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Afrezza
Mar 5, 2017 12:36:54 GMT -5
Post by peppy on Mar 5, 2017 12:36:54 GMT -5
quote: that glucose binds to your hemoglobin and doesn't want to let go so you get less oxygen - you feel breathless. reply: glycation. the bonding of a sugar molecule to a protein or lipid molecule without enzymatic regulation as you will know aged, that is what your hgA1c is measuring. (like spilling regular 7up on the floor.)
regarding 300 mg/dl...... and your endo refused. and he knows you. Hmmmmm........
He did ask about that one rather sharply [cue tuneless whistling] As it happens I had forgotten to bolus for a meal and only caught it at bed time. That's usually the cause, that or cupcakes. additionally, breathless aged.... In the presence of oxygen 38 ATP vs 2.
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Post by dreamboatcruise on Mar 5, 2017 14:59:06 GMT -5
you can tell Stefan , to tell Onduo, he can buy the whole enchilada now for around $200 million. When you are dreaming, atleast dream big. Mannkind will be bought by Sanofi, Google partering with Apple with 200 billion. And I feel sorry myself for keep reading BS and even worse replying. I hope atleast some of the investors dont believe your BS which is similar to Kevin's stuff. Nothing I said is BS but if you can point to it I will review. The only unknown is if and to what degree afrezza may or may not be involved with Ondou's protocol. Stefan's new title is Ondou Alliance manager. This is all on him and he was the guy in May '15 that started selling the Onduo idea. With the Mann estate and Mann foundation ownership, I don't think $200M will buy MNKD. If Ondou is serious about changing the insurance market through diabetes care and if afrezza is part of this, the question is what is the real value of afrezza? Its not $200M. If Mike can get his sales guys to get each of the 2000 endo's to prescribe 1 script a week, in no time afrezza will hit the magical 12,000 scripts per week. If it were $200M to even get 51% control, Mannkind would have already been gone. The one thing Al Mann always did was make sure he was always part of the dilution to keep control. If Ondou makes it and afrezza is part of it, could you imagine selling for $200M. Actually a couple of other unknowns... Will Ondou be successful with whatever it is they are trying to do? If they are successful eventually, what sort of time frame before that success occurs in a meaningful way (will their solution require clinical trials)... is it a year or five years? Highly speculative that any of that would be meaningful in helping MNKD out of their current financial difficulties.
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Post by sayhey24 on Mar 5, 2017 19:20:04 GMT -5
Nothing I said is BS but if you can point to it I will review. The only unknown is if and to what degree afrezza may or may not be involved with Ondou's protocol. Stefan's new title is Ondou Alliance manager. This is all on him and he was the guy in May '15 that started selling the Onduo idea. With the Mann estate and Mann foundation ownership, I don't think $200M will buy MNKD. If Ondou is serious about changing the insurance market through diabetes care and if afrezza is part of this, the question is what is the real value of afrezza? Its not $200M. If Mike can get his sales guys to get each of the 2000 endo's to prescribe 1 script a week, in no time afrezza will hit the magical 12,000 scripts per week. If it were $200M to even get 51% control, Mannkind would have already been gone. The one thing Al Mann always did was make sure he was always part of the dilution to keep control. If Ondou makes it and afrezza is part of it, could you imagine selling for $200M. Actually a couple of other unknowns... Will Ondou be successful with whatever it is they are trying to do? If they are successful eventually, what sort of time frame before that success occurs in a meaningful way (will their solution require clinical trials)... is it a year or five years? Highly speculative that any of that would be meaningful in helping MNKD out of their current financial difficulties. Ondou is in direct competition with what IBM Watson is trying to do. They need to get product to market asap. Initial product release target about 12 months from now. Partners such as Dexcom with the FDA approved products need to be signed prior. The 1990's we had the internet revolution. Then we had the smartphone revolution. Both are mature markets now. The 2020's will be a technology revolution in medical which will change current insurance approaches. Both Google and IBM will be hugely successful. Medical is their future. Microsoft wants to play too as do others. Its all about applying technology to remove the doctor. With diabetes there is little need with real time sensors and real time dosing for doctors. Diabetes is the low hanging fruit for technology and a huge market. As long as you can keep the PWD baselined during fasting then its a matter of getting the PWD back to baseline ASAP after meals. I only know one product which does that which is easy and predictable and works like a healthy pancreas. It takes 10 to 15 years to mature a technology market. Onduo is planning product release in 2018. If afrezza is part of the solution, afrezza will over night become a house hold name in 2018. How Ondou maintains exclusivity would be the question. Now, Mannkind only needs 10,000 scripts a week to be profitable. In theory they should be able to do that with Mike C. and his door-to-door sales force to the endos. Onduo is targeting the PCPs, that same market Stefan Schwarz thought afrezza was ideal for. I can't speak to MNKD's current financial difficulties. If afrezza was the centerpiece of the Onduo solution, what I would be doing right now if I were Matt is looking for a bridge loan and answer the mail on the stock listing. Depending on the deal I may be limited on what I can sell right now. We know they can sell to the domestic endo market but they may be limited on international deals. I might also be walking around with out a worry in the world and I might even tell people I have an embarrassment of riches and an epic turn-around is near.
