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Post by goyocafe on Apr 16, 2020 13:52:27 GMT -5
They indicate Afrezza Pediatric study is ready for Phase III. Did they read out the data for Phase II? I thought they still had one more age cohort to do? In the info icon it has, "Currently finalizing with the FDA the study design for a Phase 3 clinical trial to evaluate the safety and efficacy of Afrezza in 8-17 year-old children and adolescents." So if I'm reading between the lines, they're skipping the final Phase II cohort of 4-8 year-old children and moving to Phase III for the older kids? I wonder if/when we'll ever here about the Phase II results?
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Post by casualinvestor on Apr 16, 2020 14:19:50 GMT -5
I think we had heard about that before, possibly on an earnings call? The 4-7 year olds were being skipped, but either I don't remember the reason or no real reason was given
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Post by sportsrancho on Apr 16, 2020 14:31:41 GMT -5
They indicate Afrezza Pediatric study is ready for Phase III. Did they read out the data for Phase II? I thought they still had one more age cohort to do? Isn’t the whole thing halted?
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Post by brotherm1 on Apr 16, 2020 14:48:00 GMT -5
Tobramycin Technosphere formulation is also scheduled for this year. Even though the COVID-19 drugs with Immix are supposed to be classified, Mike slipped up in yesterday's call and named one of them. The audio was fuzzy but I think he said Curcumin. Others will have to listen to verify that. I listened several times and never heard him say Curcumin. I think he was just clearing his throat.
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Post by sportsrancho on Apr 16, 2020 14:57:59 GMT -5
🤣
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Post by mango on Apr 16, 2020 14:59:22 GMT -5
Tobramycin Technosphere formulation is also scheduled for this year. Even though the COVID-19 drugs with Immix are supposed to be classified, Mike slipped up in yesterday's call and named one of them. The audio was fuzzy but I think he said Curcumin. Others will have to listen to verify that. I listened several times and never heard him say Curcumin. I think he was just clearing his throat. He definitely said something and it sounded like Curcumin. Another person on ST said they think he said Curcumin too.
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Post by itellthefuture777 on Apr 16, 2020 15:20:42 GMT -5
Sure I agree..if you're on a cell phone...but not if you use your laptop.. I used my laptop. hmm..interesting..I can tell you on mine it only was in the first column..I use a ThinkPad...and not chrome..try those conditions..
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Post by mannmade on Apr 16, 2020 15:31:09 GMT -5
Might make sense about Curcuman as it is supposed to lower inflamation and from what I understand about Covid 19, inflamation plays a big part.
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Post by mytakeonit on Apr 16, 2020 15:49:15 GMT -5
I think we had heard about that before, possibly on an earnings call? The 4-7 year olds were being skipped, but either I don't remember the reason or no real reason was given It was from the 1st quarter 2019 earnings call. They didn't have a 2 unit dosage yet and didn't want to over dose the kids. Oren Livnat -- H. C. Wainwright and Company -- Analyst And you just mentioned that Ped steady. Can you help us understand exactly what this plan is with these cohorts, and where this development program is going and just ultimately what kind of timing should we look for on this becoming an actual incremental opportunity? Michael Castagna -- Chief Executive Officer Yeah. So the first phase took us a little longer than we'd like, which was good and bad unfortunately for us as a company overall, because we, at the time when we started, we probably couldn't have started Phase III when we wanted to. So the fact that this took a little longer in cohorts 1 through 3, I think the timing works out better overall for the company. But when you think about each cohort, it's dosing by age group, so it's a single PK study followed for 30 days. And so cohort 1 was 13 to 17 year-olds, cohort 2 is eight to 12 year-olds and cohort 3 is four to seven year-olds. So we have to keep dosing down to prove that Afrezza absorption in kids is consistent with that of adults. And so the good news is, one thing we hear often from doctors who've never used the drug is I need a two-unit cartridge, because doctors think they are dosing so accurately and I remind them how many patients use three units of insulin a day, because it's basically what you're getting with a two-unit cartridge. And they recognize it's not a lot.And so with kids, so far down to the eight year-olds, we can safely say four units dosing is working fine and in fact we see kids going up to eight in the four to 12 and 13 and beyond. So we feel good about our dosing so far down the eight years-old. The next cohort 3, which we'll open up, will continue to look at is the four-unit cartridge appropriate or not. And then once we get cohort 3 opened, we will go ahead, submit a protocol to the FDA for a Phase III trial design. And that's really what we're in the middle of right now, is what should that Phase III trial design look like to accelerate enrollment. And so, for example, if you go against MDI, one of our challenges with these dosing study is you can't be on an insulin pump. And for you to come into the trial, you have to come off your pump, get on injectable and then switch over to Afrezza, that's a multi-month process and not easy for many parents and patients to want to do.So that's the lead enrollment. And then we have some -- IRBs take a little longer to open up, but we're basically at 12 sites and we expect cohort 3 to go a lot faster than cohorts 1 and 2. And so, we're just literally on the cusp of talking with the chairman of the program today actually and hopefully opening up cohort 3, which will get this study moving and closed out where we can start to move to the large Phase III study.
