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Post by winstonsmith on Nov 20, 2020 14:20:26 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is.
That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration.
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Post by goyocafe on Nov 20, 2020 14:28:02 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is. That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration. Read the lower half of the page. I’ve never seen any study results, just the claim on this website, so take it for what it’s worth. My understanding is it depends on the stability of the active structure. A VLP certainly appears applicable to Technosphere, but whether mRNA structures are durable enough to be processed into a dry powder has been a subject of debate. It’s a great topic for MC’s monthly fireside chat... 😏 |
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Post by nylefty on Nov 20, 2020 15:57:37 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is. That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration. MannKind can't take refrigeration off the label until the FDA gives the OK. The FDA doesn't accept anecdotal evidence such as yours. |
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Post by sportsrancho on Nov 20, 2020 16:24:49 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is. That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration. Bill and I talked to David Thompson about that, they just don’t wanna spend the money to do it. |
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Post by winstonsmith on Nov 20, 2020 17:44:15 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is. That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration. Bill and I talked to David Thompson about that, they just don’t wanna spend the money to do it. Thanks Sportsrancho, was that before COVID? That could be instrumental in this COVID setting. Plus Bill Gates said the one coming behind this one is going to be much worse. Not my words, it's coming straight from the smiling psychopath himself. www.youtube.com/watch?v=ELP2EFVOOYcwww.collective-evolution.com/2020/07/17/bill-gates-says-we-should-prepare-for-the-next-pandemic-that-will-get-attention-this-time/ |
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Post by sportsrancho on Nov 20, 2020 18:39:02 GMT -5
Yes it was before Covid ...and yes that is chilling! |
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Post by mnkdfann on Nov 21, 2020 0:56:41 GMT -5
The video is very clearly edited. It would be nice to hear his complete sentences, and the context of what he said. I suppose you may disagree, but the site 'Collective Evolution' also appears to be rather, shall we say, 'out there'. I question the spin it is putting on Gates' words. Having said all that, I feel sure Gates IS worried about a next pandemic. Many scientists are on the record as saying worse are likely in may of our lifetimes (e.g. within 20 to 30 years, say). (I can't cite names, I'm just going from my memory of various articles I've read.) |
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Post by akemp3000 on Nov 21, 2020 6:22:35 GMT -5
Spreading fear is a powerful weapon. Just imagine the earth's temperature might rapidly increase. The oceans will rise. The streets of New York and Miami will be underwater. Glaciers will melt and the ozone layer will be depleted. A consensus of scientists say life will forever change, all by the year 2010. The world must fund change now. Oh wait... Predicting another pandemic someday does not exhaust a lot of bill Gates brain cells. IMHO, a much better use of his time would be to focus on facts such as Afrezza having the potential to improve the daily lives of diabetics and to possibly deliver future vaccines.
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Post by sportsrancho on Nov 21, 2020 6:52:56 GMT -5
And don’t forget California will fall off into the ocean🤣
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Post by cretin11 on Nov 21, 2020 7:39:01 GMT -5
The video is very clearly edited. It would be nice to hear his complete sentences, and the context of what he said. I suppose you may disagree, but the site 'Collective Evolution' also appears to be rather, shall we say, 'out there'. I question the spin it is putting on Gates' words. Having said all that, I feel sure Gates IS worried about a next pandemic. Many scientists are on the record as saying worse are likely in may of our lifetimes (e.g. within 20 to 30 years, say). (I can't cite names, I'm just going from my memory of various articles I've read.) mnkdfann your instinct is correct. Per Media Bias Fact Check: “Collective-Evolution is a clickbait, conspiracy, and quackery level pseudoscience website.” |
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Post by matt on Nov 21, 2020 8:41:13 GMT -5
That being said, when is MNKD going to take refrigeration off the label? drug produced has storage specifications (temperature, humidity, etc.) and an expiration date. FDA has very specific tests that have to be performed to establish the storage and expiration portion of the drug label. If MNKD had stability data showing that Afrezza could pass the tests without refrigeration FDA would allow a label change, but without that evidence the specifications will remain as they are. You say that Afrezza does not need refrigeration based on your personal experience, but your personal experience does not replicate the range of conditions experienced in the real world while the mandated stability tests attempt to do so. I am sure MKND performed all the required testing during the development phase and the fact that the label requires refrigeration suggests that at least some samples did not meet the standards for room temperature storage. Absent a change in product chemistry, a retest is unlikely to give different results. |
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Post by sayhey24 on Nov 21, 2020 9:22:56 GMT -5
Matt - I am not sure how long you have been following MNKD but back in the day the approval process for afrezza was rigged and BP and the FDA were throwing everything at MNKD so it would not be approved. The QA team told me many years ago they had the data to show no refrigeration was needed for at least 3 months but they thought they could show much longer. I did not exam the data myself but I have no reason to think they didn't.
Could you imagine throwing "no refrigeration" into the approval ask? They were struggling to get human insulin, the exact same hormone made by the human body approved. These were the exact same people that during the Adcom accused one of the doctors of cheating because he promoted second dosing and his group had outstanding numbers. Without that 27-1 Adcom vote afrezza might never have been approved.
At some point I had the Gates foundation talking with MNKD because they were funding huge $$$ programs to develop 3rd world refrigeration for vaccines. My thought was with TS there would be no need. I think what Technovax has on their slide is correct. Why none of this ever moved forward is a head-scratcher but then again how many diabetics have ever heard of afrezza 6 years later? Why Mike did not get a BARDA contract to see if they could load mRNA on TS is also a head-scratcher.
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Post by mango on Nov 21, 2020 13:09:13 GMT -5
Do we know if a COVID vaccine can be delivered at room temperature via Technosphere? Maybe it's not like Afrezza insulin which doesn't necessarily require low temperatures....or maybe it is. That being said, when is MNKD going to take refrigeration off the label? I use Afrezza and I know it doesn't require any refrigeration. Bill and I talked to David Thompson about that, they just don’t wanna spend the money to do it. Did DT mention how much it would cost to do the room temp study? Did he say anything else about it? |
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Post by sportsrancho on Nov 21, 2020 13:54:05 GMT -5
Bill and I talked to David Thompson about that, they just don’t wanna spend the money to do it. Did DT mention how much it would cost to do the room temp study? Did he say anything else about it? No...I got the impression it’s NOT happening. I’m not sure if David was as convinced as Bill that we didn’t need the refrigeration. But you know it’s the people that actually use it that.... As I remember back I think he thinks we do need it, he may have seemed a little skeptical. Nevertheless we follow protocols to the letter at Vdex ..just saying. But Bill made it a point to bring it up amongst other things that needed to be brought up. |
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Post by joeypotsandpans on Nov 21, 2020 14:16:58 GMT -5
I've been using it now for years and live in the desert with avg. temp about 110 degrees in the summertime, I'm sure much hotter in the car when parked and never have had issues with it being out of the refrigerator. Also, didn't we ship a bunch to help the folks in Puerto Rico when their power was out after the devastation from the hurricane? I've traveled with it to various climates with high humidity. Never a problem, the technology still amazes me. Oh yeah, also well after expiration as well, seems extremely stable to me anecdotal or not, works for me and I'd bet my shares it works for most others using it as well. I think we laugh and shake our heads at the FDA from years past  |
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