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Post by kbrion77 on Mar 2, 2017 15:27:45 GMT -5
For the record. I can't believe all the doom and gloom on this board I think it's a bunch of hog wash, baloney... Everyone just do whatever you think best but just don't fall for the doom and gloom many posters are spreading. MNKD is in a new never seen before position and in my opinion great things are coming.. As far as the reverse split if it happens and I mean a big IF it happens it will be at a time when great things are in the pipe so I wouldn't count on the stock price going down to far, there are a lot of smart people out there that know a deal when they see it and will buy up all they can. We are at a time where the rubber meets the road either we go the distance or we just spin are tires and go no where. My bet is a 10-20 times banger. Call me a pumper I don't care but I know there are many here spreading fud and I think you are all getting very scared of what's to come.. Good luck. I've said my peace. R/S today and down 9%.... Any other predictions? I called him out on that as well, respectfully of course. I also found it interesting he started a thread claiming loaned shares were returned today. I mean I'm sure I'm a FUDster in his eyes since I have been tough on management and the company but I have always refused to lend my shares out, how funny.
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Post by derek2 on Mar 2, 2017 15:30:20 GMT -5
Derek, darn good reply. Thank you for the reply.
Holy Mackerel that seems like a fair share of insulin you are taking. It doesn't seem to be hurting your brain cells. peace.
added: any chance Afrezza will help? (I know I am terrible)
I live in Canada, so no Afrezza for me (yet). I expect to lower my dosage some more as Forxiga continues to help. I've had trouble with glycemic control during the last 2 years (Diabetic for 17 yrs) 9 months ago my A1c was over 10. 3 months ago it was under 9, and if the amazing results on Forxiga continue, I suspect I'll be in the 6's at my next check-in. Injections can burn, my abdomen has bruises, and the 2 pens are a bit bulky to carry. If my prandial load was in the 20's I'd try Afrezza for sure.
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Post by peppy on Mar 2, 2017 21:16:27 GMT -5
we know. What is your take? Why is such a fine insulin in terms of glycemic control not selling? Inhaling is just the frosting on the cake. How did you know it would not sell? My thinking was bingo. then average down. then look at those glucose monitors.
Well, explaining it and having you agree with the explanation will be two entirely different things. I fully believe that you'll understand my explanation, but it will not agree with your view on Afrezza. That's okay - we're all free to think as we will. But hey, at the risk of being branded a "fudster" or whatever, and being run out of town on a rail, I shall answer your question with an old, old post of mine. (Also, the "angel's share" was the loss of 90% of market cap, similar to whiskey being lost to evaporation while being aged in barrels) I wrote this after the Affinity trials were released (and before approval) Now, I received feedback at the time that the trials were poorly designed, and that far more than 37% of users would have great success with Afrezza after approval and market release. Well, what's happened? You have a small number of enthusiastic users (Sam, Eric, Spiro, etc) for whom Afrezza works well. Then you have, week after week, flat line Rx. What does that mean? Well, it means no retention. If new users stuck around, Afrezza sales would grow and grow. For every new user, one drops out. I suspect that there's a core group of users (maybe 2500) that drive 200 or so of weekly Rx. The other 50 Rx are driven by users that start and then discontinue. Pretty easy math, really. The Rx numbers - very stable numbers - point to a confirmation of the efficacy from the trials. Don't believe me? Believe Matt Pfeffer. He recently quoted efficacy as one of the top two barriers to sales. Now - I don't disagree with you. Afrezza is inded a fine insulin. It is not, however: 1. A superior insulin2. Weight advantageous (maybe a bit for T1) 3. Without hypo risk4. Without need for refrigeration 5. Exactly like a human pancreas (only mimics 1st phase panic response to huge sugar pulse, not to natural meal) 6. Free from need of titration You have been told all of these things by MNKD management at one time or another and they have never