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Post by seanismorris on Sept 12, 2015 13:51:03 GMT -5
Sanofi is probably waiting until after the Pediatric study is completed before aggressively promoting Afrezza for T1. But it's an important market...what kid wants to take a shot at school. clinicaltrials.gov/ct2/show/NCT02527265FYI This study is not yet open for participant recruitment. Verified August 2015 by Sanofi Sponsor: Sanofi I think the most important thing they are looking for is allergic reactions from anti-insulin antibodies in younger Type 1s. The allergic reaction could be very different from injected insulin vs. inhaled. Could be a violent reaction given the rapid absorption in the lungs... Not saying that's what they'll find. But it's a very very important study. Could be the difference between Afrezza being a niche product and a blockbuster. This is one of those events (when the study is completed) what would push me from a HOLD to a BUY regardless of what the scripts picture looks like.
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Post by seanismorris on Sept 12, 2015 14:12:54 GMT -5
Re: Pediatric Study The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year. --- For those investors who actively Google for Afrezza news add "Insulin human SAR439065" to you list. If we can find out how this study is going before it's completed we might be able to jump ahead of a share price pop. Another T1 Afrezza study to monitor (ending in December) PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) clinicaltrials.gov/ct2/show/NCT02485327Estimated Primary Completion Date September 2015 (final data collection date for primary outcome measure)
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Post by robsacher on Sept 12, 2015 17:50:39 GMT -5
Sanofi is probably waiting until after the Pediatric study is completed before aggressively promoting Afrezza for T1. But it's an important market...what kid wants to take a shot at school. clinicaltrials.gov/ct2/show/NCT02527265FYI This study is not yet open for participant recruitment. Verified August 2015 by Sanofi Sponsor: Sanofi I think the most important thing they are looking for is allergic reactions from anti-insulin antibodies in younger Type 1s. The allergic reaction could be very different from injected insulin vs. inhaled. Could be a violent reaction given the rapid absorption in the lungs... Not saying that's what they'll find. But it's a very very important study. Could be the difference between Afrezza being a niche product and a blockbuster. This is one of those events (when the study is completed) what would push me from a HOLD to a BUY regardless of what the scripts picture looks like. What an interesting point of information. Thank you. I see where you're going with this. If Afrezza is biologically tolerated in children, then Afrezza can become the dominant insulin among pediatrics. But, while I understand the positive implications, isn't the pediatric market really just a percentage of the T1 market and isn't the T1 market only about 5% of the entire diabetes market? Respectfully, I can't quite see how success in this area would be such a game changer for you in your decision to hold or add shares. Am I missing something?
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Post by mannmade on Sept 12, 2015 18:00:59 GMT -5
Rob, you bring up good points but I think the FDA's approval for pediatrics/children will greatly reduce any fears about safety and the lungs etc, eliminating another obstacle although not the same issue of importance as insurance coverage which I think most would agree is the main resistance point followed closely by doctor education and reluctance.
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Post by seanismorris on Sept 12, 2015 18:31:34 GMT -5
I'm not a doctor...
But, would you take a drug that has been proven safe for rats but not yet for humans...no. How about a drug that has been proven safe for children vs. adults?
The way I look at it, having something proven safe for children is the gold standard for a excellent safely profile.
I'd think passing/completing a Pediatric Study would go a long way to convince doctors a drug is safe. It doesn't matter if they ever actually treat children or not.
With the question marks raised about the safety of Afrezza, this could be something docs are waiting for. It would certainly provide ammo for Sanofi's sales teams. This may be the best thing they have; besides actually completing the cancer risk study.
mannmade is right about price (insurance coverage) holding back sales. Safety, is the other issue. Getting these studies done by the end of the year, with the addition of insurance coverage, would greatly raise my expectations for 2016. All the marketing dollars in the world won't change the forecast unless affordability and safety is addressed.
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Post by robsacher on Sept 12, 2015 18:54:31 GMT -5
Rob, you bring up good points but I think the FDA's approval for pediatrics/children will greatly reduce any fears about safety and the lungs etc, eliminating another obstacle although not the same issue of importance as insurance coverage which I think most would agree is the main resistance point followed closely by doctor education and reluctance. Ahhhhh. Yes! I see. I completely had missed the connection. Thank you. If Afrezza is OK for children then it must be OK for me. Of course… That might also help Sanofi in the company's approach with insurance providers. Great observation. By the way, I have been polling some doctors who prescribe insulin and of the doctors who do not prescribe Afrezza, most say that they are aware of Afrezza but they are taking a wait and see approach. Pediatric success could be a game changer for these doctors.
