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Post by porkini on Dec 4, 2019 16:20:24 GMT -5
Interesting how all posts on this topic focus on what Mike said and not on the questions the analyst asked. The questions reflect what Wall Street analysts are thinking, and if there are other analysts with similar questions in their mind, it's easy to envision many analysts jumping on board at some point, hopefully in the near future. Questions like what is MNKD doing different than Sanofi and looking for distinctions between the epic failure of inhaled insulin a decade ago and Afrezza, seem to indicate that Afrezza is finally getting attention of the street. While presentations and slides are great, they give us no insight into the mind of the analysts. This conference let's us in on the thinking of those that will ultimately make a difference in the stock price. The questions were great and very encouraging. Based on the prepared questions, I am very optimistic! Do you remember what the prepared Qs were? I didn't get to hear it. I still didn't listen back to it, but here's a link from MNKD corporate where it is currently available to listen: event.webcasts.com/starthere.jsp?ei=1273979&tp_key=8e1d178a65
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Post by mounts on Dec 4, 2019 16:24:21 GMT -5
It’s getting the attention of the Street all right: down more than $.08 from yesterdays high to $1.22 I'll reply as I posted just above about MNKD getting some real attention from Wall Street. So in case you were referring to my post mnkd.proboards.com/post/192365/thread above, my post was intended for those invested in MNKD that don't monitor daily incremental stock movement to gauge if MNKD is top of mind of institutional investors. It was intended for those who see MNKD at a bargain at current share prices and have the patience to wait it out. Wall Street attention reflects real humans with desk jobs who take the time to form an opinion on a company. It's always easier to get their attention with new and shiny offerings or proven performers. Regaining interest in a stock already written-off is harder. Such is human nature. When you hear an analyst wake up from a slumber and say: hey! Sanofi failed why should you succeed? Or: hey! Exubera failed, why should you succeed; it's musical! This is an analyst that's new to the story. No one paying attention to MNKD over the last 18 months is grappling with such questions. Those reading SO articles every week, are busy counting weekly scripts. Questions about Sanofi and Exubera indicate that an analyst finally blew a lot of dust off a very old file relegated to the dustbin a long time ago. When such an analyst continues to ask questions about Bluehale, that means they're evaluating potentially disrupting a market with evolving technology. Mike nicely played along and mentioned the "AI" dimension, reinforcing Afrezza's potential game changing characteristics. Mike is aware or seemingly caught on that this analyst is focused on the future. Which is why he also likely mentioned why today's kids with diabetes will determine the standard of care of the future.
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Post by sayhey24 on Dec 4, 2019 18:54:33 GMT -5
Aged - MC named it - "Ultra Acting". I never liked the name "Ultra Rapid Acting" but "Ultra Acting" sets it apart. I have been holding my breath for a long time but he said they have 5 to 7 studies which will support this for February. A few more months at this point won't kill me. Mango mentioned about SoC changes. Maybe its related to the new category which would be exciting. We know the Indian study for the T2s is soon to start. This is the big one which you have wanted for years and is the one which should place afrezza right in the mix of T2 care. Of course it should be Step 1 but get getting it in for starters is a big win. Not a 2020 change but 2021 looks real. It will be interesting to see the CGM they use for the study. MC said 2020 is the year of the T1 and this time next year we should have pediatric approval which is huge. I don't think they will use ultra as the description, and not because it isn't or anything like that but rather because of the confusion it causes. We already have fast acting (Regular insulin believe it or not!) and rapid acting (RAA), which has people asking which is quicker and what does quicker mean? That said, the other insulin makers will want it because it's a marketing tool. The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro. Aged - the phrase "ultra acting" is what MC called it not me. He mentioned in another presentation a few months ago that Dr. Kendall was working with the ADA to get the new category defined but did not name it at the time. Maybe "ultra acting" is the new category name. Time will tell but "ultra acting" is much less confusing than "ultra rapid acting". It also sounds like the trial data which defined the category will be presented in February. "Ultra Acting" seems pretty understandable and not confusing at all; fast; rapid; and ultra seem pretty straight forward to me. Rapid acting refers to a group of analogs with a pretty similar profile. Afrezza is not an analog and its profile looks nothing like the "rapid acting" analogs. Will the other BPs want