publicly corrected themselves, other than by signing off on the label that the FDA _and_ MNKD developed. The "You have to try hard to have a hypo with Afrezza" is brazen spin, based on a single trial in which T2s were given 4 units. That's dangerous for a T1 to hear and then act on. peppy , I know that you will agree that 4 units is a negligible amount to give a T2, given their insulin resistance (I, for example, take 45 units prandial at meals and 70 units basal once a day. Hey - down from 50 and 75 two months ago since I've started on Forxiga). It was a half truth with possible nasty consequences. How did I know it wouldn't sell? I didn't, that's why I took a bath on the shares and calls that I owned, right along with everybody else. I was smart enough to see the flaws yet not wise enough to get out of the way. I thought despite the lower efficacy, MNKD could capture 5% of the prandial market, which would have supported a $15 share price. The story is not over, and I have for years said that 2017 will tell the tale. I'm still watching. quote: 3. Without hypo risk
reply: In all 3 trials in insulin-using diabetics, both T1DM and T2DM, TI was associated with a clinically meaningful reduction in severe hypoglycemia event rates from that of comparators (20% [Trial 009], 43% [Trial 171] and 65% [Trial 102] reductions). Overall, in the active comparator trials, clinically relevant decreases were noted in: - the incidence of severe hypoglycemia and all-severity hypoglycemic event rate (T1DM; Trial 171) - The incidence of all-severity hypoglycemia (T1DM; Trial 009) - The incidence of all-severity and severe hypoglycemia, and all-severity hypoglycemic event rate (T2DM; Trial 102) Compared to TP (placebo), TI was associated with a greater incidence of any hypoglycemia and a small increase in severe hypoglycemic event rates (T2DM; Trial 175). www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
quote: not a superior insulin At 24-weeks, the TI-treated group had a decrease in pre- to post-meal glucose excursions compared with baseline; this effect was not seen with insulin aspart. This resulted in a flatter prandial glycemic profile for TI compared with insulin aspart.
10.1 Benefits Associated with TI Treatment TI provides a new therapeutic option in T1DM and T2DM management. TI has been tested against placebo and active comparators representative of the current standard of care. It has been evaluated in clinical trials across a broad spectrum of diabetes severity: insulin-naïve T2DM subjects with inadequate glycemic control on OADs, insulin-requiring T2DM subjects, and T1DM subjects utilizing a MDI basal/bolus regimen. Its unique PK/PD profile more closely mimics endogenous prandial insulin secretion compared with currently available RHIs and RAA insulins, thereby offering patients and HCPs flexible and convenient meal-time insulin dosing in a non-injection delivery system. Clinical trial data demonstrate glycemic efficacy, reduced hypoglycemia, weight neutrality, and consistently positive patient preference.
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Post by derek2 on Mar 2, 2017 21:54:36 GMT -5
quote: 3. Without hypo risk
reply: In all 3 trials in insulin-using diabetics, both T1DM and T2DM, TI was associated with a clinically meaningful reduction in severe hypoglycemia event rates from that of comparators (20% [Trial 009], 43% [Trial 171] and 65% [Trial 102] reductions). Overall, in the active comparator trials, clinically relevant decreases were noted in: - the incidence of severe hypoglycemia and all-severity hypoglycemic event rate (T1DM; Trial 171) - The incidence of all-severity hypoglycemia (T1DM; Trial 009) - The incidence of all-severity and severe hypoglycemia, and all-severity hypoglycemic event rate (T2DM; Trial 102) Compared to TP (placebo), TI was associated with a greater incidence of any hypoglycemia and a small increase in severe hypoglycemic event rates (T2DM; Trial 175). www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
Well, so claimed Mannkind. That was from the briefing document they wrote. Let's see what the FDA had to say'bout that in their briefing doc: So, really not contradicting what MNKD said. MNKD's findings: 43% reduction of severe hypo in 171 (note they don't put a number to the all-hypo rate, they just say it was better) and increase in hypo (expected, as you're adding insulin) in 175 still flatly contradict the claim that "you have to try to get a hypo with Afrezza". In fact the T2's got more hypos "without even trying".