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Post by mannmade on Sept 12, 2015 19:43:22 GMT -5
Rob, you bring up good points but I think the FDA's approval for pediatrics/children will greatly reduce any fears about safety and the lungs etc, eliminating another obstacle although not the same issue of importance as insurance coverage which I think most would agree is the main resistance point followed closely by doctor education and reluctance. Ahhhhh. Yes! I see. I completely had missed the connection. Thank you. If Afrezza is OK for children then it must be OK for me. Of course… That might also help Sanofi in the company's approach with insurance providers. Great observation. By the way, I have been polling some doctors who prescribe insulin and of the doctors who do not prescribe Afrezza, most say that they are aware of Afrezza but they are taking a wait and see approach. Pediatric success could be a game changer for these doctors.Thanks Rob (and sean for starting this conversation) I also just thought of another interesting possibility, which is, that while adult diabetics might not advocate with their PCP or endos for Afrezza for various reasons, I can almost guarantee a parent of a young child with Diabetes will be scouring the internet and talking to their doctor(s) about all options, especially the latest chances to help reduce Diabetes long term issues and of course the most immediate fear and dread of a night time or unsupervised (meaning w/o parent close by, such as at school) severe hypo event.
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Post by sportsrancho on Sept 12, 2015 20:59:00 GMT -5
Ahhhhh. Yes! I see. I completely had missed the connection. Thank you. If Afrezza is OK for children then it must be OK for me. Of course… That might also help Sanofi in the company's approach with insurance providers. Great observation. By the way, I have been polling some doctors who prescribe insulin and of the doctors who do not prescribe Afrezza, most say that they are aware of Afrezza but they are taking a wait and see approach. Pediatric success could be a game changer for these doctors.Thanks Rob (and sean for starting this conversation) I also just thought of another interesting possibility, which is, that while adult diabetics might not advocate with their PCP or endos for Afrezza for various reasons, I can almost guarantee a parent of a young child with Diabetes will be scouring the internet and talking to their doctor(s) about all options, especially the latest chances to help reduce Diabetes long term issues and of course the most immediate fear and dread of a night time or unsupervised (meaning w/o parent close by, such as at school) severe hypo event. How right you are! People can be timid when it comes to standing up to a doctor. But when those parents kids are involved they fight! Happy kids, happy life!
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Post by ezrasfund on Sept 13, 2015 8:54:30 GMT -5
Why is Afrezza not being prescribed? Not only are patients timid about trying new treatments, but so are doctors. When I talk to doctors who are investors two words pop up over and over, "unmet needs." If there is no alternative treatment you know the drug will be prescribed. Becoming the new standard of treatment is a much more difficult road. And if you want to get a sense of what a mess the treatment protocols for T2 diabetes really are, take a look at this page. www.accurateinsulin.org/for-doctors/deciding-whether-to-transition-your-patient-to-mealtime-insulin/
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Post by peppy on Sept 13, 2015 9:08:04 GMT -5
Why is Afrezza not being prescribed? Not only are patients timid about trying new treatments, but so are doctors. When I talk to doctors who are investors two words pop up over and over, "unmet needs." If there is no alternative treatment you know the drug will be prescribed. Becoming the new standard of treatment is a much more difficult road. And if you want to get a sense of what a mess the treatment protocols for T2 diabetes really are, take a look at this page. www.accurateinsulin.org/for-doctors/deciding-whether-to-transition-your-patient-to-mealtime-insulin/Is this meta analysis? AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY – CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN – 2015 www.aace.com/files/dm-guidelines-ccp.pdf
It is interesting to my convoluted brain, "if the treatment isn't working change the target."
