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Post by rockstarrick on Jun 28, 2019 5:25:15 GMT -5
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Post by sayhey24 on Jun 28, 2019 5:38:14 GMT -5
"Some regression of diabetic retinopathy" - We have discussed this potential for years on this board and this IMO is a big deal.
Hopefully Dr. Kendall is reading this and is working with someone to get a trial on this. Maybe the sales guys should be visiting eye doctors in addition to the endos.
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Post by hellodolly on Jun 28, 2019 5:50:13 GMT -5
"Some regression of diabetic retinopathy" - We have discussed this potential for years on this board and this IMO is a big deal. Hopefully Dr. Kendall is reading this and is working with someone to get a trial on this. Maybe the sales guys should be visiting eye doctors in addition to the endos. Sayhey, is he from the UK? Looks like a letter to the EMA or some other group about use of Afrezza in the EU? Maybe insurance coverage? |
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Post by sportsrancho on Jun 28, 2019 5:58:33 GMT -5
Yes, and in close contact with Mike.
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Post by sportsrancho on Jun 28, 2019 6:01:45 GMT -5
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Post by rtmd on Jun 28, 2019 7:20:47 GMT -5
To what end was the letter written? He scratched out after "...licensed in the U of K but..."? But what?
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Post by Deleted on Jun 28, 2019 8:44:25 GMT -5
To what end was the letter written? He scratched out after "...licensed in the U of K but..."? But what? Looks like Brendan has rounded up a few doctors to show support for Afrezza. Maybe they know MNKD will be filing their EMA soon? |
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Post by sportsrancho on Jun 28, 2019 9:17:03 GMT -5
To what end was the letter written? He scratched out after "...licensed in the U of K but..."? But what? Looks like Brendan has rounded up a few doctors to show support for Afrezza. Maybe they know MNKD will be filing their EMA soon? 👍🏻😎 |
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Post by cjm18 on Jun 28, 2019 9:59:17 GMT -5
To what end was the letter written? He scratched out after "...licensed in the U of K but..."? But what? Looks like Brendan has rounded up a few doctors to show support for Afrezza. Maybe they know MNKD will be filing their EMA soon? Not soon. Mc Mentioned it in a recent call. Maybe Q1cc |
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Post by Deleted on Jun 28, 2019 11:45:30 GMT -5
Looks like Brendan has rounded up a few doctors to show support for Afrezza. Maybe they know MNKD will be filing their EMA soon? Not soon. Mc Mentioned it in a recent call. Maybe Q1cc If I recall correctly, Mike mentioned they will file in the EU after Pediatric Approval. That will give them a stronger case and maybe a much better label to maximize pricing. |
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Post by mytakeonit on Jun 28, 2019 12:06:52 GMT -5
The VA diagnosed me with diabetes during my outgo physical. My VA doc knew about the link of diabetes to the eyes and sent me to the VA eye doc immediately. So yes, things move very slowly. BTW, I'm stable and in a "wait and see" mode. And it is good that I can see while I wait.
But, that's mytakeonit
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Post by rtmd on Jun 28, 2019 12:33:33 GMT -5
Not soon. Mc Mentioned it in a recent call. Maybe Q1cc If I recall correctly, Mike mentioned they will file in the EU after Pediatric Approval. That will give them a stronger case and maybe a much better label to maximize pricing. When is pediatric approval expected? |
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Post by cjm18 on Jun 28, 2019 13:11:08 GMT -5
If I recall correctly, Mike mentioned they will file in the EU after Pediatric Approval. That will give them a stronger case and maybe a much better label to maximize pricing. When is pediatric approval expected? 2021 I think. clinicaltrials.gov/ct2/show/NCT02527265 |
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Post by agedhippie on Jun 28, 2019 13:43:36 GMT -5
Not soon. Mc Mentioned it in a recent call. Maybe Q1cc If I recall correctly, Mike mentioned they will file in the EU after Pediatric Approval. That will give them a stronger case and maybe a much better label to maximize pricing. I would be very surprised if Afrezza didn't pass EMA but it will not be quick. I am not really clear on why they didn't file years ago as there is minimal commitment on Mannkind's side. Once you have cleared EMA you can market the drug in Europe, but now you hit the real hurdle - the national health services. Although the drug is approved that doesn't mean a health system will pick it up. In the UK the next hurdle is NICE which decides if the benefits justify the price. This is a very mechanistic process and heavily data driven where outcomes need to be quantifiable. For example saying Afrezza gives few complications would require trial data showing exactly what those numbers are - no trial data no claim. If it gets past NICE then each regional budget holder needs to decide if they want to buy it. Just because NICE approves a drug doesn't mean it necessarily ever gets prescribed. Independently of the NHS doctors can prescribe a drug that is not approved by NICE or budgeted, it's just that the patient has to pay for those out of pocket. |
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Post by peppy on Jun 28, 2019 14:23:35 GMT -5
If I recall correctly, Mike mentioned they will file in the EU after Pediatric Approval. That will give them a stronger case and maybe a much better label to maximize pricing. I would be very surprised if Afrezza didn't pass EMA but it will not be quick. I am not really clear on why they didn't file years ago as there is minimal commitment on Mannkind's side. Once you have cleared EMA you can market the drug in Europe, but now you hit the real hurdle - the national health services. Although the drug is approved that doesn't mean a health system will pick it up. In the UK the next hurdle is NICE which decides if the benefits justify the price. This is a very mechanistic process and heavily data driven where outcomes need to be quantifiable. For example saying Afrezza gives few complications would require trial data showing exactly what those numbers are - no trial data no claim. If it gets past NICE then each regional budget holder needs to decide if they want to buy it. Just because NICE approves a drug doesn't mean it necessarily ever gets prescribed. Independently of the NHS doctors can prescribe a drug that is not approved by NICE or budgeted, it's just that the patient has to pay for those out of pocket. The cost @ $250,000 to apply? |
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