the "ultra acting" category - probably not. Mike defined in the talk what "ultra acting" is - after taking you watch the CGM and see when your blood sugars start coming down. Now thats a nice simple definition. He also talked about currently doctors not really knowing the speed profile of current insulins; "starting to work" and starting to bring down the sugars is night and day. Clearly, technology in the form of the CGM has moved the goal posts and now the bar is not set at A1c but rather real time speed. We talked about this happening right here on Proboards years ago but it has now become a reality. Assuming afrezza is the first "ultra acting" in the category fiasp and the rest will have to show non-inferiority to the ultra standard - 30 minutes. Its a simple test and a trial can be completed in 1 day. Line up 100 PWDs, give them a can of coke, and they take the afrezza. 3 hours later, give the same PWDs a can of coke and give them the fiasp. The question is will fiasp be as fast in/out as afrezza; aka "ultra acting. I doubt it and I bet so do the BPs. Aged - Mike has already publicly said the Indian study is using CGMs. Thats not the question. The question is which manufacturer. In this "talk" Mike mentioned Dexcom numerous times. Thats a bit of a change. Previously he talked a lot about the Libre. With T1s being the focus of 2020, promoting Dexcom makes a lot of sense as its more geared toward the Endos. The Libre more so for PCPs and T2s. In a study like this the eversense would probably make the most "sense" and our friends in Baltimore would probably jump at the chance to provide at no cost. Heck - their pps makes MNKD's look good.
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Post by mango on Dec 4, 2019 19:41:01 GMT -5
I don't think they will use ultra as the description, and not because it isn't or anything like that but rather because of the confusion it causes. We already have fast acting (Regular insulin believe it or not!) and rapid acting (RAA), which has people asking which is quicker and what does quicker mean? That said, the other insulin makers will want it because it's a marketing tool. The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro. Aged - the phrase "ultra acting" is what MC called it not me. He mentioned in another presentation a few months ago that Dr. Kendall was working with the ADA to get the new category defined but did not name it at the time. Maybe "ultra acting" is the new category name. Time will tell but "ultra acting" is much less confusing than "ultra rapid acting". It also sounds like the trial data which defined the category will be presented in February. "Ultra Acting" seems pretty understandable and not confusing at all; fast; rapid; and ultra seem pretty straight forward to me. Rapid acting refers to a group of analogs with a pretty similar profile. Afrezza is not an analog and its profile looks nothing like the "rapid acting" analogs. Will the other BPs want the "ultra acting" category - probably not. Mike defined in the talk what "ultra acting" is - after taking you watch the CGM and see when your blood sugars start coming down. Now thats a nice simple definition. He also talked about currently doctors not really knowing the speed profile of current insulins; "starting to work" and starting to bring down the sugars is night and day. Clearly, technology in the form of the CGM has moved the goal posts and now the bar is not set at A1c but rather real time speed. We talked about this happening right here on Proboards years ago but it has now become a reality. Assuming afrezza is the first "ultra acting" in the category fiasp and the rest will have to show non-inferiority to the ultra standard - 30 minutes. Its a simple test and a trial can be completed in 1 day. Line up 100 PWDs, give them a can of coke, and they take the afrezza. 3 hours later, give the same PWDs a can of coke and give them the fiasp. The question is will fiasp be as fast in/out as afrezza; aka "ultra acting. I doubt it and I bet so do the BPs. Aged - Mike has already publicly said the Indian study is using CGMs. Thats not the question. The question is which manufacturer. In this "talk" Mike mentioned Dexcom numerous times. Thats a bit of a change. Previously he talked a lot about the Libre. With T1s being the focus of 2020, promoting Dexcom makes a lot of sense as its more geared toward the Endos. The Libre more so for PCPs and T2s. In a study like this the eversense would probably make the most "sense" and our friends in Baltimore would probably jump at the chance to provide at no cost. Heck - their pps makes MNKD's look good. I agree on the Ultra Acting. Presents itself as being easily understandable and distinguishable. If this wasn’t a slip of the tongue, and is really what the new category will be called then I say, great. If not, oh well. And to repeat what you said, once Afrezza is the first in this Ultra Acting category, any and all other insulins will have to complete the appropriate clinical trial(s) to show at least non-inferiority to be considered for the same category—however, currently there is no insulin or insulin analog currently on the market or being developed that has a time-action profile anywhere close to being similar as Afrezza’s. Can’t wait til February!