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Post by sayhey24 on Mar 2, 2017 21:58:25 GMT -5
Hmmmm - one thing is for sure it is not being perscribed and renewals are unbelievably sad. What the issue is with the renewals I think we would all like to know
However as far as afrezza goes 1. A superior insulin - to what? it is the exact same insulin as released from the pancreas. Nothing more and nothing less. It is not a genetically modified analog. It is not an RAA, it is monomer human insulin. If you are looking for an insulin which works like the pancreas afrezza is it. You can't do any better from an insulin perspective.
2. Weight advantageous (maybe a bit for T1) - so they say. It really depends on diet. Stay to a low carb diet and you will probably loose some weight. Eat lots of chocolate cake and pizza because you can with afrezza and you will probably gain some weight.
3. Without hypo risk - afrezza will work like pancreatic released insulin. Its going to mimic phase 1 release and signal to the liver to stop releasing sugar and if you start going low it will be out of the body fast enough to let the liver recover. If you are taking metformin don't count on the liver working normally.
4. Without need for refrigeration - the label says to refrigerate it. Off label you could throw it in a desk draw for a couple of years and it would be fine.
5. Exactly like a human pancreas (only mimics 1st phase panic response to huge sugar pulse, not to natural meal) - true, for the first puff and if it is not enough you will need to mimic second phase and take another puff. This is where the CGM comes in and the biggest shortfall of the 171/175 trials. Only one doctor had his patients mimic phase 2 release.
6. Free from need of titration - think like a pancreas, what did I need the last time for a meal like this and take it up front. Its better to take more initially and trust the liver which is a really scary concept for existing diabetics and endos.
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Post by peppy on Mar 2, 2017 22:20:28 GMT -5
Hmmmm - one thing is for sure it is not being perscribed and renewals are unbelievably sad. What the issue is with the renewals I think we would all like to know However as far as afrezza goes 1. A superior insulin - to what? it is the exact same insulin as released from the pancreas. Nothing more and nothing less. It is not a genetically modified analog. It is not an RAA, it is monomer human insulin. If you are looking for an insulin which works like the pancreas afrezza is it. You can't do any better from an insulin perspective. 2. Weight advantageous (maybe a bit for T1) - so they say. It really depends on diet. Stay to a low carb diet and you will probably loose some weight. Eat lots of chocolate cake and pizza because you can with afrezza and you will probably gain some weight. 3. Without hypo risk - afrezza will work like pancreatic released insulin. Its going to mimic phase 1 release and signal to the liver to stop releasing sugar and if you start going low it will be out of the body fast enough to let the liver recover. If you are taking metformin don't count on the liver working normally. 4. Without need for refrigeration - the label says to refrigerate it. Off label you could throw it in a desk draw for a couple of years and it would be fine. 5. Exactly like a human pancreas (only mimics 1st phase panic response to huge sugar pulse, not to natural meal) - true, for the first puff and if it is not enough you will need to mimic second phase and take another puff. This is where the CGM comes in and the biggest shortfall of the 171/175 trials. Only one doctor had his patients mimic phase 2 release. 6. Free from need of titration - think like a pancreas, what did I need the last time for a meal like this and take it up front. Its better to take more initially and trust the liver which is a really scary concept for existing diabetics and endos. say hey, I started reading this because I thought I would look at the conditions for the long term lung/cardio study. I found the reason for poor renewals. The afrezza dosage goes up quite a bit over time. I'll dig it up. (remember Amy T asking if anyone was having.....)
added:
Here is my GUESS. the liver gets use to the large dose of insulin.
