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Post by agedhippie on Apr 17, 2024 7:53:54 GMT -5
For what ever reason Oshmyansky was not involved in the discussions. BTW - I have never gotten a box of afrezza shipped. I doubt they refrigerate it. If they do there is no need to except for the bad label. ... You know what I get from my wife now - now who are you talking to. You just never know. We did get an invite to the west wing of the Whitehouse and got some good pictures one time. I think she liked that. What I never knew was why they call the Whitehouse reporters "pool reporters" - the press pool. The Whitehouse briefing "room" is literally over FDR's old pool which Nixon never used so they covered it and the press meet at the pool. So the CEO wasn't involved in the discussions? It cannot have been very serious in that case. Afrezza must be refrigerated for shipping, it's not optional. The label requires, it just like every other insulin, and unless MNKD wants to do the evaluation to prove that Afrezza doesn't require refrigeration (which they won't) that is how it will stay. Someone was pulling your leg over the pool reporter line While the briefing room really is the old swimming pool that isn't why they are are called pool reporters. Pool reporters are members of a press pool and those occur any time that there are more reporters than space. Interestingly FDR was the first president to formalize the press pool at the White House!
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Post by mayday on Apr 17, 2024 8:38:47 GMT -5
Once again. Thanks. I did not know that. I seem to be receiving conflicting statements.
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Post by dh4mizzou on Apr 17, 2024 8:45:12 GMT -5
As for the refrigeration question. I can't believe that a study would be very costly at all.
All they'd have to do is pick a lot of Afrezza off the line and set it aside for a period of time (6 - 12 months). Then while they're waiting, they could line up participants who would like to help them test and give them the unrefrigerated Afrezza for free and then check their results.
Seems simple to me but I am very simple minded.
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Post by uvula on Apr 17, 2024 9:03:49 GMT -5
The refrigeration issue keeps coming up and is one of the most perplexing things about mnkd. A low cost performance test and we have anecdotal evidence that it will pass.
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Post by mayday on Apr 17, 2024 9:26:23 GMT -5
I can't handle this pressure...
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Post by sayhey24 on Apr 17, 2024 9:27:38 GMT -5
As for the refrigeration question. I can't believe that a study would be very costly at all. All they'd have to do is pick a lot of Afrezza off the line and set it aside for a period of time (6 - 12 months). Then while they're waiting, they could line up participants who would like to help them test and give them the unrefrigerated Afrezza for free and then check their results. Seems simple to me but I am very simple minded. A long time ago I was at Danbury and was talking with the QA group. They said 100% based on their work no refrigeration is required for 3 months. Then they went on a said the real number was 2 years. The work has already been done. It needs to be found, presented and the label needs updating.
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Post by prcgorman2 on Apr 17, 2024 9:29:43 GMT -5
The refrigeration issue keeps coming up and is one of the most perplexing things about mnkd. A low cost performance test and we have anecdotal evidence that it will pass. I assume "easy", "fast", "cheap", and like terms do not apply when it comes to getting anything approved by the FDA.
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Post by dh4mizzou on Apr 17, 2024 9:49:57 GMT -5
So what you're saying sayhey24 is that this would be even cheaper than we think?
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Post by porkini on Apr 17, 2024 10:55:06 GMT -5
The refrigeration issue keeps coming up and is one of the most perplexing things about mnkd. A low cost performance test and we have anecdotal evidence that it will pass. I assume "easy", "fast", "cheap", and like terms do not apply when it comes to getting anything approved by the FDA. I'm not able to research it at the moment, and maybe someone else remembers, but I recall Mike C. saying at one point in a presentation or conference call that MNKD would not be pursuing a label change in regard to refrigeration. Anyone?
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Post by ktim on Apr 17, 2024 11:39:17 GMT -5
From what I can tell, Afrezza will be a welcome tool in the toolkit of persons with diabetes who want an ultra-rapid acting insulin (is anything faster than human insulin?) to cut the legs off a stubborn high. And for those willing to put in the work, it will help them achieve very good A1C/TIR results. But, unless doctors prescribe it, at scale, the result won't be a blockbuster. That idea, not a blockbuster really used to bother me no end. I thought of it as wrong. A tragedy. Not now. I want Afrezza to continue to be available until there is something better. e.g., a new functional pancreas grown from stem cells of a person with diabetes (easy to say but not easy to do). Now I look at MannKind like I should have looked at it from the start. A small pipeline company with a promising technology. And I should have invested accordingly. If I had, my investment would be way smaller than it is, but now I would be adding. And I plan to add more, but mostly trading around a core. I bought a bit more just above $4... so you can thank me for the fact you can now pick up some shares with a $3 handle Now I'll probably wait to see where we settle. If we close above $4 I might call that a very flimsy floor, otherwise will want to see what happens. Of course MNKD very susceptible to risk-off market conditions.
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Post by sayhey24 on Apr 17, 2024 13:01:38 GMT -5
So what you're saying sayhey24 is that this would be even cheaper than we think? What would be cheaper - getting the refrigeration issue updated on the label? Assuming they still have all the info they have to go through the FDA process. The FDA is a process and will probably cost a couple $M. Mike has already said after the kids trial they are going for label changes. Hopefully this is in there - in a couple of years. If you read some of the social media stuff people leave it in their hot cars for weeks and say they have no issue with it, which makes sense. I know some people want to say "all insulin" and lump afrezza in with all the other insulin but its not. This will take some lobbying with the FDA and BP is going to push back on it. I hope when they go for changes they also get rid of the 4u/8u/12u and replace it with small, medium and large. Existing T1s converting won't like it but for everyone else including the T1 kids it would make so much sense.
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Post by prcgorman2 on Apr 17, 2024 14:03:55 GMT -5
There's a YouTube of an Afrezza user who buried some of their stash in an outdoor potted plant and left it there for months before digging it back up and using it.
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Post by mytakeonit on Apr 17, 2024 14:24:39 GMT -5
Matt Bendall buried it in the ground - Jan. 2016
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Post by brentie on Apr 17, 2024 15:50:39 GMT -5
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Post by agedhippie on Apr 17, 2024 16:35:40 GMT -5
The refrigeration issue keeps coming up and is one of the most perplexing things about mnkd. A low cost performance test and we have anecdotal evidence that it will pass. Matt covered this ages ago (https://mnkd.proboards.com/post/150435/thread) and talked about what would be involved. It looked cheap to do, but with a long timeline.
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