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Post by dreamboatcruise on Sept 30, 2015 15:40:46 GMT -5
dreamboatcruise you certainly could be right! The location of the clamp study is in Germany. Regardless though, I believe it's a much slower process to prove out than many want to admit. I think they will use everything in their arsenal to enhance the label and gain global approval. I think there could be more trials in the works in the future if need be. At the end of the day, Afrezza's science is superior. Once Sanofi is given the right to make bold claims, the advertising will start. Share price will follow. Like Al says (and Pfeffer references), "take care of the patients first and the stock value will follow." Management has indeed said that label improvement studies will occur, but also stated that they would first start all of the FDA mandated additional trials and THEN start the ones aimed at label improvement. Personally I would suspect that they are wanting to gather feedback from early patients in order to develop protocols for trials which will best demonstrate lowered A1c with low hypo risk across a wide range of patients.
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Post by cfield23 on Sept 30, 2015 15:51:22 GMT -5
dreamboatcruise you certainly could be right! The location of the clamp study is in Germany. Regardless though, I believe it's a much slower process to prove out than many want to admit. I think they will use everything in their arsenal to enhance the label and gain global approval. I think there could be more trials in the works in the future if need be. At the end of the day, Afrezza's science is superior. Once Sanofi is given the right to make bold claims, the advertising will start. Share price will follow. Like Al says (and Pfeffer references), "take care of the patients first and the stock value will follow." Management has indeed said that label improvement studies will occur, but also stated that they would first start all of the FDA mandated additional trials and THEN start the ones aimed at label improvement. Personally I would suspect that they are wanting to gather feedback from early patients in order to develop protocols for trials which will best demonstrate lowered A1c with low hypo risk across a wide range of patients. I think you're right!
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Post by mnkdnut on Sept 30, 2015 16:54:40 GMT -5
Nice post, cfield, and thanks for laying out your case. As a fellow marketer, I agree with most of your analysis and the general steps you put forth. I'd disagree on 2 main points however (and unfortunately). One: as others have mentioned, the clamp study was not designed to be able to expand the label to make claims about lower A1Cs, lower incidences of hypos, or any other clinical outcomes we need to claim superiority. I am hopeful that evidence from the clamp study and the PK&PD study will allow Sanofi to convince FDA to allow them to claim "faster acting" or similar. This would be a good intermediate step to being able to claim the superior clinical outcomes we believe to be true based on the early adopters. We still need a much larger and more comprehensive outcomes trial (the holy grail) to prove it clinically. Are they planning one in Europe or elsewhere - we just don't know. Two: I don't think we know enough about Sanofi's strategy to label it "brilliant" quite yet. At this point, with so little of their thinking disclosed, I'd say they are taking a thoughtful, sensible and cautious approach given the cards they were dealt.
As always with MNKD, it's all about patients and patience.
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Post by mssciguy on Sept 30, 2015 17:11:07 GMT -5
Nice post, cfield, and thanks for laying out your case. As a fellow marketer, I agree with most of your analysis and the general steps you put forth. I'd disagree on 2 main points however (and unfortunately). One: as others have mentioned, the clamp study was not designed to be able to expand the label to make claims about lower A1Cs, lower incidences of hypos, or any other clinical outcomes we need to claim superiority. I am hopeful that evidence from the clamp study and the PK&PD study will allow Sanofi to convince FDA to allow them to claim "faster acting" or similar. This would be a good intermediate step to being able to claim the superior clinical outcomes we believe to be true based on the early adopters. We still need a much larger and more comprehensive outcomes trial (the holy grail) to prove it clinically. Are they planning one in Europe or elsewhere - we just don't know. Two: I don't think we know enough about Sanofi's strategy to label it "brilliant" quite yet. At this point, with so little of their thinking disclosed, I'd say they are taking a thoughtful, sensible and cautious approach given the cards they were dealt. As always with MNKD, it's all about patients and patience. Good points, also (and this may have been covered already) the ads in the magazines seem to indicate via photos "convenience" but that's not enough for insurers to justify higher cost. We really really really need the superior pharmacokinetics, fast action and clearance, and reduced or non-existent hypoglycemic events to drive coverage on a wider scale to benefit more than just the "very niche" customers with superior benefits or deep pockets of their own. If it's medically the best thing for patients, the patients want it, the doctors want it, and the insurers might have to work a little harder for their large slice of the health care cost pie. Just my two cents fwiw.
