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Post by jkendra on May 21, 2024 10:31:47 GMT -5
How long did the citizen's petition sandbag MNKD for? Just curious if LQDA is also going to have a similar fate. ~9 months
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Post by mango on May 22, 2024 8:07:25 GMT -5
Unlike Liquidia’s citizen petition against Tyvaso DPI, this petition filed by UT against Liquidia is a legit concern, and one FDA will have to further investigate even though it seems they had already been aware their API manufacturer was producing tainting ingredients.
This also begs the questions:
1) Was Liquidia aware their API manufacturer had tainted API and if so, when were they made aware?
2) If Liquidia was aware, did they disclosure of this to FDA in their filing?
3) Did Liquidia use tainted API in their clinical trials?
There’s a lot to this problem for Liquidia.
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Post by hellodolly on May 22, 2024 10:02:42 GMT -5
Unlike Liquidia’s citizen petition against Tyvaso DPI, this petition filed by UT against Liquidia is a legit concern, and one FDA will have to further investigate even though it seems they had already been aware their API manufacturer was producing tainting ingredients. This also begs the questions: 1) Was Liquidia aware their API manufacturer had tainted API and if so, when were they made aware? 2) If Liquidia was aware, did they disclosure of this to FDA in their filing? 3) Did Liquidia use tainted API in their clinical trials? There’s a lot to this problem for Liquidia. #3 is a concern. Can't imagine a redo on the trial(s), or portion of them? Does LQDA need to prove they received certified CGMP materials (DPI) from their supplier to get the go ahead? They could get asked for materials. MNKD and UTHR provided overwhelming evidence in their case against the CP. Can LQDA do the same?
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Post by cppoly on May 22, 2024 11:05:03 GMT -5
Is it strange there's no press releases about the petition from LQDA in yahoo finance? I can't recall but I feel like there was one for MNKD when it happened.
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Post by mango on May 22, 2024 11:25:49 GMT -5
Unlike Liquidia’s citizen petition against Tyvaso DPI, this petition filed by UT against Liquidia is a legit concern, and one FDA will have to further investigate even though it seems they had already been aware their API manufacturer was producing tainting ingredients. This also begs the questions: 1) Was Liquidia aware their API manufacturer had tainted API and if so, when were they made aware? 2) If Liquidia was aware, did they disclosure of this to FDA in their filing? 3) Did Liquidia use tainted API in their clinical trials? There’s a lot to this problem for Liquidia. #3 is a concern. Can't imagine a redo on the trial(s), or portion of them? Does LQDA need to prove they received certified CGMP materials (DPI) from their supplier to get the go ahead? They could get asked for materials. MNKD and UTHR provided overwhelming evidence in their case against the CP. Can LQDA do the same? Wow, you bring about a very sound point with Liquidia providing evidence of certified CGMP materials to be used in their clinical trials. FDA would never allow a company to do a clinical trial with tainted API. The questions then becomes, did Liquidia know about this and if so, did they inform FDA? I would think it would be impossible for Liquidia to not know, IMO. Also, from the petition we learn that the API manufacturer whom Liquidia relies on for Yutrepia has a long and sordid history of noncompliance with regulations and its inspections dating back to 2010 show Liquidia’s API manufacturer has been plagued by repeated drug quality and misbranding vilations.
