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Post by Clement on Apr 30, 2020 7:41:19 GMT -5
The following is from the transcript of the UTHR earnings call. The transcript says "trade T" where it should say TreT. finance.yahoo.com/news/edited-transcript-uthr-earnings-conference-040922723.htmlLeigh Peterson, United Therapeutics Corporation - VP of Product Development [9] -------------------------------------------------------------------------------- Yes, sure. Thank you. So this BREEZE study, as you may already know, is a study with patients who are on Tyvaso are transitioned over to our trade T formulation with the dry powder. And the device that we have with mankind. And so we had -- so this study was actually a 45-patient study. It's not very big. FDA has agreed to this. And we were -- we're about 1/3 of the way through enrollment. In fact, the study's primary endpoint is taken at 3 weeks after the patient starts. And so we were lucky enough to have had all of the patients who were currently enrolled to complete that period. So we won't have missing data on the ongoing patients. And as far as timing due to the pause, we have -- again, we have about 2/3 of the patients to enroll. And we had about -- not quite, but about 17 sites open for enrollment in this study. And so what we've done is we've taken the time to do the paperwork and to prep additional sites to conduct this study. So when we do open, we can -- the plan is to make up for lost time and finish that study actually close to the original time line. So we don't -- we hope not to have a big -- really a big delay there. We've already started the additional phase, the one -- the second phase study that FDA has agreed that we conduct for this product. We started that, that is about halfway finished. That's in healthy volunteers, a bioequivalence study. And again, those patients had completed, so we won't lose any data there, and we'll be able to finish that one up quickly as well. Again, it's easier to enroll, it's healthy volunteers. So overall, we're hoping to not expect a big delay in that due to the halting of enrollment in that study. |
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Post by mango on Apr 30, 2020 8:47:41 GMT -5
Nice!
TreT timeline is still very close to original plan and will more than likely still file with FDA towards the end of this year.
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Post by mango on Apr 30, 2020 8:56:27 GMT -5
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Post by Clement on Apr 30, 2020 10:13:55 GMT -5
Wow! Cmax for same dose of TreT is about 50% more than Liquidia!
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Post by mango on Apr 30, 2020 11:18:56 GMT -5
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Post by robbmo on Apr 30, 2020 11:56:56 GMT -5
Does anyone know the TreT dosing ratio used for the TreT vs Tyvaso charts above? Thank you in advance.
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Post by mango on Apr 30, 2020 12:43:45 GMT -5
Does anyone know the TreT dosing ratio used for the TreT vs Tyvaso charts above? Thank you in advance. Dosages are plotted on the bottoms of the graphs |
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Post by robbmo on Apr 30, 2020 13:02:12 GMT -5
Does anyone know the TreT dosing ratio used for the TreT vs Tyvaso charts above? Thank you in advance. Dosages are plotted on the bottoms of the graphs I am pretty sure those are dosing equivalents and not 1:1. For instance, LQDA used 1.5:1 for their LIQ861 vs Tyvaso studies. |
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Post by mango on Apr 30, 2020 13:04:36 GMT -5
Dosages are plotted on the bottoms of the graphs I am pretty sure those are dosing equivalents and not 1:1. For instance, LQDA used 1.5:1 for their LIQ861 vs Tyvaso studies. Oh I see what you mean. I am not sure. But I do know that we can pack at least 100mcg in a single cartridge. I think Mike said maybe 150 in a single cartridge? Can't remember, he talks about that in the presentation where he disclosed those slides. Was during an UT event. |
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Post by Deleted on Apr 30, 2020 13:40:13 GMT -5
I am pretty sure those are dosing equivalents and not 1:1. For instance, LQDA used 1.5:1 for their LIQ861 vs Tyvaso studies. Oh I see what you mean. I am not sure. But I do know that we can pack at least 100mcg in a single cartridge. I think Mike said maybe 150 in a single cartridge? Can't remember, he talks about that in the presentation where he disclosed those slides. Was during an UT event. Mike said they can take TreT up to 150 mcg. |
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Post by rfogel on Apr 30, 2020 15:23:32 GMT -5
The following is from the transcript of the UTHR earnings call. The transcript says "trade T" where it should say TreT. finance.yahoo.com/news/edited-transcript-uthr-earnings-conference-040922723.htmlLeigh Peterson, United Therapeutics Corporation - VP of Product Development [9] -------------------------------------------------------------------------------- Yes, sure. Thank you. So this BREEZE study, as you may already know, is a study with patients who are on Tyvaso are transitioned over to our trade T formulation with the dry powder. And the device that we have with mankind. And so we had -- so this study was actually a 45-patient study. It's not very big. FDA has agreed to this. And we were -- we're about 1/3 of the way through enrollment. In fact, the study's primary endpoint is taken at 3 weeks after the patient starts. And so we were lucky enough to have had all of the patients who were currently enrolled to complete that period. So we won't have missing data on the ongoing patients. And as far as timing due to the pause, we have -- again, we have about 2/3 of the patients to enroll. And