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Post by mango on Apr 14, 2020 18:11:26 GMT -5
My thinking is they are waiting until after successful TreT trial and/or approval before triggering the green light on the second molecule. Makes logical sense. I personally believe TreT will meet all of the primary and secondary endpoints and become a life-changer for people suffering with PAH. FDA ever fast track a drug because of patient requests/humanitarian reasons? We are working with a pretty well understood drug. Just a passing thought. Approval by end of 2021 would be sweet. FDA fast tracks drugs for rare diseases all the time. PAH is a rare disease. The possibility is there. rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/
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Post by hopingandwilling on Apr 14, 2020 18:23:10 GMT -5
Broterm, Liquidia has already filed their NDA with the FDA and they have formally accepted the filing documents. Sadly... Liquida will be about a year ahead of MNKD potential for approval. The most disturbing thing about the Liquidia product is the potential for producing their product cheaper than Mannkind can produce Tre-t.
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Post by mango on Apr 14, 2020 18:26:51 GMT -5
Broterm, Liquidia has already filed their NDA with the FDA and they have formally accepted the filing documents. Sadly... Liquida will be about a year ahead of MNKD potential for approval. The most disturbing thing about the Liquidia product is the potential for producing their product cheaper than Mannkind can produce Tre-t. UT controls the market. Liquidia isn't a threat, IMO.
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Post by sluggobear on Apr 14, 2020 18:51:08 GMT -5
If all goes as hoped with the study, what kind of income can MNKD hope to receive if FDA approved, etc., etc? I do not know. However, smarty pants over here is wondering if TrepT will disappear from pharmacy shelves like hydroxychloroquine. I don't know what the recently touted partnership with Immix Biopharma, Inc. is going to produce in any relevant time course. But I thought Treprostenil would be a much better "last ditch" drug to treat the most severe breathing/oxygen symptoms of (what I understand is pulmonary hypertension). I listened to the interview of Dr. Cameron Kyle-Sidell...see what y'all think. www.medscape.com/viewarticle/928156 or www.youtube.com/watch?v=QWaq8HoEROU
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Post by brotherm1 on Apr 14, 2020 21:32:12 GMT -5
Broterm, Liquidia has already filed their NDA with the FDA and they have formally accepted the filing documents. Sadly... Liquida will be about a year ahead of MNKD potential for approval. The most disturbing thing about the Liquidia product is the potential for producing their product cheaper than Mannkind can produce Tre-t. Thanks for the correction: “The following excerpt is from the company's SEC filing. RESEARCH TRIANGLE PARK, N.C., April 08, 2020 - Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT technology, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) seeking marketing approval for LIQ861 for the treatment of pulmonary arterial hypertension (PAH). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a goal date of November 24, 2020. LIQ861 is an investigati onal, inhaled dry powder formulation of treprostinil designed using the Company’s novel PRINT technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler. The NDA was submitted under the 505(b)(2) regulatory pathway and includes data from three clinical studies to establish the safety, tolerability and pharmacokinetic profile of LIQ861. "FDA acceptance of this NDA is a significant milestone for our company and our PRINT technology. PRINT was the cornerstone that allowed for the precise engineering and development of LIQ861 into its current form and serves as the foundation for all of our products in development,” said Neal Fowler, Chief Executive Officer of Liquidia. “If approved, LIQ861 will represent an important step forward in addressing the unmet needs of PAH patients by providing a convenient alternative to existing therapies. We look forward to working closely with the FDA through the NDA review process.” I’m wondering why though you say LQDA could potentially produce it cheaper? Does LQDA even have a large production facility?
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Post by figglebird on Apr 14, 2020 23:55:30 GMT -5
Cheaper you've gotta be out of your mind there are so many obstacles other than the lead that El que DA has.
1. Your respective of 5052b This does not give free rein with respect to drug device regulation and they very well may need to pay for extra documentation showing their generic device which by the way they do not manufacture themselves but rather rely upon 3rd party.
2. As mentioned prior say do not possess a manufacturing facility this poses numerous issues the most obvious being not cost but the ability to actually go alone in the event they are hung able to find a partner - Frankly they would be unable to go alone because of post regulation inspection obligations.
