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Nov 22, 2016 14:42:33 GMT -5
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Post by cjm18 on Nov 22, 2016 14:42:33 GMT -5
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Deleted
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Post by Deleted on Nov 22, 2016 14:54:11 GMT -5
So I would assume the next couple of weeks is where and if we see anything. Thanks for the info!
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ican
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Post by ican on Nov 22, 2016 15:27:24 GMT -5
Does anyone know many locations are currently up and running for VDEX?
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Nov 22, 2016 15:29:15 GMT -5
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Post by Deleted on Nov 22, 2016 15:29:15 GMT -5
Does anyone know many locations are currently up and running for VDEX? 1
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Post by agedhippie on Nov 22, 2016 17:08:37 GMT -5
As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission? I am not that convinced that the label change to ultra fast insulin will sell it to endos. A label change for reduced hypos would stand a far better chance of selling it. Ultra fast without being superior is a feature, not a benefit whereas reduced hypos is a clear benefit.
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Nov 22, 2016 17:42:27 GMT -5
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Post by cjm18 on Nov 22, 2016 17:42:27 GMT -5
So I would assume the next couple of weeks is where and if we see anything. Thanks for the info! 3 weeks of data since then isn't enough? Unless they were doing samples first and not titration packs.
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Post by lakers on Nov 25, 2016 13:07:30 GMT -5
As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission? I am not that convinced that the label change to ultra fast insulin will sell it to endos. A label change for reduced hypos would stand a far better chance of selling it. Ultra fast without being superior is a feature, not a benefit whereas reduced hypos is a clear benefit. My #RealWorldAfrezza Observations Last time I shared my Afrezza experiences was during the summer. Not much has changed, for the most part -- aside from now having Tresiba on board, too. I recently found myself in a meeting room with a few other Afrezza users, and noticed that I was the only one who stepped out to inhale. Despite the fact that the inhaler is small and discreet, I personally just find the dosing procedure a bit too loud and distracting when sitting in a board room or other quiet public space. Opinions may vary on that, but I would rather be step away for a quick moment to inhale to avoid drawing attention to myself. As to my #RealWorldAfrezza results, I find that I usually start seeing it impacting my blood sugars within 30 minutes, if not a bit sooner -- which is great for quick corrections. I've also noticed that I can "turbo-charge" the action by adding exercise to the mix. Similar to injectable insulin, if I inhale just prior to starting a moderate walk or bike ride, or during that exercise, the Afrezza kicks in much faster. I've heard others describe this same experience, and MannKind Corp tells me they've heard numerous users describe that same "exercise effect" with Afrezza. Yet that hasn't led to low blood sugars. In fact, I've had fewer hypos over the course of these past six months using this inhaled insulin.
Fewer Hypos? You bet. I would say without a doubt, that Afrezza (along with Tresiba) has slashed my hypoglycemia rate, and although I still experience them at times thanks to my own mismanagement, this is a huge selling point, IMHO. (Note that FDA restricted MannKind from adding 'less hypoglycemia' to its product labeling, even though studies showed it was a significant effect; MannKind is planning to ask for a label change on this point before long, too.)I'm now using Afrezza mostly during the day and am going back to NovoLog in the evening hours, in large part due to what I refer to as my "Afrezza Resistance." There are just times when it doesn't work as effectively for me. Sometimes, not at all. It can be very frustrating, especially since sometimes Afrezza works so magically but at other times it doesn't seem to work at all (almost like when my insulin is water.) No, it's not a basal issue and isn't specific to carbs on board -- I have trial-tested and eliminated those factors, by bumping up my basal and not eating at specific times. Generally, I notice that my Afrezza needs are higher than they were in the early months of using it, and sometimes the 4-unit (blue) cartridge doesn't seem to work as well as it did previously, so I've bumped up to the 8-unit (green) variety more often. (Note to MannKind: the blue and green cartridges are very difficult to tell apart, especially in dark places and for those of us who are even partially color-blind -- can you make them more distinct please?!) I have yet to try out the 12-unit (yellow) cartridges that MannKind Corp is now selling, but that's about to change as I have a pending Rx to obtain a box of those soon. I'm also happy that my co-pay isn't be more than $30, thanks to the Afrezza savings card that makes this much more affordable than what I'd normally be paying for this highest tier medication. I remain quite concerned about the survival prospects of manufacturer MannKind Corp, but that's a concern for another day... In the meantime, I'm inhaling like a champ and enjoying the experience for as long as I can. Read more: mnkd.proboards.com/thread/6532/afrezza-on-twitter-ii?page=8#ixzz4R2pDZrDw
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Post by mannmade on Nov 25, 2016 15:42:13 GMT -5
Just to be clear the print/post in bold is not my post. I bolded it as a repost with my reply to it above in the original post I made. Please see below for context... TY Mn, For what its worth regarding the below quote I lifted from your above post, I recall Ray saying they were expecting to hear approval of label change (not a decision on label change) from the FDA in 4th Q 2017 as I recall. I actually posted about this as I thought it was either a slip or a very confident prognosis. They are in communication with FDA about the label change which has now been submitted so perhaps the strategy is to maintain price while they wait for the label change which puts AFREZZA in the class by itself that it deserves. Just a thought as I do not know more than this. As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?Read more: mnkd.proboards.com/thread/6734/abc-news?page=2#ixzz4R3TxQptT
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Post by mnholdem on Nov 25, 2016 17:21:17 GMT -5
