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Post by stevil on Dec 11, 2015 16:14:01 GMT -5
Actually, there may be some instances where early intensive insulin treatment does, in fact, result in what some would describe as a cure. A study by a group of Japanese researchers revealed that, caught early enough, several weeks of intensive insulin therapy healed the pancreas. After the EIIT was discontinued, approximately 40% of the patients required no further diabetes treatment whatsoever.
When I hear comments like this, I can understand why doctors have such a hard time changing. What I was taught in my class is that what you're describing is called relieving beta cell exhaustion. It is already known (as I was taught this recently) that the beta cells of the pancreas become exhausted from oversecretion of insulin. The pancreas doesn't work as efficiently as it used to so it upregulates the secretion of insulin, making the beta cells work harder to produce the physiological baseline of blood glucose concentration. It would make sense if this is what you're talking about because insulin therapy would allow the remaining beta cells to "relax" and not get exhausted. But we were taught that once the beta cells become completely exhausted, they're essentially dead and without any kind of stem cell regeneration, are lost forever. I'll have to look into it, but it's funny to me that I'm already having this problem. My first flinch is that you either don't know what you're talking about or that you're mistaken in what you think know simply because it disagrees with what I believe is "fact" in my mind. But I will leave room to be humble because I have great respect for you and because this is a new kind of insulin so maybe it's producing results we haven't seen yet. I'll take a look at it when I get a little more time. Next week is a little chaotic as they're trying to cram everything in before Christmas break...
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Post by stevil on Dec 11, 2015 13:57:15 GMT -5
rrtzmd That screen cast did have the type 2 first insulin response. It was interesting. I posted the chart because it also shows a normal non diabetic first insulin response. Matt, a type 1, talked about a normal non diabetic first insulin response being the signaling to the liver to stop gluconeogenesis. Matt said, he believes afrezza sends that same signal. Matt said that signal is not given with fast acting analogues.
Type 2 totally different. as you pointed out, type 2 still have working beta. try to stay with me.
"On a side note, Matt, said, he thinks part of the affectiveness of afrezza is; Afrezza signals the first phase insulin response: which signals the liver to stop putting glucose into the blood. I kept a chart of normal first phase insulin response.
screencast.com/t/ssSzINDM"
Peppy, please tag me in whatever you find on these comments. This doesn't make sense to me... The mechanism used by metformin bypasses insulin receptors, so that would make sense if that's what he's saying. If he's talking about GLP-1s also would make sense as they also bypass insulin receptors. But if those fast-acting analogues are insulin analogues, that wouldn't make sense to me. Insulin is insulin to the liver, irrespective of its source. The only thing that would turn off gluconeogenesis in the liver is a high insulin to glucagon ratio. That's why insulin is needed to turn it off. But I don't know why that effect would be limited to Afrezza, if that indeed is what Matt is saying... Thanks!
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Post by stevil on Dec 11, 2015 13:25:46 GMT -5
Dudley,
Sorry to nitpick, but there's a pretty big disparity between cure and treatment.
Afrezza will never cure diabetes. Just wanted to make that point clear lest you mislead others.
Afrezza will also not be the only treatment option needed for diabetes. The liver is constantly regulating glucose levels in the blood. A basal insulin will always be needed post-prandial to help with those spikes in glucose levels.
All Afrezza does is help decrease the post-prandial glucose spike back to physiological levels.
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Post by stevil on Dec 11, 2015 12:45:43 GMT -5
Mnkd most likely will get $25M dev for qualifying Sny's insulin in 1H16, $30M for EU approval in 2H16, ~$150M TS pain, migraine upfront in 1H16. Consider the later as more than likely as mgmt is obliged to keep Hakan's promise to avoid SH litigation. It's in Mnkd's interest to expand quickly in more Territories. With 12 Territories, if each sells $20.84M in the same calendar year (a low bar), Mnkd will get $250M milestone bonus. This is achievable in 2017. $20M for Japan approval could be in 2H16 or 1H17. More upfront licensing $$ for MS, antiemetic, PAH, cancer in 2H16 and 2017. All of these are not pies in the sky but realistic. In hindsight, I'd ask for $0.5B upfront for Afrezza. Al was so confident about Afrezza that he thought $650M sales bonus was achievable in first 3 years. Are you or anyone else able to expand upon the additional funds SNY has said they would be willing to loan to us? I thought I'd seen it mentioned that we could borrow from SNY if we needed more capital as well... Obviously not ideal, but better than BK.
