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Post by agedhippie on May 20, 2019 8:25:49 GMT -5
I thought afterwards that I could check for myself so I went and had a look at the India trials database ( ctri.nic.in for those who are interested) and there is nothing filed yet so I suspect we are some time away from clearance in India. I don't think the CGM part is going to happen looking at other insulin trials. That makes sense in a trial since you need everyone to be on the technology the end patients will be using so there are no hidden dependencies, and CGMs for Type 2s in India are not going to be common. Do the powers that be in America generally give credence to trials in other parts of the world, and in particular India? I mean, assuming the trial goes well, would the FDA allow the Afrezza label to be changed based on this new trial, and would the ADA be likely to change the SOC? Trials in India could definitely be published and talked about in the US. I am no expert in this area, but from what I have seen the FDA is very unlikely to allow the label to be changed on the basis of the India trials because they are done under India's remit. I suspect that it could be used as supporting evidence though. It would probably be more important in the same way as STAT-1 was - as a guide as to the approach to be taken when they finally do a superiority trial. I strongly believe that until there are new large scale trials the ADA is done changing the SOC materially with respect to Afrezza. If it could be done I believe it would have been done because Dr Kendall of all people knows how that particular game is played so it would have changed if it was going to.
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Post by peppy on May 20, 2019 8:26:09 GMT -5
Aged - why would you want to save a few pennies on CGM's when the results would be worth $Billions in results??? CGM, connected care and afrezza are the future but all three are available today. I have been working with several Indian groups trying to get both Libre's and afrezza into India. A similar reaction from ALL the doctors is this is a mircale. CGM's and afrezza simply floors them. Why would you want to save pennies by not using CGMs? Because when Afrezza is released it will be used with meters and not CGMs. A later trial could be done to see the impact of CGM vs. meters, but not for the acceptance trial. Plus this trial is paid for by Cipla so they are going to want to keep their costs down and giving people CGMs with training and support is going to be more than pennies. I believe I read somewhere, that the new criteria, Insulin trial durations can be shortened if CGM's are used. Correct me if I a wrong.
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Post by agedhippie on May 20, 2019 8:32:05 GMT -5
Is it possible that Cipla's plan for Afrezza is a premium market? In that case, CGMs and Afrezza could go together. And a trial (for that premium end-market) could include CGMs and Afrezza. That's not a bad question and I think that probably is their market. The aim though is to get approval for Afrezza in India and the criteria is going to be HbA1c as usual. Cipla are going to be looking to get there as fast as possible, and as cheaply as possible. We have already seen that Afrezza could manage that with the original protocol so why take chances? There can always be follow on trials later. I am not sure how prevalent CGMs are in India. Dexcom and Medtronics both sell there, and Abbott sell the Libre Pro (curious that they don't sell the regular Libre).
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Post by agedhippie on May 20, 2019 8:34:32 GMT -5
Why would you want to save pennies by not using CGMs? Because when Afrezza is released it will be used with meters and not CGMs. A later trial could be done to see the impact of CGM vs. meters, but not for the acceptance trial. Plus this trial is paid for by Cipla so they are going to want to keep their costs down and giving people CGMs with training and support is going to be more than pennies. I believe I read somewhere, that the new criteria, Insulin trial durations can be shortened if CGM's are used. Correct me if I a wrong. I don't know to be honest. However the primary endpoint is usually HbA1c reduction and that requires at least three months. A lot of these trials are six months though by the time you add on ramp up times so there is scope to cut down the time by a month or two.
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Post by peppy on May 20, 2019 8:38:03 GMT -5
I believe I read somewhere, that the new criteria, Insulin trial durations can be shortened if CGM's are used.Correct me if I a wrong. I don't know to be honest. However the primary endpoint is usually HbA1c reduction and that requires at least three months. A lot of these trials are six months though by the time you add on ramp up times so there is scope to cut down the time by a month or two.That is the new gig when CGM's are used in the newest standards of care, by memory.
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Post by uvula on May 20, 2019 8:50:35 GMT -5
(Not a dr or clinical trial expert.)
If the clinical trial is done with cgms we won't know if the good results are from afrezza or the cgms. You need to test 1 thing at a time while keeping everything else the same.
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Post by peppy on May 20, 2019 8:57:14 GMT -5
(Not a dr or clinical trial expert.) If the clinical trial is done with cgms we won't know if the good results are from afrezza or the cgms. You need to test 1 thing at a time while keeping everything else the same. That is crazy talk. If the trials are done with CGM's the user learns on a read out screen how to use afrezza and the effects the dosing has. All insulins have over the course of their development dosing learning curves. Additionally, not all foods (different food choices) and not all bodies absorb food carbohydrate, fat and protein the same way. we act like they do. CGM are a learning tool, not the glucose lowering medication.