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Post by scottiemac on Sept 30, 2015 17:40:13 GMT -5
LOL - instead of convenience, picture slack-jawed doctors looking at the patient's chart exclaiming over the drop in A1c numbers. Nicely illustrated with colored charts showing an arrow headed due south.
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Post by mssciguy on Sept 30, 2015 17:48:54 GMT -5
LOL - instead of convenience, picture slack-jawed doctors looking at the patient's chart exclaiming over the drop in A1c numbers. Nicely illustrated with colored charts showing an arrow headed due south. Yep that would work, but even the RAA long-acting insulins are on the A1c train now. What is so great about Afrezza is you get it without near-death (or worse) hypoglycemic events
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Post by cfield23 on Sept 30, 2015 18:47:44 GMT -5
Nice post, cfield, and thanks for laying out your case. As a fellow marketer, I agree with most of your analysis and the general steps you put forth. I'd disagree on 2 main points however (and unfortunately). One: as others have mentioned, the clamp study was not designed to be able to expand the label to make claims about lower A1Cs, lower incidences of hypos, or any other clinical outcomes we need to claim superiority. I am hopeful that evidence from the clamp study and the PK&PD study will allow Sanofi to convince FDA to allow them to claim "faster acting" or similar. This would be a good intermediate step to being able to claim the superior clinical outcomes we believe to be true based on the early adopters. We still need a much larger and more comprehensive outcomes trial (the holy grail) to prove it clinically. Are they planning one in Europe or elsewhere - we just don't know. Two: I don't think we know enough about Sanofi's strategy to label it "brilliant" quite yet. At this point, with so little of their thinking disclosed, I'd say they are taking a thoughtful, sensible and cautious approach given the cards they were dealt. As always with MNKD, it's all about patients and patience. Yes as you and others have mentioned, you're correct on the clamp study. My point was less about the specific study, but more around the fact that they need to work on label enhancements. I strongly believe the clamp study will be of use in helping them make more succinct claims about Afrezza. They'll be able to measure glucose levels right at the height of mealtime and thus might gain clearance to say something like "at least XX% better at lowering mealtime highs than Humalog" ... that type of statistical callout is one of the things they're in dire need of for advertising. Did you read this: quarterly.insigniam.com/leadership/how-sanofi-will-roll-out-new-products/ yet? I do believe their plan is to gain a grassroots following for their drugs..... and then, and only then, will they commit resources to launch fully. I think caring about the patient first is the best approach and something that Al Mann has always said. So while we can debate semantics over "brilliant" or whatever, the point was to draw attention to how they've handled it well so far, as compared with the constant complaining/bashing of the launch we're all so accustomed to seeing/reading/writing.
