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Post by tomtabb on Nov 4, 2018 4:27:23 GMT -5
What is this image saying -- they plan to launch tyvaso for PH due to COPD before "technosphere"? The 'Perfect Study" won't be complete for another 2 years -- clinicaltrials.gov/ct2/show/NCT03496623. Does that mean, then that nothing can be expected for "technosphere" for at least 2 years? And why don't they come up with a name for it? Calling it just "technosphere" seems confusing.
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Post by Clement on Nov 4, 2018 7:28:17 GMT -5
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Post by peppy on Nov 4, 2018 8:55:08 GMT -5
What is this image saying -- they plan to launch tyvaso for PH due to COPD before "technosphere"? The 'Perfect Study" won't be complete for another 2 years -- clinicaltrials.gov/ct2/show/NCT03496623. Does that mean, then that nothing can be expected for "technosphere" for at least 2 years? And why don't they come up with a name for it? Calling it just "technosphere" seems confusing. A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With PH Due to COPD Experimental: Inhaled Treprostinil Inhaled treprostinil delivered via an ultrasonic nebulizer with a target dosing regimen of 12 breaths (72 mcg) 4 times daily (QID)Primary Outcome Measures :Change in 6-Minute Walk Distance (6MWD) from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]The intent of the 6-Minute Walk Test (6MWT) is a validated and reliable measure of exercise ability in patients with chronic respiratory diseases.Secondary Outcome Measures : Change in Borg dyspnea score from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (no dyspnea at all) to 10 (very, very severe dyspnea). clinicaltrials.gov/ct2/show/NCT03496623============================================================================ This is all good. This is to see if COPD with pulmonary hypertension could be helped with trept. MNKD/united therapeutic trails up to the plate.
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Post by tomtabb on Nov 4, 2018 20:59:32 GMT -5
Did you notice that it says: "Actual Enrollment : 0 participants"? No doubt that makes it a lot easier. It also says: "Recruitment Status : Withdrawn (Business decision)" On the other hand, the one I listed -- clinicaltrials.gov/ct2/show/NCT03496623 -- has 314 participants which helps explain why it's going to take so long.
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Post by mango on Nov 4, 2018 21:20:53 GMT -5
What is this image saying -- they plan to launch tyvaso for PH due to COPD before "technosphere"? The 'Perfect Study" won't be complete for another 2 years -- clinicaltrials.gov/ct2/show/NCT03496623. Does that mean, then that nothing can be expected for "technosphere" for at least 2 years? And why don't they come up with a name for it? Calling it just "technosphere" seems confusing. If you get confused just listen to the music play
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Post by mnholdem on Nov 5, 2018 5:56:23 GMT -5
Neither of the UTC clinical trials linked above is for Treprostinil Technosphere but are related to a nebulizer. TreT is Phase 3 ready, however, and United Therapeutics is likely finalizing the trial protocols with the FDA and will soon be recruiting patients. Then we'll see it listed with the other clinical trials.
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Post by lakers on Nov 9, 2018 0:39:46 GMT -5
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Post by tomtabb on Nov 9, 2018 9:26:41 GMT -5
How much insulin is MNKD contracted to buy yearly from Amphastar?
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Post by agedhippie on Nov 9, 2018 10:23:41 GMT -5
How much insulin is MNKD contracted to buy yearly from Amphastar? It varies, but annually €8.9M (about $10M) in 2018, €11.6M (about $13M) in 2019, and so on. There is more detail in the contract but the interesting bits are withheld.
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Post by mango on Nov 16, 2018 8:56:19 GMT -5
AFREZZA THE PREFERRED PATIENT EXPERIENCE
MannKind Q3 2018 Earnings Call Nov. 1, 2018 —CEO Mile Castagna
• We have our work cut out for us to change the standard of care, but as we look out we don't see any competitive entrants, and we believe we have over 15 years of patent life ahead of us to make this dream a reality.
• Keep in mind, our competition gives away $0.50 to $0.70 of every dollar spent in rebates to payers to ensure patient and provider access is difficult for new entrants like us. However, I believe we are moving to an outcomes-based healthcare system where interconnect care and outcomes will matter instead of volume of care.
• Afrezza, we are focused on building the next standard of care in mealtime insulin. I know we have been saying for awhile. But it's important to know that changing habits just takes time. We have used insulin the same way for 95 years and we don't expect to change that overnight.
• And as we go in pediatrics and the believability in our future and being here but also the technology being utilized in pediatrics, demonstrating safety as well as technology being delivered to the lung and other disease area continues to bring confidence to our prescriber base here in the U.S.
• The comment on Kendall is a very interesting one. I mean, it's really changed the top echelon of endocrinologists that they really just didn't know our data, and so they'll make comments that are really not based on science, and not based on scientific information, and that's really where Kendall has brought a lot of credibility to sit there and go toe to toe with them and educate them on our historical data because that's something MannKind has not always done as well as we wanted. So what this brings thought leaders along, demonstrate why the product is unique. It's not just that it's inhaled, and that's not the reason you should ever use the drug. But it's really that uniqueness of the PKPD, the endogenous glucose suppression, and what this really means from hypoglycemia.
• But David has done a tremendous amount of work, not only on the thought leaders but the scientific publications which -- one of the problems that we see is when you go to talk about guidelines and changing guidelines, when you don't have any data published, we're sitting on 65 trials and thousands of patients. They need that data published in order to look at adjusting guidelines or highlighting unique aspects of our product, and that's a major effort of our.
• And so we're going in the right direction, we've been in constant dialog, I know a lot of these guys personally and so we'll continue to make good progress as we go forward and I think that's good because doctors took time to learn. They're still taking that time to learn, but as they get more educated, they get that experience and contracts get easier and friction gets removed [indiscernible]. I look out over the coming years and I see nothing but barriers removed and continued growth by more and more prescribers. So those two things go hand in hand.
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