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Post by neil36 on Oct 18, 2021 10:15:39 GMT -5
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Post by Chris-C on Oct 18, 2021 10:20:33 GMT -5
It's interesting that Mike completed the sale lease back around this time. Agreed. IF this is the lab in question, given the extent of the deficiencies at the lab and the tone of the FDA letter, UTHR and MNKD must have expected a Complete Response Letter. Since the FDA cited the lab deficiency as one reason for the denial, I’m guessing UTHR lawyers are reviewing their options with respect to actions against the lab, depending on the wording of the testing contract. UTHR may also be able to claim damages for lost revenue. I am sure the lab company president has had some difficult days recently and has been reviewing the firm’s liability insurance. Regarding the remainder of the CRL, I’ll confess some concern about mention of the citizen’s petition. How common is it for that to appear in a CRL if it is “incidental”? Does this feel like deja vu to any other aging long investor on the board? Good things happen to those who wait, (and wait, and wait…). GLTAL Chrisc |
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Post by mannmade on Oct 18, 2021 10:26:23 GMT -5
It's interesting that Mike completed the sale lease back around this time. Exactly my thought... |
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Post by itellthefuture777 on Oct 18, 2021 10:37:44 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. If it is this testing house..and they fixed everything else listed..except one item. Which item takes the longest of all items listed? |
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Post by Actual Investor on Oct 18, 2021 11:01:24 GMT -5
Questions:
1. Does UTHR use the same lab for its current product?
2. If so, why doesn't the FDA want current production stopped until the issue is resolved?
It would seem that the negative effects of the deficit would apply across the board if the only problem is with a 3rd party testing of an ingredient common to both formulations. If the lab was used for the dry power only, why was the change and why not go with the approved facility?
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Post by itellthefuture777 on Oct 18, 2021 11:01:26 GMT -5
"It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any OOS results or significant problems encountered during the testing of these drugs,” FDA wrote."
This looks like another client say a client that hates UTHR..was the client making lab demands to do this or that..and then..lets the agency know of these specific records..and sabotages..an approval..hmm
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Post by veritasfiliatemporis on Oct 18, 2021 11:09:53 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.
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Post by awesomo on Oct 18, 2021 11:20:21 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. |
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Post by itellthefuture777 on Oct 18, 2021 11:32:57 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
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Post by itellthefuture777 on Oct 18, 2021 11:42:03 GMT -5
First of all the purchasing controls and supplier quality audits should have been on top of these issues when selecting a supplier. So it's noted the test house falsified reports to the clients. But it also notes clients told them to test fresh samples. So the client knew..the question is which client..as there were other clients..clients that may have had it out for UTHR's approval and might benefit from the delay..a little sabotage job..and then if a client slow walking the response of data back to the test house to complete the response for that one item back to the FDA. Yeah..that's my guess..a hit job..
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Post by radgray68 on Oct 18, 2021 11:58:11 GMT -5
U G H H !!!!!!!! REALLY? AGAIN?! AGAIN!!!!!!!!!!!!!!!'
Anybody else wanna tell the FDA to go eat sh__ and die?
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bkdmd
Researcher
Posts: 79
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Post by bkdmd on Oct 18, 2021 12:06:55 GMT -5
The problem isn't if the FDA is corrupt or not. The problem is that people believe the FDA is corrupt.
Ugh here we sit again.
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Post by veritasfiliatemporis on Oct 18, 2021 12:28:12 GMT -5
Who knows the new time schedule for a review ?
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Post by peppy on Oct 18, 2021 12:34:39 GMT -5
Who knows the new time schedule for a review ? I wondered if the "laboratory insurance company" will need to pay for the resubmitted application? |
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Post by awesomo on Oct 18, 2021 12:35:49 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." |
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