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Post by agedhippie on Oct 30, 2022 13:07:25 GMT -5
We are discussing different thing here. You are talking about a meal time response, and I am talking about a systemic state. It's a macro vs. micro scope, neither is right or wrong but just different. Carb counting is rather more complicated than that, I wish all carb loads were equal  OK - point me to some research papers on what you are talking about. What I am talking about is insulin resistance after post prandial response by the pancreas with T2s. The longer you let the pancreas try and get the blood sugar down the more afrezza you need. This is basically the feedback diagram the Wensveens have in their paper. Its also interesting in that if you stop the spike with afrezza and get the PWD back to a non-diabetic baseline over several months it seems to take less afrezza to get the same response. Maybe this is what Al Mann was seeing and why he talked about reversing the condition. Al didn't spend $1B without research backing it up. I still wonder what was in Dave Kendall's "Nuggets of Gold". uvula - No one is sure what causes either T1 or T2 but we do know people react different to the same virus - just look at Covid. We also know its not specifically genetic as numerous studies have been done with identical twins. Is the root cause viral based? I vote yes but no one is 100% sure. Could the same virus cause minimal beta cell loss in some people and nearly 100% in others - I would think yes just as covid killed some people while others never even knew they had it. Its also important to remember while we say T1 and T2 diabetes is really on a spectrum. We also know from lab tests numerous viruses have been able to infect the beta cells. Covid is just one of them. It is also interesting that some people have reported that they have built up an immunity to afrezza after a period of time after it worked great. There is a lot going on in the body and how a person's immune system works and reacts. There aren't really any research papers on the concept of systemic insulin resistance since it's taken as fundamental so you would need text books rather than papers - it's considered settled. If Al Mann had the research to back up is views why did he, or his successors, never release it? More to the point where are the researchers he worked with? My feeling is that if David Kendall didn't release it then it probably doesn't exist in a form that would withstand review. |
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Post by sayhey24 on Oct 31, 2022 14:41:58 GMT -5
Aged - there are no papers but there are books, really??? To answer your question on researchers - if you remember discussions we have had from the past right here on proboards guys like Jay Skyler were very much involved. I don't know what happened with Kendall. He seemed so excited after seeing some of the data and then went cold. I always got the feeling Lilly did not want afrezza competing with Mounjaro and was willing to throw the kitchen sink at stopping afrezza but I have no proof. Its just a feeling. Per the 3Q2009 Quarterly call Al Mann said - I have long argued that AFRESA does not require complex meal titration. Certainly there is no need for carb counting and so forth. The basis of my view was derived from the dose escalation study with meal challenges in which better glucose control was achieved with ever greater doses of AFRESA, yet without any hypos. Yet based on decades of battling these challenges of conventional insulin therapy, some physicians have questioned my suggestion. Therefore, I proposed a meal escalation study in which patients would take a fixed dose of AFRESA and then a series of meal challenges. Our clinical team designed a protocol to set a standard meal with 50 g of carbohydrates. That was the 100% challenge. This was followed by challenges at 200%, 50% and zero percent. When I heard of zero I was shocked. Surely there would be severe hypo. The remarkable thing was that with the regular prescribed dose of AFRESA regardless of carbohydrate intake between zero and 100 grams the range of excursion is only plus or minus 30-35 mg [reduction] from baseline for all of the Type II patients in the study. At the ASDA meeting I described to Dr. [Jay Skyler] the finding that in Type II diabetes with a fixed dose of AFRESA and even with no food there is excellent control without hypo risk. I asked him how that was possible. "Obvious," he responded. He was basing his comments on our recently reported 118 trial in which we showed rapid and virtually complete sensation of [hepatic] glucose relief with AFRESA and the common inability of the remaining endogenous insulin to maintain control, as is the case for a healthy person without diabetes. Indeed, I mentioned this result to a number of KOL's who agree with Jay. So I say to you that AFRESA is what no other insulin has ever done for Type II diabetes. AFRESA restores more physiologic hepatic function, takes a load off the pancreas and avoids the hyperinsulinemia resulting from resistance of other insulins. It better mimics the normal pancreas response. So what does all this mean? First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early, certainly after failure with Metformin and as a first sign therapy for a significant portion of patients who are not candidates for Metformin or who do not do well with Metformin. It should be used well before fasting glucose is out of control and as we have seen, AFRESA even leads to lower fasting levels by eliminating the excessive gluconeogenesis. Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date. From what we have seen in our extensive clinical program, AFRESA should benefit the entire progression spectrum of Type II diabetes with a very simple therapy and the experts tell us that it could even stop the progression of the disease. Read more: mnkd.proboards.com/thread/9453/jdrf-partners-eoflow-develop-wearable#ixzz563IqzdqJ |
