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Post by sportsrancho on Sept 24, 2017 5:58:00 GMT -5
Thanks! Wow, so interesting to go back and read.
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Post by mango on Sept 24, 2017 6:34:12 GMT -5
******* Wet blanket warning ******* Afrezza is anecdotally claimed by some to be stable at room temperature. MNKD, however, ran a 2-year stability study, and measured the rate of decomposition at room temperature. Based upon this 2-year study, MNKD and the FDA agreed on refrigeration requirements that are stricter than modern SC insulins. Who to believe... anecdote (including Al speaking off the cuff before the label was agreed to, or the company, their chemista and FDA chemists. Remember - the company makes no undertaking to correct anything that they say on conference calls or in interviews, BUT the label is a correction by the company, and they have not claimed room temperature stability since then. Thus, the position of the company is that Afrezza requires refrigeration and is only acceptably stable for 10 days at room temperature. Those that claim stability after "hold my beer and watch this" experiments have no idea of the chemical changes in the insulin they're inhaling. www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000ChemR.pdf[EDIT] Not trying to deny disaster victims life saving medication. Those decisions are made away from anything that's said on this message board. Just trying to give a rational point of view of where and why the label says what it does, as opposed to wishful, or wistful thinking. That's fine and all but what we do know is that injectable insulins have been know to be and are highly suspeptible to degrading prior to injecting due to their highly unstable formulations and some with added unwisely exipients which facilitate this process even more under certain stress. With Afrezza, what we know is that there has never been a single documented case report or scientific study demonstratng Afrezza can even degrade or misfold into insulin-amyloids anywhere within the respiratory tract or in peripheral circulation. I fail to see the point you're trying to make. The Gen2 inhalation device not only has different key differences, the Gen1 data cannot rightfully support data for a new and different device that was never supported with by the Gen1 data. There also was not feasible time to conduct such a thing, which honestly has more to do with them wanting MannKind to conduct "shaking" and vertical drop tests with the cartridge and inhaler. I could throw a Dreamboat out a plane and jump onto a cartridge box and still have zero worry about degradation into A-Ins whilst also reliably getting prandial first phase insulin response like that in healthy nondiabetic.
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Post by sayhey24 on Sept 24, 2017 8:23:36 GMT -5
Brentie - you are a GD genius - thanks - thats her. Her last log into this message board was April. In addition to posting on PB there was also a great article in one of the magazines. Anyone have a link? I forgot she was a compassionate user before approval. If so MNKD should have her contact info which solves the problem. Thanks again.
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Post by straightly on Sept 24, 2017 10:47:06 GMT -5
Brentie - you are a GD genius - thanks - thats her. Her last log into this message board was April. In addition to posting on PB there was also a great article in one of the magazines. Anyone have a link? I forgot she was a compassionate user before approval. If so MNKD should have her contact info which solves the problem. Thanks again. WOW to Afrezza and double WOW to Brentie, and others of this PB.
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Post by brentie on Sept 25, 2017 9:31:43 GMT -5
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