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Post by rockyp on Jun 23, 2015 14:37:22 GMT -5
FWIW, my son had his endo appointment yesterday. The doctor mentioned that her Sanofi rep had visited recently. The rep indicated that Sanofi is planning to start a pediatric study with Afrezza within the next year. The doc seemed pretty excited about the study.
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Post by jimbering on Jun 24, 2015 20:48:00 GMT -5
FWIW, my son had his endo appointment yesterday. The doctor mentioned that her Sanofi rep had visited recently. The rep indicated that Sanofi is planning to start a pediatric study with Afrezza within the next year. The doc seemed pretty excited about the study. That's good news. The last I heard the pediatric study was listed as delayed. Pediatric studies are problematic for many reasons. There is the moral aspect of having children using and testing new drugs who really can't give informed consent. Then there is the practical aspects. At the age of 7 the participant can end the study at any time he or she wants. If you have kids or dealt with them you know they will decide to make decisions that have no logical reasons that an adult can understand. Well except maybe instead of going to the doctor's office next Saturday they would rather go with their friends rafting or whatever. Unfortunately that is part of it. It takes a lot of effort, time and money to design a pediatric study. Most companies just say no. Good for Sanofi. It can't be for money since the amount of money doesn't amount to that much considering the patient base. They are doing the right thing. It does happen with some companies although we tend to doubt it nowadays. Maybe Al Mann urged them on. It would seem like something he would do. 80% of drugs are not approved for pediatric use but many are prescribed off label as Afrezza already has been. Getting it approved for pediatric use will be a feather in the cap of Sanofi, not to mention a win for children with diabetes. Good for Sanofi! |
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Post by mnholdem on Jun 26, 2015 8:57:51 GMT -5
I mentioned this in another thread, but it's worth repeating. Sanofi knocked nearly a year off the FDA end date estimate on the upcoming clamp trial. I wouldn't be surprised to learn that the pediatric trial will be completed much earlier than the FDA current has quoted.
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Post by sportsrancho on Jun 28, 2015 18:08:16 GMT -5
Someone could call Katie at MNKD and ask when it starts. My client with the kids on Afrezza ( 14 and 17 ) would still be talking to her except now the kids are on it so no need to get them in the trials. They find they do not need the 2 unit like was thought at first. But are looking foreword to the 12 unit. Dad says that the 2 would be good for under 70 pounds. Also he did not fire is Endo for saying no. He just went and got the scripts from a GP. Went back to the Endo with the great numbers and she was so happy to see it and said she was now on board!! The kids take the Dreamboat to school and the other kids think it cool. The scripts are good for a year and he gets them filled every 3 months. sports
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Post by 1 percenter on Jun 28, 2015 19:03:08 GMT -5
Someone could call Katie at MNKD and ask when it starts. My client with the kids on Afrezza ( 14 and 17 ) would still be talking to her except now the kids are on it so no need to get them in the trials. They find they do not need the 2 unit like was thought at first. But are looking foreword to the 12 unit. Dad says that the 2 would be good for under 70 pounds. Also he did not fire is Endo for saying no. He just went and got the scripts from a GP. Went back to the Endo with the great numbers and she was so happy to see it and said she was now on board!! The kids take the Dreamboat to school and the other kids think it cool. The scripts are good for a year and he gets them filled every 3 months. sports Do you have any info on how the kids are doing on Afrezza? Any issues? How much better are they doing on AFrezza vs their old therapy? Thanks |
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Post by sportsrancho on Jun 28, 2015 19:26:30 GMT -5
I can get back to you on the exact numbers. Daughter has been T1 all her life. Son was told he was T1 less than a year ago so he has been on his honeymoon period. He was so upset because he had seen what his sister had gone through! He took to it right away. No issues. She was on the pen and was used to it but when she saw how well her brother was doing she got on board. No more lows in the middle of the night! No more trips to the ER! Life changing for the family! When I told the Dad over a year ago about Al Mann and Afrezza he became very long MNKD stock and was bent on getting his kids on it right away! He knows the science well.
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Post by kc on Jun 28, 2015 23:40:36 GMT -5
Leanne that is so good to hear how well they are going on Afrezza. Makes a person really happy to know that Afrezza is a game changer for a diabetic. Especially a young one.
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