we had about -- not quite, but about 17 sites open for enrollment in this study. And so what we've done is we've taken the time to do the paperwork and to prep additional sites to conduct this study. So when we do open, we can -- the plan is to make up for lost time and finish that study actually close to the original time line. So we don't -- we hope not to have a big -- really a big delay there. We've already started the additional phase, the one -- the second phase study that FDA has agreed that we conduct for this product. We started that, that is about halfway finished. That's in healthy volunteers, a bioequivalence study. And again, those patients had completed, so we won't lose any data there, and we'll be able to finish that one up quickly as well. Again, it's easier to enroll, it's healthy volunteers. So overall, we're hoping to not expect a big delay in that due to the halting of enrollment in that study. I'm not quite sure what she means by "bioequivalence study." Per wikpedia: "Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same." So Mannkind's phase 1 wasn't enough to do that? It just strikes me as kind of odd that they would even start the other study with PAH patients without knowing the degree of bioequivalence. |
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Post by mango on Apr 30, 2020 16:52:10 GMT -5
The following is from the transcript of the UTHR earnings call. The transcript says "trade T" where it should say TreT. finance.yahoo.com/news/edited-transcript-uthr-earnings-conference-040922723.htmlLeigh Peterson, United Therapeutics Corporation - VP of Product Development [9] -------------------------------------------------------------------------------- Yes, sure. Thank you. So this BREEZE study, as you may already know, is a study with patients who are on Tyvaso are transitioned over to our trade T formulation with the dry powder. And the device that we have with mankind. And so we had -- so this study was actually a 45-patient study. It's not very big. FDA has agreed to this. And we were -- we're about 1/3 of the way through enrollment. In fact, the study's primary endpoint is taken at 3 weeks after the patient starts. And so we were lucky enough to have had all of the patients who were currently enrolled to complete that period. So we won't have missing data on the ongoing patients. And as far as timing due to the pause, we have -- again, we have about 2/3 of the patients to enroll. And we had about -- not quite, but about 17 sites open for enrollment in this study. And so what we've done is we've taken the time to do the paperwork and to prep additional sites to conduct this study. So when we do open, we can -- the plan is to make up for lost time and finish that study actually close to the original time line. So we don't -- we hope not to have a big -- really a big delay there. We've already started the additional phase, the one -- the second phase study that FDA has agreed that we conduct for this product. We started that, that is about halfway finished. That's in healthy volunteers, a bioequivalence study. And again, those patients had completed, so we won't lose any data there, and we'll be able to finish that one up quickly as well. Again, it's easier to enroll, it's healthy volunteers. So overall, we're hoping to not expect a big delay in that due to the halting of enrollment in that study. I'm not quite sure what she means by "bioequivalence study." Per wikpedia: "Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same." So Mannkind's phase 1 wasn't enough to do that? It just strikes me as kind of odd that they would even start the other study with PAH patients without knowing the degree of bioequivalence. My guess is because United Therapeutics wants to use TreT regardless. The bioequivalent study would essentially be all that needs to be done to allow TreT to replace Tyvaso for all the other indications from all the other clinical trials being conducted currently for the additional indications. It would eliminate the need to do anymore additional trials. The BREEZE clinical trial just covers the largest patient population currently on Tyvaso, and they will all be transitioned to TreT once TreT is approved. |
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Post by radgray68 on Apr 30, 2020 17:28:19 GMT -5
Would we start to get paid royalties for the patients who choose to continue on the Tre-T? I can't see a reason why we wouldn't. Service ordered, service provided. I'd love to see another source of revenue appear on our balance sheet sooner than analysts predict. FDA doesn't have some left field rules about that do they?
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Post by Deleted on Apr 30, 2020 18:46:45 GMT -5
Would we start to get paid royalties for the patients who choose to continue on the Tre-T? I can't see a reason why we wouldn't. Service ordered, service provided. I'd love to see another source of revenue appear on our balance sheet sooner than analysts predict. FDA doesn't have some left field rules about that do they? It's only 45 patients in the trial. |
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Post by Clement on Apr 30, 2020 19:01:44 GMT -5
Would we start to get paid royalties for the patients who choose to continue on the Tre-T? I can't see a reason why we wouldn't. Service ordered, service provided. I'd love to see another source of revenue appear on our balance sheet sooner than analysts predict. FDA doesn't have some left field rules about that do they? Radgray, I enjoy reading your posts. The enrollees in this trial are allowed an extension with TreT if they want (that is, if they really like TreT and don't want to go back to Tyvaso). It's written into the trial. See clinicaltrials.gov and search Tret. You'll find it. |
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