3.Q3.1. Outpatient Glucose Targets for Nonpregnant Adults • R11. Glucose targets should be individualized and take into account life expectancy, disease duration, presence or absence of micro- and macrovascular complications, CVD risk factors, comorbid conditions, and risk for hypoglycemia, as well as the patient’s psychological status (Grade A; BEL 1). In general, the goal of therapy should be an A1C level ≤6.5% for most nonpregnant adults, if it can be achieved safely (Table 7) (Grade D; BEL 4). To achieve this target A1C level, FPG may need to be <110 mg/dL, and the 2-hour PPG may need to be <140 mg/dL (Table 7) (Grade B, BEL 2). In adults with recent onset of T2D and no clinically significant CVD, glycemic control aimed at normal (or near-normal) glycemia should be considered, with the aim of preventing the development of micro- and macrovascular complications over a lifetime, if it can be achieved without substantial hypoglycemia or other unacceptable adverse consequences (Grade A; BEL 1). Although it is uncertain that the clinical course of established CVD is
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Post by agedhippie on Sept 13, 2015 9:46:17 GMT -5
What an interesting point of information. Thank you. I see where you're going with this. If Afrezza is biologically tolerated in children, then Afrezza can become the dominant insulin among pediatrics. But, while I understand the positive implications, isn't the pediatric market really just a percentage of the T1 market and isn't the T1 market only about 5% of the entire diabetes market? Respectfully, I can't quite see how success in this area would be such a game changer for you in your decision to hold or add shares. Am I missing something?Type 1 is around 20% of the diabetic population and the pediatric market is quite difficult. It is very common to put children on insulin pumps because that way the adult can control the dosing remotely plus it delivers the basal insulin. Without a pump you would still have to inject daily anyway for the basal plus you would have to get the child to either inject or inhale mealtime insulin. Contrary to what people think the big issue to children isn't injecting itself, it's being different and using an inhaler before every meal qualifies. Why pediatrics? The options currently are pump or injection. Once you in a routine you are unlikely to change so to capture the young adult market you need the pediatric market.
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Post by blindhog1 on Sept 24, 2015 7:36:58 GMT -5
My FBG was 105 this morning. Not to shabby for an old guy. But like anything good you've got to work at it. In my defense about these numbers, because of Afrezza I've been taking better care of myself. It's like having a new sailboat.
I'm also picking up my 3rd Rx today. That means 8th week. We all know that time fly's but after my A1C in November I'll stop thinking about how long I've been on Afrezza.
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Post by Deleted on Sept 24, 2015 9:26:04 GMT -5
What an interesting point of information. Thank you. I see where you're going with this. If Afrezza is biologically tolerated in children, then Afrezza can become the dominant insulin among pediatrics. But, while I understand the positive implications, isn't the pediatric market really just a percentage of the T1 market and isn't the T1 market only about 5% of the entire diabetes market? Respectfully, I can't quite see how success in this area would be such a game changer for you in your decision to hold or add shares. Am I missing something?Type 1 is around 20% of the diabetic population and the pediatric market is quite difficult. It is very common to put children on insulin pumps because that way the adult can control the dosing remotely plus it delivers the basal insulin. Without a pump you would still have to inject daily anyway for the basal plus you would have to get the child to either inject or inhale mealtime insulin. Contrary to what people think the big issue to children isn't injecting itself, it's being different and using an inhaler before every meal qualifies. Why pediatrics? The options currently are pump or injection. Once you in a routine you are unlikely to change so to capture the young adult market you need the pediatric market. Another reason for the pediatric approval would be to treat the pre-diabetes population of which, many are children.
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Post by blindhog1 on Sept 28, 2015 6:27:29 GMT -5
What a beautiful morning. My FBG was 110. Nice numbers today to begin month 3 of better health and diabetes control. SOOOOOO in the morning I'm going to the BEACH. I know you'll miss my reports. For myself I'll be eating fresh seafood and drinking cold beer.
Saturday I met with Sam Finta (Afrezzauser) in Atlanta. What a nice guy. We went through many topics concerning diabetes but the most important is the ability of Doctors in the prescribing and monitoring process. It's a wide open question that needs to be answered.
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Post by blindhog1 on Oct 6, 2015 11:30:19 GMT -5
Today's FBG was 109. It's all about control. No one missed me when I was gone....but the stickman an I had a wonderful time.
Lordy did I get exercise. It's not the fact that I walked twice the distance I do at home it's the sand on the beach that made it a workout. I'd like to recommend a roll on muscle rub for your calves called "STOPAIN"
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