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Post by dudley on Jul 18, 2016 18:13:23 GMT -5
I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. The clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence.
On a personal satisfaction level it also validates my "the laws of nature and statistics do not lie" mantra. I've always felt that ANY patient who tries Afrezza with proper titration should experience the same sort of benefit that we have seen so frequently by other users since monomeric insulin should work essentially the same way in any given human body. Now there is a scientifically valid study that demonstrates that precisely. The new sample packs should provide adequate time for titration so there is no reason that the vast majority of patients on the new sample packs will not be having this superior outcome and then be raving about THEIR results (thus creating the rapid growth curve investors have long hoped for). The 10 day packs used by Sanofi never came close to really unleashing this phenomenon and was a major reason for the slow uptake - in fact was probably detrimental since patients who quit probably told others they saw no benefit.
I like the energy of the 2.0 team, the new sample pack strategy, the nurse educator desk, the call support, reimbursement assistance team, lots of things that seemed to be completely missing from the Sanofi debacle. Cash has been a concern as long as I have been around MNKD so nothing new there. There has to be an element of hoping for the best with this investment and I think Matt will find a way to get cash when push comes to shove. I'm feeling pretty good about the clamp study results and the new sample packs waiting to give the Afrezza miracle to lots and lots of new patients.
Just my thoughts for whatever they may be worth. Sometimes it's nice to see something optimistic.
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Post by babaoriley on Jul 18, 2016 18:50:22 GMT -5
dudley, great sentiments!! But, it sounds like after more than 100 days on the wagon, you have fallen off.  Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can! Do we all agree that the reps can legitimately sing the praises of the clamp study to the docs they visit? I believe they can, anyone out there think differently? |
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Post by dudley on Jul 18, 2016 19:21:46 GMT -5
Baba, this is really hard to nail down definitively. I was researching last year and came up with FDA Modernization Act"The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use."
"The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners." It seems to me that they have already disseminated the information by publishing it in the press release and there are also numerous articles about it now as well. It is an official study sanctioned by the FDA and filed accordingly. I can't imagine that mentioning this study in conversations with doctors or patients or emailing a link to the press release is going to be against the law. How can telling someone the study exists and is on public record - which it IS - against the law? Better legal minds than mine may disagree but it seems to me almost impossible that this will not come up in conversations in doctor offices if push comes to shove. There are plenty of regulations that get ignored believe it or not. As to regressing to my hopeless gambler state, what can I say? Gotta play to win, right? |
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Post by Deleted on Jul 18, 2016 19:24:08 GMT -5
Kowalaski is a DR by PhD ... Not medicine and he is a scientist
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Post by cm5 on Jul 18, 2016 20:11:57 GMT -5
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Post by mnkdfann on Jul 18, 2016 20:40:13 GMT -5
Kowalaski is a DR by PhD ... Not medicine and he is a scientist Good thing or bad thing? |
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Post by sweedee79 on Jul 18, 2016 21:09:45 GMT -5
dudley, great sentiments!! But, it sounds like after more than 100 days on the wagon, you have fallen off. Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can! Do we all agree that the reps can legitimately sing the praises of the clamp study to the docs they visit? I believe they can, anyone out there think differently? It is my understanding that the reps cant push anything that isn't on the label... unless the docs specifically asks the rep for info on the clamp study..... I could be wrong but I don't think so.. if so our hands are still tied by the label, however, Matt stated at the last annual shareholder meeting that they would be seeking label changes yet this year, using the clamp study.. |
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Post by dreamboatcruise on Jul 18, 2016 21:48:13 GMT -5
dudley, great sentiments!! But, it sounds like after more than 100 days on the wagon, you have fallen off. Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can! Do we all agree that the reps can legitimately sing the praises of the clamp study to the docs they visit? I believe they can, anyone out there think differently? A year ago or more I happened to overhear a conversation at a doctors office between doctor and sales rep. Reading between the lines of what I heard it would seem that sales reps are not allowed to talk about medical papers, but rather must stick to very constrained literature that has been vetted... but if a doctor is interested in talking about papers in medical literature, the sales rep can put them in touch with someone within the company qualified to have that discussion... i.e. another doctor or researcher. Seems like a reasonable policy to me. It might be an issue of compensation as well as qualification. Probably wouldn't want a sales person spinning papers even if they were an M.D. themselves. Separation of powers... or some such. |
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Post by centralcoastinvestor on Jul 18, 2016 22:19:54 GMT -5
Welcome back! It sure doesn't hurt to hear optimism from time to time.