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Post by stevil on Dec 10, 2015 14:05:23 GMT -5
May well have signed an NDA... likely did. I just don't understand why this meeting having patients and doctors talk about Afrezza would at all give you a reason to think that a BO is in the works. These medical advisory meetings are common practice. I agree with you. That meeting, no matter what the results and a buyout can't have any strong correlation. OTOH, it could be an indication that SNY's getting closer to a full launch for Afrezza as they gather and hopefully plan to use real-world results in their advertising to mitigate some of the label limitations. I don't think that's prohibited. If none of the existing drugs have allowed PWDs to achieve non-diabetic numbers consistently with low episodes of hypoglycemia, and you can get patient data and testimonials to the fact that they're not only getting great results, but that it's easier and less intrusive on their lives, that would be cool. It would even be cooler if the ads warned patients that their endos and physicians may not be up to completely up to speed on the unique properties of Afrezza. They could then provide a physician help line and web site where physicians could go to get better educated on Afrezza . I think we found our new MNKD CEO
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Post by stevil on Dec 10, 2015 13:46:48 GMT -5
I certainly haven't sold any. It is tempting to average down, but of course that inclination is what already has me having lost meaningfully more than is comfortable for me. For now I think I will be more disciplined and wait for some positive catalyst even if that means I miss a bottom. If things work out as we all hope, the share price will have a long way to run. That's current thinking... but subject to mood swings. I may buy just a tiny bit because it's so cheap... ok, who's going to chime in as my 12 step buddy? Ya, I'm getting all my ducks in a row right now to make a quick strike. I have a fidelity amex card that pays back 2% on every purchase and other credit card rewards that I haven't cashed in yet. Sucks being a poor student right now if a big catalyst comes ha. But I'll do what I can I'm going to wait also, at least until we see what's moving below the water. But holy cow, it's shooting up right now... (relatively)
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Post by stevil on Dec 10, 2015 13:37:06 GMT -5
What is going on right now? a 10% swing in the past 20 min or so... Did news break or is this just part of their game?
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Post by stevil on Dec 10, 2015 13:15:47 GMT -5
Yeah, it's such a pain to get money in to my Roth - have put it into an IRA 1st and then convert... takes time. I maxed out my annual contribution, according to Scottrade, so now my couch cushion funding of MNKD shares have to go into my cash account. By taking the circuitous route of depositing in your conventional IRA and transferring to your Roth, can you get around the limit for annual contributions to your Roth that way?
Any tax lawyers lurking about?
Yes, see attached link. It's time-consuming, but honestly, the only way to go from my eyes... With the state of the global economy, I don't see taxes going lower any time soon... money.usnews.com/money/blogs/on-retirement/2015/09/03/the-power-of-the-backdoor-roth-ira
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Post by stevil on Dec 10, 2015 12:17:21 GMT -5
Ya... How awesome is it that you have to suffer and lose permanent function of something before they'll over something that probably would have prevented that permanent loss from ever happening. It's sick.
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Post by stevil on Dec 10, 2015 11:36:25 GMT -5
GREAT comments, save the "SNY is bound by label" line. I'm glad a doc can discuss it but SNY won't address it. Wish they'd let us know if/how they're going to go about fixing it...