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Post by peppy on Mar 5, 2017 20:46:59 GMT -5
I am repeating this information on this Afrezza thread.
Trial MKC-TI-175 Population: T2DM Results: TI + basal insulin was noninferior to BPR 70/30 in terms of the primary assessment of HbA1c change at 52 weeks. TI + basal insulin, like BPR 70/30, provided a significant reduction in HbA1c that was sustained over 52 weeks. TI + basal insulin resulted in less weight gain. The 7-point blood glucose measurements indicated that postprandial glycemic excursions were of lesser magnitude with TI + basal insulin than with BPR 70/30. There were more hypoglycemic events in the BPR 70/30 group than in the TI group.
www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
Trial MKC-TI-117 Population: T1DM Results: The original protocol-specified sample size was 230 subjects. However, because of the decision by MKC to focus development efforts on the Gen2 device and no longer support clinical trials with the MedTone device, this trial was prematurely terminated. Only 56% of required subjects had been recruited at the time of trial termination (65 subjects per treatment group). Despite the small sample size, a non-prespecified interim analysis noted that noninferiority for the primary efficacy endpoint was met: HbA1c change from baseline - 0.10% for TI group, -0.03% for insulin lispro; mean treatment difference -0.07 (-0.31, 0.17). Fewer TI-treated subjects reported severe hypoglycemia events than those treated with insulin lispro (23% versus 35%). page 185
Trial MKC-TI-009 (Argentina, Brazil, Canada, Chile, Mexico, Poland, the Russian Federation Spain, United Kingdom, and United States) Population: T1DM, HbA1c > 7.0% and ≤ 11.0%, FEV1 ≥ 70% predicted; TLC ≥ 80% Results: Noninferiority of TI + basal insulin with respect to insulin aspart + basal insulin in reducing HbA1c levels could not be confirmed because the between group difference was 0.24 (95% CI [0.08, 0.40]) in favor of insulin aspart + basal insulin with the upper bound missing the pre specified noninferiority criterion that this should be <0.40. However, TI + basal insulin treatment resulted in lower FPG and 1-hour PPG and less total hypoglycemia in the context of weight neutrality. page 184
Trial MKC-TI-171 Population: T1DM, Results: TI Gen2 plus basal insulin was noninferior to insulin aspart plus basal insulin with regard to HbA1c improvement over 24 weeks of treatment. Additionally, prandial TI Gen2 with basal insulin resulted in lower FPG values, reduced risk of hypoglycemia, and less weight gain (weight neutrality) compared with the insulin aspart regimen. The overall safety profiles were similar regardless of the inhaler used to administer TI. page 183
Trial MKC-TI-102 Population: T2DM, Results: TI + basal insulin was noninferior to BPR 70/30 in terms of the primary assessment of HbA1c change at 52 weeks. TI + basal insulin, like BPR 70/30, provided a significant reduction in HbA1c that was sustained over 52 weeks. TI + basal insulin resulted in less weight gain. The 7-point blood glucose measurements indicated that postprandial glycemic excursions were of lesser magnitude with TI + basal insulin than with BPR 70/30. There were more hypoglycemic events in the BPR 70/30 group than in the TI group.
