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Post by harryx1 on Sept 2, 2015 5:53:40 GMT -5
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Post by harryx1 on Sept 2, 2015 6:11:08 GMT -5
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Post by harryx1 on Sept 2, 2015 6:48:46 GMT -5
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Post by esstan2001 on Sept 2, 2015 7:13:39 GMT -5
Findings... HbA1c decrease from baseline was greater with subcutaneous insulin than with Technosphere inhaled insulin (net difference 0·16%, 95% CI 0·06–0·25; eight trials). ... Quality of life and overall patient satisfaction did not differ significantly between inhaled insulin groups and active comparator groups (no numerical estimate). However, inhaled insulin was associated with less weight gain... and a smaller risk of severe hypoglycaemia ... mild transient cough was increased in people allocated to inhaled insulin ...compared with those allocated to active comparator groups, as was the decrease in forced expiratory volume in 1 s... InterpretationGlycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin. This is what Sanofi is up against...what a revelation once they can use flexible dosing to prove how wrong this is.
Hopefully the wait does not do us in.
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Post by centralcoastinvestor on Sept 2, 2015 8:37:29 GMT -5
Findings... HbA1c decrease from baseline was greater with subcutaneous insulin than with Technosphere inhaled insulin (net difference 0·16%, 95% CI 0·06–0·25; eight trials). ... Quality of life and overall patient satisfaction did not differ significantly between inhaled insulin groups and active comparator groups (no numerical estimate). However, inhaled insulin was associated with less weight gain... and a smaller risk of severe hypoglycaemia ... mild transient cough was increased in people allocated to inhaled insulin ...compared with those allocated to active comparator groups, as was the decrease in forced expiratory volume in 1 s... InterpretationGlycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin. This is what Sanofi is up against...what a revelation once they can use flexible dosing to prove how wrong this is.
Hopefully the wait does not do us in. I haven't fully appreciated the significance that early users like Afrezzauser will bring to the ultimate success of Afrezza. Without their real world experiences demonstrating that Afrezza can be used in a first and second phase approach just like the human body, it is possible the world would have never known this. The a1c results from actual Afrezza users is remarkable but it will take time for the scientific world to buy in.
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Deleted
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Post by Deleted on Sept 2, 2015 9:01:28 GMT -5
Findings... HbA1c decrease from baseline was greater with subcutaneous insulin than with Technosphere inhaled insulin (net difference 0·16%, 95% CI 0·06–0·25; eight trials). ... Quality of life and overall patient satisfaction did not differ significantly between inhaled insulin groups and active comparator groups (no numerical estimate). However, inhaled insulin was associated with less weight gain... and a smaller risk of severe hypoglycaemia ... mild transient cough was increased in people allocated to inhaled insulin ...compared with those allocated to active comparator groups, as was the decrease in forced expiratory volume in 1 s... InterpretationGlycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin. This is what Sanofi is up against...what a revelation once they can use flexible dosing to prove how wrong this is.
Hopefully the wait does not do us in. And yet the real world results are completely different than this with Sam and 90% of the people on Afrezza screaming from the mountain top how great Afrezza is along with unprecedented reductions in A1c. Me thinks Sanofi needs to grow a pair and develop some type of patient roadshow featuring diabetics currently using Afrezza to start telling the real story or start pitching the PK graph, better glucose control lower A1c to docs and health insurance companies. Courts just said Rx manufacturers can talk about their products and efficacy if they believe what they are saying is true. Sanofi needs to get very aggressive and they need to do it now. They have one of the if not the greatest Rx product ever for people with diabetes and they are behaving like sheep.
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Post by tayl5 on Sept 2, 2015 10:30:59 GMT -5
Anecdotes and individuals will not get us there. We need formal trials where Afrezza is used optimally against legitimate standard-of-care therapies. Anything else is just noise to doctors and payors. These trials may appear over time if endocrinologist/scientists want to make an accept/reject case for their institution. Even so, a peer-reviewed post-launch study organized by Sanofi involving a few thousand patients would do the trick.