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Post by mnkdnut on Jul 18, 2016 23:44:17 GMT -5
I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. T he clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence. Hate to be a wet blanket, but the clamp study does nothing to refute the non-inferior clinical trial results. MNKD still has to show that the speed advantage results in actual outcomes that matter (eg. lowering A1C, lower hypos, etc.). I think Mike's intent is that FDA will allow the label to say "faster", and that will enable the reps to convince more docs to give it a try. That's the slow, grinding one-patient-at-a-time process we're stuck with without convincing superiority data, but the PK/PD becomes the hook. I think a time-in-range study that Mike mentioned would be a big help, but I'm not sure it's even started yet. Sounds like an attempt to generate fresh superiority data will be done in the pediatric study first. Just add patience and money. |
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Post by peppy on Jul 19, 2016 9:17:53 GMT -5
I bailed on MNKD last March intending to wait and watch. I re-entered today once it broke under $1. The single biggest reason I re-entered was the clamp study which definitively shows both the rapid in and rapid out quality of Afrezza. Even though most people who follow MNKD with any attention already know about this, the company has been hamstrung by not being able to speak of it. There are many articles now about it, word has to be circulating amongst the endo population and others. We have a leading doctor in the field (Dr. Kowalski) definitively stating "The drug is simply astounding". These are very tangible and verifiable aspects that did not exist previously - almost all the eye-popping results were from current users and open to the "yes, but they are biased and how do we know they are telling the truth?" argument. I'm very impressed with Mike Castagna - I think Matt made a stellar choice there. There seems to be a coherent and effective plan to move forward and of course Afrezza is just as good as it has always been. I might regret the decision to re-enter but I just feel optimistic that things are heading the right direction and the company has some mojo. T he clamp study is key - now there is published, easily verifiable evidence of clear superiority. Although not on the label -yet - it is still a quantum leap over the only other previously published information which of course was the clinical trial data showing only non-inferiority. I think that is huge and will be a factor in convincing both doctors and patients who were previously on the fence. Hate to be a wet blanket, but the clamp study does nothing to refute the non-inferior clinical trial results. MNKD still has to show that the speed advantage results in actual outcomes that matter (eg. lowering A1C, lower hypos, etc.). I think Mike's intent is that FDA will allow the label to say "faster", and that will enable the reps to convince more docs to give it a try. That's the slow, grinding one-patient-at-a-time process we're stuck with without convincing superiority data, but the PK/PD becomes the hook. I think a time-in-range study that Mike mentioned would be a big help, but I'm not sure it's even started yet. Sounds like an attempt to generate fresh superiority data will be done in the pediatric study first. Just add patience and money. Mnkdnut: Afrezza users say they feel better. That is an actual outcome that matters/ will matter.
Dudley, nice to see you. Yes, on the clamp study. Spectacular. Hard to believe the laws are set up, so the rep can only restate what is on the label. What seems reasonable to me is the following conversation. "The FDA upon afrezza approval mandated a euglycemic clamp study. Peer review papers are being written. The clamp study results, Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U Lispro.
Cmax and AUC for Afrezza and Lispro were approximately doseproportional
over the dose range studied
• Each 4 unit Afrezza cartridge provides approximately the same
insulin exposure as 3.1 U Lispro"
Hard to believe talking to the physician about the FDA mandated euglycemic clamp study results is against the law.
www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
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Post by Deleted on Jul 19, 2016 9:56:33 GMT -5
dudley, great sentiments!! But, it sounds like after more than 100 days on the wagon, you have fallen off. Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can! Do we all agree that the reps can legitimately sing the praises of the clamp study to the docs they visit? I believe they can, anyone out there think differently? A year ago or more I happened to overhear a conversation at a doctors office between doctor and sales rep. Reading between the lines of what I heard it would seem that sales reps are not allowed to talk about medical papers, but rather must stick to very constrained literature that has been vetted... but if a doctor is interested in talking about papers in medical literature, the sales rep can put them in touch with someone within the company qualified to have that discussion... i.e. another doctor or researcher. Seems like a reasonable policy to me. It might be an issue of compensation as well as qualification. Probably wouldn't want a sales person spinning papers even if they were an M.D. themselves. Separation of powers... or some such. I wonder if Mike can handle some of those calls. Its similar to a second voice approach in sales. |
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Post by babaoriley on Jul 19, 2016 10:35:40 GMT -5
Baba, this is really hard to nail down definitively. I was researching last year and came up with FDA Modernization Act"The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use."
