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Post by dreamboatcruise on Mar 6, 2018 2:04:11 GMT -5
VDEX is doing fine from what I hear. And I'm not at liberty to say where I hear it, but I do hear it (I gotta be honest, though, there is some amount of money that I would take in return for telling you, though). They have had some very, very good ideas, and now they have to see if their very, very good ideas, work in the very, very different real world. I can also say there's some misinformation going on in this thread (kinda like most of the others). Now, is Afrezza flying off the shelves anywhere - no. But VDEX is accounting for its share and beyond that, providing the follow up that is critical for keeping people on. It's my understanding that they even help people to get insurance to cover as much as possible. Seems like a lot of work for any particular patient, but once they learn how to use it, they have a happy and hopefully long time customer - and it boils down to the insurance wars. It's not an easy business for now, if Afrezza ever hits the limelight, I'm sure they'll add to their locations quickly, but it would be imprudent to borrow money, etc., to expand too soon. Do their efforts make up a large percentage of weekly rxs? Come on Baba a little info, please. What do you hear? The fun of being a MNKD shareholder isn't actually knowing anything, it's the game of connecting the dots. If Baba doesn't tell us then it can be anything we wish it to be. I think we all know from past experience that when things aren't talked about that means great things are happening behind the scenes. Sort of like RLS... that's been silent for so long now it has to be something phenomenal about to be sprung on us. OK... that's a post.
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Post by dreamboatcruise on Mar 6, 2018 0:15:41 GMT -5
This is really great to see. Steve Edelman was said to the the architect of the Onduo protocol. Hopefully, afrezza has been incorporated into it. Where has it even been said that Onduo is developing protocols? I've recently read about Onduo supporting technology in their app to help recommend dosing of insulin, but that is actually just tying in software that was developed by a different company... and by the looks of it, is likely based on current subq insulins. I think hoping a Sanofi funded company advocates for Afrezza is a bit of a stretch.
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Post by dreamboatcruise on Mar 5, 2018 21:08:11 GMT -5
seanismorris ... there are three in the Los Angeles area. Can't comment on their financial success or lack thereof. Why is it that they are always closed when someone if the board drops by? Why do they still share an office with some other small business? Their representatives told the board that they found the secret sauce to help their patients stay in range. So why is this not spreading like wildfire? Or is the truth quite simple: Most of the T2 diabetics are too stubborn/dumb/misinformed/undisziplined to help themselves and to be helped? I've known numerous professionals in the LA area (doctors, accountants, etc.) that have multiple offices that they split their time between to make it easier for their clients since driving even fairly short distances can be monumental pain in LA. They might be in one office on MWF and a different one on T and Th. Perhaps that is what is happening if they often don't seem open. Given that one of the founders is a participant here, I suppose they can jump in and shed light if they see fit.
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Post by dreamboatcruise on Mar 5, 2018 16:26:16 GMT -5
seanismorris... there are three in the Los Angeles area. Can't comment on their financial success or lack thereof.