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Post by cfield23 on Sept 30, 2015 18:57:06 GMT -5
Nice post, cfield, and thanks for laying out your case. As a fellow marketer, I agree with most of your analysis and the general steps you put forth. I'd disagree on 2 main points however (and unfortunately). One: as others have mentioned, the clamp study was not designed to be able to expand the label to make claims about lower A1Cs, lower incidences of hypos, or any other clinical outcomes we need to claim superiority. I am hopeful that evidence from the clamp study and the PK&PD study will allow Sanofi to convince FDA to allow them to claim "faster acting" or similar. This would be a good intermediate step to being able to claim the superior clinical outcomes we believe to be true based on the early adopters. We still need a much larger and more comprehensive outcomes trial (the holy grail) to prove it clinically. Are they planning one in Europe or elsewhere - we just don't know. Two: I don't think we know enough about Sanofi's strategy to label it "brilliant" quite yet. At this point, with so little of their thinking disclosed, I'd say they are taking a thoughtful, sensible and cautious approach given the cards they were dealt. As always with MNKD, it's all about patients and patience. Good points, also (and this may have been covered already) the ads in the magazines seem to indicate via photos "convenience" but that's not enough for insurers to justify higher cost. We really really really need the superior pharmacokinetics, fast action and clearance, and reduced or non-existent hypoglycemic events to drive coverage on a wider scale to benefit more than just the "very niche" customers with superior benefits or deep pockets of their own. If it's medically the best thing for patients, the patients want it, the doctors want it, and the insurers might have to work a little harder for their large slice of the health care cost pie. Just my two cents fwiw. Exactly! So by spending just a little on advertising, they're taking a "first touch" approach where they're trying to familiarize the prospective patients with the fact that an inhaled option is available. This approach will almost certainly scoop up the "low hanging fruit", or better put, those who see the inhaler vs. injection as a top priority. Sanofi will get these patients to convert to scripts relatively quickly and inexpensively because it's important to them and because they aren't spending a whole lot on advertising. For those who see the ad but don't convert, they'll file it away in their brain as "oh that's cool" but because the advertising play is "convenience", they won't convert to scripts unless they're feeling like the current standard of care is less convenient or worse. However, and this is important, the next time they see an ad, they're more likely to engage and explore. For example, for banner ads, people have to see the ad 7 - 10 times on average before they decide to even click on it. You have to "touch" the same people with your brand and messaging many many times before they even recognize the brand and remember it. Then you have to convince them. Advertising takes time! This is the first stage!
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Post by james on Sept 30, 2015 20:03:52 GMT -5
Yes as you and others have mentioned, you're correct on the clamp study. My point was less about the specific study, but more around the fact that they need to work on label enhancements. I strongly believe the clamp study will be of use in helping them make more succinct claims about Afrezza. They'll be able to measure glucose levels right at the height of mealtime and thus might gain clearance to say something like "at least XX% better at lowering mealtime highs than Humalog" ... that type of statistical callout is one of the things they're in dire need of for advertising. Did you read this: quarterly.insigniam.com/leadership/how-sanofi-will-roll-out-new-products/ yet? I do believe their plan is to gain a grassroots following for their drugs..... and then, and only then, will they commit resources to launch fully. I think caring about the patient first is the best approach and something that Al Mann has always said. So while we can debate semantics over "brilliant" or whatever, the point was to draw attention to how they've handled it well so far, as compared with the constant complaining/bashing of the launch we're all so accustomed to seeing/reading/writing. cfield - I hope you can temper your expectation for the clamp study. The test is administered in a controlled office setting with glucose being administered via infusion (not orally) to a constant level which is maintained throughout the duration of the test. The primary metric being observed is 'glucose infusion rate (GIR)' along with insulin concentration and these are plotted through time. The purpose of the test is to help the provider determine appropriate dosing (dose response relationship and so forth) and perhaps in this case additional clarity about timing. Other than the fact that there are different dosing levels and a few more patients in this study, no one would expect it to yield new information. It certainly won't allow for statements about lowering mealtime highs as it is not occurring in the setting of a meal nor taking into consideration the action of other physiologic systems. It also says nothing about hypoglycemia as the glycemic level is held at a constant. All you can do in those regards is speculate what might be expected to happen from the shape of the curve. I don't know what EU requirement might be in play, but I believe the FDA required it because of the change in Afrezza unit designations from when the submitted clamp data from MKC-TI-176 / MKC-TI-177 was developed and the actual submission. In changing the unit designations, the equivalent subcutaneous dosages came into question and had to be provided as an extrapolation. This point was severely harped on by a couple of panel members and this test is cleaning up after that questionable decision which put approval at some risk. This was one of those very difficult to follow discussions (for me anyway) during the advisory committee meeting.