"The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners." It seems to me that they have already disseminated the information by publishing it in the press release and there are also numerous articles about it now as well. It is an official study sanctioned by the FDA and filed accordingly. I can't imagine that mentioning this study in conversations with doctors or patients or emailing a link to the press release is going to be against the law. How can telling someone the study exists and is on public record - which it IS - against the law? Better legal minds than mine may disagree but it seems to me almost impossible that this will not come up in conversations in doctor offices if push comes to shove. There are plenty of regulations that get ignored believe it or not. As to regressing to my hopeless gambler state, what can I say? Gotta play to win, right? Thanks, Dudley, much appreciated. Regulations ignored? Oh, you just must be kidding! |
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Post by oldfishtowner on Jul 19, 2016 10:37:05 GMT -5
I bailed on MNKD last March intending to wait and watch. ....... I like the energy of the 2.0 team, the new sample pack strategy, the nurse educator desk, the call support, reimbursement assistance team, lots of things that seemed to be completely missing from the Sanofi debacle. Cash has been a concern as long as I have been around MNKD so nothing new there. There has to be an element of hoping for the best with this investment and I think Matt will find a way to get cash when push comes to shove. I'm feeling pretty good about the clamp study results and the new sample packs waiting to give the Afrezza miracle to lots and lots of new patients. Just my thoughts for whatever they may be worth. Sometimes it's nice to see something optimistic. I agree that there will be no difficulty finding the needed cash, particularly if the PPS stays above $1. The only question as stockholders is - at what cost to us? Obviously, the higher the PPS the less pain we will feel if an equity sale or exercising the ATM facility is needed. So from here on out it is all about execution of the marketing plan and achieving a significant increase in scripts in a short amount of time. As you say, here's hoping management will succeed. |
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Post by dreamboatcruise on Jul 19, 2016 12:11:01 GMT -5
Baba, this is really hard to nail down definitively. I was researching last year and came up with FDA Modernization Act"The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use."
"The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners." It seems to me that they have already disseminated the information by publishing it in the press release and there are also numerous articles about it now as well. It is an official study sanctioned by the FDA and filed accordingly. I can't imagine that mentioning this study in conversations with doctors or patients or emailing a link to the press release is going to be against the law. How can telling someone the study exists and is on public record - which it IS - against the law? Better legal minds than mine may disagree but it seems to me almost impossible that this will not come up in conversations in doctor offices if push comes to shove. There are plenty of regulations that get ignored believe it or not. As to regressing to my hopeless gambler state, what can I say? Gotta play to win, right? Some of this is regulation rather than law... i.e. rules that FDA has created pursuant to the authority given to them under law. Sometimes there are grey areas as to when an agency has overstepped its bounds. Sometimes even when an agency oversteps its bounds there may be reasons why a particular company would choose to not be the one testing and pushing beyond those bounds. As most of us are well aware, having enemies at the FDA may not be the best position to be in. It does appear that the FDA takes a different view of general dissemination of information vs marketing aimed at doctors vs marketing aimed at consumers. This approach seems reasonable to me in general. Something that you might tell potential investors about a possible benefit of the medication might be inappropriate to tell doctors unless in the full context of the statistical limitations of a particular study, and what you tell doctors may not be suitable for a TV commercial aimed at patients. It seems like that new change in law you cite is not necessarily changing this concept but rather changing the process to allow companies to make there own determinations in certain circumstances about what meets the standards of appropriateness for each type of communication... act first as long as in good faith you believe you'll get permission later. Seems consistent with trend towards "self regulation" that have occurred in many industries. my 1 cent worth. |
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Well, okay, you know what you need to do, call your sponsor and get to a meeting as soon as you can!
