|
|
Post by cppoly on Nov 19, 2024 17:26:00 GMT -5
If the primary endpoint is met, what impact do you think this has?
If SUPERIORITY is demonstrated, what impact does this have?
|
|
|
|
Post by prcgorman2 on Nov 19, 2024 20:12:24 GMT -5
I'm not qualified to provide a usable response, so I'll provide an unqualified probably unusable response. Primary endpoint, meh. Superiority, well, that is new ground. Was that a goal? If superiority is demonstrated, the situation is much more interesting. But superiority in whose eyes? ADA? FDA? Let's say both. SOC change. Label change. Possibility of insurance coverage change. I'll hold my breath.
|
|
|
|
Post by Clement on Nov 20, 2024 8:33:43 GMT -5
The upcoming top line readout will probably give us the primary outcome measure, which is "Change in HbA1c from baseline to Week 26, for noninferiority assessment." clinicaltrials.gov/study/NCT04974528?term=inhale-1&rank=1There are three measures for "superiority assessment" listed under "Secondary Outcome Measures". Will we hear about them in the top line readout? |
|
|
|
Post by agedhippie on Nov 20, 2024 9:16:20 GMT -5
Results from pediatric and adult trials are not interchangeable. Superiority in pediatrics would not count as superiority in adults, that would take another trial. Of course, superiority in pediatrics would strongly indicate that such a trial may well be successful.
The data that is going to matter in the pediatrics trial is going to be the performance of Afrezza against AID pumps. Mike commented at the last conference that those were the competition.
|
|
|
|
Post by radgray68 on Nov 20, 2024 13:18:18 GMT -5
The impact would be transformative. $6-7 becomes $12-15 real quick.
An AI search says it’s about $9 billion, growing 13%, with one third being insulin sales. I’m inclined to believe it. So my best guess is $3 Billion a year.
I’m alright with 10-30% of that market.
|
|
|
|
Post by sayhey24 on Nov 20, 2024 14:29:53 GMT -5
Results from pediatric and adult trials are not interchangeable. Superiority in pediatrics would not count as superiority in adults, that would take another trial. Of course, superiority in pediatrics would strongly indicate that such a trial may well be successful. The data that is going to matter in the pediatrics trial is going to be the performance of Afrezza against AID pumps. Mike commented at the last conference that those were the competition. While pediatric and adult trials may not be interchangeable I think Inhale-3 results are a pretty good indicator of what we will see with the kids. Given the moms are "personal coaches" for the kids I am expecting some damn great results. Now, we know wearing a pump while playing sports is not great. About 40% of 10 year olds play basketball. Wearing a pump while playing basketball is not great. Its not great playing soccer either which is the second largest youth participation sport. Then you have the moms talking and if they are hearing no pump, great control and few worries about "lows" and I think we have a winner. We also only have about 1500 pediatric endos to target and some well organized "mom" social media groups. |
|
|
|
Post by radgray68 on Nov 20, 2024 14:45:31 GMT -5
I’m sure they’re keeping track of weight loss/gain during trials but don’t remember if it’s even an expected secondary outcome. Having trouble opening clinical trials site.
Anybody think with proper dosing we could show something good here? Imagine the headline “Weight loss without Needles”
p.s. just pictured a commercial showing a gal working out with a letch peeping at her. Narrator says “ladies, now you can get your sugars in control and lose weight (pan over to the letch) without all the pricks.”
Lol, I know, far fetched but I got a little giddy at the prospects here.
|
|
|
|
Post by sayhey24 on Nov 20, 2024 15:09:21 GMT -5
I’m sure they’re keeping track of weight loss/gain during trials but don’t remember if it’s even an expected secondary outcome. Having trouble opening clinical trials site. Anybody think with proper dosing we could show something good here? Imagine the headline “Weight loss without Needles” p.s. just pictured a commercial showing a gal working out with a letch peeping at her. Narrator says “ladies, now you can get your sugars in control and lose weight (pan over to the letch) without all the pricks.” Lol, I know, far fetched but I got a little giddy at the prospects here. I don't see tracking weight in the study. You may have to wait until we do the afrezza/glp1 adder study for the T2s. |
|
|
|
Post by agedhippie on Nov 20, 2024 20:27:18 GMT -5
While pediatric and adult trials may not be interchangeable I think Inhale-3 results are a pretty good indicator of what we will see with the kids. Given the moms are "personal coaches" for the kids I am expecting some damn great results. Now, we know wearing a pump while playing sports is not great. About 40% of 10 year olds play basketball. Wearing a pump while playing basketball is not great. Its not great playing soccer either which is the second largest youth participation sport. Then you have the moms talking and if they are hearing no pump, great control and few worries about "lows" and I think we have a winner. We also only have about 1500 pediatric endos to target and some well organized "mom" social media groups. I would be shocked if Afrezza wasn't approved for kids. That still leaves the issues of cost and inertia. I would expect the insurance formulary coverage to be identical between kids and adults since they are both using the same insurer. I would also expect pre-approval issue to be the same for kids as it is for adults. As for inertia, Omnipod is pretty much standard for newly diagnosed kids and the clinics are very comfortable with that as they understand them and can get good results. As for sport, don't remember that mother complaining about Levemir being discontinued because it meant her daughter went low playing sports? The basal insulin problem remains. You can fix that by eating a load of carbs before you start exercising, but that's going to spike you and having high levels is bad for sport. You might want to revisit the reduced salesforce strategy in light of the changes. They are tightly focused on hospital groups now. |