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Post by ktim on Dec 4, 2019 20:38:58 GMT -5
How can they not use CGM’s ? Only works to our advantage in a big way . I would be very surprised if they did not .. from back in the day with Matt P / this whole thing was predicated on the cgm being implemented in our success.. the tool too prove our true superiority. The trial is apparently (I think there was some doubt) paid for by Cipla, and I confidently expect that Cipla will want to do just the minimum the same as Sanofi did. If Mannkind is paying for the trial then it's a different case and CGMs could definitely be an option. Use of CGM may be decided by the regulatory body. If it is anticipated that very few patients in India would have one due to financial constraints, the regulators might want to judge Afrezza outcomes without the patients having benefit of it. Though a blinded CGM could still be used to get TIR numbers. At least I would logically think that could be a factor.
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Post by ktim on Dec 4, 2019 20:50:54 GMT -5
I don't think they will use ultra as the description, and not because it isn't or anything like that but rather because of the confusion it causes. We already have fast acting (Regular insulin believe it or not!) and rapid acting (RAA), which has people asking which is quicker and what does quicker mean? That said, the other insulin makers will want it because it's a marketing tool. The protocol and plan for the India trial still has to be even filed. I am curious to see if they do use CGMs because it's an unnecessary expense for Cipro. ... Assuming afrezza is the first "ultra acting" in the category fiasp and the rest will have to show non-inferiority to the ultra standard - 30 minutes. Its a simple test and a trial can be completed in 1 day. Line up 100 PWDs, give them a can of coke, and they take the afrezza. 3 hours later, give the same PWDs a can of coke and give them the fiasp. The question is will fiasp be as fast in/out as afrezza; aka "ultra acting. I doubt it and I bet so do the BPs. ... No need for new trials. Peppy has been posting that pk/pd data for Afrezza and Fiasp for a very long time... and she even got it from FDA approved sources, the prescribing lit for each. So yes, given Peppy's diligence in posting it, I'd be 100% confident Novo is aware of the pk/pd profiles
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Post by letitride on Dec 4, 2019 21:01:21 GMT -5
The ultra acting coke challenge trial. I would love to see that presented to the ADA.
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Post by ktim on Dec 4, 2019 21:03:03 GMT -5
Aged - the phrase "ultra acting" is what MC called it not me. He mentioned in another presentation a few months ago that Dr. Kendall was working with the ADA to get the new category defined but did not name it at the time. Maybe "ultra acting" is the new category name. Time will tell but "ultra acting" is much less confusing than "ultra rapid acting". It also sounds like the trial data which defined the category will be presented in February. "Ultra Acting" seems pretty understandable and not confusing at all; fast; rapid; and ultra seem pretty straight forward to me. Rapid acting refers to a group of analogs with a pretty similar profile. Afrezza is not an analog and its profile looks nothing like the "rapid acting" analogs. Will the other BPs want the "ultra acting" category - probably not. Mike defined in the talk what "ultra acting" is - after taking you watch the CGM and see when your blood sugars start coming down. Now thats a nice simple definition. He also talked about currently doctors not really knowing the speed profile of current insulins; "starting to work" and starting to bring down the sugars is night and day. Clearly, technology in the form of the CGM has moved the goal posts and now the bar is not set at A1c but rather real time speed. We talked about this happening right here on Proboards years ago but it has now become a reality. Assuming afrezza is the first "ultra acting" in the category fiasp and the rest will have to show non-inferiority to the ultra standard - 30 minutes. Its a simple test and a trial can be completed in 1 day. Line up 100 PWDs, give them a can of coke, and they take the afrezza. 