page 187
This Appendix contains brief summaries of the following trials: page 182 MKC-TI-171, MKC-TI-009, and MKC-TI-117 in subjects with type 1 diabetes mellitus MKC-TI-175, MKC-TI-102, and MKC-TI-014 in subjects with type 2 diabetes mellitus
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Post by dreamboatcruise on Mar 6, 2017 11:35:20 GMT -5
Actually a couple of other unknowns... Will Ondou be successful with whatever it is they are trying to do? If they are successful eventually, what sort of time frame before that success occurs in a meaningful way (will their solution require clinical trials)... is it a year or five years? Highly speculative that any of that would be meaningful in helping MNKD out of their current financial difficulties. Ondou is in direct competition with what IBM Watson is trying to do. They need to get product to market asap. Initial product release target about 12 months from now. Partners such as Dexcom with the FDA approved products need to be signed prior. The 1990's we had the internet revolution. Then we had the smartphone revolution. Both are mature markets now. The 2020's will be a technology revolution in medical which will change current insurance approaches. Both Google and IBM will be hugely successful. Medical is their future. Microsoft wants to play too as do others. Its all about applying technology to remove the doctor. With diabetes there is little need with real time sensors and real time dosing for doctors. Diabetes is the low hanging fruit for technology and a huge market. As long as you can keep the PWD baselined during fasting then its a matter of getting the PWD back to baseline ASAP after meals. I only know one product which does that which is easy and predictable and works like a healthy pancreas. It takes 10 to 15 years to mature a technology market. Onduo is planning product release in 2018. If afrezza is part of the solution, afrezza will over night become a house hold name in 2018. How Ondou maintains exclusivity would be the question. Now, Mannkind only needs 10,000 scripts a week to be profitable. In theory they should be able to do that with Mike C. and his door-to-door sales force to the endos. Onduo is targeting the PCPs, that same market Stefan Schwarz thought afrezza was ideal for. I can't speak to MNKD's current financial difficulties. If afrezza was the centerpiece of the Onduo solution, what I would be doing right now if I were Matt is looking for a bridge loan and answer the mail on the stock listing. Depending on the deal I may be limited on what I can sell right now. We know they can sell to the domestic endo market but they may be limited on international deals. I might also be walking around with out a worry in the world and I might even tell people I have an embarrassment of riches and an epic turn-around is near. Not only MNKD but I've seen with many other things in medicine, it seems to be a field where change often comes slower than people would desire or anticipate. Apple has been dabbling with health/medical technology probably as long as Google has and yet what they brought to market has caused barely a ripple in the market rather than some huge impact. I am certainly hoping that MNKD isn't hanging the hopes on something external like the success of yet another company, whether it is VDEX, RLS or one like Onduo where there isn't even any verified relationship. I also believe you are taking some of management's comments entirely out of context. We certainly know "embarrassment of riches" was reference to TI drug pipeline, not to some hypothetical Onduo solution. That and "epic turn-around" were statements from long ago. We certainly know that things haven't turned out as management expected in the interim as Matt clearly said he didn't expect we'd be under $1 and needing to do a RS... and yet he was forced to. They sure as heck had better be worried at this point.
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Afrezza
Mar 6, 2017 11:38:52 GMT -5
Post by peppy on Mar 6, 2017 11:38:52 GMT -5
I got an old glucose monitor that I have a lot of strips for working. (Batteries) I have been figure poking my finger, to get glucose levels. It doesn't hurt and I do not mind. However, with frequent pokes I am turning into a pin cushion. We need continuous glucose monitors.
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Post by dreamboatcruise on Mar 6, 2017 12:44:52 GMT -5
I got an old glucose monitor that I have a lot of strips for working. (Batteries) I have been figure poking my finger, to get glucose levels. It doesn't hurt and I do not mind. However, with frequent pokes I am turning into a pin cushion. We need continuous glucose monitors. I have family that have diabetes and diagnosed as pre-diabetic. I'm actually hoping to see a non-invasive solution such as Glucowise. I think that would be quickly picked up by many early T2 patients and help them get things under control. Maybe there will be something both non-invasive and continuous, but it doesn't seem like anything is yet on the immediate horizon. Out of curiosity I've used a BG meter, and the finger sticks didn't bother me at all... and some do it on arm which supposedly is even less noticeable. Even if pain is no longer a huge issue... it is still inconvenient, not something one would likely want to do in public, and expensive if one were to test throughout the day. Glocuwise would solve all these problems... IF it is accurate enough. Sadly is still a year or more away.
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