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Post by james on Sept 30, 2015 20:27:49 GMT -5
I don't know of which oral agents you are specifically referring to? I do think that diabetes is such a huge market that Afrezza doesn't need a big share of the market to become profitable. Thanks for your thorough reply! I'm perhaps guilty of parroting others who bring up a marketing push by the orals. Certainly I have seen plenty of commercials about Farxiga, Invokana, and Xeralto (I think those are the main ones) in the recent past. If it's possible to establish a moat around that category of drugs, their sponsors are certainly trying to do so. You've done a nice job of discussing their drawbacks. It would be a crime for Afrezza to fail due to disinterest because pills are perceived as easier. I very much agree with your questions on the other studies. And for goodness sakes why the holdup (other than the clamp study) in pursuing an EMA approval or at least more discussion about timeline for such? Are they still developing feedback from the US launch in determining how to go about this?
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Post by mbseeking on Sept 30, 2015 20:58:48 GMT -5
Believe the clamp study is T1 only. I would assume this would limit any claims that could be made for T2s. This is the huge untapped market for Afrezza , not T1.
Cfield23, your analysis makes a lot of sense. Believe you have identified the weaknesses , and hit upon a viable strategy . But if this clamp study does not give Sanofi what it needs to relabel , strengthen advertising message, what does?
You may be being too benign toward Sanofi - which is where the focus must now be to determine if Afrezza 1.0 will succeed. . There remains a chance they, Sanofi, are just going through the motions. This chance defined to me by the fact that script growth is too slow, and there is still no headway in better insurance coverage. Now add to these two items : pathway to a better label, on which this clamp study seems ambiguous. These are now all areas that Sanofi must address and for which we have zero direct communication on .
We knew where Viebacher stood on the MNKD deal : he inked it. But Brandicourt remains silent. Make this the 4th factor to watch on Sanofi's commitment. And if I recall correctly Brandicourt played an important related role at Pfizer during Exubera.
For me , right now the Sanofi marketing plan is either Brilliant, or its Asleep.
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Post by ricguy on Sept 30, 2015 21:34:16 GMT -5
nice post but your sticking your head in the sand if you think what is occurring is "brilliant". Things are not going the way mnkd expected, it's clear as day.
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Post by cfield23 on Sept 30, 2015 21:35:53 GMT -5
james yes I'm not betting the house on a single study, but I do think it will be a step in the right direction. I think at the very least it'll allow them to talk about dosing when proper vs "before the meal"... I'm with you. I think it's just a piece. @mbseeking I think it's too premature to compare or analyze Brandicourt's previous actions or current non actions. I am happy with the fact that I believe MNKD did their due diligence and selected who they truly believed would be abke to bring their product to market. I may be dead wrong, but I'm not going to work myself crazy thinking of all the possibilities for failure. I don't want to FUD all over myself I will just trust the process and see where we end up in the years ahead.
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Post by cfield23 on Sept 30, 2015 21:38:01 GMT -5
nice post but your sticking your head in the sand if you think what is occurring is "brilliant". Things are not going the way mnkd expected, it's clear as day. And what specifically would you have done differently?
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Post by mbseeking on Sept 30, 2015 21:48:28 GMT -5
nice post but your sticking your head in the sand if you think what is occurring is "brilliant". Things are not going the way mnkd expected, it's clear as day. And what specifically would you have done differently? Cfield23.. Differently? I believe you have nailed that already in your post. Fix the box labelling.. and then strong advertising can follow. You have articulated perfectly what is required to market this product. That's where we need committed executive leadership at Sanofi to make it happen. Remember internally at Sanofi, Afrezza competes with other home grown products. There is no middle level executive to speak up for it.. Brandicourt is it.
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