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Post by stevil on Dec 10, 2015 11:24:30 GMT -5
ugh had a response but then I hit backspace and apparently the cursor wasn't in the text box... Grrr wish this had a draft feature. Anyway, I was going to say that I was unaware of the pediatric trials- that's actually great news. But would you say any of the trials are proof of SNY's commitment outside of being a barometer? I'm just wondering if SNY is giving Afrezza a test run in some of these trials with few participants. They can't be used for anything that I'm aware of. Then, is SNY going to stick with Afrezza the way Al did after the CRL's? That's what I want to know/see. Unfortunately, as you've stated, all of those things are being done behind the scenes. So time is our only ally here. We're just gonna have to wait it out because SNY will not show an outward commitment... Stevil Why do you think they required the CGM's for the pediatric trial, but not the other trials ?? Do think it has anything to do with all the social media chatter claiming Afrezza + CGM = ?? Thanks I don't really know, maybe it's a compliance thing... Children are less apt to follow protocols because they are less responsible. It eliminates the need to remember supplies and if they ever miss a dose, it's recorded for them. Takes out much of the error in recording and monitoring. CGMs should be used for every trial, regardless, for the same reasons. Surely it would add on a significant cost, but at least you'd know your data was accurate. Diabetics are notorious for being lackadaisical about their health/health maintenance.
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Post by stevil on Dec 9, 2015 21:33:04 GMT -5
ugh had a response but then I hit backspace and apparently the cursor wasn't in the text box... Grrr wish this had a draft feature.
Anyway,
I was going to say that I was unaware of the pediatric trials- that's actually great news. But would you say any of the trials are proof of SNY's commitment outside of being a barometer? I'm just wondering if SNY is giving Afrezza a test run in some of these trials with few participants. They can't be used for anything that I'm aware of. Then, is SNY going to stick with Afrezza the way Al did after the CRL's? That's what I want to know/see. Unfortunately, as you've stated, all of those things are being done behind the scenes. So time is our only ally here. We're just gonna have to wait it out because SNY will not show an outward commitment...
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Post by stevil on Dec 9, 2015 21:13:33 GMT -5
I would fully be in accordance with you, except that SNY has not shown any type of commitment to Afrezza as of yet. At best, they have dipped their toe in the water to check the temperature before jumping in. Their feet are still on the pool deck.
They could just as easily have locked MNKD up from the grips of their competitors whilst giving Afrezza a test drive. Again, I would feel much more at ease if they showed one iota of commitment to Afrezza, but they're just as easily to toss us aside as they are to stick with us.
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Post by stevil on Dec 9, 2015 14:01:16 GMT -5
Ya, that didn't sound good to me either. The only time you don't let information out is when that information isn't good. If there was good news to share, there wouldn't be opposition to communication. Wondering why there would need to be an "excuse" to let info out. Wonder if that's in regards to SNY? So what I hear you saying is that as CFO of a publicly traded company, if there was good news, Matt would have shared it via email response prior to announcing the good news in a formal PR. Do you really believe that to be the proper course of action, seriously? No, what you heard me saying was not what I said. We currently have a CEO, not named Matt, CFO. If Matt has been encouraging him to address this issue and there has been opposition to it, that doesn't really give me warm and fuzzies. It doesn't bother me that Matt didn't answer his question in an email. It bothers me that there has been opposition to addressing this with communication. What mdcenter61 said, they must favor communicating during scheduled events. They aren't the type of company that makes preemptive announcements. I guess I'm guilty of hope as well- hope that they would do something out of their norm and address this before we keep spiraling more and more.
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Post by stevil on Dec 9, 2015 13:44:57 GMT -5
is your endo observing the same - reduced basal with his other patients? Did he say the reason why is that happening and why you would be needing reduced basal - i want to know his thought process and if he gets/understands what afrezza is capable of...does he even care? I can tell you from the bottom of my heart....... I don't give a f--k what you want to know. It is hard for me to fathom the stupidity of your response. www.youtube.com/watch?time_continue=7&v=FONN-0uoTHIhaha please don't get upset with me. Probably shouldn't have posted this as I'm probably stoking the fire, but can we simmer it down a little? I appreciate your contributions to the board blindhog. I suspect you don't care much for me, but I'm glad you're here and able to share your experiences with Afrezza. It's an invaluable asset to our board.
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