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Post by sweedee79 on Oct 19, 2021 10:15:45 GMT -5
Well maybe they both get it from the same lab.. maybe lqda knew about this situation.. Roger Jeff's who is now at lqda was Co-CEO at UTHR.. If anything was actually tainted it would be shut down you would think.. like Harry said what about the other trep drugs that UTHR has? None of it makes any sense.. Why not give us a tentative approval til it's fixed..? . Lqda has a tentative PDUFA on Nov 7... I looked. Liquida get their Treprostinil from Sandoz and so does UTHR. SANDOZ is a Novartis division. Liquida states Sandoz their Treprostinil suppliers their website. Who manufactures treprostinil? Princeton, New Jersey, March 25, 2019 – Sandoz today announced the US availability of Treprostinil Injection , the first fully substitutable AP rated generic version of Remodulin®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product.Mar 26, 2019 Looks like same Treprostinil chit different day. I did not see a device for the Liquida dry powder Treprostinil. ( An injection able dry powder is made by Liquida as well.) Both you and Sports are all over Liquida, is this from stock wits? I am disappointed Martine did not have all the bases covered. The lab that supposedly caused the problems is an analytical lab.. not sure if that is the same as the supplier.. ? Yes.. we and a few others have been on the lqda board.. learned a lot over there .Mango and Harry have been relentless..and figglebird Lqda is also very well connected with PBM Capital. |
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Post by peppy on Oct 19, 2021 10:23:43 GMT -5
I looked. Liquida get their Treprostinil from Sandoz and so does UTHR. SANDOZ is a Novartis division. Liquida states Sandoz their Treprostinil suppliers their website. Who manufactures treprostinil? Princeton, New Jersey, March 25, 2019 – Sandoz today announced the US availability of Treprostinil Injection , the first fully substitutable AP rated generic version of Remodulin®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product.Mar 26, 2019 Looks like same Treprostinil chit different day. I did not see a device for the Liquida dry powder Treprostinil. ( An injection able dry powder is made by Liquida as well.) Both you and Sports are all over Liquida, is this from stock wits? I am disappointed Martine did not have all the bases covered. The lab that supposedly caused the problems is an analytical lab.. not sure if that is the same as the supplier.. ? Yes.. we and a few others have been on the lqda board.. learned a lot over there .Mango and Harry have been relentless..and figglebird Lqda is also very well connected with PBM Capital. Where or what is the delivery system for Liquida? Both need to be approved? |
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Post by sweedee79 on Oct 19, 2021 10:29:32 GMT -5
peppyAnalytical Testing Analytical testing services pertain to a wide range of chemical and microbiological assays. Analytical laboratory services include method development and validation, sample analysis for concentration confirmation, purity, homogeneity, and stability assays on preliminary formulations and finalized drug products for IND, NDA, and ANDA submissions.
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Post by peppy on Oct 19, 2021 10:32:08 GMT -5
peppy Analytical Testing Analytical testing services pertain to a wide range of chemical and microbiological assays. Analytical laboratory services include method development and validation, sample analysis for concentration confirmation, purity, homogeneity, and stability assays on preliminary formulations and finalized drug products for IND, NDA, and ANDA submissions. NorthEast BioLab offers sophisticated analytical testing laboratory services to help detect, measure, and analyze the performance of your drug or personal care product chemical and microbiological assays. Sandoz is making it, the assays and chemicals should be equal across the board. It sounds like a speciality lab.... that does all the Treprostinil would not be a stretch. and it may have been a purity issue..... harryx1 mango thoughts? |
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Post by sweedee79 on Oct 19, 2021 10:48:04 GMT -5
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Post by peppy on Oct 19, 2021 11:02:54 GMT -5
ok, it is funny. Delivery Method: UPS Next Day Product: Drugs I saw itell put this up. I got the vague impression the problem may have been at the Lab that does this? I could be wrong.  |
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Post by itellthefuture777 on Oct 19, 2021 11:23:15 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..
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Post by peppy on Oct 19, 2021 11:35:37 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. |
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Post by itellthefuture777 on Oct 19, 2021 11:43:37 GMT -5
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Post by itellthefuture777 on Oct 19, 2021 11:57:44 GMT -5
They were not marketing it..they were not making money really..so they would likely want retest verses recall right..but we don't know..speculating..so when picking a test house..pick one that doesn't need your business to the extent they don't do what this lab did..falsified reports for a client that was getting out of a drug and just doing test to do test until their drug inventory was depleted..that's why they said check a fresh sample..they were not making it anymore..won't be making it anymore..so that's also why they couldn't do a root cause analysis on the production process as that production was shut down is my guess..basically. So note..root cause analysis may be shelf life..and easily can be shown the drug breaks down over time..or a bigger can of worms for that manufacturers process..so my guess It they knew they had a problem and got the hell out of it by shutting down that line to limit risk..but..FDA found it..but it they shut it down before FDA was able to inspect their facilities..typical..so in my view and opinion..has nothing to do with UTHR..except they had the wrong test house..with some client covering tracks while exiting a market..hmm..yeah quick fix switch test lab..test lots show FDA done..don't make that little test lab control the Future..move it..another lab can test all lots really quickly.. |
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Post by veritasfiliatemporis on Oct 19, 2021 12:01:33 GMT -5
If you are right, I pretend you to be saint immediately....  |
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Post by itellthefuture777 on Oct 19, 2021 12:06:36 GMT -5
So we are all clear-
The CRL is for a test lab and the finding was on another clients drug test and that client did a recall of that drug.
If it were UTHR's drug it would have had a recall..but didn't
The simple fix would be (and I'll bet UTHR did this) to change test labs and retest all lots in "short order"
FDA can then check that lab which solves the whole issue.
The FDA may have said we have this finding at the test lab on another of their clients drug testing and recommend changing labs and retest all lots..before the due date..and maybe the FDA did that..maybe the new lab isn't done just yet..but will be any moment..hmm
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Post by peppy on Oct 19, 2021 12:17:16 GMT -5
Most likely only one lab in the USA does testing on UTHR's Treprostinil.
Most likely the same lab UTHR other Treprostinil for their other Treprostinil products are tested in.
This impression a bit from Amy Rosenthal talking about the work done at Columbia university and their labs.
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Post by itellthefuture777 on Oct 19, 2021 12:20:29 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.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) |
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Post by solicurance on Oct 19, 2021 12:20:44 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?
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