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Post by lifebreath on Jan 13, 2020 20:50:14 GMT -5
Very disappointed in this schedule. No royalties for 2 - 2.5 years yet? I thought TreT would be available early 2021. Boy was I wrong! did you hear that from Mike Castagna?
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Post by boca1girl on Jan 13, 2020 22:04:11 GMT -5
Lifebreath - read posts in this thread from UtHR’s presentation regarding schedule. How could MNKD receive royalties before TreT is launched?
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Post by Thundersnow on Jan 13, 2020 22:10:53 GMT -5
Lifebreath - read posts in this thread from UtHR’s presentation regarding schedule. How could MNKD receive royalties before TreT is launched? Early 2021 was very optimistic. We all know timetables are unreliable when it comes to the FDA. Plus UTHR takes their time in making sure all T's are crossed and every "I" is DOTTED. They can't afford unforced errors.
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Post by lifebreath on Jan 13, 2020 22:46:45 GMT -5
Lifebreath - read posts in this thread from UtHR’s presentation regarding schedule. How could MNKD receive royalties before TreT is launched? I know about the UTHR timeline, and I listened to Martin on the webcast this afternoon. Followed by questions. I am asking what made you think the drug release would be sooner than what Martin said today during the questions. Thank-you
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Post by georgethenight2 on Jan 13, 2020 23:00:41 GMT -5
Lifebreath - read posts in this thread from UtHR’s presentation regarding schedule. How could MNKD receive royalties before TreT is launched? Early 2021 was very optimistic. We all know timetables are unreliable when it comes to the FDA. Plus UTHR takes their time in making sure all T's are crossed and every "I" is DOTTED. They can't afford unforced errors. A much better point of discussion would be: if Trep T isnt being targeted until late '21 or early '22, UTHR will be determined to see MNKD survive. We in turn benefit from this relationship.
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Post by Thundersnow on Jan 13, 2020 23:31:45 GMT -5
Early 2021 was very optimistic. We all know timetables are unreliable when it comes to the FDA. Plus UTHR takes their time in making sure all T's are crossed and every "I" is DOTTED. They can't afford unforced errors. A much better point of discussion would be: if Trep T isnt being targeted until late '21 or early '22, UTHR will be determined to see MNKD survive. We in turn benefit from this relationship. As long as Afrezza sales keep climbing MNKD will be fine. They need 1 more partner for about $30M to get them over the hump along with UTHR's milestones for 2020. I wish RLS would step up and give MNKD some of the $99M but then again they have limited resources also.
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Post by Clement on Jan 14, 2020 8:17:36 GMT -5
Someone asked a question on this. Breeze trial enrollment expected to complete by May 2020. 12-month product stability test to complete by end of 2020. FDA submission is expected end of year 2020. Product (TreT) will probably be launched in the fourth quarter of 2021 or first half of 2022. Product stability -- Perhaps UTHR is shooting for room temperature storage rather than refrigeration?
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Post by brotherm1 on Jan 14, 2020 8:27:37 GMT -5
And where in FDA approval is ralinepag that UTHR paid Arena $1B for? I still think , and now more than ever, that UTHR bought Trepostinil from MNKD for a few beans just to shelve it.
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Post by boca1girl on Jan 14, 2020 8:53:06 GMT -5
Lifebreath - read posts in this thread from UtHR’s presentation regarding schedule. How could MNKD receive royalties before TreT is launched? I know about the UTHR timeline, and I listened to Martin on the webcast this afternoon. Followed by questions. I am asking what made you think the drug release would be sooner than what Martin said today during the questions. Thank-you From the thread about UTHR royalties: it looks like UTHR will send a NDA (505(b)(2) Pathway in the H2 of 2020 after it has finished all the necessary Studies. how long does the FDA Prozess take? From the UTHR 10-Q We commenced a clinical study (called BREEZE) in September 2019 to evaluate the safety and pharmacokinetics of switching PAH patients from Tyvaso to Treprostinil Technosphere. During the first half of 2020, we plan to commence a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval Read more: mnkd.proboards.com/thread/11581/uthr-royalties?page=3#ixzz6B0pBOp4sFrom this I “assumed” that they would gain FDA approval in 2H2021, even with the second 12 month study starting 1H2020. I guess I was wrong.
