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Post by brotherm1 on Feb 24, 2020 14:10:45 GMT -5
”Oh I see what you're saying...Well, regardless, all Tyvaso patients will be transitioned over to TreT and Tyvaso will be fazed out—and that is coming directly from the source itself (Martine Rothblatt). Doesn't matter to me what path they choose to take, what it's happening regardless.”
I guess I forgot she said that Mango. Would you happen to have the link for that? I need a pick me up today.
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Post by mango on Feb 24, 2020 14:14:48 GMT -5
”Oh I see what you're saying...Well, regardless, all Tyvaso patients will be transitioned over to TreT and Tyvaso will be fazed out—and that is coming directly from the source itself (Martine Rothblatt). Doesn't matter to me what path they choose to take, what it's happening regardless.” I guess I forgot she said that Mango. Would you happen to have the link for that? I need a pick me up today. Somewhere in SA in a transcript. Was a few CCs.
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Post by jkendra on Feb 24, 2020 14:30:06 GMT -5
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Post by brotherm1 on Feb 24, 2020 14:46:50 GMT -5
Very nice. Thank you.
“The new mannkind device literally fits in the palm of your hand, you can put it right in your pocket or handbag and go about your day. Most importantly though with regard to the mannkind device, we decided to make this investment in it because we are confident that the Tyvaso market is set to triple over the next few years as a result of bringing Tyvaso into an entirely new disease space called group 3 Pulmonary hypertension.
Group 3 Pulmonary hypertension is a set of obstruction pulmonary diseases quite different from group 1 pulmonary hypertension where all of our products and and all other pulmonary hypertension products are currently approved.
Group 3 pah includes indications such as PA fibrosis , Interstitial lung disease and CoPD.“
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Post by mango on Feb 24, 2020 15:23:35 GMT -5
Very nice. Thank you. “The new mannkind device literally fits in the palm of your hand, you can put it right in your pocket or handbag and go about your day. Most importantly though with regard to the mannkind device, we decided to make this investment in it because we are confident that the Tyvaso market is set to triple over the next few years as a result of bringing Tyvaso into an entirely new disease space called group 3 Pulmonary hypertension. Group 3 Pulmonary hypertension is a set of obstruction pulmonary diseases quite different from group 1 pulmonary hypertension where all of our products and and all other pulmonary hypertension products are currently approved. Group 3 pah includes indications such as PA fibrosis , Interstitial lung disease and CoPD.“ "So we feel quit confident that we will have a positive result on the increase trial it was base on very good earlier phase 2 work and this will open us up to a 30k patient group 3 virgin population that has previously been able to benefit from any previous PAH medicine. This 30k population with COPD, IPF, ILD they will be much more willing to rapidly adopt our technology if it is a small hand held Mannkind device than compared to a more complicated nebulizer. So we have timed the Mannkind acquisition or in-licensing and development to be timed with out drugs into the Group 3 PAH. This will be a major vector for our business." --------------------- Emphasis on: "They will be much more willing to rapidly adopt our technology if it is a small hand held MannKind device compared to a more complicated nebulizer."
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Post by akemp3000 on Feb 24, 2020 15:29:12 GMT -5
As people use and love the Mannkind device for TreT, it will not only mean increasing revenue royalties for MNKD but will logically increase public awareness and acceptance that will carry over to diabetics also wanting to use a palm size inhaler. This won't happen overnight but IMO will happen big overtime. I like the idea of Martine Rothblatt and big money UTHR promoting use of the Mannkind device.
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Post by longliner on Feb 25, 2020 20:42:52 GMT -5
Did anyone see Mango's find on UTHR buying MNKD Warrants. I wonder if they hold the ballance as well?
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Post by mango on Feb 25, 2020 20:50:12 GMT -5
Did anyone see Mango's find on UTHR buying MNKD Warrants. I wonder if they hold the ballance as well? A pretty damn significant thing for UT to do. I'm not talking about the small amount of money, but just simply the fact that UT bought MannKind warrants to help them raise money. Let that sink in...
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Post by longliner on Feb 25, 2020 20:51:34 GMT -5
Did anyone see Mango's find on UTHR buying MNKD Warrants. I wonder if they hold the ballance as well? A pretty damn significant thing for UT to do. I'm not talking about the small amount of money, but just simply the fact that UT bought MannKind warrants to help them raise money. Let that sink in... A benevolent warrant holder would be a major change.
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Post by Clement on Feb 26, 2020 8:59:30 GMT -5
from today's UTHR press release regarding financial results:
Treprostinil Technosphere® dry powder inhaler - BREEZE. Enrollment is ongoing for the BREEZE study comparing our new dry powder inhaler (DPI) form of treprostinil, which we in-licensed from MannKind, to Tyvaso.
The phase I BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new DPI. The primary endpoint of the study is the number of subjects with treatment-emergent adverse events after three weeks of treatment with the DPI.
We expect to receive results of the BREEZE study by mid-year 2020. During the first half of 2020, we also plan to commence a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. We expect these two studies, combined with long-term stability studies of the DPI product, will form the basis of a 505(b)(1) new drug application to the FDA for our treprostinil DPI delivery product.
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Post by casualinvestor on Feb 26, 2020 10:08:14 GMT -5
clinicaltrials.gov/ct2/show/NCT03950739Actual Study Start Date : September 17, 2019 Estimated Primary Completion Date : May 2020 Estimated Study Completion Date : August 2020 The second clinical study will use health volunteers, so that should be fairly quick?
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Post by mango on Feb 26, 2020 12:14:05 GMT -5
clinicaltrials.gov/ct2/show/NCT03950739Actual Study Start Date : September 17, 2019 Estimated Primary Completion Date : May 2020 Estimated Study Completion Date : August 2020 The second clinical study will use health volunteers, so that should be fairly quick? It will be a very quick clinical trial, and will most likely closely mimic, or perhaps exceed, the results from the small PK study MannKind did a while back. As you will see below, the TreT results were enormously significant, and far exceeded Tyvaso's PK abilities (and I imagine also Liquidia's product as well). This is why so many people are very, very excited about TreT and the future of the MannKind/United Therapeutics partnership, as well as, the future applications of Technosphere.
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Post by mango on Feb 26, 2020 12:44:36 GMT -5
Another potential indication using Treprostinil Technosphere is sarcoidosis-associated interstitial lung disease and pulmonary hypertension, a rare lung disease. United Therapeutics already has an ongoing clinical trial evaluating inhaled treprostinil for this orphan lung disease, of course, using Tyvaso. Did I fail to mention that MannKind has changed their pipeline focus to orphan lung diseases? Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension (SAPPHIRE)clinicaltrials.gov/ct2/show/NCT03814317
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Post by mango on Feb 27, 2020 14:50:18 GMT -5
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Post by longliner on Mar 4, 2020 11:31:39 GMT -5
My thought is with UTHR's focus on lung disease, that they (we) are better suited for treatment of the Coronavirus rather than a vaccine. With the ability to treat the deep lungs that seems like a more likely scenario to me (at least an immediate area of focus). I like that for the short term the President has agreed to remove regulatory hurdles as they come up, hopefully that applies to treatments as well as vaccines.
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