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Post by agedhippie on Oct 31, 2022 21:55:05 GMT -5
Aged - there are no papers but there are books, really??? ... Per the 3Q2009 Quarterly call Al Mann said; ... First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early... ...Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date... A reputable journal isn't going to publish a paper if it's teaching textbook level. That's what textbooks are for! Per the 3Q2009 call; nice find. Notice that his immediate reaction is that this will need large trials to see if the results can be reproduced and to prove his hypothesis. Also, as he says, the trial needs to be specific. There was a small study, NCT00747006, which started mid 2010 and completed in 2011 looking at what happened with variable carbs for a fixed dose. I suspect this was a sanity check before the cost of a large scale hypo trial. The Type 1 side didn't work and had to be stopped. The Type 2 side did produce results, but there were hypos. It seems to have been enough to persuade Al Mann not to continue down that line. The upshot of this is that there has never been a large scale trial of either fixed large doses, nor of the impact of Afrezza on Type 2 with early use. Al Mann recognized the need for these trials, but they have not happened and so the hypothesis remains just that (unfortunately). |
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Post by akemp3000 on Nov 1, 2022 6:34:08 GMT -5
Aged - there are no papers but there are books, really??? ... Per the 3Q2009 Quarterly call Al Mann said; ... First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early... ...Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date... A reputable journal isn't going to publish a paper if it's teaching textbook level. That's what textbooks are for! Per the 3Q2009 call; nice find. Notice that his immediate reaction is that this will need large trials to see if the results can be reproduced and to prove his hypothesis. Also, as he says, the trial needs to be specific. There was a small study, NCT00747006, which started mid 2010 and completed in 2011 looking at what happened with variable carbs for a fixed dose. I suspect this was a sanity check before the cost of a large scale hypo trial. The Type 1 side didn't work and had to be stopped. The Type 2 side did produce results, but there were hypos. It seems to have been enough to persuade Al Mann not to continue down that line. The upshot of this is that there has never been a large scale trial of either fixed large doses, nor of the impact of Afrezza on Type 2 with early use. Al Mann recognized the need for these trials, but they have not happened and so the hypothesis remains just that (unfortunately). If a novice were to read this, they might think Afrezza should never have been approved by the FDA and especially not considered for pediatrics. A lot has happened in the 13 years since. One thing Al Mann repeatedly said remains true, "To be successful with a new drug, you need three things; the first is money, the second is money and the third is money." That's not the exact quote but close enough. IMO, everyone agrees large scale trials would be great and hopefully after pediatric approval, a BP giant with items one, two and three will step up and take over. If not, pediatric approval will still remove the largest barrier to prescriptions which is doctor reluctance because they've all been taught prescribing insulin should be the last resort. Insurance coverage, being the second largest barrier will be pushed by parental demand for Afrezza. The opportunity for Mannkind to be successful with Afrezza going alone still exists. It's just a much longer runway without mega bucks for both the big trials and the marketing. Again, just one opinion. |
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Post by agedhippie on Nov 1, 2022 9:15:56 GMT -5
If a novice were to read this, they might think Afrezza should never have been approved by the FDA and especially not considered for pediatrics. A lot has happened in the 13 years since. One thing Al Mann repeatedly said remains true, "To be successful with a new drug, you need three things; the first is money, the second is money and the third is money." That's not the exact quote but close enough. IMO, everyone agrees large scale trials would be great and hopefully after pediatric approval, a BP giant with items one, two and three will step up and take over. If not, pediatric approval will still remove the largest barrier to prescriptions which is doctor reluctance because they've all been taught prescribing insulin should be the last resort. Insurance coverage, being the second largest barrier will be pushed by parental demand for Afrezza. The opportunity for Mannkind to be successful with Afrezza going alone still exists. It's just a much longer runway without mega bucks for both the big trials and the marketing. Again, just one opinion. It's the problem with a thread being read by different audiences, but hopefully this isn't the only thing they have ever read on the subject. The outcome highlighted was the outcome from that study, but what the novices need to understand is that studies fail all the time by design. You have an idea, you test it, and it may or may not work. In this case the result was patchy and so it wasn't followed up. The study was looking at what happened if you ignored the dosing direction so it wasn't a normal use case.
