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Post by agedhippie on May 23, 2024 22:54:33 GMT -5
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. Almost exactly that. This is the wording from the contract defining the roles: WHEREAS, Manufacturer is a pharmaceutical company engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supplier is a pharmaceutical company engaged in the marketing, distribution and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supply Party is willing to manufacture and supply the API(s) to Purchaser upon the terms and conditions set forth herein.WHEREAS, Purchaser is a company that is engaged in the development, distribution and sale of certain pharmaceutical products utilizing the APIIt identifies Yonsung Fine Chemicals (aka. YS Lifesciences) as the manufacturer, LGM Pharma as the supplier, LQDA as the purchaser, and defines the supplier party as the combination of the manufacturer and the supplier. The testing and certification is the responsibility of the manufacturer, and the role of the supplier is to forward that paper work along with the drug. LQDA is also required to inspect the drug itself on delivery to ensure that it conforms to the specification.
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Post by Clement on May 24, 2024 7:24:35 GMT -5
So, they are an API supplier but did not supply the active ingredient for LQDA's Yutrepia. Gotcha. Almost exactly that. This is the wording from the contract defining the roles: WHEREAS, Manufacturer is a pharmaceutical company engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supplier is a pharmaceutical company engaged in the marketing, distribution and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supply Party is willing to manufacture and supply the API(s) to Purchaser upon the terms and conditions set forth herein.WHEREAS, Purchaser is a company that is engaged in the development, distribution and sale of certain pharmaceutical products utilizing the APIIt identifies Yonsung Fine Chemicals (aka. YS Lifesciences) as the manufacturer, LGM Pharma as the supplier, LQDA as the purchaser, and defines the supplier party as the combination of the manufacturer and the supplier. The testing and certification is the responsibility of the manufacturer, and the role of the supplier is to forward that paper work along with the drug. LQDA is also required to inspect the drug itself on delivery to ensure that it conforms to the specification. Aged, are you claiming that LGM never has possession (at any location) of the API treprostinil enroute to LQDA? I guess there's legal possession and physical possession so please break it down I am not a lawyer but it seems this would be a point that could cause a delay.
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Post by Clement on May 24, 2024 8:28:20 GMT -5
Is there any news from the American Thoracic Society meeting?
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Post by agedhippie on May 24, 2024 8:33:14 GMT -5
Almost exactly that. This is the wording from the contract defining the roles: WHEREAS, Manufacturer is a pharmaceutical company engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supplier is a pharmaceutical company engaged in the marketing, distribution and sale of Active Pharmaceutical Ingredients (“API(s)”);WHEREAS, Supply Party is willing to manufacture and supply the API(s) to Purchaser upon the terms and conditions set forth herein.WHEREAS, Purchaser is a company that is engaged in the development, distribution and sale of certain pharmaceutical products utilizing the APIIt identifies Yonsung Fine Chemicals (aka. YS Lifesciences) as the manufacturer, LGM Pharma as the supplier, LQDA as the purchaser, and defines the supplier party as the combination of the manufacturer and the supplier. The testing and certification is the responsibility of the manufacturer, and the role of the supplier is to forward that paper work along with the drug. LQDA is also required to inspect the drug itself on delivery to ensure that it conforms to the specification. Aged, are you claiming that LGM never has possession (at any location) of the API treprostinil enroute to LQDA? I guess there's legal possession and physical possession so please break it down I am not a lawyer but it seems this would be a point that could cause a delay. Basically LGM performs the same role as FEDEX or UPS. They pick up a consignment, complete the paperwork, and deliver it. Think of this like shipping a FEDEX package internationally - you contract with FEDEX for them to move a package from point A to point B with all the attendant customs paperwork and package tracking. Once FEDEX accepts the package it is legally in their care from a liability standpoint but it does not become their property. This is why I think this petition gets dismissed out of hand - UTHR went after the mail man and not the company making the API. Going after YS Lifescience who make the API would be problematic for UTHR to say the least since they are one of UTHR's partners, a deal which, entertainingly, was set up by Roger Jeffs.
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Post by Clement on May 24, 2024 8:35:34 GMT -5
The testing and certification is the responsibility of the manufacturer, and the role of the supplier is to forward that paper work along with the drug. LQDA is also required to inspect the drug itself on delivery to ensure that it conforms to the specification. Aged, are you claiming that LGM never has possession (at any location) of the API treprostinil enroute to LQDA? I guess there's legal possession and physical possession so please break it down I am not a lawyer but it seems this would be a point that could cause a delay. When I say delay, I'm talking about enough time for some legal entertainment which ultimately rules against UTHR. I'm guessing several months.