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Post by peppy on May 22, 2024 11:34:27 GMT -5
Unlike Liquidia’s citizen petition against Tyvaso DPI, this petition filed by UT against Liquidia is a legit concern, and one FDA will have to further investigate even though it seems they had already been aware their API manufacturer was producing tainting ingredients. This also begs the questions: 1) Was Liquidia aware their API manufacturer had tainted API and if so, when were they made aware? 2) If Liquidia was aware, did they disclosure of this to FDA in their filing? 3) Did Liquidia use tainted API in their clinical trials? There’s a lot to this problem for Liquidia. Is my memory correct? UTHR brought Tyvasso production in house secondary to a problem with manufacturing that caused a delay in the Tyvasso DPI approval. Does anyone recall? Not the PR, just a PR. July 24, 2023 United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation. ir.unither.com/~/media/Files/U/United-Therapeutics-IR/documents/press-releases/2023/2023-07-24-CAFC-decision-FINAL.pdf
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Post by celo on May 22, 2024 11:52:34 GMT -5
Nice steady climb of UTHR stock. Probably reflective of their stock buyback. 1 billion can go a long way when you have a market cap of 11 billion
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Post by hellodolly on May 22, 2024 12:05:40 GMT -5
#3 is a concern. Can't imagine a redo on the trial(s), or portion of them? Does LQDA need to prove they received certified CGMP materials (DPI) from their supplier to get the go ahead? They could get asked for materials. MNKD and UTHR provided overwhelming evidence in their case against the CP. Can LQDA do the same? Wow, you bring about a very sound point with Liquidia providing evidence of certified CGMP materials to be used in their clinical trials. FDA would never allow a company to do a clinical trial with tainted API. The questions then becomes, did Liquidia know about this and if so, did they inform FDA? I would think it would be impossible for Liquidia to not know, IMO. Also, from the petition we learn that the API manufacturer whom Liquidia relies on for Yutrepia has a long and sordid history of noncompliance with regulations and its inspections dating back to 2010 show Liquidia’s API manufacturer has been plagued by repeated drug quality and misbranding vilations. Dig deeper and one has to ask why would LQDA continue using this vendor if they knew a Permanent Injunction was in place for these substantive issues? My guess LQDA knew after they had already been supplied with enough trial inventory of DPI and after the trials had concluded (I didn't look at clinical trials site but think the trials were complete) and either neglected it or, just as noteworthy, got a free pass on this one from the FDA. Any other trials, wherein LGM was a supplier, called into question? Therein would be a possible answer.
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Post by mango on May 22, 2024 13:52:19 GMT -5
Wow, you bring about a very sound point with Liquidia providing evidence of certified CGMP materials to be used in their clinical trials. FDA would never allow a company to do a clinical trial with tainted API. The questions then becomes, did Liquidia know about this and if so, did they inform FDA? I would think it would be impossible for Liquidia to not know, IMO. Also, from the petition we learn that the API manufacturer whom Liquidia relies on for Yutrepia has a long and sordid history of noncompliance with regulations and its inspections dating back to 2010 show Liquidia’s API manufacturer has been plagued by repeated drug quality and misbranding vilations. Dig deeper and one has to ask why would LQDA continue using this vendor if they knew a Permanent Injunction was in place for these substantive issues? My guess LQDA knew after they had already been supplied with enough trial inventory of DPI and after the trials had concluded (I didn't look at clinical trials site but think the trials were complete) and either neglected it or, just as noteworthy, got a free pass on this one from the FDA. Any other trials, wherein LGM was a supplier, called into question? Therein would be a possible answer. Check this out, from last year! FDA Charges Florida Pharma Supplier with Re-Selling Suspect Drug IngredientsIn a lawsuit filed in the U.S. District Court in south Florida, the FDA charged that LGM Pharma LLC, based in Boca Raton, had unlawfully distributed drug ingredients that contained impurities, had failed to perform quality control measures, had re-labeled compounds without verifying their content, and had re-shipped medications after they were flagged by customers as substandard. Some of the violations were the same as those found by FDA inspectors in a 2018 inspection of the LGM facility, the FDA said. www.insurancejournal.com/news/southeast/2023/01/19/703705.htm#:~:text=In%20a%20lawsuit%20filed%20in,content%2C%20and%20had%20re%2Dshipped
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Post by agedhippie on May 22, 2024 16:20:59 GMT -5
Wow, you bring about a very sound point with Liquidia providing evidence of certified CGMP materials to be used in their clinical trials. FDA would never allow a company to do a clinical trial with tainted API. The questions then becomes, did Liquidia know about this and if so, did they inform FDA? I would think it would be impossible for Liquidia to not know, IMO. Also, from the petition we learn that the API manufacturer whom Liquidia relies on for Yutrepia has a long and sordid history of noncompliance with regulations and its inspections dating back to 2010 show Liquidia’s API manufacturer has been plagued by repeated drug quality and misbranding vilations. Dig deeper and one has to ask why would LQDA continue using this vendor if they knew a Permanent Injunction was in place for these substantive issues? My guess LQDA knew after they had already been supplied with enough trial inventory of DPI and after the trials had concluded (I didn't look at clinical trials site but think the trials were complete) and either neglected it or, just as noteworthy, got a free pass on this one from the FDA. Any other trials, wherein LGM was a supplier, called into question? Therein would be a possible answer. This doesn't go anywhere. The API is not manufactured by LGM, it's manufactured by YS Lifesciences in Korea. LGM just provide the shipping logistics so the drug cannot be tainted. The past history of LGM is irrelevant to approval of Yutrepia since LGM is in good standing with the FDA right now and that's what matters. This is why the share price didn't budge - nobody sees it as material. There was a BLaw article along with the Blaw document link that was posted that pretty much summed it up as "nothing to see here".