It's easy to say this with hindsight, but the time to do those trials was back when Al Mann was saying they were needed back in 2009 (interestingly the study was registered in 2008 so around the time he was talking about this and started in 2010 so around the time of the Jay Skyler conversation). Having his hypothesis on the behavior of T2 with Afrezza proven by a large scale trial would have been a game changer and that is still the case.
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Post by cretin11 on Nov 1, 2022 9:25:41 GMT -5
Yes, Al did say that. Agree with you (akemp) a BP will be helpful (or necessary) after peds approval. I don’t agree that parental demand will alone move the needle (pun intended) on scripts. JMO and I hope yours is more accurate there. We greatly overestimated the consumer demand for inhalable insulin the last go around. As someone who detests needles, I probably projected that dislike to consumers/PWDs in general. Seemed unfathomable to me that people would opt for needles when such an alternative was available. But was I ever wrong about that. PWDs are ok with needles and resistant to change (and learning the nuances of Afrezza), my guess is parents will be similar, especially when their doctors will be pushing the same old stuff. We need the education and hand holding components (VDEX anyone?) in order to gain meaningful traction.
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Post by akemp3000 on Nov 1, 2022 10:33:28 GMT -5
Good points both aged and cretin. While we often have different perspectives, I always appreciate your knowledge and posts!
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Post by sayhey24 on Nov 1, 2022 12:48:11 GMT -5
A reputable journal isn't going to publish a paper if it's teaching textbook level. That's what textbooks are for! Per the 3Q2009 call; nice find. Notice that his immediate reaction is that this will need large trials to see if the results can be reproduced and to prove his hypothesis. Also, as he says, the trial needs to be specific. There was a small study, NCT00747006, which started mid 2010 and completed in 2011 looking at what happened with variable carbs for a fixed dose. I suspect this was a sanity check before the cost of a large scale hypo trial. The Type 1 side didn't work and had to be stopped. The Type 2 side did produce results, but there were hypos. It seems to have been enough to persuade Al Mann not to continue down that line. The upshot of this is that there has never been a large scale trial of either fixed large doses, nor of the impact of Afrezza on Type 2 with early use. Al Mann recognized the need for these trials, but they have not happened and so the hypothesis remains just that (unfortunately). If a novice were to read this, they might think Afrezza should never have been approved by the FDA and especially not considered for pediatrics. A lot has happened in the 13 years since. One thing Al Mann repeatedly said remains true, "To be successful with a new drug, you need three things; the first is money, the second is money and the third is money." That's not the exact quote but close enough. IMO, everyone agrees large scale trials would be great and hopefully after pediatric approval, a BP giant with items one, two and three will step up and take over. If not, pediatric approval will still remove the largest barrier to prescriptions which is doctor reluctance because they've all been taught prescribing insulin should be the last resort. Insurance coverage, being the second largest barrier will be pushed by parental demand for Afrezza. The opportunity for Mannkind to be successful with Afrezza going alone still exists. It's just a much longer runway without mega bucks for both the big trials and the marketing. Again, just one opinion. If you are referring to NCT00747006 when saying about the FDA not approving, I think NCT00747006 is actually the pilot study referred to in the 3Q2009 call. It was filed in 2008 and posted in 2014 after drug approval. I would not read anything into the official report. Based on this study and others like the 118 Al decided to put $1B of his own money into this. I would put more weight into what Al said "AFRESA should be used very early, certainly after failure with Metformin and as a first line therapy for a significant portion of patients who are not candidates for Metformin or who do not do well with Metformin. It should be used well before fasting glucose is out of control" The big T2 study was not completed until 2013 and for the most part afrezza was UNDER DOSED in this study. AFREZZA combined with oral therapy, compared to oral therapy alone, showed: Superior reductions in A1c levels; Significantly more patients reached A1c target levels; Reduced postprandial glucose excursions; and No significant difference in the incidence of severe hypoglycemia. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-reports-positive-data-phase-3-clinical-study-afrezza-0At this point its not a question of is afrezza better than the other T2 meds - Affinity2 showed it was. The big question is how much better. If it can come close to stopping progression its a game changer. We know from the ADCOM where PWDs were properly dosed they had significantly better results than those dosed according to the label. We also know the BIG fear of insulin which is severe hypoglycemia does not exist with afrezza. As our friends at VDex have said "our belief was that it would be difficult to produce hypoglycemia" static1.squarespace.com/static/5a37ff648fd4d234be3cea06/t/5d8d07778c19b57ec64e5202/1569523580485/vdex-whitepaper-092619.pdfIts really up to Mike to come up with a plan for the T2 market. BP will do everything they can to stop afrezza. Mike needs to develop a strategy to do the end around on them. The thing is Mike is sitting on the greatest advance in diabetes care since Banting and Best. |
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Post by agedhippie on Nov 1, 2022 17:34:37 GMT -5
... At this point its not a question of is afrezza better than the other T2 meds - Affinity2 showed it was. ... Lets be clear on this. AFFINITY-2 took two groups of diabetics who had failed with oral meds. The treatment was intensified in one group by adding insulin, and the other group was left alone. It's hardly a shock that the group where you add insulin gives better results. That is the whole point of treat to fail, when the treatment fails you intensify it and don't just leave it alone. The 175 trial proved that the SoC approach works - when oral meds fail add the next step. There have been interesting trials, but 175 is not one of them! |
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Post by sayhey24 on Nov 1, 2022 19:03:57 GMT -5
Aged - The big T2 study has been done. You keep saying it has not. It has. Now you say its not interesting. Its simple, afrezza won. We don't need another "not interesting" general study.
Afrezza was superior to 3 oral meds being taken at the same time. During the 175 study aka Affinity2 afrezza for the most part was UNDER DOSED. We know that from the ADCOM when the FDA team attacked the one doctor who second dosed and the FDA lady said he cheated. As Al Mann said at the time “We are pleased that Study 175 met its primary endpoint of demonstrating that AFREZZA, when added to a regimen of metformin with or without a second or third oral medication, produced superior A1c reductions compared to oral therapy alone”.
OK - so the ADA step program failed when the second and third orals meds were added but worked when afrezza was added. We know the current ADA SoC step program fails. The orals don't work long term and never have starting with Orinase. Some of these people were on three oral meds in the 175. The entire point is afrezza should be front line treatment. Al Mann had said this many times and I see nothing showing he was wrong. Point me to the study or text book that says he was wrong. As a result of what they learned after a 12 month study period, Vdex recommended a new treatment paradigm for diabetes - use afrezza as the first med. If afrezza did not work as frontline treatment Bill from VDex could have and should have closed the doors at VDex.
What study do you want? Are you suggesting the 175 study should be done in reverse, first put the PWD on afrezza and then add the oral? OK, but afrezza needs to be properly dosed for your study. Once you put the PWD on afrezza you won't need the oral and you may see an increase in hypos. IMO, Affinity2 already covers your study as it beat metformin, metformin+1 and metformin+2. It wins with three oral meds and it won't matter which order you start the additional orals. For the "afrezza first" study I am sure VDex has those numbers.
The real question is why is Mike not doing a similar 175 study specific for Mounjaro. This was not available at the time of the 175 but afrezza will still kick butt and based on past experience with GLP1s most PWDs stop using in a year. The difference with Mounjaro is it seems that people are losing more weight but also have worse reactions so we will see how many will be using in a year. My guess is not many and IMO thats the sweet spot for Mike and afrezza.
