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Post by mytakeonit on Nov 21, 2020 14:35:27 GMT -5
akemp mentions the year 2010  sports says that it was mentioned that California will fall off of the map How much wine did I drink last night ? I thought those two things already happened !!! And with the rising tides ... I will have beach front property soon !!! BTW, I also mentioned to those people at the VA that Afrezza doesn't have to be refrigerated ... and that someone once dug a hole in his yard and stuck a box of Afrezza in it for a few months. When he dug it up it was fine. But, keeping it in the refrigerator sounds like a good idea ... so that you know where it is and don't have to rummage thru drawers, medicine cabinets, etc to find it. But, that's mytakeonit |
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Post by mnkdfann on Nov 21, 2020 15:28:19 GMT -5
BTW, I also mentioned to those people at the VA that Afrezza doesn't have to be refrigerated ... and that someone once dug a hole in his yard and stuck a box of Afrezza in it for a few months. When he dug it up it was fine. For 1000s of years, people have been burying food (and more) / sticking it in root cellars to keep it cool and preserve it. Basically, your someone was refrigerating, old school style. |
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Post by porkini on Nov 21, 2020 16:00:52 GMT -5
BTW, I also mentioned to those people at the VA that Afrezza doesn't have to be refrigerated ... and that someone once dug a hole in his yard and stuck a box of Afrezza in it for a few months. When he dug it up it was fine. For 1000s of years, people have been burying food (and more) / sticking it in root cellars to keep it cool and preserve it. Basically, your someone was refrigerating, old school style. I think it was a potted plant, here you go mnkd.proboards.com/post/60577/thread. I also agree that your root/bomb/tornado cellar is also a good place to practice old school refrigeration.  |
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Post by mytakeonit on Nov 21, 2020 16:01:34 GMT -5
That is true, but this person did it in a warm area and the temperature was 78 degrees. We have been discussing this for a very long time. You may be able to scroll back to the post but I don't know what thread it was on. Oh, and there you have the video. Ha! Joey mentioned the 110 degrees earlier. But, that's mytakeonit |
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Post by casualinvestor on Nov 21, 2020 20:48:29 GMT -5
I'd assume these things are air tight for long term storage (something like blister packs?), so I don't see why 100% humidity would be a consideration, aside from sounding impressive.
But right now I can see that the cost of doing a trial to prove no refrigeration needed might cost enough to not be worth it. Refrigeration is not difficult in 99% of the Afrezza market. And it's the same for 90% of the vaccine market.
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Post by mango on Nov 21, 2020 21:45:19 GMT -5
We have a heat stable formulation patent. I think it primarily pertains to oxytocin though. Heat-stable dry powder pharmaceutical compositions and methodsDisclosed herein are heat-stable dry powders which include peptides or protein such as oxytocin for use as a pharmaceutical composition. The composition is highly stable at increased temperatures and relatively high humid environments, and are intended for storage at room temperature with an improved shelf-life. In particular, the dry powders are intended for inhalation, however, other routes of administration can be used when reconstituted in solution. patents.justia.com/patent/10413513 |
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Post by alethea on Nov 22, 2020 9:58:02 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 Same thing for me. I do not bother to refrigerate my Afrezza EVER. Mine never is stored below 62 degrees Fahrenheit (lowest temperature occurring in my house). Another deliberate obstacle to Afrezza by opposition forces. Whether they be Big Pharma insulin makers, FDA or big Wall Street shorting/manipulating hedge funds. |
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Post by matt on Nov 22, 2020 11:44:23 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. Stability testing is standardized for a reason, and all regulatory agencies follow similar procedures. If the company had data that Afrezza was stable without refrigeration for three months, then they could have gotten that on the label BUT if they could only show three months then they would also have gotten a three month expiration date. Three month expiration is not as bad as, say radiopharmaceuticals, but in the real world that is a very short shelf life; many customers will not accept product without at least six months remaining before expiration barring exceptional circumstances. When a company submits the CTD to the agency either the data supports room temperature storage or it does not. The tests are extremely simple to do; the drug and packaging are placed inside a test facility with specific temperatures, lighting, humidity, etc. and samples are drawn out at set intervals and the product is tested to see if the molecule or protein has changed. If there is no change then the drug is considered stable under the specified conditions (there are companies that do nothing but stability testing for the industry). Approval of the label copy is not a matter of what BP wants, what competitors want, or what the company itself wants. If the required data from properly administered tests exists then that is what goes on the label. It is not a political decision, it is a chemistry test. |
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Post by goyocafe on Nov 22, 2020 11:57:11 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. Stability testing is standardized for a reason, and all regulatory agencies follow similar procedures. If the company had data that Afrezza was stable without refrigeration for three months, then they could have gotten that on the label BUT if they could only show three months then they would also have gotten a three month expiration date. Three month expiration is not as bad as, say radiopharmaceuticals, but in the real world that is a very short shelf life; many customers will not accept product without at least six months remaining before expiration barring exceptional circumstances. When a company submits the CTD to the agency either the data supports room temperature storage or it does not. The tests are extremely simple to do; the drug and packaging are placed inside a test facility with specific temperatures, lighting, humidity, etc. and samples are drawn out at set intervals and the product is tested to see if the molecule or protein has changed. If there is no change then the drug is considered stable under the specified conditions (there are companies that do nothing but stability testing for the industry). Approval of the label copy is not a matter of what BP wants, what competitors want, or what the company itself wants. If the required data from properly administered tests exists then that is what goes on the label. It is not a political decision, it is a chemistry test. Any idea what it costs to test? The notion that Mannkind does not think it is worth the cost seems very short sighted. The cold chain requirement for Afrezza cannot be cheap, and the perception and actual utility of it would certainly go up if patients and doctors didn’t need to have an extra fridge to store it or the consideration and concern of having to keep it cold. |
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Post by mytakeonit on Nov 22, 2020 16:15:33 GMT -5
Or, you can leave the label as is and not worry about liability. Social media is doing fine for spreading the word about not needing to refrigerate ... also about how great Afrezza works !!!
