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Post by peppy on Apr 6, 2022 13:13:41 GMT -5
I have used cartridges that have been in my laptop bag for months past expiration and never had an issue. If I recall, Sam Finta also stated in the past he used "expired" non refrigerated cartridges as well We have been given a leg up on this one. Easy enough to do. We know what to expect. Mike has some money now. Inspire the under 18 trial is going on. Our long time users have told us, the afrezzza cartridge lowers their blood glucose when non- refrigerated. Definitely needed for Mission Mars. |
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Post by robbmo on Apr 6, 2022 13:19:32 GMT -5
a refrigeration / non refrigeration study. Useful and I would think affordable. I tried to find Matt Bendall's video, he did a test, Matt put afrezza in a plastic bag in a flowerpot in a green house for a few months. Matt is a seasoned type 1 diabetic. After a few months he got the Afrezza out of the green house and used it. Matt reported his blood glucose levels came down as normal. www.youtube.com/channel/UC7EV3DuK0vfGbnoA6NZotCA/videosThe study may be useful for Trept as well. I do not know the storage requirements. I say we get water heaters to last longer than ten years prior to Mars. Additionally, have you ever considered that creatures could live on Mars, under the surface, and human beings could make great slaves? It is called "Afrezza: Extreme Thermal Stability". Here you go: vimeo.com/153597580?embedded=true&source=vimeo_logo&owner=42027124 |
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Post by peppy on Apr 6, 2022 13:21:08 GMT -5
a refrigeration / non refrigeration study. Useful and I would think affordable. I tried to find Matt Bendall's video, he did a test, Matt put afrezza in a plastic bag in a flowerpot in a green house for a few months. Matt is a seasoned type 1 diabetic. After a few months he got the Afrezza out of the green house and used it. Matt reported his blood glucose levels came down as normal. www.youtube.com/channel/UC7EV3DuK0vfGbnoA6NZotCA/videosThe study may be useful for Trept as well. I do not know the storage requirements. I say we get water heaters to last longer than ten years prior to Mars. Additionally, have you ever considered that creatures could live on Mars, under the surface, and human beings could make great slaves? It is called "Afrezza: Extreme Thermal Stability". Here you go: vimeo.com/153597580?embedded=true&source=vimeo_logo&owner=42027124wow, nice find, thank you. Matt is so likable. |
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Post by brentie on Apr 6, 2022 13:30:59 GMT -5
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Post by akemp3000 on Apr 7, 2022 6:22:32 GMT -5
The upcoming board meeting should provide a good opportunity for someone to ask why Mannkind is not pursuing the refrigeration issue. A wild guess would be that it might be a dangerous subject that could actually open a door for further FDA questions, delays and rejections. It might also require extensive and costly testing to pursue.
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Post by uvula on Apr 7, 2022 6:33:13 GMT -5
If it was an in person mtg you could jump up and down and grab a microphone.
Since it is a virtual mtg there is almost no chance that they will take a nonprearranged question from an unknown caller.
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Post by stockwhisperer on Apr 7, 2022 7:33:15 GMT -5
MC took questions in advance for the Virtual SH meeting last year. No reason to think he won’t do the sam this year. Just submit them.
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Post by uvula on Apr 7, 2022 7:42:02 GMT -5
The questions are screened ahead of time. He will not answer a question for which he does not have a good answer.
(This is not a negative comment about MC. This is just good business practice.)
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Post by akemp3000 on Apr 7, 2022 8:41:50 GMT -5
Speculation that MC may or may not have a good answer is the precise reason to ask. If the company chooses to ignore it, so be it. Still better to ask.
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Post by stockwhisperer on Apr 7, 2022 9:13:58 GMT -5
You won’t know if you don’t ask. Give it a try. You might even be surprised.
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Post by hellodolly on Apr 7, 2022 9:40:29 GMT -5
Might very well be that the risk is not worth the reward. Consider what value would be added by spending hard earned money by doing a controlled study of various air temperatures to determine temperature stability vs spending money to conduct a Pediatric trial? My guess there's a better value add getting kids on Afrezza at an early age, simply for the million reasons $$$$$$$$ it will have a much better reward.
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Post by robbmo on Apr 7, 2022 11:15:07 GMT -5
Might very well be that the risk is not worth the reward. Consider what value would be added by spending hard earned money by doing a controlled study of various air temperatures to determine temperature stability vs spending money to conduct a Pediatric trial? My guess there's a better value add getting kids on Afrezza at an early age, simply for the million reasons $$$$$$$$ it will have a much better reward. I agree. IMO, Label changes and Pediatric approval would have much greater impact. |
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Post by markado on Apr 7, 2022 11:37:41 GMT -5
Might very well be that the risk is not worth the reward. Consider what value would be added by spending hard earned money by doing a controlled study of various air temperatures to determine temperature stability vs spending money to conduct a Pediatric trial? My guess there's a better value add getting kids on Afrezza at an early age, simply for the million reasons $$$$$$$$ it will have a much better reward. I agree. IMO, Label changes and Pediatric approval would have much greater impact. I don't disagree with the priorities, but, this only takes a designated refrigeration space, a reasonable room temperature space, a certain number of each cartridge type to be stored in each area and time. If room temperature cartridges proved stable over time, you increase the convenience factor for diabetes patients, as well as mitigate risk for T1's that travel or may have to deal with prolonged power outages or lack of access to refrigeration, plus you expand the addressable market by being able to ship Afrezza anywhere in the world without the need of a refrigerated container. Moreover, prove it with Afrezza, and it might be worth proving for other DPI formulations, as well. This may be a lower cost, lower risk, medium reward opportunity, but, it should not be ignored out of hand. And, if MNKD doesn't like what it finds, it does not have to share it. This test can be done in-house, or with a third party under NDA, and results disclosed, only if favorable, at the company's discretion. There's virtually no reason not to do it. More can be gained than lost by knowing the answer. |
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Post by akemp3000 on Apr 7, 2022 11:47:32 GMT -5
Considering the various perspectives and opinions, it would be good for MC to address.
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Post by mango on Apr 7, 2022 12:14:11 GMT -5
I think it's a great question. It may just be viewed as unnecessary. The question is, would it produce more scripts if we could claim room temp for x amount of months? Likely not.
We do have patents for heat stable dry powder pharmaceutical compositions and methods. Insulin is mentioned within the embodiments, but not in the claims. I believe the patents were originally designed for Mintaka Foundation when Robin Offord was pitching inhaled oxytocin. He gave a great presentation on it and MannKind "marvel of engineering" inhalers.
Maybe now that we have some cash we can poke at Mintaka again. Hey, another great question for MC.
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