To sum things up - AFREZZA combined with oral therapy, compared to oral therapy alone, showed:
- Superior reductions in A1c levels;
- Significantly more patients reached A1c target levels;
- Reduced postprandial glucose excursions; and
- No significant difference in the incidence of severe hypoglycemia.
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-reports-positive-data-phase-3-clinical-study-afrezza-0
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Post by sportsrancho on Nov 1, 2022 21:42:57 GMT -5
Aged - The big T2 study has been done. You keep saying it has not. It has. Now you say its not interesting. Its simple, afrezza won. We don't need another "not interesting" general study. Afrezza was superior to 3 oral meds being taken at the same time. During the 175 study aka Affinity2 afrezza for the most part was UNDER DOSED. We know that from the ADCOM when the FDA team attacked the one doctor who second dosed and the FDA lady said he cheated. As Al Mann said at the time “We are pleased that Study 175 met its primary endpoint of demonstrating that AFREZZA, when added to a regimen of metformin with or without a second or third oral medication, produced superior A1c reductions compared to oral therapy alone”. OK - so the ADA step program failed when the second and third orals meds were added but worked when afrezza was added. We know the current ADA SoC step program fails. The orals don't work long term and never have starting with Orinase. Some of these people were on three oral meds in the 175. The entire point is afrezza should be front line treatment. Al Mann had said this many times and I see nothing showing he was wrong. Point me to the study or text book that says he was wrong. As a result of what they learned after a 12 month study period, Vdex recommended a new treatment paradigm for diabetes - use afrezza as the first med. If afrezza did not work as frontline treatment Bill from VDex could have and should have closed the doors at VDex. What study do you want? Are you suggesting the 175 study should be done in reverse, first put the PWD on afrezza and then add the oral? OK, but afrezza needs to be properly dosed for your study. Once you put the PWD on afrezza you won't need the oral and you may see an increase in hypos. IMO, Affinity2 already covers your study as it beat metformin, metformin+1 and metformin+2. It wins with three oral meds and it won't matter which order you start the additional orals. For the "afrezza first" study I am sure VDex has those numbers. The real question is why is Mike not doing a similar 175 study specific for Mounjaro. This was not available at the time of the 175 but afrezza will still kick butt and based on past experience with GLP1s most PWDs stop using in a year. The difference with Mounjaro is it seems that people are losing more weight but also have worse reactions so we will see how many will be using in a year. My guess is not many and IMO thats the sweet spot for Mike and afrezza. To sum things up - AFREZZA combined with oral therapy, compared to oral therapy alone, showed: - Superior reductions in A1c levels; - Significantly more patients reached A1c target levels; - Reduced postprandial glucose excursions; and - No significant difference in the incidence of severe hypoglycemia. investors.mannkindcorp.com/news-releases/news-release-details/mannkind-reports-positive-data-phase-3-clinical-study-afrezza-0 “This is correct.” ~Bill |
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Post by agedhippie on Nov 3, 2022 8:32:30 GMT -5
... To sum things up - AFREZZA combined with oral therapy, compared to oral therapy alone, showed: - Superior reductions in A1c levels; - Significantly more patients reached A1c target levels; - Reduced postprandial glucose excursions; and - No significant difference in the incidence of severe hypoglycemia. I entirely agree with this. What is more I have no argument with the early use of insulin, and if I was a Type 2 I would jump to insulin after metformin (one pill a day vs several doses a day is a winner for me although I would expect Afrezza would allow me to have tighter control than with metformin). My argument here is that you are apply a level of weight to this trial that is incorrect. This was a phase 3 trial and those are designed to see if the drug meets it's objectives and as such you set up a challenge between Afrezza or a placebo. Literally the placebo was pure technosphere so the only variable was the presence of insulin. Forget Afrezza for a moment and think of TreT; if you set up a trial between TreT and a placebo which do you think will treat PAH more effectively? Why would you think the same sort of test with Afrezza is any different? In both cases the active ingredient is known to be effective for treating the disease. This is why 175 is largely ignored - it's a statement of the obvious. I heartily agree with you about the need for a trial against Mounjaro and basal insulin. Since Mounjaro includes GLP-1 it would also serve as a proxy for a trial against GLP-1 - beating Mounjaro would automatically be considered beating GLP-1. This would need to be a large scale trial though, and it would need to show better outcomes. This trial would be a game changer placing insulin ahead of GLP-1 and basal insulin. |
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Post by sayhey24 on Nov 3, 2022 13:49:56 GMT -5
Aged - lets be clear on Metformin. When Al said to use afrezza "certainly after failure with Metformin" I don't think he was suggesting new PWDs should use metformin first and not afrezza. I think he 100% thought like Bill from VDex "afrezza first, afrezza always". Not even Ralph DeFronzo recommends using metformin any more. As Ralph said “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save."
