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Post by itellthefuture777 on Oct 19, 2021 12:25:52 GMT -5
If Lupin is pulling their drug 10/14/21, why doesn’t this become a non-factor with the FDA. Do they go back and reinspect the facility? This is only a test lab issue..meaning the lab will be changed and product tested elsewhere..the other drug recalls..may not be hypertension or test result related..some are test related but not hypertension drugs meaning this lab focus is hypertension drugs...remember the lab has to be "accredited" for specific tests..basically.. |
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Post by itellthefuture777 on Oct 19, 2021 12:32:50 GMT -5
Drug recalls happen all the time based on test lab results..
Root cause investigations happen as a result..it's all part of a quality ecosystem that works without FDA intervention..In this case one of the recalls involves a company that has a drug they don't market anymore...
That's a red flag to me
They have no budget..it's end of life..they just want to exhaust their inventories that are already out there or in their warehouse..sitting on a shelf..
This is why the test house can't get the manufacturer to do a root cause as production was shut down a while ago..This is a simple fix for UTHR to simply switch the test house test lots have FDA reinspect done..the test house issue..and CAPA..is really not UTHR's problem after switching suppliers..and testing lots was probably already done..
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Post by mnkdfann on Oct 19, 2021 12:49:56 GMT -5
Dumb this down for me. Is there a problem with the compound, Treprostinil? Or is there a problem at the lab testing the Treprostinil? MNKD is getting its Treprostinil from UTHR correct? Who get it from Sandoz, a division of Novartis. The FDA's letter noted only a single 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.In a nutshell..the test lab got hit The fix is simply to change to another lab and test lots. Have FDA look at new lab..done (prefer a dedicated lab with no out of production clients) The problem is that simple often isn't easy. "Simple means something basic and not complicated. Easy means not difficult." |
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Post by peppy on Oct 19, 2021 12:54:20 GMT -5
I think the drugs analytical lab had an issue with another clients drug and how they processed the testing when a test failed. That client would tell the test house to retest a fresh sample and pass it. They didn't do a root cause analysis on why the first sample failed. Makes sense so far? Ok..so the supplier audit for UTHR would have never uncovered this issue as it was another clients drug and the test house would never show what they did with another clients drug testing to a UTHR Supplier Quality auditor..makes sense so far? Ok..Mannkind is still making the drug and building inventory so there wasn't this issue of failed test results with UTHR drug. This warning letter to the lab was from another clients drug! A CAPA would have been generated and that client is slow walking responses because it does impact their drug on market or in test directly..if that drug is on market look for drug recalls around the warning letter timeframe to figure out the who. That said, the test lab or supplier of testing is in part under UTHR so when that lab f'ed up another client drug testing process of corrective action of not doing a root cause analysis it called into question their quality system controls on several levels. No validated excel sheet..no part 11 compliant software password protections as well as not doing a root cause analysis and record retentions. The FDA bridged probably on the software Part 11 and records retention. All records were probably there for UTHR but that software they used was probably the one remaining item as the FDA can't include the other clients drug test root cause failures on UTHR's drug or test. Ok..so we're talking about a software fix..short order..it's not the drug and it's not the testing..once that fix is done...it's over. But the CAPA has other items unrelated but it's open until all items are closed. The FDA should have gotten a CAPA number for an adequate response..and when thee item that relates to UTHR is completed then the FDA still has to wait for the CAPA closing. It won't close until the client has given all required data to the lab. A slow walk maybe related to recall impact of that client. Usually they have just 30 days to do all this but the investigation and root cause can take longer and actually has to be timely but has not set timeline. Meaning effectiveness check may be after 3 lots are processed. That could be done in a week but then there is that over time verses 3 lots and it may include more than one clients drugs to be tested. Which is why I think MNKD still is making drug and lots being tested..over time. Ok so Iron Mike says it's a fix in "short order"..means that fix is a quick fix. Test 3 lots and done. UTHR is probably doing supplier audits and also second sourcing for another test lab...either way or both ways..but to see who F'ed this up by demanding that lab retest a fresh sample..look to drug recalls..from Sept..to now..must be one of them.. Dumb this down for me. Is there a problem with the compound, Treprostinil? Or is there a problem at the lab testing the Treprostinil? MNKD is getting its Treprostinil from UTHR correct? Who get it from Sandoz, a division of Novartis. The FDA's letter noted only a single 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.Quote, related to an open inspection issue at a third party lab. Read simply, the problem is the lab has an issue that is open so too bad so sad, denied? By George, I think I've got it? I am a slow read. |
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Post by sweedee79 on Oct 19, 2021 12:56:25 GMT -5
That doesn't seem right at all does it? It sounds like Tyvaso dpi was fine. Also, I thot the citizen petition should have been reviewed before our PDUFA date.. why hadn't it been reviewed?