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Post by Deleted on Sept 2, 2015 12:15:44 GMT -5
Anecdotes and individuals will not get us there. We need formal trials where Afrezza is used optimally against legitimate standard-of-care therapies. Anything else is just noise to doctors and payors. These trials may appear over time if endocrinologist/scientists want to make an accept/reject case for their institution. Even so, a peer-reviewed post-launch study organized by Sanofi involving a few thousand patients would do the trick. I appreciate your comments as they are well founded. What concerns me is Sanofi is a big company with big overhead. Can they afford to continue on the path they are on with an expensive salesforce pushing Afrezza with weekly NRx stagnant? There is some chatter on this board about european approval but as best I can tell, no one has provided definitive information about any type of regulatory filing being done for the european market so based on this, it's all about the US market which is not generating adequate sales revenue. I know Sanofi appears to be moving ahead with some important trials but we have all seen large companies spend money as if they are moving forward and then kill a project / product at the drop of a hat. Afrezza is a game changer and I have no doubt it can have one of the if not the greatest impact on people with diabetes as any pharmaceutical product has ever had but time is no longer Sanofi or Mannkind's friend. There needs to be a much greater sense of urgency in building Afrezza's sales. Does anyone on this board believe that if we do not see NRx count start to pick up this fall that we are going to have a problem. September in my book does not count but I think it is fair to say come October, we need to see stronger growth and a couple of ads in Time magazine and Diabetes Forecast are not going to do it. At this point in the game, even with the prior authorization issue likely starting to decline very very slowly, aggressive sales efforts (frequency and reach) and physician to physician education programs are what will drive sales along with continued efforts to work with the insurance companies. If need be, Sanofi can hire some people to help doctors with prior authorization paperwork, phone calls etc to take that time burden away from the docs and their office staff.
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Post by obamayoumama on Sept 2, 2015 13:04:08 GMT -5
Anecdotes and individuals will not get us there. We need formal trials where Afrezza is used optimally against legitimate standard-of-care therapies. Anything else is just noise to doctors and payors. These trials may appear over time if endocrinologist/scientists want to make an accept/reject case for their institution. Even so, a peer-reviewed post-launch study organized by Sanofi involving a few thousand patients would do the trick. I appreciate your comments as they are well founded. What concerns me is Sanofi is a big company with big overhead. Can they afford to continue on the path they are on with an expensive salesforce pushing Afrezza with weekly NRx stagnant? There is some chatter on this board about european approval but as best I can tell, no one has provided definitive information about any type of regulatory filing being done for the european market so based on this, it's all about the US market which is not generating adequate sales revenue. I know Sanofi appears to be moving ahead with some important trials but we have all seen large companies spend money as if they are moving forward and then kill a project / product at the drop of a hat. Afrezza is a game changer and I have no doubt it can have one of the if not the greatest impact on people with diabetes as any pharmaceutical product has ever had but time is no longer Sanofi or Mannkind's friend. There needs to be a much greater sense of urgency in building Afrezza's sales. Does anyone on this board believe that if we do not see NRx count start to pick up this fall that we are going to have a problem. September in my book does not count but I think it is fair to say come October, we need to see stronger growth and a couple of ads in Time magazine and Diabetes Forecast are not going to do it. At this point in the game, even with the prior authorization issue likely starting to decline very very slowly, aggressive sales efforts (frequency and reach) and physician to physician education programs are what will drive sales along with continued efforts to work with the insurance companies. If need be, Sanofi can hire some people to help doctors with prior authorization paperwork, phone calls etc to take that time burden away from the docs and their office staff. The shorts have been consistently wrong on their predictions. Won't pass Adcom, won't get approved, no partner, etc. They have been able to reduce the PPS through increasing their short position and bringing doubt into shareholders minds. The latest is that SNY will drop Afrezza. One would need to ask why? Most drugs to market like this cost several Billion dollars to get FDA approval. SNY is into Afrezza for less than 1/10 the cost of developing a drug like Afrezza. SNY is working on the "road blocks". Once SNY gets past thes road blocks then they will do their full court press on getting scripts. Many here and on YMB thought SNY should have started with TV ads months ago. Looking back the right "chess move" was to clear up the road blocks before the full launch of Afrezza. Look at the ADA, did SNY have a booth and did they showcase Afrezza? I believe that that the scripts will really start their increase once the insurance road block is resolved.