3. Last I will point out but not the last of their issues United there a puget's has an extraordinarily detailed documented record of protecting their mode whether through acquisition legal recourse Or both you can bet your bottom dollar that is going to happen in some form here in the event things progress as they are
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Post by lakon on Apr 15, 2020 5:28:14 GMT -5
The first piece of information I'm looking for is the retention rate of patients on Tre-T; those who request to stay on it after they've completed the trial. My guess/hope is, we have close to 100% ask to remain on it but anything close to 70% or more might still excite researchers and, more importantly, new shareholders. Am I the only one who is still hopeful for go ahead on the 2nd undisclosed molecule later this year if Tre-T trials are stellar? Low dropouts due to cough and high percentage wanting to remain would be good. It also could raise questions and hopefully answers about dropouts on Afrezza. The answers would be nice to socialize from PWPAH to PWD... From a marketing perspective, it would be nice to overcome objections about inhaled Technosphere Platform by referencing another chronic disease (PAH), this one being pulmonary... As an oncologist once said, insulin gets to the lungs via the BLOOD so it is NOT like inhalation is such a big factor or even that new of an idea after all...
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Post by rfogel on Apr 15, 2020 11:36:52 GMT -5
Broterm, Liquidia has already filed their NDA with the FDA and they have formally accepted the filing documents. Sadly... Liquida will be about a year ahead of MNKD potential for approval. The most disturbing thing about the Liquidia product is the potential for producing their product cheaper than Mannkind can produce Tre-t. UT controls the market. Liquidia isn't a threat, IMO. I don't know but I see that a month ago Liquidia was trading at $3.34 and today it is at $6.54. Somebody has hope for it.
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Post by lakon on Apr 16, 2020 19:32:30 GMT -5
UT controls the market. Liquidia isn't a threat, IMO. I don't know but I see that a month ago Liquidia was trading at $3.34 and today it is at $6.54. Somebody has hope for it. Might be an opportunity to short at some point IF somebody HOPES too much...
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Post by hopingandwilling on Apr 16, 2020 21:17:43 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!
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Post by mango on Apr 16, 2020 22:14:22 GMT -5
Doesn't UT intend to manufacture TreT long term?
Think I've read that in the SEC filings.
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Post by brotherm1 on Apr 16, 2020 22:15:50 GMT -5
Hope, unfortunately, I’m not able to answer all or your concerns. Regarding the manufacturing though by MNKD, the agreement changed somewhere along the line. Mr. Castagna said a few months ago MNKD will be doing the commercial manufacturing for UTHR and MNKD will be expanding their production facility to do so.
Regarding labeling of the product, UTHR is running the clinicals and MNKD is basically the pawn, so I would assume that part is up to UTHR.
Although I have difficulty understanding everything figglebird posts, he appears far more knowledgeable in the subject than I. Perhaps he will weigh in.
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Post by goyocafe on Apr 16, 2020 23:22:14 GMT -5
Hope, unfortunately, I’m not able to answer all or your concerns. Regarding the manufacturing though by MNKD, the agreement changed somewhere along the line. Mr. Castagna said a few months ago MNKD will be doing the commercial manufacturing for UTHR and MNKD will be expanding their production facility to do so. Regarding labeling of the product, UTHR is running the clinicals and MNKD is basically the pawn, so I would assume that part is up to UTHR. Although I have difficulty understanding everything figglebird posts, he appears far more knowledgeable in the subject than I. Perhaps he will weigh in. With all that is going on in the world, it seems to me that the manufacturing capabilities in Danbury are becoming more valuable on a daily basis. UTHR might think MNKD is a pawn to be done with as they please, but I submit that this perspective will only last until MNKD finds itself in a better negotiating position. I don’t know how bound MNKD is to serve UTHR at its pleasure, but if there are any holes in that agreement, I would not lose a minute of sleep should MNKD step up, take control of its destiny, and let UTHR know it’s time to level the playing field or step out of the way. JMHO
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Post by boca1girl on Apr 17, 2020 6:30:43 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.
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Post by mango on Apr 17, 2020 7:46:05 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.
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