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Post by derek2 on Mar 2, 2017 22:27:01 GMT -5
Hmmmm - one thing is for sure it is not being perscribed and renewals are unbelievably sad. What the issue is with the renewals I think we would all like to know However as far as afrezza goes 1. A superior insulin - to what? it is the exact same insulin as released from the pancreas. Nothing more and nothing less. It is not a genetically modified analog. It is not an RAA, it is monomer human insulin. If you are looking for an insulin which works like the pancreas afrezza is it. You can't do any better from an insulin perspective. 2. Weight advantageous (maybe a bit for T1) - so they say. It really depends on diet. Stay to a low carb diet and you will probably loose some weight. Eat lots of chocolate cake and pizza because you can with afrezza and you will probably gain some weight. 3. Without hypo risk - afrezza will work like pancreatic released insulin. Its going to mimic phase 1 release and signal to the liver to stop releasing sugar and if you start going low it will be out of the body fast enough to let the liver recover. If you are taking metformin don't count on the liver working normally. 4. Without need for refrigeration - the label says to refrigerate it. Off label you could throw it in a desk draw for a couple of years and it would be fine. 5. Exactly like a human pancreas (only mimics 1st phase panic response to huge sugar pulse, not to natural meal) - true, for the first puff and if it is not enough you will need to mimic second phase and take another puff. This is where the CGM comes in and the biggest shortfall of the 171/175 trials. Only one doctor had his patients mimic phase 2 release. 6. Free from need of titration - think like a pancreas, what did I need the last time for a meal like this and take it up front. Its better to take more initially and trust the liver which is a really scary concept for existing diabetics and endos. A point by point refutation neither backed up by clinical proof nor by context given by management. #3 just ignores the numbers and restates the incorrect "no hypo" truism #4 is just a way of saying "I believe Al Mann's off the cuff remark instead of the instructions attested to by the FDA and management". Yep there's one data point by the guy with that stunt in Australia. Shocking to say, but we're not going to convince one another. Vive la difference! I'm data driven and don't trust narrative. You're narrative driven and don't trust statistics. Different ways of knowing. EDIT: I read my first like talking about "a line by line blah blah blah..." Occurred to me that although it was meant as a bit of a swipe, it could easily refer to my post. Perhaps I should lighten up a bit. Sorry, sayhey24. I may have been a bit rude there. No insult intended.
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Post by peppy on Mar 2, 2017 22:43:07 GMT -5
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Post by sayhey24 on Mar 3, 2017 6:45:38 GMT -5
Hmmmm - one thing is for sure it is not being perscribed and renewals are unbelievably sad. What the issue is with the renewals I think we would all like to know However as far as afrezza goes 1. A superior insulin - to what? it is the exact same insulin as released from the pancreas. Nothing more and nothing less. It is not a genetically modified analog. It is not an RAA, it is monomer human insulin. If you are looking for an insulin which works like the pancreas afrezza is it. You can't do any better from an insulin perspective. 2. Weight advantageous (maybe a bit for T1) - so they say. It really depends on diet. Stay to a low carb diet and you will probably loose some weight. Eat lots of chocolate cake and pizza because you can with afrezza and you will probably gain some weight. 3. Without hypo risk - afrezza will work like pancreatic released insulin. Its going to mimic phase 1 release and signal to the liver to stop releasing sugar and if you start going low it will be out of the body fast enough to let the liver recover. If you are taking metformin don't count on the liver working normally. 4. Without need for refrigeration - the label says to refrigerate it. Off label you could throw it in a desk draw for a couple of years and it would be fine. 5. Exactly like a human pancreas (only mimics 1st phase panic response to huge sugar pulse, not to natural meal) - true, for the first puff and if it is not enough you will need to mimic second phase and take another puff. This is where the CGM comes in and the biggest shortfall of the 171/175 trials. Only one doctor had his patients mimic phase 2 release. 