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Post by cretin11 on Oct 18, 2021 12:52:08 GMT -5
The test lab is down to resolving just one..one remaining item. That said it must be another client slowing the response...the FDA and CAPA should only relate to this drug this client..but the test house touches other clients drugs..and those clients could be slow walking their responses..I can guess who became a client there..hmm What is your guess who became a client there? |
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Post by cretin11 on Oct 18, 2021 12:55:37 GMT -5
UTHR drops is around 2% did anybody find quite astonishing the drop off MNKD, shouldn't be the opposite? Btw I bought at medium price 4.13, the reality MNKD was pumped quite a lot in the last 2 months. Not that surprising given MannKind's future is far more reliant on this than UT. Unfortunately you are correct. UTHR is a company churning out over $10 per share in earnings. MNKD is not yet CFBE, and now we have to wait longer than we expected to get there. |
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Post by lazyb767 on Oct 18, 2021 13:14:23 GMT -5
United Therapeutics being a publicly traded company, how hard can it be to get a list of contractors/suppliers???
It shouldn't take a FOIA request of the FDA.
Bueller, Bueller, anyone?
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Post by veritasfiliatemporis on Oct 18, 2021 13:19:35 GMT -5
Who knows the new time schedule for a review ? From UTHR's PR... "We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier." They have to submit a new request then... |
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Post by itellthefuture777 on Oct 18, 2021 15:06:32 GMT -5
A 3rd party test house
1 item to fix
Product still being made means that the product being made tested good..
Looks like a short trap..
Get'em Iron Mike!
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Post by veritasfiliatemporis on Oct 18, 2021 16:40:22 GMT -5
Maybe Mannkind can provide a better processing, packing and holding of the "stuff".. Looks like I was right UTHR expand agreement with Mannkind to manufacturing Tre-t through 2031... On October 18, 2021, MannKind issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) issued a complete response to United Therapeutics regarding the New Drug Application (“NDA”) for Tyvaso DPI™ for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacture, testing and packaging of finished Tyvaso DPI, including its associated device. |
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Post by mnkdfann on Oct 18, 2021 18:04:47 GMT -5
FWIW, we should all keep in mind we are only getting a biased part of the story from UTHR (biased in the sense that UTHR is only telling us what it wants us to hear, and may be leaving parts out or phrasing things in an overly optimistically manner). www.agencyiq.com/the-fdas-complete-response-letter-secrecy-could-be-on-a-crash-course-with-covid/A study of CRLs published in the British Medical Journal compared the full CRLs with press releases by the companies to which the CRLs were issued (the authors, who were FDA staffers, had access to both). The study concluded:
“FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters.
Press releases are incomplete substitutes for the detailed information contained in complete response letters.”
These findings suggest that companies are cherry-picking what to disclose when the FDA doesn’t approve a drug or biologic outright.
Even with high profile drugs that have demonstrated safety and efficacy and are likely to ultimately gain approval, drugmakers can downplay or remain opaque about the contours of the CRL. |
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Post by itellthefuture777 on Oct 18, 2021 18:12:10 GMT -5
The test lab is down to resolving just one..one remaining item. That said it must be another client slowing the response...the FDA and CAPA should only relate to this drug this client..but the test house touches other clients drugs..and those clients could be slow walking their responses..I can guess who became a client there..hmm What is your guess who became a client there? It's obvious..but..if I were The test house I would send everything to another test house..which is probably done already..so the internal issue left is probably a processing over time thing to verify and validate a new process with more controls in place..they should be very close as these things take time but not much time..hmm..reset FDA visit..could be a couple or three weeks..or next week depending..we just don't know..would have to see the response to the letter to get some idea what's left..which item..seems a rolling review..maybe it's a snap..and then approve..but FDA is like..a strange animal..never pet them..they bite |
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Post by cretin11 on Oct 18, 2021 20:36:48 GMT -5
Thanks for elaborating itell. What’s obvious to you is not obvious to me in this instance (as with some others in the past). Always interesting to see how you connect dots.
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Post by goyocafe on Dec 27, 2021 7:04:45 GMT -5
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Post by MnkdWASmyRtrmntPlan on Dec 27, 2021 7:15:18 GMT -5
On October 18, 2021, United Therapeutics Corporation (“UT”) issued a press release disclosing that it had received a Complete Response from the U.S. Food and Drug Administration (the “FDA”) concerning UT’s new drug application (“NDA”) for Tyvaso DPI™. On December 27, 2021, UT disclosed that it had resubmitted the NDA to the FDA. |
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Post by hellodolly on Dec 27, 2021 7:52:23 GMT -5
3rd party test house cleaned up or UTHR moved on to a new one? Question for those that have the background...If they moved forward with a new contractor, would they've had to perform tests on the product to show they're standards are superior and up-to-date before UTHR refiled the NDA or can UTHR find an FDA pre-approved facility that has recently been inspected and meets testing proficiency levels?
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Post by anderson on Dec 27, 2021 8:23:38 GMT -5
3rd party test house cleaned up or UTHR moved on to a new one? Question for those that have the background...If they moved forward with a new contractor, would they've had to perform tests on the product to show they're standards are superior and up-to-date before UTHR refiled the NDA or can UTHR find an FDA pre-approved facility that has recently been inspected and meets testing proficiency levels? Think that is the big question. Probably the difference between a class 1(2 months) and class 2(6 months) response. Note the fda documentation states "A resubmission that requires a reinspection also would be a Class 2 resubmission". So I definitely hope it is an already inspected testing facility. Guess we will know in 30 days when they Issue an acknowledgement letter. At least the clock starts at the receipt of the resubmission. What are the chances of a second complete response letter? Hoping for the best, but preparing for the worst. |
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Post by boca1girl on Dec 27, 2021 8:42:46 GMT -5
3rd party test house cleaned up or UTHR moved on to a new one? Question for those that have the background...If they moved forward with a new contractor, would they've had to perform tests on the product to show they're standards are superior and up-to-date before UTHR refiled the NDA or can UTHR find an FDA pre-approved facility that has recently been inspected and meets testing proficiency levels? UTHR has said in the past that they were moving this testing “in house”. |
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Post by liane on Dec 27, 2021 8:50:58 GMT -5
I renamed this thread given the optimism of today's news.
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