3 hours later, give the same PWDs a can of coke and give them the fiasp. The question is will fiasp be as fast in/out as afrezza; aka "ultra acting. I doubt it and I bet so do the BPs. Aged - Mike has already publicly said the Indian study is using CGMs. Thats not the question. The question is which manufacturer. In this "talk" Mike mentioned Dexcom numerous times. Thats a bit of a change. Previously he talked a lot about the Libre. With T1s being the focus of 2020, promoting Dexcom makes a lot of sense as its more geared toward the Endos. The Libre more so for PCPs and T2s. In a study like this the eversense would probably make the most "sense" and our friends in Baltimore would probably jump at the chance to provide at no cost. Heck - their pps makes MNKD's look good. I agree on the Ultra Acting. Presents itself as being easily understandable and distinguishable. If this wasn’t a slip of the tongue, and is really what the new category will be called then I say, great. If not, oh well. And to repeat what you said, once Afrezza is the first in this Ultra Acting category, any and all other insulins will have to complete the appropriate clinical trial(s) to show at least non-inferiority to be considered for the same category—however, currently there is no insulin or insulin analog currently on the market or being developed that has a time-action profile anywhere close to being similar as Afrezza’s. Can’t wait til February! That is pure speculation. I'd certainly take a bet against that being the case. Think far more likely if they (one or the other of FDA or ADA) do come up with a naming differentiator, it would simply be based on some thresholds for the pd profile. If you're speculation is correct then it seems Lispro would immediately qualify for this "Ultra" because MNKD's own trials used for approval would show Lispro non-inferior to Afrezza.
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Post by mango on Dec 4, 2019 21:29:37 GMT -5
I agree on the Ultra Acting. Presents itself as being easily understandable and distinguishable. If this wasn’t a slip of the tongue, and is really what the new category will be called then I say, great. If not, oh well. And to repeat what you said, once Afrezza is the first in this Ultra Acting category, any and all other insulins will have to complete the appropriate clinical trial(s) to show at least non-inferiority to be considered for the same category—however, currently there is no insulin or insulin analog currently on the market or being developed that has a time-action profile anywhere close to being similar as Afrezza’s. Can’t wait til February! That is pure speculation. I'd certainly take a bet against that being the case. Think far more likely if they (one or the other of FDA or ADA) do come up with a naming differentiator, it would simply be based on some thresholds for the pd profile. If you're speculation is correct then it seems Lispro would immediately qualify for this "Ultra" because MNKD's own trials used for approval would show Lispro non-inferior to Afrezza. You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up...
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Post by ktim on Dec 4, 2019 21:37:00 GMT -5
That is pure speculation. I'd certainly take a bet against that being the case. Think far more likely if they (one or the other of FDA or ADA) do come up with a naming differentiator, it would simply be based on some thresholds for the pd profile. If you're speculation is correct then it seems Lispro would immediately qualify for this "Ultra" because MNKD's own trials used for approval would show Lispro non-inferior to Afrezza. You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up... I actually haven't seen any concrete information about this proposed new category. If you know of some please forward links to it. I believe it is all speculation at this point. If you are agreeing that it likely would be based on pk/pd then there needn't be trials pitting any drugs against each other since the pk/pd profiles are already known for every insulin and it would only require deciding on a threshold for what what would be considered ultra rapid.
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Post by agedhippie on Dec 4, 2019 22:48:54 GMT -5
That is pure speculation. I'd certainly take a bet against that being the case. Think far more likely if they (one or the other of FDA or ADA) do come up with a naming differentiator, it would simply be based on some thresholds for the pd profile. If you're speculation is correct then it seems Lispro would immediately qualify for this "Ultra" because MNKD's own trials used for approval would show Lispro non-inferior to Afrezza. You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up... They are not going to move off A1c as the gold standard for a few more years I suspect. It is going to take solid data to prove better outcomes for TIR and that work is only just starting. Right now TIR is promoted as a way of lowering A1c rather than less complications. Rapid PK/PD is one way to get good TIR, never going out of range in the first place is another and that's the approach used by the new pumps (the Medtronics 780G has an over 80% TIR with trial data to support that). The ADA is going to need to see evidence that a new class makes sense, and that evidence is going to have to be outcome based which currently is not there. The only way I see around that is if Lilly and Novo throw their weight behind a new class and that's not going to happen unless they are in it.