6. Free from need of titration - think like a pancreas, what did I need the last time for a meal like this and take it up front. Its better to take more initially and trust the liver which is a really scary concept for existing diabetics and endos. A point by point refutation neither backed up by clinical proof nor by context given by management. #3 just ignores the numbers and restates the incorrect "no hypo" truism #4 is just a way of saying "I believe Al Mann's off the cuff remark instead of the instructions attested to by the FDA and management". Yep there's one data point by the guy with that stunt in Australia. Shocking to say, but we're not going to convince one another. Vive la difference! I'm data driven and don't trust narrative. You're narrative driven and don't trust statistics. Different ways of knowing. EDIT: I read my first like talking about "a line by line blah blah blah..." Occurred to me that although it was meant as a bit of a swipe, it could easily refer to my post. Perhaps I should lighten up a bit. Sorry, sayhey24 . I may have been a bit rude there. No insult intended. I will go back to the study results for #3, but from page 125 of the Adcom document -The event rate for all hypoglycemia, mild/moderate hypoglycemia, and hypoglycemia with glucose ≤36 mg/dL was significantly lower for the Afrezza TI Gen2 group than the insulin aspart group. The event rate for severe hypoglycemia trended lower for the Afrezza TIGen2 group (8.05 events per 100-subject months) vs the insulin aspart group (14.45 events per 100-subject months) but did not reach statistical significance. The numbers of events of severe hypoglycemia were low (8.05 per 100 subject-months vs 14.45 per 100 subject-months, p= 0.1022). For #4, I never heard Al say that or if I did I don't remember. On one of the factory tours there were a few ladies from the QA group. I specifically asked them about this. While it is not an official MNKD stance they did do non-refrigeration testing. I specifically asked them using the "2 years in a draw" line. She said she could not recommend doing this but it would be fine. I think Sam Finta has discussed leaving afrezza in his car and its been fine. This was why the Gates foundation was looking at Technosphere for African use.
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Post by derek2 on Mar 3, 2017 7:01:36 GMT -5
A point by point refutation neither backed up by clinical proof nor by context given by management. #3 just ignores the numbers and restates the incorrect "no hypo" truism #4 is just a way of saying "I believe Al Mann's off the cuff remark instead of the instructions attested to by the FDA and management". Yep there's one data point by the guy with that stunt in Australia. Shocking to say, but we're not going to convince one another. Vive la difference! I'm data driven and don't trust narrative. You're narrative driven and don't trust statistics. Different ways of knowing. EDIT: I read my first like talking about "a line by line blah blah blah..." Occurred to me that although it was meant as a bit of a swipe, it could easily refer to my post. Perhaps I should lighten up a bit. Sorry, sayhey24 . I may have been a bit rude there. No insult intended. I will go back to the study results for #3, but from page 125 of the Adcom document -The event rate for all hypoglycemia, mild/moderate hypoglycemia, and hypoglycemia with glucose ≤36 mg/dL was significantly lower for the Afrezza TI Gen2 group than the insulin aspart group. The event rate for severe hypoglycemia trended lower for the Afrezza TIGen2 group (8.05 events per 100-subject months) vs the insulin aspart group (14.45 events per 100-subject months) but did not reach statistical significance. The numbers of events of severe hypoglycemia were low (8.05 per 100 subject-months vs 14.45 per 100 subject-months, p= 0.1022). For #4, I never heard Al say that or if I did I don't remember. On one of the factory tours there were a few ladies from the QA group. I specifically asked them about this. While it is not an official MNKD stance they did do non-refrigeration testing. I specifically asked them using the "2 years in a draw" line. She said she could not recommend doing this but it would be fine. I think Sam Finta has discussed leaving afrezza in his car and its been fine. This was why the Gates foundation was looking at Technosphere for African use. The Gates foundation only used the inhaler for Oxytocin. They didn't use Technosphere. Interesting, about the convo you had with the folks from the QA group. Thanks for sharing.
