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Post by yash on Aug 17, 2020 5:22:34 GMT -5
United Therapeutics Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Tyvaso® For Pulmonary Hypertension Associated With Interstitial Lung Disease PR Newswire PR Newswire•August 17, 2020 finance.yahoo.com/news/united-therapeutics-announces-u-fda-100000382.htmlSILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in April 2021. "Tyvaso, if approved by the FDA, would be the first and only therapeutic approved for the treatment of PH-ILD, a condition that afflicts approximately 30,000 people in the United States," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We look forward to working with the Agency during the regulatory review process, with the goal of expanding the population of patients with pulmonary hypertension who could benefit from this important medicine." |
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Post by boytroy88 on Aug 17, 2020 6:35:16 GMT -5
Let's see if this will cross over to us and effect some positive price action. Fingers crossed!
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Post by mango on Aug 17, 2020 10:39:01 GMT -5
$100M+ in annual royalties from $UTHR just got one step closer to becoming reality.
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Post by brotherm1 on Aug 17, 2020 11:35:12 GMT -5
will ILD use in MNKD’s inhaler be included in the anticipated Q1 2021 NDA by UTHR for PAH? Or will a new study be needed to use MNKD’s inhaler and ingredients for ILD?
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Post by peppy on Aug 17, 2020 11:36:38 GMT -5
will ILD use in MNKD’s inhaler be included in the anticipated Q1 2021 NDA by UTHR for PAH? Or will a new study be needed to use MNKD’s inhaler and ingredients for ILD? dreamboat with bluehale. I believe. mango? |
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Post by cjm18 on Aug 17, 2020 11:45:49 GMT -5
This is a different filing from what mike mentioned in the last earnings call? That was supposed to happen in 21q1.
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Post by mango on Aug 17, 2020 13:57:49 GMT -5
will ILD use in MNKD’s inhaler be included in the anticipated Q1 2021 NDA by UTHR for PAH? Or will a new study be needed to use MNKD’s inhaler and ingredients for ILD? dreamboat with bluehale. I believe. mango? No further tests will be required. TreT will be replacing Tyvaso entirely, for all its FDA approved indications. Yep, believe they intend to use the Bluhale. |
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Post by brotherm1 on Aug 17, 2020 15:30:06 GMT -5
If no further testing for ILD, then how will the dosage for it from the dreamboat be determined?
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Post by buyitonsale on Aug 18, 2020 0:22:18 GMT -5
Currently about 3000 Tyvaso patients with earnings over 400M a year. Opportunity to add 30,000 ILD patients for additional earnings of 4B a year. The potential royalties from 4.4 billion will be a bit higher than the figure above in this thread... This is what Castagna was referring to (our future royalties may be greater than current market cap). Mid term pipeline also involves COPD indication trials, and if approved opens up additional 100,000 patient market... something to think about for the ultimate MNKD long term investors  Almost forgot, UTHR will file NDA for TreT in about 7-8 months. Whoever remains on the short train after that will have about 9 months to get off... or the return ticket may get expensive  |
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Post by casualinvestor on Aug 18, 2020 8:15:05 GMT -5
$133k per patient per year? To expand to a larger group, I think the cost is going to come down. But I'm ok with 10% royalties on $2B |
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Post by neil36 on Aug 18, 2020 8:18:04 GMT -5
$133k per patient per year? To expand to a larger group, I think the cost is going to come down. But I'm ok with 10% royalties on $2B $11,000 per month per patient?? |
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Post by casualinvestor on Aug 18, 2020 8:51:38 GMT -5
3000 patients costing 400M/year = $133k/year. I know of at least one cancer tratment that is that expensive, and there are probably many others.
I didn't check the accuracy of 3000 or $400M, just pulled it from buyitonsale's post. My point is that a sky-high cost for 3000 people will not happen for 30,000
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Post by neil36 on Aug 18, 2020 9:29:01 GMT -5
Currently about 3000 Tyvaso patients with earnings over 400M a year. Opportunity to add 30,000 ILD patients for additional earnings of 4B a year. The potential royalties from 4.4 billion will be a bit higher than the figure above in this thread... This is what Castagna was referring to (our future royalties may be greater than current market cap). Mid term pipeline also involves COPD indication trials, and if approved opens up additional 100,000 patient market... something to think about for the ultimate MNKD long term investors Almost forgot, UTHR will file NDA for TreT in about 7-8 months. Whoever remains on the short train after that will have about 9 months to get off... or the return ticket may get expensive Can you point us to where you got the “3000 patients with earnings of $400 million” numbers? Thanks |
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Post by ronw77077 on Aug 18, 2020 10:00:05 GMT -5
Recently I posed the following questions to MNKD and received the responses below:
Question:
I would appreciate some guidance as to when Mannkind believes royalties from Tret T would begin. I would also appreciate some guidance as to when Afrezza sales to pediatrics may begin. I understand that there are variables not under control of the company. With whatever caveats are needed, I'd appreciate some guidance on both of these matters.
Response:
I’ll answer as best I can. TreT is still being studied in the clinic. The trials were interrupted by COVID, but are now recruiting patients again. We currently expect the studies to be completed by the end of the year, but there are factors not in our control that can impact those timelines. United Therapeutics is responsible for conducting the clinical trials and preparing the regulatory submission. It is probably safe to say that TreT will not be available commercially until at least sometime in 2022.
Sales of Afrezza to pediatric patients will take some time as well. We need to conduct a Phase 3 trial in 8-17 year olds before we can submit a supplemental NDA. That trial will take at least 18 months and the protocol for it has not yet been agreed to by the FDA. At the moment, we cannot say when we will be in a position to start that trial.
Subsequent to this exchange, UT put out its press release expecting FDA review completion in April 2021. Per Mango, "No further tests will be required. TreT will be replacing Tyvaso entirely, for all its FDA approved indications."
Can anyone shed some light on whether the UT press release implies royalties to MNKD would begin prior to 2022?
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Post by buyitonsale on Aug 18, 2020 12:01:08 GMT -5
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