|
|
|
Post by sayhey24 on Nov 21, 2024 8:09:49 GMT -5
While pediatric and adult trials may not be interchangeable I think Inhale-3 results are a pretty good indicator of what we will see with the kids. Given the moms are "personal coaches" for the kids I am expecting some damn great results. Now, we know wearing a pump while playing sports is not great. About 40% of 10 year olds play basketball. Wearing a pump while playing basketball is not great. Its not great playing soccer either which is the second largest youth participation sport. Then you have the moms talking and if they are hearing no pump, great control and few worries about "lows" and I think we have a winner. We also only have about 1500 pediatric endos to target and some well organized "mom" social media groups. I would be shocked if Afrezza wasn't approved for kids. That still leaves the issues of cost and inertia. I would expect the insurance formulary coverage to be identical between kids and adults since they are both using the same insurer. I would also expect pre-approval issue to be the same for kids as it is for adults. As for inertia, Omnipod is pretty much standard for newly diagnosed kids and the clinics are very comfortable with that as they understand them and can get good results. As for sport, don't remember that mother complaining about Levemir being discontinued because it meant her daughter went low playing sports? The basal insulin problem remains. You can fix that by eating a load of carbs before you start exercising, but that's going to spike you and having high levels is bad for sport. You might want to revisit the reduced salesforce strategy in light of the changes. They are tightly focused on hospital groups now. I just did a quick non-scientific search. I bet if we had one rep who focused on CHOP in PA we would hit most kids in the Philadelphia area. Thanks to Obamacare there are not too many independent practices anymore. You bring up cost. To date afrezza has three issues; label; SoC; and cost. This is not different for the kids than the adults. Lets hope we can fix the label with this trial and Inhale-3. Lets also hope we can move the ball a bit with the SoC. That leaves cost. Can the Mom's get insurance for afrezza? Lets hope. |
|
|
|
Post by cjm18 on Nov 21, 2024 8:34:20 GMT -5
The impact would be transformative. $6-7 becomes $12-15 real quick. An AI search says it’s about $9 billion, growing 13%, with one third being insulin sales. I’m inclined to believe it. So my best guess is $3 Billion a year. I’m alright with 10-30% of that market. 10% of peds market is something like 150m according to earnings slides. 4x is 600m of market cap. So $2 per share. |
|
|
|
Post by stevil on Nov 21, 2024 9:32:16 GMT -5
My n is about 4…. For some reason I don’t have hardly any DM1 patients but Afrezza has been approved without a PA for all of them. Not sure if that’s because they have better insurance or if insurance coverage is better for Afrezza for type 1s.
Type 2s have so many steps (and RAAs) before insurance wants to cover it. Type 1s only have 1 hurdle at most because they need insulin. Again, TIFWIW due to the small sample size but it seems (to me) to be way easier to get type 1s covered. If insurance doesn’t readily accept Afrezza for peds, it will likely be dead forever.
To add to this- all 4 of them stopped using afrezza on their own or were afraid of inhaling insulin despite my endless reassurance that it’s safe. So there’s that…
|
|
|
|
Post by parrerob on Nov 21, 2024 9:50:00 GMT -5
The impact would be transformative. $6-7 becomes $12-15 real quick. An AI search says it’s about $9 billion, growing 13%, with one third being insulin sales. I’m inclined to believe it. So my best guess is $3 Billion a year. I’m alright with 10-30% of that market. 10% of peds market is something like 150m according to earnings slides. 4x is 600m of market cap. So $2 per share. 150m (or 600m) Earnings or Revenues ? $2 per share, Earnings, is a lot of stuff..... $2 per share, Revenues is good as well ! Yearly Run rate today is around $1.1 Q3 24 Earnigs vs Revenues were around 20% (but the ratio should increase in the long term) adding $2 Revenue per share could bring PPS towards $20 adding $2 Earning per share could bring PPS north of $40 Hope We will not take years to get the 20-30% of the market ! |
|
|
|
Post by agedhippie on Nov 21, 2024 10:26:18 GMT -5
... You bring up cost. To date afrezza has three issues; label; SoC; and cost. This is not different for the kids than the adults. Lets hope we can fix the label with this trial and Inhale-3. Lets also hope we can move the ball a bit with the SoC. That leaves cost. Can the Mom's get insurance for afrezza? Lets hope. I feel the label change for dosing is a done deal. I would be very surprised if that doesn't happen in the next six months. The SoC is a challenge. The section for children specifically says both new and existing patients on MDI (Afrezza counts as MDI) should be offered AID pumps (14.20, 14.21) with a category A evidence rating. That evidence rating makes the SoC very hard to change. In other words a superiority finding in this trial alone would not do it and there would need to be a much larger follow on trial against AID pumps alone. The use of Afrezza for treating gestational diabetes would be a far easier change. Once it is established for that it gives a lot of credibility for other areas. On cost, I checked the Caremark formulary for my insurance and Afrezza is covered with just prior auth and doesn't need step therapy. That is a change from a few months ago when it was flatly not covered. |
|
|
|
Post by agedhippie on Nov 21, 2024 10:34:01 GMT -5
... To add to this- all 4 of them stopped using afrezza on their own or were afraid of inhaling insulin despite my endless reassurance that it’s safe. So there’s that… I am curious as to why they stopped using it on their own if you can share that. |
|