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Post by mango on Apr 16, 2020 16:01:28 GMT -5
I think we had heard about that before, possibly on an earnings call? The 4-7 year olds were being skipped, but either I don't remember the reason or no real reason was given It was from the 1st quarter 2019 earnings call. They didn't have a 2 unit dosage yet and didn't want to over dose the kids. Oren Livnat -- H. C. Wainwright and Company -- Analyst And you just mentioned that Ped steady. Can you help us understand exactly what this plan is with these cohorts, and where this development program is going and just ultimately what kind of timing should we look for on this becoming an actual incremental opportunity? Michael Castagna -- Chief Executive Officer Yeah. So the first phase took us a little longer than we'd like, which was good and bad unfortunately for us as a company overall, because we, at the time when we started, we probably couldn't have started Phase III when we wanted to. So the fact that this took a little longer in cohorts 1 through 3, I think the timing works out better overall for the company. But when you think about each cohort, it's dosing by age group, so it's a single PK study followed for 30 days. And so cohort 1 was 13 to 17 year-olds, cohort 2 is eight to 12 year-olds and cohort 3 is four to seven year-olds. So we have to keep dosing down to prove that Afrezza absorption in kids is consistent with that of adults. And so the good news is, one thing we hear often from doctors who've never used the drug is I need a two-unit cartridge, because doctors think they are dosing so accurately and I remind them how many patients use three units of insulin a day, because it's basically what you're getting with a two-unit cartridge. And they recognize it's not a lot.And so with kids, so far down to the eight year-olds, we can safely say four units dosing is working fine and in fact we see kids going up to eight in the four to 12 and 13 and beyond. So we feel good about our dosing so far down the eight years-old. The next cohort 3, which we'll open up, will continue to look at is the four-unit cartridge appropriate or not. And then once we get cohort 3 opened, we will go ahead, submit a protocol to the FDA for a Phase III trial design. And that's really what we're in the middle of right now, is what should that Phase III trial design look like to accelerate enrollment. And so, for example, if you go against MDI, one of our challenges with these dosing study is you can't be on an insulin pump. And for you to come into the trial, you have to come off your pump, get on injectable and then switch over to Afrezza, that's a multi-month process and not easy for many parents and patients to want to do.So that's the lead enrollment. And then we have some -- IRBs take a little longer to open up, but we're basically at 12 sites and we expect cohort 3 to go a lot faster than cohorts 1 and 2. And so, we're just literally on the cusp of talking with the chairman of the program today actually and hopefully opening up cohort 3, which will get this study moving and closed out where we can start to move to the large Phase III study. I can imagine the kids just loving Afrezza. What kid wouldn't, right? And, think of the ease of mind and safety confidence with the parents. It really is a win-win.
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Post by mytakeonit on Apr 16, 2020 17:12:50 GMT -5
I believe the thought was that creating a new size that would have minimal usage wasn't worth it financially. Parents with young kids wouldn't want to spend the $$$ unless the child was very diabetic and they had insurance coverage. If parents could afford it, they could give their kids the 4 unit cartridge ... or try to do that 4 unit split to 2 units on their own.
But, that's mytakeonit
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Post by sportsrancho on Apr 16, 2020 18:40:55 GMT -5
I believe the thought was that creating a new size that would have minimal usage wasn't worth it financially. Parents with young kids wouldn't want to spend the $$$ unless the child was very diabetic and they had insurance coverage. If parents could afford it, they could give their kids the 4 unit cartridge ... or try to do that 4 unit split to 2 units on their own. But, that's mytakeonit Exactly
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Post by nylefty on Apr 16, 2020 19:10:55 GMT -5
When I look at the Pipeline my First Thought is you have NO approved drugs in your pipe...and why is that?? Because the Bar stops with all of them including Afrezza in column 1.... Also the Covid item should be moved up in Priority order in the Rows if we have our pipeline shut off for it..and also each item for Covid should be broken out with made up names even.. and detailing what upfront testing position it is in.. to show a rapid review of feasibility..special for Covid items only..for example one..already tested..doesn't work..red line it..show your on the other three..more pictorial..this one hides everything in an information icon..just saying.. When I look at it, the bar for Afrezza goes across all six columns, indicating approved status. When I first looked at it on my desktop PC (Windows 10) the Afrezza bar did not go across all six columns. But then I used Windows' zoom feature and it did. MannKind needs to fix this. www.businessinsider.com/how-to-zoom-in-on-pc
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Post by brotherm1 on Apr 16, 2020 21:37:39 GMT -5
From yesterday’s investor call per MC:
We are working on four different Covid oppurtunity formulas, 2 anti-viral and 2 anti-infective. One we believe will not make it due to the powder load required to reach efficacy...the other three we are working on the API on one of them, and the other two our (new?) team is working on several formulas for and we’re very excited ....We have been in discussions with BARDA and we’ll continue to look for external funding to support this COVID oppurtunity as well as for partners to help with this oppurtunity....earnings call is in three weeks and we can update you at that time.
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Post by itellthefuture777 on Apr 16, 2020 21:45:18 GMT -5
When I look at it, the bar for Afrezza goes across all six columns, indicating approved status. When I first looked at it on my desktop PC (Windows 10) the Afrezza bar did not go across all six columns. But then I used Windows' zoom feature and it did. MannKind needs to fix this. www.businessinsider.com/how-to-zoom-in-on-pc Wake up the IT department..I'll check the pipe again tonight and tomorrow morning.
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