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Post by goyocafe on May 20, 2019 8:58:44 GMT -5
(Not a dr or clinical trial expert.) If the clinical trial is done with cgms we won't know if the good results are from afrezza or the cgms. You need to test 1 thing at a time while keeping everything else the same. Couldn't a third arm of a trial be added to include "treatment of choice/not Afrezza", and let Afrezza show it's better in the CGM environment than any other? All treatment options would be tested with CGM thus making the CGM part of the background data.
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Post by uvula on May 20, 2019 9:28:03 GMT -5
If the only goal is to get approval in India then it doesn't matter how the trial is done as long as we get good results.
If we want to be able to say afrezza is better than other insulin we need to either repeat the other insulin's trial with cgms or do the afrezza trial without cgms. Otherwise it is not an apples to apples comparison.
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Post by rockstarrick on May 20, 2019 9:46:38 GMT -5
(Not a dr or clinical trial expert.) If the clinical trial is done with cgms we won't know if the good results are from afrezza or the cgms. You need to test 1 thing at a time while keeping everything else the same. Afrezza is the drug, the CGM is the Interface, (device/meter), they’ll know. Pull the Afrezza for a day or two and see how well the CGM is working. Managing Diabetic mealtime glucose has got to be the biggest challenge that PWD and their caregivers deal with. I would imagine if Afrezza really does make mealtime glucose spikes easier to manage, they’ll know. This isn’t their first Rodeo ! ✌🏻😎
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Post by uvula on May 20, 2019 10:10:17 GMT -5
I go to a shooting range at night with gun A and a flashlight. I do a great job hitting the target. I can rightly claim that gun A is a good gun.
I go back to the shooting range at night with gun B but don't bring the flashlight. I do a bad job hitting the target. I cannot say that gun A is better than gun B. In order to compare gun A to gun B I need to control all of the other factors such as lighting.
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Post by longliner on May 20, 2019 10:11:06 GMT -5
Are you f*cking kidding me? Not at all. But I'm not explaining my point very well. You kinda did, then you kinda didn't. I like the idea of Afrezza + CGM (against) CGM + treatment of your choice. (All comers, any time, any place). (What goyocafe said above)
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Post by ktim on May 20, 2019 10:53:39 GMT -5
>> That's not correct... Well.. every model has its limitations and every reader can have his/her opinion, but assuming a linear trend it will take a bit more than 2 years to reach 9mil$/month revenue.
>> If linear trend will continue we will need much much more then 30-50 million $
Currently, Mannkind already had more than 20Mil$ revenue this year, so your numbers seem awfully pessimistic. if the linear trend continues like that, we should get a revenue above 60mil
this year and that is for adults in USA alone. >> We need to sale about 18 million $ / month.
And I think peppy mentioned somewhere that the earning/revenue ratio is about 0.47 these days, so I guess, a revenue of 9mil$/month from that trend is too low, but 18mil$/month is way too high.
If we generate revenue from other sources, we could go green before the two years.
$9M a month is around the requirement today and it could be larger in order to do large and sustained consumer marketing campaign.
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Post by seanismorris on May 20, 2019 11:03:35 GMT -5
I go to a shooting range at night with gun A and a flashlight. I do a great job hitting the target. I can rightly claim that gun A is a good gun. I go back to the shooting range at night with gun B but don't bring the flashlight. I do a bad job hitting the target. I cannot say that gun A is better than gun B. In order to compare gun A to gun B I need to control all of the other factors such as lighting. I get what you’re saying... Afrezza + CGM > Afrezza The counter argument is: Afrezza + CGM = Afrezza + time In other words, once you figure out your correct titration you no longer need a CGM. I agree with you, not only will Afrezza with CGM always be better than Afrezza alone, in a short study (6 months) you’re going to see significantly better results when you use a CGM to assist in titration/dosing. But the conclusion is the same. Afrezza will shown to be equivalent or superior, which is the goal of the study (+ safety considerations).
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Post by cretin11 on May 20, 2019 11:46:07 GMT -5
I go to a shooting range at night with gun A and a flashlight. I do a great job hitting the target. I can rightly claim that gun A is a good gun. I go back to the shooting range at night with gun B but don't bring the flashlight. I do a bad job hitting the target. I cannot say that gun A is better than gun B. In order to compare gun A to gun B I need to control all of the other factors such as lighting. I get your analogy, but IMO it fails because in the shooting range example, the flashlight is integral to obtaining the good result. With Afrezza, the CGM doesn't "obtain" the result, rather it simply measures and displays it. (I'm not a CGM user so i might be offbase, just going from my understanding of what it does.)
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