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Post by slugworth008 on Jun 30, 2018 9:20:54 GMT -5
If you own stock listen to the webcast. You will then be assured where this is going! 16 people called me yesterday and asked me what I thought of the call because they didn’t listen to it. Do your own gosh darn homework! Don’t ask somebody else to. You have to hear it or see it with your own ears:-) They got this! Was it a good call Sports.  I know they got this (it was a good call IMO) but golly jeepers creepers can the PPS get off the floor. Geez already. |
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Post by steve on Jun 30, 2018 12:07:55 GMT -5
If you own stock listen to the webcast. You will then be assured where this is going! 16 people called me yesterday and asked me what I thought of the call because they didn’t listen to it. Do your own gosh darn homework! Don’t ask somebody else to. You have to hear it or see it with your own ears:-) They got this! Yeah, I saw that the other day. Then they got pissy with you when you told them that. The one guy which is posting on stocktwits all day said he didn't have the time?!!!! Wtf! |
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Post by uvula on Jun 30, 2018 12:24:17 GMT -5
If you own stock listen to the webcast. You will then be assured where this is going! 16 people called me yesterday and asked me what I thought of the call because they didn’t listen to it. Do your own gosh darn homework! Don’t ask somebody else to. You have to hear it or see it with your own ears:-) They got this! Yeah, I saw that the other day. Then they got pissy with you when you told them that. The one guy which is posting on stocktwits all day said he didn't have the time?!!!! Wtf! I don't have time to follow stocktwits. What did the guy say? |
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Post by agedhippie on Jun 30, 2018 12:29:20 GMT -5
All we need it the major JDRF trial...  More seriously that trial was key and without it I doubt they would be covering CGMs yet. The insurers really did not want to cover CGMs because they are expensive so they argued for them as adjunct therapy (the argument Medicare finally gave up last year after 11 years) and unproven since there had been no big trial. Even then they managed to get kids largely excluded. Aged - any idea of the relationship/timeframe between CGM approval, when they got into the standard of care and insurance? The CGM got it's first mention in the Standard of Care in 2009 on the back of the JDRF trial, so three years after FDA approval. The wording left a lot of wiggle room and the insurers took full advantage and made the preauthorization phase as difficult as possible (C-peptide scores, documented hypo unaware, poor A1c, everything!) The real change came in 2014 as an outcome from the ASPIRE trial when they said that pump/CGM combinations for Type 1 diabetics "should be strongly encouraged". At that point the insurers pretty much rolled over. So eight years between FDA approval and routine approval. The early CGMs were not very accurate and it was a lot of work to keep them on target (I still have a Dexcom Seven somewhere) and you had to be careful what fingerstick data you gave it or it would wander completely off target and you had to restart the sensor. I skipped the Seven Plus and the G4 because they were to much work. I got the G5 because it pretty much runs itself without much intervention. Low friction is important. |
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Post by steve on Jun 30, 2018 12:56:09 GMT -5
He said he was too busy and wanted sports to fill him in. I can't remember what exactly. he just got testy. Said he had a life blah blah blah and did not have time to listen to it. I am going to listen to it a second time yet. I thought it was very worth while as an investor to listen to this. Makes me wonder how many people there are not another variety of charlatan/trolls.
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Post by uvula on Jun 30, 2018 13:27:55 GMT -5
He said he was too busy and wanted sports to fill him in. I can't remember what exactly. he just got testy. Said he had a life blah blah blah and did not have time to listen to it. I am going to listen to it a second time yet. I thought it was very worth while as an investor to listen to this. Makes me wonder how many people there are not another variety of charlatan/trolls. Sorry to cause you to type all this. I guess I should have added a smiley face to my previous comment. |
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Post by compound26 on Jul 18, 2018 14:40:44 GMT -5
My "take"on the stat study has been determined in part on the actual results, which by and large seem actually pretty good, but also on what I consider to be the promise of what it has shown us and for which Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes. When the stat study first came out I was expecting more positive comments from people. I am not a true science person so I was a bit confused at what I thought was the underwhelming response to the study, espcially given a few people on this board whom I respect for their science background that did not see the merits as very positive.. But upon further study and hearing more comments it is now my personal beleif that the stat study results are quite positive and lay the groundwork for the new mannkind and the new conversation about Afrezza that goes with it. That conversation imho is as follows: 1. Stat study showed how Afrezza can accomplish exactly, if not better control, as what an RAA can accomplish in less time with less hypos. To me, this in and of itself is good news. You can debate whether or not the numbers are statiscally relevant. Does it make Afrezza superior? I beleive it does. 2. Now the promise... what the study did not do is show how Afrezza can work to keep better control and TIR at significanntly lower levels of fasting BG which would require in many cases higher does of basal insulin and/or adjusments to prandial dosing. But as we know from the many anecdotal posters on social media, they are getting non diabetic numbers in the 5's and even more of them in the low to mid 6's for Hba1c's using Afrezza by targeting lower fasting BG at anywhere from 120 to 140. So why didn't the stat study show this as a goal? because imho it could not as a first of its kind study with a comparison to RAA's as its basis, since doing so would require dosing that most docs will not do with traditional RAA insulins as it would drive pwd into more severe hypos. (The stat study targeted 160 for fasting BG.) A separate study targeting lower BG will likely have to be done under more direct management if a comparison is done or with Afrezza only. THIS is the NEW story that could not be told now without the stat study... Remember that the ADA recently raised the acceptable Hba1c level to 8 from 7 or so because it has been too hard to get pwd to the lower levels without hypos and compliance is difficult with all that it entails for a T1. Afrezza changes all of this. Just think if you can now get pwd to a range of 5.5 to 6.5 with the same or less hypos... You don't think this would have to be the new SOC? And this is what Dr. likely meant when stating that Afrezza should be the SOC. Now again I do not have diabetes and I am not a science person so someone with a better understanding may be able to correct me if I have mispoken and hope they will but what imho I beleive is the true value of the stat study is the conversation Dr. K and the reps can now have with other docs that they had no basis for prior to the stat study... After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#Based on Dr. Kendall’s presentation, here are my thoughts: 1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185. You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front. 