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Post by prcgorman2 on May 24, 2024 9:00:01 GMT -5
We should create a pool to guess how long the delay will be! I'll take 1 month.
But when should we say the delay starts (or started)?
LQDA already missed the estimated launch for selling Yutrepia. We know the delay was FDA approving both indications in the application instead of just the one LQDA trialed. (Corrections welcome if I got any of that wrong.)
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Post by cppoly on May 24, 2024 13:06:49 GMT -5
Right, and then once approved how long after that for there to be any market penetration. Approval was supposed to be Jan 2024? T-DPI is sinking its teeth in and in full force. I can't imagine anyone switching to Yutrepia once already on T-DPI. Oh yea I'll take the inhaler that is more likely to let powder get stuck in my throat and requires a larger dose to be equally as effective.
So I suppose, Yutrepia would be siphoning off new T-DPI conversions that haven't happened yet. But the longer the delay, the harder it'll be for LQDA.
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Post by Clement on Jun 6, 2024 11:16:19 GMT -5
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Post by Clement on Jun 12, 2024 9:02:16 GMT -5
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Patrick Poisson, Executive Vice President, Technical Operations, will provide an overview and update on the company’s operations during a fireside chat session at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, Florida. The session will take place on Wednesday, June 12, 2024, from 4:00 p.m. to 4:35 p.m., Eastern Daylight Time finance.yahoo.com/news/united-therapeutics-corporation-present-goldman-110000004.html
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Post by Clement on Jun 12, 2024 14:35:15 GMT -5
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Post by dh4mizzou on Jun 13, 2024 7:29:33 GMT -5
Anyone listen to this 'chat'? If so, was anything stated that could directly affect MNKD? TIA
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Post by Clement on Jun 13, 2024 8:54:51 GMT -5
UTHR at the Goldman Sachs 45th Annual Global Healthcare Conference. T-DPI comments from 6:00 to 16:00:
Ratio of T-DPI to T-Neb is about 60/40 and is moving toward 70/30.
T-Neb is covered under Medicare Part B. T-DPI is now covered under Part D. Recent changes in the way Part D is reimbursed are a tailwind for T-DPI.
Rate of free drug (Tyvaso) in Q4 was high teens %. By end of Q1 this dropped to low double digits. Expect that to drift down.
MNKD T-DPI production capacity now can support 25K patients. UTHR manufacturing expansion in RTP began 1.5 years ago and continues.
TETON-2 is now closed to screening and you can expect full enrollment in the next month or two. (PH-IPF)
TETON-1 -- expect complete enrollment by end of year. (PH-IPF)
UTHR says continuing feedback from doctors indicates sotatercept will compliment prostacyclin therapy in PAH.
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Post by peppy on Jun 13, 2024 9:28:20 GMT -5
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Post by Clement on Jun 14, 2024 7:50:13 GMT -5
UTHR at the Goldman Sachs 45th Annual Global Healthcare Conference. T-DPI comments from 6:00 to 16:00: Ratio of T-DPI to T-Neb is about 60/40 and is moving toward 70/30. T-Neb is covered under Medicare Part B. T-DPI is now covered under Part D. Recent changes in the way Part D is reimbursed are a tailwind for T-DPI. Rate of free drug (Tyvaso) in Q4 was high teens %. By end of Q1 this dropped to low double digits. Expect that to drift down. MNKD T-DPI production capacity now can support 25K patients. UTHR manufacturing expansion in RTP began 1.5 years ago and continues. TETON-2 is now closed to screening and you can expect full enrollment in the next month or two. (PH-IPF)
TETON-1 -- expect complete enrollment by end of year. (PH-IPF)UTHR says continuing feedback from doctors indicates sotatercept will compliment prostacyclin therapy in PAH. On clinicaltrials.gov, it shows that for both TETON studies, estimated study completion date is June of 2025. This IPF indication is important for UTHR partly because it has orphan drug designation. "The FDA has granted Tyvaso orphan drug designation for the treatment of IPF. As a result, if the FDA updates Tyvaso's labeling to include an IPF indication following a successful TETON study, the FDA should confer seven years of market exclusivity in the United States following marketing approval by FDA." ir.unither.com/press-releases/2021/06-03-2021-161750034
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Post by cppoly on Jun 14, 2024 7:59:14 GMT -5
Also want to add per UTHR's conference that MNKD finished their facility with 25,000 capacity. UTHR is in the process of completing an additional facility with 50,000 capacity. It was mentioned that having a need for more than 75,000 is a GOOD problem to have
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