far as the FDKP and the long term risks, who knows. The particle appears totally inert and MNKD in their trials were able to account for near 100%. But who knows. We have high confidence afrezza is safer than all the T2 meds and other insulins. So far after 12 years things are exceeding expectations, except for sales but that's not an engineering problem.
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Post by lennymnkd on Jan 15, 2018 11:12:44 GMT -5
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Post by sportsrancho on Jan 15, 2018 19:29:52 GMT -5
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Post by mnholdem on Jan 15, 2018 19:37:22 GMT -5
And there you have it Mango! It can't get any better than that! So why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? Afrezza should be what every Endo and Diabetic are talking about. And here we sit, under .50 pre split. A brutal beating! Simple... need clinical trial data showing the benefits. Mike addressed this topic a bit during the Q&A session at the Cantor Fitzgerald Healthcare Conference last September. Castagna: And just maybe some perspective, the company has done well over – almost $3 billion in investments, 65 trials and over 6,000 patients in the development program. So we have a lot of data and the majority of data has never been published. So it’s been presented at conferences is one and done, but you will do us [indiscernible]you wouldn’t come up with over a lung data, you want to come up with our alpha cell data. And so trying to again get some of those data publish is important, because we found as we have the data that answer people’s questions, they just have never seen it.
And so how do we actually package that data and get that out there. So that’s the good news as we don’t need real large trials to start to change to the paradigms. We have to communicate effectively with the data that we have. Okay?Link: seekingalpha.com/article/4109298-mannkinds-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conference-transcript?part=single
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Post by olebob1 on Jan 15, 2018 19:41:58 GMT -5
too late to change to Vreedom from Diabetes. "Vreedom, Vreedom" William Wallace, Braveheart.
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Post by straightly on Jan 15, 2018 21:07:45 GMT -5
And there you have it Mango! It can't get any better than that! So why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? Afrezza should be what every Endo and Diabetic are talking about. And here we sit, under .50 pre split. A brutal beating! Why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? The simple answer is that there is no trial data to support those assertions and for that reason the reps cannot use them. If there was trial data then the claims could be reflected on the label, the reps could use it, and doctors would listen. That is probably also why Mike was so excited with the advances of CGMs. People need to see to believe?
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Post by xanet on Jan 15, 2018 21:09:05 GMT -5
Simple... need clinical trial data showing the benefits. Mike addressed this topic a bit during the Q&A session at the Cantor Fitzgerald Healthcare Conference last September. Castagna: And just maybe some perspective, the company has done well over – almost $3 billion in investments, 65 trials and over 6,000 patients in the development program. So we have a lot of data and the majority of data has never been published. So it’s been presented at conferences is one and done, but you will do us [indiscernible]you wouldn’t come up with over a lung data, you want to come up with our alpha cell data. And so trying to again get some of those data publish is important, because we found as we have the data that answer people’s questions, they just have never seen it.
And so how do we actually package that data and get that out there. So that’s the good news as we don’t need real large trials to start to change to the paradigms. We have to communicate effectively with the data that we have. Okay?Link: seekingalpha.com/article/4109298-mannkinds-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conference-transcript?part=singleWould love to see that data! (Preferably the raw data, since I'm always a little skeptical of someone else's analysis, lol.)
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Post by timri on Jan 15, 2018 21:11:46 GMT -5
Why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? The simple answer is that there is no trial data to support those assertions and for that reason the reps cannot use them. If there was trial data then the claims could be reflected on the label, the reps could use it, and doctors would listen. That is probably also why Mike was so excited with the advances of CGMs. People need to see to believe? They don’t realize how out of whack their sugars are until they have a cgm. Then they realize how bad of a job their prior insulin was doing keep them in range.
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Post by peppy on Jan 15, 2018 21:13:05 GMT -5
Why is it that BP and the rest of the medical community still fail to see the obvious and apparent benefits of Afrezza? The simple answer is that there is no trial data to support those assertions and for that reason the reps cannot use them. If there was trial data then the claims could be reflected on the label, the reps could use it, and doctors would listen. That is probably also why Mike was so excited with the advances of CGMs. People need to see to believe? I saw a television commercial this evening for Dexcom. (after 60 minutes?) The advertising was going after DEXCOM potential medicare patients. "if you are a diabetic over 65....."
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Post by straightly on Jan 15, 2018 21:13:08 GMT -5
That is probably also why Mike was so excited with the advances of CGMs. People need to see to believe? They don’t realize how out of whack their sugars are until they have a cgm. Then they realize how bad of a job their prior insulin was doing keep them in range. This is definitely my hope.
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Post by digger on Jan 16, 2018 5:22:47 GMT -5
They don’t realize how out of whack their sugars are until they have a cgm. Then they realize how bad of a job their prior insulin was doing keep them in range. This is definitely my hope. Why doesn't MNKD simply recruit a hundred patients who use afrezza as their sole mealtime insulin, hook them to CGMs for six months and then report the results?
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