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Post by dreamboatcruise on Mar 5, 2018 15:32:03 GMT -5
The interesting thing is that Types 1 and 2 add up to 95 to 100% of all Db (90-95% + 5%). So, that implies that Types 1.5 and 3 (Alzheimers) are both subcomponents of Types 1 and 2. In other words, to have type 1.5 or 3, you have to have either Type 1 or 2 ... so ... you must be diabetic to get Alzheimers. Which makes you wonder if you can take one more step here and imply that Diabetes causes Alzheimers. Certainly not conclusive evidence here, but it builds on the evidence I have been reviewing. And, most importantly for readers here, first, consider Afrezza's already huge market for T1 and T2 diabetics. Once this news starts getting reported to the public (i.e., that diabetes causes alzheimers), adding the sales market of diabetes "preventative care" to Afrezza's already huge diabetic care sales market could increase Afrezza's sales market by a factor of 2 or 3. Not just people who HAVE Alzheimers, but also everyone who is afraid of getting it. As people age, they are not so scared about getting Db, so that factor is not compelling enough to drive patients to their doctor for an Afrezza Rx. But they are scared sh!t-less about getting Alzheimers. Talk about HUGE!!!Though IF the one researcher cited is correct about the causal link (quote below), exogenous insulin such as Afrezza would not be helpful in preventing Alzheimers. However, I think it is far some settled what the causal link is if any. I thought there have been some trial results that show nasal insulin delivery does provide cognitive benefit for those with dementia " Schilling posits this happens because of the insulin-degrading enzyme, a product of insulin that breaks down both insulin and amyloid proteins in the brain—the same proteins that clump up and lead to Alzheimer’s disease. People who don’t have enough insulin, like those whose bodies’ ability to produce insulin has been tapped out by diabetes, aren’t going to make enough of this enzyme to break up those brain clumps. Meanwhile, in people who use insulin to treat their diabetes and end up with a surplus of insulin, most of this enzyme gets used up breaking that insulin down, leaving not enough enzyme to address those amyloid brain clumps."
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Post by dreamboatcruise on Mar 5, 2018 15:13:48 GMT -5
compound26... it does seem there was hinting going on regarding India and China, but I wouldn't rule out it merely being a tease, like has been done with RLS. Certainly nothing he said was concrete enough that he could get in trouble for misleading if deals aren't pending in those countries. But I suppose they are as plausible as any other for deals that might get done. If it's China and the term sheet is with anyone other than Amphastar, then Amphastar gets right to jump in based on the same terms.
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Post by dreamboatcruise on Mar 5, 2018 11:31:01 GMT -5
peppy... interesting that the 5 listed in the video are not the same as the five listed in the article. Taking the two sources together it seems there are 7 different types. Of course the Type 1.5 in the video possibly could just be considered a patient having developed both T1 and T2.
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Post by dreamboatcruise on Mar 5, 2018 11:00:39 GMT -5
Am I correct in remembering that MannKind has tested 45 drugs on Technosphere and found that 43 had no pulmonary issues? There certainly haven't been Phase I safety studies. I think the statement that you are referring to is that of the APIs they tested almost all of them could could be bound to TS and result in particles of the correct size for inhalation.
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Post by dreamboatcruise on Mar 2, 2018 18:44:54 GMT -5
DBC - I for one am expecting them to go way beyond what's on the label. Good Grief, if thats what they are doing its no surprise we have 400 scripts a week. Next week they all need to be briefed on the 118 trial for starteres and they better have all the info highlighted here including all studies done Precisely... and here we sit at 400. Unfortunately those are the constraints of the FDA. Maybe you can get in touch with a pharma rep and ask about this point if you don't believe it.
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Post by dreamboatcruise on Mar 2, 2018 18:33:36 GMT -5
Can you explain what that means? Post by mytakeonit on about an hour ago "From an accounting standpoint, you never lose money selling something. You may not be profitable now, but it seems like that may be resolved shortly." Yeah, I could use a little help with this business concept myself. One might say from a cash standpoint you don't lose money selling something... as the cash is lost when you purchase and/or manufacture it. From an accounting standpoint you don't accrue the loss until you sell it... until then it sits as an inventory asset, unless it expires or it's determined that it is unlikely to ever be sold above its COGS value and thus must be written down.
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Post by dreamboatcruise on Mar 2, 2018 17:56:30 GMT -5
He won't be at the annual meeting as he is not a shareholder. He is a paid shill..... I won't go conspiracy theory on anyone (at the moment); but I'd be willing to bet there are paid shills on this board as we speak Shills and shorts and bears! oh my! Just stick to the yellow road and everyone will get what they need when we reach the Emerald City.