Concerning the 175 study - whats wrong with a phase 3 trial? You say they are designed to meet objectives? Heaven forbid we try and achieve objectives. The 175 was not setup between insulin and a placebo. It was setup between afrezza and PWDs using metformin, metformin+1, and metformin+2 oral agents They gave every participant an inhaler but half the participants only got cartridges with FDKP without insulin. The other half got insulin in the cartridge. The FDA helped designed the study so it could answer any question which the FDA may have had in approving afrezza and Al wanted it to support earlier findings from his smaller studies. My goodness, it replicated three steps in the ADA's treat to fail protocol. Afrezza WON. It showed SUPERIOR A1c reduction and reduce postprandial excursions and no severe hypos which is the death nail excuse for not giving T2s insulin.
The reason 175 is largely ignored is because BP has done everything they could to bury it. The headlines at the time were all about the Affinity 1 and how it was barely non-inferior. Then they were able to conflated Affinity 1 results with the 175 study and got people thinking for T2s it was non-inferior versus showing superior A1c results. All the chat on message boards at the time was how afrezza was never getting FDA approval. The crazy thing is it was A1c SUPERIOR and it was grossly under dosed.
It was a remarkable effort by BP but then Sanofi put the deal together based on this study. They said at the time their focus was the T2 market. The next thing you know their CEO gets axed and in comes Brandicourt to kill the deal. BP then paints afrezza as a failed non-inferior product with Mannkind going bankrupt. At the same time they flood the market with all kinds of money promoting GLP1s. Then we get sleepy Mike who took a 2 year nap in addressing the T2 market and still has not announced a plan. We are going on year 3.
Now - explain the study you want. The 175 already included other meds such as DDP-4s. RYBELSUS was not approved until 2019 so there would not have been GLP1 users. Clearly it did not have any Mounjaro users.
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Post by agedhippie on Nov 4, 2022 12:54:38 GMT -5
... Concerning the 175 study - whats wrong with a phase 3 trial? You say they are designed to meet objectives? Heaven forbid we try and achieve objectives. The 175 was not setup between insulin and a placebo. It was setup between afrezza and PWDs using metformin, metformin+1, and metformin+2 oral agents ... From the Clinical Trials site ( clinicaltrials.gov/ct2/show/NCT01451398):
The Arm Intervention section is a table in the trial data but it doesn't copy so I bolded the two sections. Phase 3 trials are specifically aimed at quantifying the gain of the treatment over not using the treatment, in this case adding Afrezza over not adding Afrezza, not adding Afrezza vs. adding random other drugs as can be seen by the protocol. The trial should be rerun substituting Mounjaro for the placebo which could be done since it would not be a phase 3 trial. |
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Post by sayhey24 on Nov 5, 2022 17:04:58 GMT -5
Aged - yes, what you outlined above is what I have been telling you. The 175 was actually a pretty great study. The ADCOM panel also recommended 14 to 0 for approval.
I went back to try and see some reasons it got no traction in addition to conflating it with the Affinity-1. There was article after article about how afrezza was going to cause cancer. Maybe all these fake predictions is where your endo's concerns came from.
Your study is to leverage the 175 and replace the placebo with Mounjaro. OK, leverage the 175 is good. Since the 175 we already have some people taking Mounjaro. I would be ok adding another arm and add afrezza to the Mounjaro users. I would also want CGMs as part of the trial along with proper and second dosing of afrezza.
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