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Post by Deleted on Mar 3, 2017 7:26:48 GMT -5
I will go back to the study results for #3, but from page 125 of the Adcom document -The event rate for all hypoglycemia, mild/moderate hypoglycemia, and hypoglycemia with glucose ≤36 mg/dL was significantly lower for the Afrezza TI Gen2 group than the insulin aspart group. The event rate for severe hypoglycemia trended lower for the Afrezza TIGen2 group (8.05 events per 100-subject months) vs the insulin aspart group (14.45 events per 100-subject months) but did not reach statistical significance. The numbers of events of severe hypoglycemia were low (8.05 per 100 subject-months vs 14.45 per 100 subject-months, p= 0.1022). For #4, I never heard Al say that or if I did I don't remember. On one of the factory tours there were a few ladies from the QA group. I specifically asked them about this. While it is not an official MNKD stance they did do non-refrigeration testing. I specifically asked them using the "2 years in a draw" line. She said she could not recommend doing this but it would be fine. I think Sam Finta has discussed leaving afrezza in his car and its been fine. This was why the Gates foundation was looking at Technosphere for African use. The Gates foundation only used the inhaler for Oxytocin. They didn't use Technosphere. Interesting, about the convo you had with the folks from the QA group. Thanks for sharing. wrong. The inhaler + API ( Oxytocin) stabilized on technosphere . The main advantage of technosphere was that , it didnt had to be refrigerated.let us know if thats not the case.
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Post by derek2 on Mar 3, 2017 7:51:51 GMT -5
The Gates foundation only used the inhaler for Oxytocin. They didn't use Technosphere. Interesting, about the convo you had with the folks from the QA group. Thanks for sharing. wrong. The inhaler + API ( Oxytocin) stabilized on technosphere . The main advantage of technosphere was that , it didnt had to be refrigerated. let us know if thats not the case. First: a correction. The Mintaka foundation is the partner. They got seed funding from the Gates Foundation. Second: The excipient was NOT Technosphere. "The OT dry powders were prepared by spray drying using excipients chosen to promote OT stability including trehalose, isoleucine, polyvinylpyrrolidone, citrate (sodium citrate and citric acid), and zinc salts (zinc chloride and zinc citrate)."\ No mention of Technosphere or FDKP www.mintakafoundation.org/wp-content/uploads/mannkind-Oxytocin-manuscript-reprint-15_0318.pdf www.mintakafoundation.org/heat-stable-oxytocin-to-prevent-maternal-death-in-childbirth/Another example of a truism that nobody questions because it is complementary to their investing thesis. This is often touted as proof that FDKP (Technosphere) stabilizes powders at room temp. Thing is: It wasn't used in this case. But you know what? Hooray for MNKD for being part of this humanitarian effort. They developed a cool inhaler and are sharing it for the greater good.
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Post by Deleted on Mar 3, 2017 8:00:27 GMT -5
wrong. The inhaler + API ( Oxytocin) stabilized on technosphere . The main advantage of technosphere was that , it didnt had to be refrigerated. let us know if thats not the case. First: a correction. The Mintaka foundation is the partner. They got seed funding from the Gates Foundation. Second: The excipient was NOT Technosphere. "The OT dry powders were prepared by spray drying using excipients chosen to promote OT stability including trehalose, isoleucine, polyvinylpyrrolidone, citrate (sodium citrate and citric acid), and zinc salts (zinc chloride and zinc citrate)."\ No mention of Technosphere or FDKP www.mintakafoundation.org/wp-content/uploads/mannkind-Oxytocin-manuscript-reprint-15_0318.pdf www.mintakafoundation.org/heat-stable-oxytocin-to-prevent-maternal-death-in-childbirth/Another example of a truism that nobody questions because it is complementary to their investing thesis. This is often touted as proof that FDKP (Technosphere) stabilizes powders at room temp. Thing is: It wasn't used in this case. But you know what? Hooray for MNKD for being part of this humanitarian effort. They developed a cool inhaler and are sharing it for the greater good. cool. This is news to many here . And thats why Mannkind is silent about this. Eye opening with facts
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