|
Post by mnkdfann on Aug 8, 2021 9:23:04 GMT -5
I find it interesting that the UTHR press release refers to the "Tyvaso DPI manufacturing facility in Danbury...operated by our partner Mannkind Corporation" It could have said, "owned by our partner Mannkind Corporation" or could it? Update anyone? It could have, but why would it? I think the important thing is who is operating the plant and doing the manufacture. The PR focussed on what is important to UTHR investors. I think if UTHR now owned the facility then that would be relevant to UTHR investors and the PR would have commented on ownership. Otherwise, who owns the plant isn't noteworthy.
|
|
|
Post by akemp3000 on Aug 8, 2021 12:42:31 GMT -5
Who owns the plant is highly noteworthy to UTHR, MNKD and investors. It would have been easy and more accurate to simply say, "...owned and operated by our partner Mannkind Corporation..." There was certainly nothing wrong with only saying operated but the possibility exists that there may have been movement regarding a sale and lease back that is not yet known publicly. I was hoping someone might have an update.
|
|
|
Post by awesomo on Aug 8, 2021 13:00:40 GMT -5
Who owns the plant is highly noteworthy to UTHR, MNKD and investors. It would have been easy and more accurate to simply say, "...owned and operated by our partner Mannkind Corporation..." There was certainly nothing wrong with only saying operated but the possibility exists that there may have been movement regarding a sale and lease back that is not yet known publicly. I was hoping someone might have an update. We'll know soon enough during the earnings call. Probably just reading too much into the wording...
|
|
|
Post by ronw77077 on Aug 11, 2021 13:45:55 GMT -5
This is what Tyvaso treats - from a Doctor friend:
Access CME/MOC on PF-ILD NuInvite Optimizing the Care of Patients With Progressive-Fibrosing Interstitial Lung Disease: Applying the Latest Data
Watch experts discuss treatment strategies for patients with progressive fibrosing interstitial lung disease (PF-ILD), review the importance of treatment adherence for patients with PF-ILD as well as strategies to keep patients on treatment for as long as possible, and evaluate effective multidisciplinary strategies to improve the comprehensive management of patients with PF-ILD.
Faculty
Activity Chair Steven D. Nathan, MD Medical Director, Advanced Lung Disease and Transplant Program Inova Fairfax Hospital Falls Church, VA
Disclosure: Consulting Fee: Bellerophon, Boehringer Ingelheim, Galapagos, Roche/Genentech, United Therapeutics Speakers Bureau: Boehringer Ingelheim, Roche/Genentech
Kevin R. Flaherty, MD, MS Professor of Medicine Division of Pulmonary/Critical Care Medicine Director, Michigan Medicine Interstitial Lung Disease Clinic University of Michigan Ann Arbor, MI
Disclosure: Consulting Fee: Bellerophon, Blade Therapeutics, Boehringer Ingelheim, Respivant Sciences, Shionogi, United Therapeutics Contracted Research: Boehringer Ingelheim
Nina M. Patel, MD Adjunct Associate Professor of Medicine Columbia University New York, NY
Disclosure: Advisory Board: Boehringer Ingelheim Accredited By
This continuing medical education activity is provided by
Target Audience
The intended audience for this activity is pulmonologists, internists, rheumatologists, and other health care professionals involved in the management of patients with progressive fibrosing interstitial lung disease (PF-ILD).
Learning Objectives
Upon successful completion of the activity, participants should be better able to: Apply the latest guidelines to identify patients with progressive fibrosing interstitial lung disease (PF-ILD) in a timely manner. Implement treatment strategies for patients with PF-ILD based on the latest clinical evidence. Review the importance of treatment adherence for patients with PF-ILD and strategies to keep patients on treatment for as long as possible. Evaluate effective multidisciplinary strategies to improve the comprehensive management of patients with PF-ILD. Activity Description
Interstitial lung disease (ILD) describes a group of more than 200 rare pulmonary conditions characterized by fibrosis of the lung. ILD can have several causes, including environmental antigens, bacterial, viral, and fungal infections, gastroesophageal reflux, occupational hazards (eg, asbestos), or a connective tissue disease (CTD). Patients with systemic sclerosis (SSc), rheumatoid arthritis (RA), or poly-/dermatomyositis (PM/DM), have the greatest risk of developing CTD-associated ILD. Idiopathic pulmonary fibrosis (IPF) is the most common ILD, though patients who develop a progressive-fibrosing phenotype ILD (PF-ILD) are subject to similar outcomes. With historically limited treatment options—pulmonologists, rheumatologists, radiologists, and other providers who care for patients with PF-ILD are unaware of how new options and data for patients with IPF may benefit patients with PF-ILD. In this educational activity, expert clinicians will discuss the latest approaches to managing patients with PF-ILD.
