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Post by winstonsmith on Apr 17, 2020 8:49:03 GMT -5
Broterm, Concerning your request for clarification on my speculating that Liquidia might be able to produce their drug for less than MannKinds –to be honest I don’t have the scientific knowledge, this subject is way over my head. What I suggest you do –go to he Liquidia website and enter the PRINT Technology section _P.R.I.N.T- stands for Particle Replication in NONWETTING Templates. The key word is nonwetting! liquidia.com/print-technology/Note the discussion about how their technology works. Then note the pictures and simplicity for their actual machines used to create their product. When you compare this to the equipment in Danbury, they have not only mixing vats, but they also have huge drying equipment necessary to then create the dry particles. This is how I understand the Mannkind process is performed —any corrections would be appreciated. I would welcome any and all input on the points that I ‘assumed’ by looking at what Liquidia is saying. Now go to the Publication section of Liquidia’s website. liquidia.com/print-technology/publications/Read the first article for 2020—this is a bioavailability clinical trial where LIquidia has already funded and obtained results by two Columbia University scientist. The study is direct comparison of Liquidia’s drug and the United drug—Tyvaso. The drug that MannKind’s drug will support the Tyvasso revenue stream—as I understand. The good news is this clinical research project proves that the Liquidia product is bioavailable to Tyasso. The reason this is good news—the odds that MannKind’s drug is not 99.9% bioavailable is remote—thus being a viable drug! Good for MannKInd and United both. But what I do not understand is why has MannKind not learned how product labels are required to be based on clinical data that supports the claim. At some point the bioavailability of TRE-t must be proven to match that of Tyvaso if they want to promote that Tre-t is comparable as Tyvaso. And this creates my last concern—why did United stipulate that MannKind would manufacture TRE-t until the drug is approved by the FDA—then United will take over—if United takes over and farms out the manufacturing to a third party---United controls TRE-t, leaving them only paying a royalty fee to MannKind and not the lucrative manufacturing revenue that would be paid to them. And one final item that I have noted on the bioavailability study---the Liquidia inhaler allows the user to take two breathes of their drug. If what I read about Afrezza is correct—the user gets one inhalation try and if it does not deliver the correct dose, then the user must reload another cartridge. If this is the case—the user will be paying more for the MannKind’s product. So Broterm---this is what I ponder about the cost of manufacturing a new Treprostinil drug that is a DPI dosed by another company. If anyone can correct my assumptions—owning MannKind might have potential. Let me repeat—I’m not a scientist and my assumption are hopefully wrong! "If what I read about Afrezza is correct—the user gets one inhalation try and if it does not deliver the correct dose, then the user must reload another cartridge."......you might be over thinking this one. You inhale in the powder and visually check the cartridge to see if there's more in it. If there is you take another inhalation to get the remainder. Some might give the inhaler a little tap also to loosen things up.
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Post by brotherm1 on Apr 17, 2020 11:07:19 GMT -5
I would not classify MNKD as a pawn in their relationship with UT. From what I remember, MNKD would be producing product for clinical trials and early commercial sales. UT would then have the option to produce Tre-T for themselves. There was a lot of discussion on this board about the complexity and capital requirement required and the excess capacity at Danbury. My guess is that MNKD will be UT’s contract manufacturer for the foreseeable future. A win/win. I agree. And, unless something has changed, UT intends to take over manufacturing of TreT long-term. We talked about it a lot on here. Well if that’s the case that UTHR will eventually be doing the manufacturing, it seems bizarre, as MC said just a few months ago that they had expanded the production capability for Trep and now will need to do so again. He said they plan on building on for it and have it ready for commercialization. Why would they build manufacturing for it if UTHR would be doing it?
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Post by peppy on Apr 17, 2020 11:32:31 GMT -5
I agree. And, unless something has changed, UT intends to take over manufacturing of TreT long-term. We talked about it a lot on here. Well if that’s the case that UTHR will eventually be doing the manufacturing, it seems bizarre, as MC said just a few months ago that they had expanded the production capability for Trep and now will need to do so again. He said they plan on building on for it and have it ready for commercialization. Why would they build manufacturing for it if UTHR would be doing it?These manufacturing plants go through an approval process. The UTHR addition has been approved as I recall.
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Post by mango on Apr 17, 2020 12:44:30 GMT -5
I agree. And, unless something has changed, UT intends to take over manufacturing of TreT long-term. We talked about it a lot on here. Well if that’s the case that UTHR will eventually be doing the manufacturing, it seems bizarre, as MC said just a few months ago that they had expanded the production capability for Trep and now will need to do so again. He said they plan on building on for it and have it ready for commercialization. Why would they build manufacturing for it if UTHR would be doing it? The way I understand it is MannKind is manufacturing for the clinical trials and early on commercialization, and it will be transferred to United's new manufacturing facility they recently built and they will take over the long-term manufacture of TreT. You'll have to email IR if you're still confused.
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Post by brotherm1 on Apr 17, 2020 13:07:54 GMT -5
Are you saying UT also built a new manufacturing facility for it?
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Post by mango on Apr 17, 2020 14:25:25 GMT -5
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Post by dh4mizzou on Apr 17, 2020 14:33:59 GMT -5
So do I understand correctly? Once UT starts manufacturing the drug themselves there will no longer be any costs for MNKD and the royalties will be icing on the cake so to speak?
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Post by Deleted on Apr 17, 2020 15:03:29 GMT -5
So do I understand correctly? Once UT starts manufacturing the drug themselves there will no longer be any costs for MNKD and the royalties will be icing on the cake so to speak? Yes unless UTHR wants MNKD to be their Contract Manufacturer. If that happens then the agreement will have to be amended.
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Post by agedhippie on Apr 17, 2020 18:26:17 GMT -5
So do I understand correctly? Once UT starts manufacturing the drug themselves there will no longer be any costs for MNKD and the royalties will be icing on the cake so to speak? That's not likely to happen for a while which is good for Mannkind. Manufacturing would let Mannkind utilize idle lines at Danbury and that would both be a revenue stream from the manufacturing, and remove the overhead of idle lines from Afrezza's costs. UTHR will take over manufacturing when they can justify the cost of building the plant based on what they are paying Mannkind. Until then it's cheaper for they to leave manufacturing to Mannkind. Initial commercial supplies covers the manufacturing since initial is a flexible term.
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Post by brotherm1 on Apr 17, 2020 19:38:06 GMT -5
MC interview at SVB Leerink in February, about 18 minutes in: MNKD expanded production capability last year - based upon the current UTHR $500 million Tyvaso sales - to be able to meet manufacturing demand for the first 12-24 months of launch. But now due to new interstitial lung disease data, sales could double or triple and we “will need a bigger boat”. He talks about plenty of space at Danbury to expand. “We expect to be the manufacturing organization for the inhaled Treprostinil” “We will meet next quarter to talk about it” (referring to building more production capability). Good listen even if you heard it before. You might want to check it out again as it will soon no longer be available. SVB Leerink link under Events and Presentations: investors.mannkindcorp.com/events-and-presentations
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