Just to be clear the print/post in bold is not my post. I bolded it as a repost with my reply to it above in the original post I made. Please see below for context... TY Mn, For what its worth regarding the below quote I lifted from your above post, I recall Ray saying they were expecting to hear approval of label change (not a decision on label change) from the FDA in 4th Q 2017 as I recall. I actually posted about this as I thought it was either a slip or a very confident prognosis. They are in communication with FDA about the label change which has now been submitted so perhaps the strategy is to maintain price while they wait for the label change which puts AFREZZA in the class by itself that it deserves. Just a thought as I do not know more than this. As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?Read more: mnkd.proboards.com/thread/6734/abc-news?page=2#ixzz4R3TxQptTI have those very same thoughts, that MannKind is working closely with the FDA's advisors. I imagine that I come across as a naysayer, but it's an old "risk analysis" habit of mine from being involved in so many medical device companies when I find myself asking, "What can go wrong?" There are are so many things that haven't happened which, IMO, should have by now. For example, I was truly excited when Dr. Shannon returned to accept an appointment to the Board of Directors. With his connections throughout the diabetes treatment industry and his background with GlaxoSmithKline and Novartis I thought that we would be seeing him coordinate with industry KOLs and, later, CMO Dr. Raymond Urbanski to spearhead a number of major medical publications about Technosphere and how it can change drug delivery for so many diseases, especially after CEO Matt's Pfeffer's remarks in January about how Technosphere would become the driving force for MannKind's growth as a company. He eluded to a deal, which shortly thereafter we all saw revealed as Receptor Life Sciences, and I expected the company to follow up with an effort to publish pieces in the NEJM, Lancet and/or AMA journals about the medical advantages of Technosphere pulmonary delivery. Sanofi did coordinate with some doctors to get the post-market trial data peer-reviewed and MannKind further saw to it that Afrezza trial data posters were published at ADA-2016. Perhaps the ADA conventions venue is the proper communications vehicle for the diabetes treatment industry. I always was of the opinion that the major journals would be THE place to quickly build both awareness and credibility for Technosphere with most physicians in the USA and abroad. My strategy would have been more than Afrezza. I'd leave that marketing to the CCO and utilize the CMO, and even Dr. Shannon if he were willing, and promote the hell out of Technosphere, much as Alfred E. Mann did during the years before his health declined and limited his activities, taking advantage of every opportunity to educate why Technosphere pulmonary drug delivery represents a paradigm shift, a major leap forward for medicine. My concern is that as more and more time slips by the medical industry will interpret the silence to signify that there is nothing special about Technosphere technology. Plus, to be brutally honest, I think that MannKind has shown themselves to be inexperienced, if not naive, in the past (e.g. an over-reliance on FDA advisors in the design of Afresa/Afrezza trial protocols) and I don't trust the FDA. Again, I just think more like a risk manager and my reflections can make some shareholders uncomfortable (yes, those bitching words that you put in boldface were mine). Hopefully some major journal publications are forthcoming, which would reach more physicians than a 60-person sales force, IMHO, and that there is much more going on behind the scenes than marketing the company primarily through social media.
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Post by agedhippie on Nov 25, 2016 17:26:49 GMT -5
Just to be clear the print/post in bold is not my post. I bolded it as a repost with my reply to it above in the original post I made. Please see below for context... TY Mn, For what its worth regarding the below quote I lifted from your above post, I recall Ray saying they were expecting to hear approval of label change (not a decision on label change) from the FDA in 4th Q 2017 as I recall. I actually posted about this as I thought it was either a slip or a very confident prognosis. They are in communication with FDA about the label change which has now been submitted so perhaps the strategy is to maintain price while they wait for the label change which puts AFREZZA in the class by itself that it deserves. Just a thought as I do not know more than this. As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?Read more: mnkd.proboards.com/thread/6734/abc-news?page=2#ixzz4R3TxQptTSorry, I didn't mean to mislead. I may have overdone the edit.
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Post by letitride on Nov 25, 2016 22:05:15 GMT -5
Don't sweat it what if's are endless, what is , is what happens when the definition of is, is someone did it.
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Post by ilovekauai on Nov 26, 2016 14:07:29 GMT -5
Mn: I still suspect that published pieces on the benefits of Afrezza in the NEJM and other prestigious publications are forthcoming. 2017 is a key year for MNKD. Much will have happened all to the good, a year from now. It will be an entirely different landscape IMO. Cheers.
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Post by mnholdem on Nov 26, 2016 18:42:23 GMT -5
High Impact Journals
Superfund Research Program
Many SRP scientists have published their findings in "high-impact journals" - those considered to be highly influential in their fields. A journal's impact factor is a measure of the frequency with which an average article in a journal has been cited in a particular year. The following list highlights some recent SRP-funded publications in high impact journals.
New England Journal of Medicine (impact factor: 59.558)
The Lancet (impact factor: 44.002)
Nature Biotechnology (impact factor: 43.113)
Nature Reviews Immunology (impact factor: 39.416)
Nature Materials (impact factor: 38.891)
Nature Reviews Molecular Cell Biology (impact factor: 38.602)
Nature (impact factor: 38.138)
JAMA - Journal of the American Medical Association (impact factor: 37.684)
Chemical Reviews (impact factor: 37.369)
Nature Nanotechnology (impact factor: 35.267)
[Top 10 listed]
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Source: National Institutes of Health | U.S. Dept of Health & Human Services tools.niehs.nih.gov/srp/publications/highimpactjournals.cfm
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Post by steve on Dec 11, 2016 23:19:18 GMT -5
Sports,
Someone was posting about trying to get there child on afrezza but having endo issue of refusal. Who is this Tom fellow. I have seen them post somewhere but can't remember. Does anyone remember?
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Post by sportsrancho on Dec 12, 2016 6:21:34 GMT -5
Sports,
Someone was posting about trying to get there child on afrezza but having endo issue of refusal. Who is this Tom fellow. I have seen them post somewhere but can't remember. Does anyone remember? You mean my client Tom? Two kids on Afrezza.
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