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Post by peppy on Oct 31, 2019 9:21:40 GMT -5
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Post by mango on Oct 31, 2019 9:51:44 GMT -5
Same API. Both are treprostinil |
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Post by brotherm1 on Oct 31, 2019 16:09:36 GMT -5
So we’ve been misled again. |
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Post by peppy on Oct 31, 2019 16:48:12 GMT -5
So we’ve been misled again. sports posted some thing from stockwitts probably @ 4 weeks ago. added: correction it was lakers. lakers posted: SO was right on. MannKind- Conflicts And Misperception Over Bioavailability And The Correct Status For The Clinical Trial For Tre-T Has Created Self-Inflected Confusion. $MNKD seekingalpha.com/article/4296437 Read more: mnkd.proboards.com/user/1370/recent#ixzz63yGD9yU9 |
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Post by Clement on Oct 31, 2019 16:53:42 GMT -5
Holdem, are you saying that Mannkind used a different stereochemical configuration of treprostinil from that of treperostinil in Tyvaso? .... or something else?
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Post by buyitonsale on Oct 31, 2019 17:30:51 GMT -5
More FUD ? www.tyvaso.com/dtc/What is Tyvaso? Tyvaso (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. Tyvaso can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking Tyvaso. It is not known if Tyvaso is safe and effective in children under 18 years of age. |
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Post by buyitonsale on Oct 31, 2019 17:36:00 GMT -5
Secondary Outcome Measures :
Analysis of treprostinil plasma concentration (pharmacokinetics [PK]) [ Time Frame: Serial PK measurements at Baseline and Week 3 ]
Systemic exposure of treprostinil will be evaluated in subjects with PAH when delivered as Tyvaso and TreT
Change in 6-Minute Walk Distance (6MWD) from Baseline to Week 3 [ Time Frame: After 3 weeks of treatment with TreT ]
6MWD will be evaluated at study entry and after 3 weeks of treatment with TreT
Number of subjects with treatment-emergent adverse events [Long-term Safety and Tolerability] during an Optional Extension Phase [ Time Frame: Every 4 weeks beginning on Week 7 until study termination, an average of 1 year ]
The long-term safety and tolerability of TreT in subjects with PAH currently treated with Tyvaso will be evaluated by the number of subjects with treatment-emergent adverse events during an Optional Extension Phase of the study
Subject satisfaction with and preference for inhaled treprostinil devices [ Time Frame: At Baseline (Tyvaso Inhalation System) and after 3 weeks of treatment (TreT Inhaler) ]
Subject satisfaction with and preference for inhaled treprostinil devices will be evaluated with the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD)
Patient-reported PAH symptoms and impact [ Time Frame: After 3 weeks and 11 weeks (for subjects participating in the Optional Extension Phase) of treatment with TreT ]
Patient-reported PAH symptoms and impact will be evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire
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Post by mango on Oct 31, 2019 17:48:55 GMT -5
So we’ve been misled again. sports posted some thing from stockwitts probably @ 4 weeks ago. added: correction it was lakers. lakers posted: SO was right on. MannKind- Conflicts And Misperception Over Bioavailability And The Correct Status For The Clinical Trial For Tre-T Has Created Self-Inflected Confusion. $MNKD seekingalpha.com/article/4296437 Read more: mnkd.proboards.com/user/1370/recent#ixzz63yGD9yU9Can you summarize that for those of us who can’t/won’t read the article? |
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Post by agedhippie on Oct 31, 2019 18:50:08 GMT -5
So we’ve been misled again. sports posted some thing from stockwitts probably @ 4 weeks ago. added: correction it was lakers. lakers posted: SO was right on. MannKind- Conflicts And Misperception Over Bioavailability And The Correct Status For The Clinical Trial For Tre-T Has Created Self-Inflected Confusion. $MNKD seekingalpha.com/article/4296437 Read more: mnkd.proboards.com/user/1370/recent#ixzz63yGD9yU9That article is by Looking For Diogenes, and not Spencer Osborne. It's the wrong side of a paywall now and while I did read it at the time I cannot remember what it said. |
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Post by sayhey24 on Oct 31, 2019 19:30:09 GMT -5
Mango - Diogenes thought he made a brilliant discovery in that only about 40% of the powder in a cartridge hits the lung. He heard Mike in an interview say 70% left the cartridge and 30% was left in the cartridge but he did not understand another 30% is lost in the mouth, throat, etc.
As the super sleuth he is he tried to contact Mike but did not seem to have a direct email as many here do. MNKD IR however did respond.
It was pretty much nothing about nothing. However, I have been seeing a lot of positive interest in the dpi space lately. I am interested to see what Mike says next week. Last time he mentioned 3 new companies having interest in TS. Maybe its real.
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Post by radgray68 on Oct 31, 2019 19:46:13 GMT -5
Mannkind now has the ability to produce its own high potency molecules. Here: finance.yahoo.com/news/mannkind-expands-commercial-scale-manufacturing-201449886.htmlI believe our latest milestone was somewhat related to the achievement of this goal. My guess: The FDA may need another trial to be sure the molecules produced by Mannkind will work as well as the ones used in prior trials. Very thorough, this FDA. Also, the reason why we have been weighed down by the enormous insulin supply contract with Amphistar. |
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Post by mnholdem on Nov 1, 2019 7:55:16 GMT -5
Holdem, are you saying that Mannkind used a different stereochemical configuration of treprostinil from that of treperostinil in Tyvaso? .... or something else? Different suppliers. Not all API (Active Pharmaceutic Ingredients) are created alike, even if they have the same name or chemical makeup. India, for example, has been encountering problems with the FDA in regards to generics being manufactured there. I should have been a bit more clear about what I meant.  |
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Post by casualinvestor on Nov 1, 2019 9:05:38 GMT -5
So I did a little digging and managed to dumb it down for myself. The MNKD Phase 1 TrepT study clinicaltrials.gov/ct2/show/NCT03464864 The new one by UTC clinicaltrials.gov/ct2/show/NCT03950739 (BREEZE), also Phase 1 The main difference is that the UTC study is being done on people with PAH and the MNKD study was done with normal healthy volunteers. Minor difference, BREEZE is using a stable dose over 3 weeks (dosage based on subject's current stable Tyvaso dose), rather than rising dosage This means that the BREEZE study will have a lot more information regarding people with PAH like 6 minute walk test results and "questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact" They are both being done with Drug: Treprostinil Inhalation Powder. Also, MNKD managed to wrap this one up in 3 months EDIT: The resource link for the drugs in both studies point to the same links: Treprostinil, Treprostinil sodium and Treprostinil diolamine |
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Post by doubleo7 on Nov 2, 2019 2:10:02 GMT -5
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Post by rossomalley on Nov 2, 2019 17:06:35 GMT -5
So I did a little digging and managed to dumb it down for myself. The MNKD Phase 1 TrepT study clinicaltrials.gov/ct2/show/NCT03464864 The new one by UTC clinicaltrials.gov/ct2/show/NCT03950739 (BREEZE), also Phase 1 The main difference is that the UTC study is being done on people with PAH and the MNKD study was done with normal healthy volunteers. Minor difference, BREEZE is using a stable dose over 3 weeks (dosage based on subject's current stable Tyvaso dose), rather than rising dosage This means that the BREEZE study will have a lot more information regarding people with PAH like 6 minute walk test results and "questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact" They are both being done with Drug: Treprostinil Inhalation Powder. Also, MNKD managed to wrap this one up in 3 months EDIT: The resource link for the drugs in both studies point to the same links: Treprostinil, Treprostinil sodium and Treprostinil diolamine [ Thanks for correcting the misinformation about this! |
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