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Post by celo on Oct 18, 2021 8:06:55 GMT -5
Does UTHR have to reformulate into DPI before Mannkind puts their molecule on to it at their facility? MNKD creates the DPI version from what I understand. Crazy the issue happened at an analytical testing facility for Treprostinil. "The FDA's letter noted only a single deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance." Not even part of the manufacturing process. Some QA/QC facility. Switch to another lab. This can't be that hard. |
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Post by lazyb767 on Oct 18, 2021 8:42:58 GMT -5
MNKD creates the DPI version from what I understand. Crazy the issue happened at an analytical testing facility for Treprostinil. "The FDA's letter noted only a single deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance." Not even part of the manufacturing process. Some QA/QC facility. Switch to another lab. This can't be that hard.I wonder. This is the FDA. "Simon didn't say" switch to another lab, we'll get back to you... |
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Post by falconquest on Oct 18, 2021 8:44:50 GMT -5
Wow, the Mannkind curse continues. Unbelievable!
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Post by Clement on Oct 18, 2021 8:48:15 GMT -5
I have a question. UTHR has 5 products, three being, Treprostinil. Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension Extended release, Treprostinil.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension. Treprostinil injection.
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of: Treprostinil Solution.
Here is the question. Secondary to this, deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.Does the FDA finding effect the products UTHR has on the shelves? Hmmm? I have the same exact question. My question is does this third-party facility issue that performs analytical testing of trepostinil drug substance is used in the current nebulized Tyvaso drug product being sold to patients now? I wonder the same thing. But UTHR is only down 1.1% right now. |
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Post by celo on Oct 18, 2021 8:49:07 GMT -5
Crazy the issue happened at an analytical testing facility for Treprostinil. "The FDA's letter noted only a single deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance." Not even part of the manufacturing process. Some QA/QC facility. Switch to another lab. This can't be that hard.I wonder. This is the FDA. "Simon didn't say" switch to another lab, we'll get back to you... The lab basically cost United 100 million. |
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Post by itellthefuture777 on Oct 18, 2021 8:55:00 GMT -5
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Post by itellthefuture777 on Oct 18, 2021 8:55:43 GMT -5
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Post by tlundy on Oct 18, 2021 9:02:08 GMT -5
Lqda is up 10%
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Post by falconquest on Oct 18, 2021 9:03:57 GMT -5
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Post by veritasfiliatemporis on Oct 18, 2021 9:06:17 GMT -5
Maybe Mannkind can provide a better processing, packing and holding of the "stuff"..
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Post by uvula on Oct 18, 2021 9:06:49 GMT -5
This letter was Sept 30. I doubt uthr could have kept this hidden for several weeks. |
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Post by cjm18 on Oct 18, 2021 9:07:20 GMT -5
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Post by harryx1 on Oct 18, 2021 9:18:53 GMT -5
It's your choice to believe whether there was/is manipulation/corruption in the decision but IMO this reeks of it. The creator and leader of Trepostinil with 3 FDA approved drugs that use the molecule gets denied approval for a third party facility that preforms analytical testing on trepostinil drug substance? It's obvious to me that they were grasping at straws hoping they could find something to delay Tyvaso DPI. Again, the question is, are the current drugs being sold using the same facility and drug? If so, how does declining to approve Tyvaso DPI make any sense.
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Post by ptass on Oct 18, 2021 9:34:08 GMT -5
It's interesting that Mike completed the sale lease back around this time. |
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Post by pbaumgarten on Oct 18, 2021 9:59:05 GMT -5
It would have been nice had they specified exactly the nature of the "single deficiency" and explained what will be involved in fixing it.
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