Still sounds like it was an excuse to me.. FDA needed more time due to citizen petition.. ? Or maybe they are tired of companies playing hardball with each other .. and the time it costs the FDA..
They did get 105mil out of the deal..
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Post by itellthefuture777 on Oct 19, 2021 13:53:35 GMT -5
If you are right, I pretend you to be saint immediately....  Yes that must be it..manufactured in India..and they don't make it anymore and can't travel to India..under Covid-19 right.. what a fk'ed up situation for them..for UTHR is to find another lab which my guess is they did so and retested everything of theirs not that anything was wrong with it but that they disconnect from that test house..MNKD is making inventory for approval so that means nothing is wrong with the drug itself or the test results..and that must have already been retested elsewhere..just resubmitting new test house to FDA and drop that other test house like a rock..done! |
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Post by hellodolly on Oct 19, 2021 14:55:47 GMT -5
That doesn't seem right at all does it? It sounds like Tyvaso dpi was fine. Also, I thot the citizen petition should have been reviewed before our PDUFA date.. why hadn't it been reviewed? Still sounds like it was an excuse to me.. FDA needed more time due to citizen petition.. ? Or maybe they are tired of companies playing hardball with each other .. and the time it costs the FDA.. They did get 105mil out of the deal.. I thought UTHR bought the PRV from another biotech. FDA doesn't sell them as far as I know. I could be off. |
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Post by hellodolly on Oct 19, 2021 14:57:22 GMT -5
If you are right, I pretend you to be saint immediately.... Yes that must be it..manufactured in India..and they don't make it anymore and can't travel to India..under Covid-19 right.. what a fk'ed up situation for them..for UTHR is to find another lab which my guess is they did so and retested everything of theirs not that anything was wrong with it but that they disconnect from that test house..MNKD is making inventory for approval so that means nothing is wrong with the drug itself or the test results..and that must have already been retested elsewhere..just resubmitting new test house to FDA and drop that other test house like a rock..done! I have read every post....thank you so much. What details! Easy read, BRAVO! |
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Post by sweedee79 on Oct 19, 2021 15:47:19 GMT -5
That doesn't seem right at all does it? It sounds like Tyvaso dpi was fine. Also, I thot the citizen petition should have been reviewed before our PDUFA date.. why hadn't it been reviewed? Still sounds like it was an excuse to me.. FDA needed more time due to citizen petition.. ? Or maybe they are tired of companies playing hardball with each other .. and the time it costs the FDA.. They did get 105mil out of the deal.. I thought UTHR bought the PRV from another biotech. FDA doesn't sell them as far as I know. I could be off. Yes.. you are correct.. FDA doesn't sell vouchers.. I'm learning a lot in this conversation.. Itell has really helped clear up this complex situation to help us understand... I really appreciate him.. I still think the decision was bull*'";t!!! And they should have reviewed citizen petition by our PDUFA date.... |
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Post by dh4mizzou on Oct 19, 2021 15:55:08 GMT -5
Sweedee,
Number one rule of government agencies. Never do today what you can put off until tomorrow.
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Post by peppy on Oct 19, 2021 16:01:34 GMT -5
If you are right, I pretend you to be saint immediately.... Yes that must be it..manufactured in India..and they don't make it anymore and can't travel to India..under Covid-19 right.. what a fk'ed up situation for them..for UTHR is to find another lab which my guess is they did so and retested everything of theirs not that anything was wrong with it but that they disconnect from that test house..MNKD is making inventory for approval so that means nothing is wrong with the drug itself or the test results. .and that must have already been retested elsewhere..just resubmitting new test house to FDA and drop that other test house like a rock..done! Sandoz is world wide. Itell? “We are very pleased with the FDA’s feedback on the label, which will ultimately enable us to bring Tyvaso DPI to thousands of patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “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.”
