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Post by Clement on Aug 4, 2021 8:57:26 GMT -5
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Post by Clement on Aug 4, 2021 9:00:58 GMT -5
UTHR up 12% this morning
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Post by peppy on Aug 4, 2021 9:13:48 GMT -5
PFE broke out a couple of days ago. UTHR owned 12% PFE was news to me. |
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Post by lennymnkd on Aug 4, 2021 9:21:09 GMT -5
Not to mention/ mnkd ,Danbury was mentioned in United CC 😀
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Post by cjm18 on Aug 4, 2021 9:26:00 GMT -5
Good news from uhtr. Thanks for posting.
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Post by longliner on Aug 4, 2021 9:26:15 GMT -5
PFE broke out a couple of days ago. UTHR owned 12% PFE was news to me. Have you a link peppy? |
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Post by longliner on Aug 4, 2021 9:28:45 GMT -5
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Post by akemp3000 on Aug 4, 2021 9:36:48 GMT -5
I find it interesting that the UTHR press release refers to the "Tyvaso DPI manufacturing facility in Danbury...operated by our partner Mannkind Corporation" It could have said, "owned by our partner Mannkind Corporation" or could it? Update anyone?
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Post by peppy on Aug 4, 2021 9:47:08 GMT -5
PFE broke out a couple of days ago. UTHR owned 12% PFE was news to me. Have you a link peppy? Darn, I have tried to find the post. Someone posted it, I looked, it seemed to be out of PFE's 10q or UTHR 10q Said better, PFE owns 12% of UTHR. Reminded me of Sanofi owning % of Regeneron. longliner From Kevin on ST, according to this, Eli Lilly owns 11.72% of UTHR. One big happy family  .
www.wallstreetzen.com/stocks/us/nasdaq/uthr/ownershipI am an idiot. |
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Post by longliner on Aug 4, 2021 9:50:00 GMT -5
I find it interesting that the UTHR press release refers to the "Tyvaso DPI manufacturing facility in Danbury...operated by our partner Mannkind Corporation" It could have said, "owned by our partner Mannkind Corporation" or could it? Update anyone? Martine doesn't seem to misspeak often... |
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Post by longliner on Aug 4, 2021 10:06:47 GMT -5
Darn, I have tried to find the post. Someone posted it, I looked, it seemed to be out of PFE's 10q or UTHR 10q Said better, PFE owns 12% of UTHR. Reminded me of Sanofi owning % of Regeneron. longliner From Kevin on ST, according to this, Eli Lilly owns 11.72% of UTHR. One big happy family .
www.wallstreetzen.com/stocks/us/nasdaq/uthr/ownershipI am an idiot.Nope, just human. |
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Post by geomean on Aug 4, 2021 10:10:55 GMT -5
Could the "operated by Mannkind" reference be a way of reflecting a completed sale/leaseback financing of the Danbury facility?
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Post by geomean on Aug 4, 2021 10:13:24 GMT -5
Interesting that the chart suggested a bottom yesterday and we have UTHR earnings news and projection on FDA action in October today and an associated price pivot off the short term trend line of the recent lows. You can't make this technical stuff up!
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Post by itellthefuture777 on Aug 4, 2021 12:16:23 GMT -5
Finally, we're excited about our pending application at FDA for Tyvaso DPI. We're pleased that the PAI, a general facility inspection, at our partner MannKind's Danbury, Connecticut facility has commenced as scheduled and is ongoing. Our PDUFA action date is in October of this year and we're working hard to build launch quantities and mobilizing our commercial teams to support the launch soon after approval.
So there's a lot of positive things happening on the commercial front. We remain focused on executing against our plans through the second half of the year, and, importantly, making progress toward our near-term goal of doubling the number of patients on Tyvaso by the end of 2022.
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Post by Clement on Aug 4, 2021 12:43:28 GMT -5
s1.q4cdn.com/284080987/files/doc_financials/2021/q2/UTHR-10Q-Q2-2021-Draft-8-(with-exhibits)-August-3-2021-8PM.pdfFor anyone who would like a condensed history of Tyvaso DPI, the following is from UTHR 10Q for Q2 2021, page 28: Tyvaso DPI We have developed a dry powder formulation of inhaled treprostinil called Tyvaso DPI, under an in-license from MannKind Corporation (MannKind). Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. If the FDA approves Tyvaso DPI, we believe this new inhaled treprostinil therapy will provide substantial lifestyle benefits to PAH and PH-ILD patients, as compared with nebulized Tyvaso Inhalation Solution therapy, because it will be: (1) less time consuming to administer and easier to maintain as the device and drug will be provided in a pre-filled, single use, disposable cassette eliminating the need for cleaning and filling; and (2) mobile and more convenient, as the compact design of the Dreamboat device and drug cassettes used with Tyvaso DPI enables the device to easily fit into the patient’s pocket and the device does not require electricity to function. We completed two clinical studies of Tyvaso DPI. One was a study in healthy volunteers, comparing the pharmacokinetics of Tyvaso DPI to Tyvaso Inhalation Solution. We completed the study in October 2020, and announced in January 2021 that the study demonstrated comparable systemic treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution. In December 2020, we completed a clinical study called BREEZE, which evaluated the safety and pharmacokinetics of switching PAH patients from Tyvaso Inhalation Solution to Tyvaso DPI. The BREEZE study demonstrated safety and tolerability of Tyvaso DPI in subjects with PAH transitioning from Tyvaso Inhalation Solution, and comparable systemic treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution. In April 2021, we filed an NDA with the FDA seeking approval for Tyvaso DPI to treat both PAH and PH-ILD. In January 2021, we purchased a pediatric disease priority review voucher for $105.0 million, which we redeemed upon submission of the Tyvaso DPI NDA. In June 2021, the FDA accepted our NDA and granted a priority review action date during October 2021. The FDA noted that approval of the NDA would be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind. This inspection has been commenced by the FDA and is ongoing.
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