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Post by roseylv on Sept 2, 2015 16:00:39 GMT -5
The shorts have been consistently wrong on their predictions. Won't pass Adcom, won't get approved, no partner, etc. They have been able to reduce the PPS through increasing their short position and bringing doubt into shareholders minds. The latest is that SNY will drop Afrezza. One would need to ask why? Most drugs to market like this cost several Billion dollars to get FDA approval. SNY is into Afrezza for less than 1/10 the cost of developing a drug like Afrezza. SNY is working on the "road blocks". Once SNY gets past thes road blocks then they will do their full court press on getting scripts. Many here and on YMB thought SNY should have started with TV ads months ago. Looking back the right "chess move" was to clear up the road blocks before the full launch of Afrezza. Look at the ADA, did SNY have a booth and did they showcase Afrezza? I believe that that the scripts will really start their increase once the insurance road block is resolved. I agree on the basis of road blocks. Almost every business experiences them and must iron out the road blocks prior to a full fledge launch. I'm in the restaurant business and work for a nationwide chain. We consistently roll out LTO (limited time offers) quarterly or every few months. Prior to these LTO roll-outs, there are logistical hurdles to overcome. I.E. Supply chain and purchasing. Getting each Distribution center the product and hopefully without hiccups. Then preparing for the on air advertising campaigns with strategic buying groups. Then comes, in store training and preparation. Can you imagine if our cooks didn't know how to prepare these LTO after a full fledged advertising campaign? And what about our sales people (i.e. food servers)? They have to be able to quasi intelligently sell the LTO. Oh and I.T department needs to add new buttons on each Point of sale systems in every store.... All I'm getting at is that for these seemingly meager LTO's that we rollout rather ofter throughout the year, there is a TON of leg work that goes on without saying. All this for a waffle or pancake promotion that only affects our customers lives while in the moment. Whereas Afrezza is a seen as a life long change, moving from a seemingly habitual therapy regiment to something really different. I've read my fair share about SNY and as much as I want to believe some of these trumped up theories as to what SNY is doing wrong etc... My money is on the 126 Billion dollar Pharma company who knows just a thing or two about a new drug roll out and how to operate within these murky waters. Sorry for the rant! And I look forward to great things moving forward from both SNY & MNKD :-)
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Post by longstocking on Sept 2, 2015 16:03:44 GMT -5
Findings... HbA1c decrease from baseline was greater with subcutaneous insulin than with Technosphere inhaled insulin (net difference 0·16%, 95% CI 0·06–0·25; eight trials). ... Quality of life and overall patient satisfaction did not differ significantly between inhaled insulin groups and active comparator groups (no numerical estimate). However, inhaled insulin was associated with less weight gain... and a smaller risk of severe hypoglycaemia ... mild transient cough was increased in people allocated to inhaled insulin ...compared with those allocated to active comparator groups, as was the decrease in forced expiratory volume in 1 s... InterpretationGlycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin. This is what Sanofi is up against...what a revelation once they can use flexible dosing to prove how wrong this is.
Hopefully the wait does not do us in. And yet the real world results are completely different than this with Sam and 90% of the people on Afrezza screaming from the mountain top how great Afrezza is along with unprecedented reductions in A1c. Me thinks Sanofi needs to grow a pair and develop some type of patient roadshow featuring diabetics currently using Afrezza to start telling the real story or start pitching the PK graph, better glucose control lower A1c to docs and health insurance companies. Courts just said Rx manufacturers can talk about their products and efficacy if they believe what they are saying is true. Sanofi needs to get very aggressive and they need to do it now. They have one of the if not the greatest Rx product ever for people with diabetes and they are behaving like sheep. Agree with everything you're saying, but from SNY perspective, what's the rush? Let it happen. Social media ads are free/cheap. Work on insurance from now until Nov-Dec, then go hard with DTC/TV ads etc.
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Post by curiousdoc on Sept 3, 2015 10:14:40 GMT -5
Social media is great, but as others have said, that might as well not exist to doctors. If you are an endocrinologist who has read the literature, why, AT THIS POINT, would you put a patient on a MORE expensive drug with similar to decreased efficacy? Not to mention the stigma that many doctors already have towards ALL new drugs. That is the hurdle Afrezza is against until better trials are completed.
Similarly, many insurance decisions are based on validated population scale efficacy and outcome data, they don't care how well a handful of patients are doing on a drug. When they see the study that Afrezza results in fewer hypos and lower sustained A1Cs (and by association fewer long term complications) they will happily open up their formularies because its a drug that will actually save them money longterm.
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