8 months. s1.q4cdn.com/284080987/files/doc_downloads/2021/10/2021-10-18-DPI-PDUFA-final-FORMATTED.pdf |
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Post by sayhey24 on Oct 19, 2021 18:12:48 GMT -5
I thought UTHR bought the PRV from another biotech. FDA doesn't sell them as far as I know. I could be off. Yes.. you are correct.. FDA doesn't sell vouchers.. I'm learning a lot in this conversation.. Itell has really helped clear up this complex situation to help us understand... I really appreciate him.. I still think the decision was bull*'";t!!! And they should have reviewed citizen petition by our PDUFA date.... They did review the petition, they just did not complete the review. The petition is still open. It was not closed. If you look at the link below you can see what Lassman submitted. You can also see Lassman has not yet submitted any scientific data to substantiate their request. If and when they do the FDA can complete the review. Until then it will probably remain open. Do you think Lassman has any scientific data showing Tyvaso can cause ACUTE BRONCHOSPASM? I doubt it. Are there any reported cases for afrezza since approval? Mango would know but even if there are afrezza is not Tyvaso and there were none during the Tyvaso trials. In the CRL the FDA noted the petition. If additional data was going to be asked for based on the Lassman submission it would have as part of this CRL. If the FDA was requiring a boxed warning, it would have been part of the draft label. Here is the link - www.regulations.gov/search?filter=tyvaso%20dpi |
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Post by sweedee79 on Oct 19, 2021 18:24:42 GMT -5
Yes.. you are correct.. FDA doesn't sell vouchers.. I'm learning a lot in this conversation.. Itell has really helped clear up this complex situation to help us understand... I really appreciate him.. I still think the decision was bull*'";t!!! And they should have reviewed citizen petition by our PDUFA date.... They did review the petition, they just did not complete the review. The petition is still open. It was not closed. If you look at the link below you can see what Lassman submitted. You can also see Lassman has not yet submitted any scientific data to substantiate their request. If and when they do the FDA can complete the review. Until then it will probably remain open. Do you think Lassman has any scientific data showing Tyvaso can cause ACUTE BRONCHOSPASM? I doubt it. Are there any reported cases for afrezza since approval? Mango would know but even if there are afrezza is not Tyvaso and there were none during the Tyvaso trials. In the CRL the FDA noted the petition. If additional data was going to be asked for based on the Lassman submission it would have as part of this CRL. If the FDA was requiring a boxed warning, it would have been part of the draft label. Here is the link - www.regulations.gov/search?filter=tyvaso%20dpiWell I think it should have been completed before our PDUFA date.. If Lassman hasn't submitted any scientific data by now it's probably because he doesn't have any... Because obviously it was just a ploy to cause a delay.. which I'm sure the FDA knows.. so why not just review it and close the matter before our PDUFA date? |
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Post by itellthefuture777 on Oct 20, 2021 10:17:48 GMT -5
Yes that must be it..manufactured in India..and they don't make it anymore and can't travel to India..under Covid-19 right.. what a fk'ed up situation for them..for UTHR is to find another lab which my guess is they did so and retested everything of theirs not that anything was wrong with it but that they disconnect from that test house..MNKD is making inventory for approval so that means nothing is wrong with the drug itself or the test results. .and that must have already been retested elsewhere..just resubmitting new test house to FDA and drop that other test house like a rock..done! Sandoz is world wide. Itell? “We are very pleased with the FDA’s feedback on the label, which will ultimately enable us to bring Tyvaso DPI to thousands of patients in need,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “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.”
8 months. s1.q4cdn.com/284080987/files/doc_downloads/2021/10/2021-10-18-DPI-PDUFA-final-FORMATTED.pdf The FDA could reinspect a test lab in just 2 weeks..so..if they take 8 months..I imagine many other elements may kick of before then...hmm. Maybe UTHR gets more of their products started on the DPI pathway.. |
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Post by biffn on Oct 20, 2021 10:32:04 GMT -5
UTHR Has got to be pushing counsel buttons with the FDA with regard to what they put up for the accelerated review. it doesn’t make sense to me that they would give up eight months so easily.
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