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Post by ktim on Dec 5, 2019 0:32:28 GMT -5
You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up... They are not going to move off A1c as the gold standard for a few more years I suspect. It is going to take solid data to prove better outcomes for TIR and that work is only just starting. Right now TIR is promoted as a way of lowering A1c rather than less complications. Rapid PK/PD is one way to get good TIR, never going out of range in the first place is another and that's the approach used by the new pumps (the Medtronics 780G has an over 80% TIR with trial data to support that). The ADA is going to need to see evidence that a new class makes sense, and that evidence is going to have to be outcome based which currently is not there. The only way I see around that is if Lilly and Novo throw their weight behind a new class and that's not going to happen unless they are in it.I wouldn't necessarily assume that is the case. At least from FDA's perspective they might decide that having a different descriptor simply provides useful information about the action profile... as in this is "ultra rapid" so you probably shouldn't pre-bolus by a significant amount of time and you might need to take follow on doses because it doesn't stick around as long. Not necessarily trying to indicate superiority, just difference in action that patients/doctors should be aware of. Question for FDA would seem to be does a distinction add useful information or needlessly add complication. To me it would seem useful to highlight that dosing will not be the same for Afrezza (or a similarly fast insulin). Though I could also see that if there is Fiasp and the new Lily one and it seems more like there is a continuum of speed profiles, it might be more confusing drawing a line somewhere implying everything on one side the same and everything on the other different. I'd also suspect those may be the types of questions being contemplated. Now if you're saying the ADA isn't going to recommend "ultra rapids" specifically without trials showing superior clinical outcomes, that I would agree with.
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Post by mango on Dec 5, 2019 2:10:51 GMT -5
You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up... I actually haven't seen any concrete information about this proposed new category. If you know of some please forward links to it. I believe it is all speculation at this point. If you are agreeing that it likely would be based on pk/pd then there needn't be trials pitting any drugs against each other since the pk/pd profiles are already known for every insulin and it would only require deciding on a threshold for what what would be considered ultra rapid. Exactly right, the PK/PD profile. It’s only logical to have Afrezza in a category separate from the others, it’s PK/PD profile is far too different and so it is incorrect to classify it as rapid-acting when it looks nothing similar to any of the rapid acting analogs (which all have similar profiles and thus can be grouped together).
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Post by sayhey24 on Dec 5, 2019 6:32:02 GMT -5
You’re referring to non-inferior A1C results, correct? This new category has nothing to do with that. It has everything to do with the information that Peppy always post, remember? You even brought it up... They are not going to move off A1c as the gold standard for a few more years I suspect. It is going to take solid data to prove better outcomes for TIR and that work is only just starting. Right now TIR is promoted as a way of lowering A1c rather than less complications. Rapid PK/PD is one way to get good TIR, never going out of range in the first place is another and that's the approach used by the new pumps (the Medtronics 780G has an over 80% TIR with trial data to support that). The ADA is going to need to see evidence that a new class makes sense, and that evidence is going to have to be outcome based which currently is not there. The only way I see around that is if Lilly and Novo throw their weight behind a new class and that's not going to happen unless they are in it. Aged - If you listen to the "talk" again - granted the audio could be better, what you are asking for is exactly what MC said. He said 5 to 7 presentations have been accepted for February which form the basis for the new category. Maybe, just maybe Dr Kendall was able to throw his weight around and deliver. He told us this was the easiest job he has ever had. Maybe we will need to start calling him "the milkman". For this category I don't think its TIR, I think it is as describe above - time to start lowing sugars. TIR has too many factor including over what period for example - 2 hours, 8 hours - 24 hours. Based on the STAT study afrezza was 100% TIR for the 2 hour and 8 hour TIR.
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Post by peppy on Dec 5, 2019 6:58:55 GMT -5
I do not understand how Fiasp can be considered for the ultra rapid mealtime insulin category. Must be the time to first measurable effect. Niacin?
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