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Post by ryster505 on May 22, 2024 21:40:23 GMT -5
Dig deeper and one has to ask why would LQDA continue using this vendor if they knew a Permanent Injunction was in place for these substantive issues? My guess LQDA knew after they had already been supplied with enough trial inventory of DPI and after the trials had concluded (I didn't look at clinical trials site but think the trials were complete) and either neglected it or, just as noteworthy, got a free pass on this one from the FDA. Any other trials, wherein LGM was a supplier, called into question? Therein would be a possible answer. This doesn't go anywhere. The API is not manufactured by LGM, it's manufactured by YS Lifesciences in Korea. LGM just provide the shipping logistics so the drug cannot be tainted. The past history of LGM is irrelevant to approval of Yutrepia since LGM is in good standing with the FDA right now and that's what matters. This is why the share price didn't budge - nobody sees it as material. There was a BLaw article along with the Blaw document link that was posted that pretty much summed it up as "nothing to see here". Aged, as I’m sure you already know, but others here may not. We know this doesn’t go anywhere in the end, what it IS going to do is start a process of further delay for Liquidia. Whether or not the fda digs deeper here, it’s just adding time to yutrepia marketing clock, which is United’s only goal at this juncture. 👍
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Post by mymann on May 22, 2024 22:32:46 GMT -5
They did it to UTHR. Why not pay them back.
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Post by prcgorman2 on May 23, 2024 6:14:44 GMT -5
UTHR’s founder and CEO, Dr. Martine Rothblatt, was a telecom attorney before she was a pharma doctorate and CEO. It was as an attorney arguing before the Federal Communications Commission that she earned the money she then used to establish United Therapeutics. She’s ensuring her legal team leaves no stone unturned. I cannot tell but wonder if there is some mix of both business saavy but also personal payback involved in the efforts to legally stall Liquidia. I don’t assume Dr. Rothblatt is vindictive, but I’d want to stay on her good side.
Not sure if MannKind bringing Nintedanib to approval will represent a similar business concern as was the case for the successful Phase 1 trial of Treprostinil on TechnoSphere (nka Tyvaso DPI), but if so, a marketing partnership with UTHR for nintedanib could be a good opportunity for further synergy with UTHR. The father of a CEO I used to know once told me, “You never make your last dollar”. I asked him what he meant by that. He said it meant that while what you have may be more valuable than what you might get for it, leaving some money on the table is OK. Enjoy your successes and don’t worry too much about being generous.
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Post by agedhippie on May 23, 2024 8:35:01 GMT -5
They did it to UTHR. Why not pay them back. I don't support that case either. I want patients to get drugs and not get stalled by spurious lawsuits. The vast majority of Citizens Petitions are drug conmpanies going after each other for delays, and the majority of those are incumbents trying to delay generics. This process has never worked as intended, but BP likes it so it's here to stay.
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Post by hellodolly on May 23, 2024 11:42:26 GMT -5
Dig deeper and one has to ask why would LQDA continue using this vendor if they knew a Permanent Injunction was in place for these substantive issues? My guess LQDA knew after they had already been supplied with enough trial inventory of DPI and after the trials had concluded (I didn't look at clinical trials site but think the trials were complete) and either neglected it or, just as noteworthy, got a free pass on this one from the FDA. Any other trials, wherein LGM was a supplier, called into question? Therein would be a possible answer. This doesn't go anywhere. The API is not manufactured by LGM, it's manufactured by YS Lifesciences in Korea. LGM just provide the shipping logistics so the drug cannot be tainted. The past history of LGM is irrelevant to approval of Yutrepia since LGM is in good standing with the FDA right now and that's what matters. This is why the share price didn't budge - nobody sees it as material. There was a BLaw article along with the Blaw document link that was posted that pretty much summed it up as "nothing to see here". So, they are an API supplier but did not supply the active ingredient for LQDA's Yutrepia. Gotcha.
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