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Post by mango on Jan 14, 2020 8:56:15 GMT -5
And where in FDA approval is ralinepag that UTHR paid Arena $1B for? I still think , and now more than ever, that UTHR bought Trepostinil from MNKD for a few beans just to shelve it. I think the opposite. Ralinepag is a NCE and is very high risk, Martine even said that too. TreT is low risk and big reward, with an almost guarantee for FDA approval. UT has long-term plans for TreT, if they simply wanted to shelf it then they wouldn’t be wasting money on clinical trials and talking about its launch etc. UT passively talks about ralinepag while they moreso showcase TreT and MannKind’s inhaler and BluHale. Remember the slide Martine had of MannKind’s inhaler with Bluhale at the BARDA industry day (Medical Counter Measures) last year where Martine was the guest speaker? Does this equate to someone that has intentions of shelving the product? Not the least bit, IMO. Notice it even says Treprostinil in next generation inhaler. medicalcountermeasures.gov/BARDA/Documents/BID2018_Presentations/Martine%20Rothblatt_%20Keynote.pdf
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Post by brotherm1 on Jan 14, 2020 9:40:51 GMT -5
And where in FDA approval is ralinepag that UTHR paid Arena $1B for? I still think , and now more than ever, that UTHR bought Trepostinil from MNKD for a few beans just to shelve it. I think the opposite. Ralinepag is a NCE and is very high risk, Martine even said that too. TreT is low risk and big reward, with an almost guarantee for FDA approval. UT has long-term plans for TreT, if they simply wanted to shelf it then they wouldn’t be wasting money on clinical trials and talking about its launch etc. UT passively talks about ralinepag while they moreso showcase TreT and MannKind’s inhaler and BluHale. Remember the slide Martine had of MannKind’s inhaler with Bluhale at the BARDA industry day (Medical Counter Measures) last year where Martine was the guest speaker? Does this equate to someone that has intentions of shelving the product? Not the least bit, IMO. Notice it even says Treprostinil in next generation inhaler. medicalcountermeasures.gov/BARDA/Documents/BID2018_Presentations/Martine%20Rothblatt_%20Keynote.pdfThen why did they pay 10x + more for ralinepag? And now dragging out the approval process?
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Post by mango on Jan 14, 2020 10:02:23 GMT -5
I think the opposite. Ralinepag is a NCE and is very high risk, Martine even said that too. TreT is low risk and big reward, with an almost guarantee for FDA approval. UT has long-term plans for TreT, if they simply wanted to shelf it then they wouldn’t be wasting money on clinical trials and talking about its launch etc. UT passively talks about ralinepag while they moreso showcase TreT and MannKind’s inhaler and BluHale. Remember the slide Martine had of MannKind’s inhaler with Bluhale at the BARDA industry day (Medical Counter Measures) last year where Martine was the guest speaker? Does this equate to someone that has intentions of shelving the product? Not the least bit, IMO. Notice it even says Treprostinil in next generation inhaler. medicalcountermeasures.gov/BARDA/Documents/BID2018_Presentations/Martine%20Rothblatt_%20Keynote.pdfThen why did they pay 10x + more for ralinepag? And now dragging out the approval process? Ralinepag is a New Chemical Entity that Arena had to develop themselves and took through clinical trials up to the point of the UT deal. That mean Arena spent significantly more time and money doing that compared with what little time and money MannKind spent on TreT development and Phase 1. UT took control of Ralinepag’s future by buying it up. Also, TreT will be indicated for WHO Groups 1 & 3. There is currently no approved therapies for WHO Group 3, and Tyvaso is currently beginning a clinical trial for this group (PH-ILD with around 30,000 patients). If approved, and if TreT becomes approved, then TreT will be used for both groups. Ralinepag on the other hand, is currently not even FDA approved and is being evaluated for: ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. clinicaltrials.gov/ct2/show/NCT03626688Estimated Study Completion Date for Ralinepag is December 2021
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Post by prcgorman2 on Jan 14, 2020 10:15:51 GMT -5
Brotherm1 - what makes you think UTHR Is dragging out the approval process? Did they say that? Mannkind had to collaborate with the FDA on Afrezza approval trial design. Does it occur to you that the FDA might be influencing the TreT trial timeline? It should.
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Post by brotherm1 on Jan 14, 2020 10:21:33 GMT -5
Why should it?
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Post by peppy on Jan 14, 2020 10:23:39 GMT -5
Then why did they pay 10x + more for ralinepag? And now dragging out the approval process? Ralinepag is a New Chemical Entity that Arena had to develop themselves and took through clinical trials up to the point of the UT deal. That mean Arena spent significantly more time and money doing that compared with what little time and money MannKind spent on TreT development and Phase 1. UT took control of Ralinepag’s future by buying it up. Also, TreT will be indicated for WHO Groups 1 & 3. There is currently no approved therapies for WHO Group 3, and Tyvaso is currently beginning a clinical trial for this group (PH-ILD with around 30,000 patients). If approved, and if TreT becomes approved, then TreT will be used for both groups. Ralinepag on the other hand, is currently not even FDA approved and is being evaluated for: ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. clinicaltrials.gov/ct2/show/NCT03626688Estimated Study Completion Date for Ralinepag is December 2021 TreT will be indicated for WHO Groups 1 & 3. There is currently no approved therapies for WHO Group 3, and Tyvaso is currently beginning a clinical trial for this group (PH-ILD with around 30,000 patients). If approved, and if TreT becomes approved, then TreT will be used for both groups. TYVASO. www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdfRalinepag is a New Chemical Entity www.arenapharm.com/wp-content/uploads/2018/03/Hemodynamic-Effects-of-the-Oral-Prostacyclin-Receptor-IP-Agonist-Ralinepag-in-Pulmonary-Arterial-Hypertension-PAH-WSPH-2018-Poster-Torres-Hemodynamic-Effects.pdf
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