2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves. Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “ based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media. Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level. 3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care. 4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data. Listened to the presentation a couple of more times (I probably have listened to it a dozen times all together). A few additionally observations: a. You can really feel Dave’s excitement and confidence. E.g., where he says his CMO job will be one of the easiest job (giving the data he already possess). b. Dave noted every time he looked at the STAT trial result data, he is getting more excited. Afrezza is providing improvement in four areas at the same time, 1. Using more insulin, 2. better BG level, 3, better Time In Range, and 4, few Hypos. No prior generation of insulin can provide improvement in all these areas at the same time. c. Dave noted that he does not see any competition to Afreza within next 15 years. d. Mike noted that they have been working to get the necessary data together so that they have a complete package to present to the doctors (while at the same time making sure that they are in compliance with FDA requirements) and they finally have such complete package of data by this ADA meeting to show what this drug can do with proper titration. e. Steve noted that when he provided samples to T1s and get them to try them, 80-90% would like to get a prescription. f. Dave noted that they recently hired a very experienced diabetes regulatory consultant and are working/planning (?) on a few very short term label-enabling studies with respect to PK and safety data (if I recall correctly). g. Mike and Dave’s goal is to “ let it be known and let it be fully known” (regarding increasing the awareness of Afreza) h. Mike and Dave now seem to have a firm grasp on the correct dosage and titration of Afrezza (note that Dave commented that they are increasingly aware that an injectable unit does not equal to an inhalable unit and that the same user may need to use 1.5 to 2.0 times of inhalable units to replace one injectable unit). i. At one point, Dave referred to Afrezza as ultra-rapid-acting insulin, though he immediately noted that FDA currently has not created a separate class for Afrezza. |
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Post by pguererro on Jul 24, 2018 20:43:34 GMT -5
Kendall heading to Canada for a week
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Post by tomtabb on Jul 25, 2018 14:52:20 GMT -5
Kendall heading to Canada for a week Scientific meeting? |
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Post by babaoriley on Jul 25, 2018 15:26:32 GMT -5
After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#Based on Dr. Kendall’s presentation, here are my thoughts: 1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185. You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front. 2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves. Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “ based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media. Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level. 3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care. 4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data. Listened to the presentation a couple of more times (I probably have listened to it a dozen times all together). A few additionally observations: a. You can really feel Dave’s excitement and confidence. E.g., where he says his CMO job will be one of the easiest job (giving the data he already possess). b. Dave noted every time he looked at the STAT trial result data, he is getting more excited. Afrezza is providing improvement in four areas at the same time, 1. Using more insulin, 2. better BG level, 3, better Time In Range, and 4, few Hypos. No prior generation of insulin can provide improvement in all these areas at the same time. c. Dave noted that he does not see any competition to Afreza within next 15 years. d. Mike noted that they have been working to get the necessary data together so that they have a complete package to present to the doctors (while at the same time making sure that they are in compliance with FDA requirements) and they finally have such complete package of data by this ADA meeting to show what this drug can do with proper titration. e. Steve noted that when he provided samples to T1s and get them to try them, 80-90% would like to get a prescription. f. Dave noted that they recently hired a very experienced diabetes regulatory consultant and are working/planning (?) on a few very short term label-enabling studies with respect to PK and safety data (if I recall correctly). g. Mike and Dave’s goal is to “ let it be known and let it be fully known” (regarding increasing the awareness of Afreza) h. Mike and Dave now seem to have a firm grasp on the correct dosage and titration of Afrezza (note that Dave commented that they are increasingly aware that an injectable unit does not equal to an inhalable unit and that the same user may need to use 1.5 to 2.0 times of inhalable units to replace one injectable unit). i. At one point, Dave referred to Afrezza as ultra-rapid-acting insulin, though he immediately noted that FDA currently has not created a separate class for Afrezza. Hey, Compound, I've probably watched Godzilla more than 25 times, admittedly most of those times was when I was less than 12, but I still don't believe the entire story.... |
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Post by compound26 on Jul 25, 2018 15:37:36 GMT -5
babaoriley , I will soon break your record of 28 times by listening to the Mannkind corp. post ADA meeting presentations a couple of times every day. I don't know if I believe the entire story either....
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Post by hellodolly on Jul 25, 2018 15:38:57 GMT -5
Kendall heading to Canada for a week Scientific meeting? Canadian kind of science. |
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Post by golfeveryday on Jul 25, 2018 18:10:17 GMT -5
Canadian kind of science. Meeting with Health Canada to confirm submission requirements for approval? |
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Post by pguererro on Jul 25, 2018 18:40:40 GMT -5
Not sure of specific reason
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Post by mnkdfann on Jul 25, 2018 19:26:28 GMT -5
Not sure of specific reason So for all you know he may just be taking vacation, possibly attending the Just for Laughs Comedy Festival this month in Montreal? Do you have any reason to believe his visit is business related? What was your source for your initial comment? |
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