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Post by dreamboatcruise on Mar 2, 2018 17:44:51 GMT -5
That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. After digging around Wikipedia for a moment or two, it seems that they redirect a lot of stuff that is branded to a "disambiguation" page. Even Tylenol or Trulicity. Comet cleanser, not so much. So, a page on Afrezza, disambiguate. A page on MannKind Corporation, reads like a press release - now here is where someone might shine to be objective and clean up a page and pick some low hanging fruit! NOTE: I did not make the rules on Wikipedia and am only reporting what I found, so please leave your attacks on why I created Wikipedia with a bias against Afrezza at home, trapped behind your fingerprints, thanks. It would seem that their model is to have the brand name redirect to a page titled with the generic name. Humalog redirects to Insulin Lispro and Novolog redirects to Insulin aspart. Given this, it seems someone needs to create a "(insulin human) Inhalation Powder" which is the generic designation for Afrezza, and have the Afrezza page redirect there. Though the generic designation for Exubera seems oddly similar. I'm surprised that the FDA didn't do a better job of distinguishing the two. If Exubera were still on the market they certainly aren't substitutes for one another.
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Post by dreamboatcruise on Mar 2, 2018 17:00:45 GMT -5
sayhey24... as if often discussed here, sales reps are limited to discuss what is in the FDA approved label and marketing materials. No one is asking them to present info to docs that goes beyond what the FDA allows... I would hope, since many pharma have gotten in big trouble for doing that in the past. I would assume at this point that the sales reps primary contribution is helping make sure clinical staff is trained on patient education and that docs are offloaded from hassle of prior auths.
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Post by dreamboatcruise on Mar 2, 2018 13:32:53 GMT -5
That was a good interview. I am curious about the very last paragraph. "I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Is there really any chance they can put patient stories and examples (anecdotal clinical data?) in product information? Is this a realistic goal, or is it more like saying "We'd love to have world peace and the end of poverty". Which idea is 'pie in the sky?' Better yet and another way to look at answering your question of this being a 'realistic goal', which idea has a better chance of happening between the two...patient stories and examples in product information or world peace and the end of poverty? We've actually been making progress on world poverty over the last couple of decades.
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Post by dreamboatcruise on Mar 2, 2018 12:12:32 GMT -5
That was a good interview. I am curious about the very last paragraph. "I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Is there really any chance they can put patient stories and examples (anecdotal clinical data?) in product information? Is this a realistic goal, or is it more like saying "We'd love to have world peace and the end of poverty". DBC - the question Dr. Kendall is addressing is "Has MannKind embraced the “Beyond A1C” message for Afrezza?" The short answer is no, they have not. Mike and guys main focus has been A1c. Are they aware of it sure but its not what they have been about. We here on Proboards have been focused on “Beyond A1C” for a very long time. We have been talking about time in range, use of the CGM, Cloud Monitoring and the Libre way before it was approved. We have known afrezza is a real time solution to a real time problem which is "Stopping the Spike" after meals. Mike and team's main focus has been A1c and not TIR. What we do know is Dr. Kendall has found the treasurer chest filled with the 60+ studies. Can he combine these studies in conjunction with non-scientifc data which shows an example like the VDex whitepaper, maybe? The thing about the VDex paper is its a do it yourself instruction kit - if you don't believe their paper try it yourself. Lets see what he can come up with. Given that they funded and have completed a TIR clinical trial I'm not sure I'd agree they don't have a focus on that. Now if you said the FDA does not have a focus on that yet, I'd agree fully. Would the FDA even allow TIR data from the STAT study into the Afrezza label... dunno? My questions were really having to do with FDA restrictions. It is my understanding that anecdotal patient experiences cannot be used in product literature or marketing material. That is unless what they say is so nonspecific that it would apply to all patients... e.g. you could have a quote from a patient saying "Afrezza allowed me to control my post meal blood glucose" but not "with Afrezza my post meal blood glucose never exceeded 140". Just curious what he meant by including patient stories, as he must understand FDA restrictions.
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