But, that's mytakeonitwaitingfortomorrow'sclosingpps
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Post by peppy on Nov 22, 2020 16:20:39 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. Stability testing is standardized for a reason, and all regulatory agencies follow similar procedures. If the company had data that Afrezza was stable without refrigeration for three months, then they could have gotten that on the label BUT if they could only show three months then they would also have gotten a three month expiration date. Three month expiration is not as bad as, say radiopharmaceuticals, but in the real world that is a very short shelf life; many customers will not accept product without at least six months remaining before expiration barring exceptional circumstances. When a company submits the CTD to the agency either the data supports room temperature storage or it does not. The tests are extremely simple to do; the drug and packaging are placed inside a test facility with specific temperatures, lighting, humidity, etc. and samples are drawn out at set intervals and the product is tested to see if the molecule or protein has changed. If there is no change then the drug is considered stable under the specified conditions (there are companies that do nothing but stability testing for the industry). Approval of the label copy is not a matter of what BP wants, what competitors want, or what the company itself wants. If the required data from properly administered tests exists then that is what goes on the label. It is not a political decision, it is a chemistry test. I love expiration dates. I laugh at them. |
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Post by mytakeonit on Nov 22, 2020 17:24:49 GMT -5
So I'm not the only one that is looking thru trash cans for expired vitamins.
But, that's mytakeonit
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Post by agedhippie on Nov 23, 2020 12:30:55 GMT -5
Any idea what it costs to test? The notion that Mannkind does not think it is worth the cost seems very short sighted. The cold chain requirement for Afrezza cannot be cheap, and the perception and actual utility of it would certainly go up if patients and doctors didn’t need to have an extra fridge to store it or the consideration and concern of having to keep it cold. I would expect a saving for the PBM. My insulin is shipped overnight delivery and packaged in a polystyrene foam box with ice blocks. I guess at the rates they pay that's not going to be a huge cost over the standard three day delivery, but it must add up. |
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Post by goyocafe on Dec 7, 2020 6:01:00 GMT -5
I found the comparison between these two articles quite intriguing. Nate Pile from Nate’s Notes acknowledges in his latest newsletter www.notwallstreet.com/the-market-seems-to-like-what-it-sees-12-6-20/“d) the possibility that MannKind will be working Pfizer (PFE – $38.62) to help develop a dry powder version of its new vaccine that would be stable at something closer to room temperature (wouldn’t that be something if Al Mann’s legacy ends up including a paragraph on helping to beat COVID-19?!)” Keith Schaefer, author of the other article, seems to think that TFF Pharmaceuticals may be in play for the same engagement. smallcappower.com/analyst-articles/small-cap-stock-pfizer-tff-pharmaceuticals/What comes to mind, even with so little said about the Mannkind option, is that Mannkind has a proven/approved product/device combination already on the market, and one in the final stages of a Phase III trial for a second. TFFP does not. And no where on the TFFP website do they make any mention of an inhaler or other delivery device. Even though the author of the TFF article points out a number of anecdotal connections that give some credence to the possibility of a Pfizer/TFFP collaboration, I see the lack of a known delivery device and no large scale use of the drug platform for any disease indication as serious impediments to this possibility. TFFP was, however, identified some months ago as being in play for a dry powder version of Remdesivir. I couldn’t find any recent updates on that possible collaboration with Gilead www.businesswire.com/news/home/20200729005605/en/TFF-Pharmaceuticals-Comments-on-Research-on-the-Re-formulation-of-Remdesivir-to-a-Dry-Powder-Form-for-COVID-19-Antiviral-Treatment. I’m holding out hope that Mannkind is in play with Pfizer, but only time will tell. |
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Post by peppy on Dec 7, 2020 6:35:20 GMT -5
I found the comparison between these two articles quite intriguing. Nate Pile from Nate’s Notes acknowledges in his latest newsletter www.notwallstreet.com/the-market-seems-to-like-what-it-sees-12-6-20/“d) the possibility that MannKind will be working Pfizer (PFE – $38.62) to help develop a dry powder version of its new vaccine that would be stable at something closer to room temperature (wouldn’t that be something if Al Mann’s legacy ends up including a paragraph on helping to beat COVID-19?!)” Keith Schaefer, author of the other article, seems to think that TFF Pharmaceuticals may be in play for the same engagement. smallcappower.com/analyst-articles/small-cap-stock-pfizer-tff-pharmaceuticals/What comes to mind, even with so little said about the Mannkind option, is that Mannkind has a proven/approved product/device combination already on the market, and one in the final stages of a Phase III trial for a second. TFFP does not. And no where on the TFFP website do they make any mention of an inhaler or other delivery device. Even though the author of the TFF article points out a number of anecdotal connections that give some credence to the possibility of a Pfizer/TFFP collaboration, I see the lack of a known delivery device and no large scale use of the drug platform for any disease indication as serious impediments to this possibility. TFFP was, however, identified some months ago as being in play for a dry powder version of Remdesivir. I couldn’t find any recent updates on that possible collaboration with Gilead www.businesswire.com/news/home/20200729005605/en/TFF-Pharmaceuticals-Comments-on-Research-on-the-Re-formulation-of-Remdesivir-to-a-Dry-Powder-Form-for-COVID-19-Antiviral-Treatment. I’m holding out hope that Mannkind is in play with Pfizer, but only time will tell. Bingo. |
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sports says that it was mentioned that California will fall off of the map 