Agenda
Updates in Imaging and Diagnosis for ILD Steven D. Nathan, MD
Updates in the Treatment of PF-ILD Kevin R. Flaherty, MD, MS
Case Discussions Nina M. Patel, MD
Conflict of Interest Policy/Disclosure Statement
In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support, all continuing medical education (CME) providers are required to mitigate and disclose to the activity audience the relevant financial relationships of the planners, teachers, and authors involved in the development of CME content. An individual has a relevant financial relationship if he or she has a financial relationship in any amount occurring in the past 12 months with a commercial interest whose products or services are discussed in the CME activity content over which the individual has control.
Reviewers: Ronald A. Codario, MD, EMBA, FACP, FNLA, RPVI, CHCP Disclosure: No relevant financial relationships to disclose.
Ronald A. Codario, Jr., MD Disclosure: No relevant financial relationships to disclose.
Vindico Medical Education Staff: Disclosure: No relevant financial relationships to disclose.
Signed Disclosures are on file at Vindico Medical Education, Office of Medical Affairs and Compliance.
Accreditation Statement
Vindico Medical Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Designation of Credit
Vindico Medical Education designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
Participants who opt-in will earn MOC points equivalent to the amount of CME credits claimed for the activity.
This enduring material is approved for 1 year from the date of original release, September 30, 2020 to September 29, 2021.
Instructions for Receiving Credit
To participate in this CME activity, you must read the objectives, answer the pretest questions, view the content, and complete the posttest and evaluation. Provide only one (1) correct answer for each question. A satisfactory score is defined as answering 3 out of 4 of the posttest questions correctly. Upon receipt of the completed materials, if a satisfactory score on the posttest is achieved, Vindico Medical Education will issue an AMA PRA Category 1 Credit(s)™ Certificate.
MIPS Qualifying Activity Vindico has identified this CME activity as an improvement activity in the Merit-Based Incentive Payment System (MIPS) of the Quality Payment Program (QPP). Participants who successfully complete the activity and its performance assessment will receive printable documentation of successful completion for MIPS self-reporting.
To meet the criteria for improvement activities in the MIPS of QPP, accredited CME providers need to implement activities that: address a quality or safety gap that is supported by a needs assessment or problem analysis, or support the completion of such a needs assessment as part of the activity; have specific, measurable aim(s) for improvement; include interventions intended to result in improvement; include data collection and analysis of performance data to assess the impact of the interventions; and define meaningful clinician participation in their activity, describe the mechanism for identifying clinicians who meet the requirements, and provide participant completion information. Statement of Commercial Support
This activity is supported by a grant from Boehringer Ingelheim Pharmaceuticals, Inc.
Unlabeled and Investigational Usage
The audience is advised that this continuing medical education activity may contain references to unlabeled uses of US Food and Drug Administration (FDA)-approved products or to products not approved by the FDA for use in the United States. The faculty members have been made aware of their obligation to disclose such usage. All activity participants will be informed if any speakers/authors intend to discuss either non–FDA-approved or investigational use of products/devices.
|
|
|
Post by boca1girl on Aug 11, 2021 17:57:00 GMT -5
Stock down 16% to $170 on Yahoo Finance but no news posted. Could that just be an error?
|
|
|
Post by cretin11 on Aug 11, 2021 18:00:51 GMT -5
Stock down 16% to $170 on Yahoo Finance but no news posted. Could that just be an error? I think no worries there, just a stray trade after hours. The bid/ask are indicating true price is a bit above $200.
|
|
|
Post by neil36 on Aug 11, 2021 18:25:55 GMT -5
|
|
|
Post by cretin11 on Aug 11, 2021 18:32:45 GMT -5
Good find Neil, and that stinks. But it seems the share price didn’t move dramatically on that announcement (though it’s been down big recently, maybe it was leaked?). And I think/hope that the $170 price Boca mentioned is a glitch as I mentioned above.
|
|
|
Post by jkendra on Aug 11, 2021 18:50:07 GMT -5
In response, United Therapeutics sued Liquidia for infringing two patents, U.S. Patent Nos. 9,604,901 and 9,593,066, and later added a third patent, U.S. Patent No. 10,716,793, in the United States District Court for the District of Delaware.
|
|
|
Post by sportsrancho on Aug 11, 2021 18:56:05 GMT -5
Does someone wanna tell me why this does not mean we are screwed because I have just gotten like 20 texts telling me we are. I knew there was something wrong with the stock, the price was not acting right, we should’ve run up to $6 by now. I hope I am over reacting and there isn’t going to be a delay for us but right now I am livid!
|
|
|
Post by avi8torslc on Aug 11, 2021 18:57:01 GMT -5
Highly unlikely a ruling goes against UTHR.
As a result of United Therapeutics' lawsuit, FDA is precluded from approving LIQ861 until the expiration of a 30-month stay in October 2022, or the entry of final judgment in the litigation, whichever comes first.
During discovery in the patent infringement case, United Therapeutics uncovered evidence that a former United Therapeutics employee took United Therapeutics' trade secrets when he left the company and joined Liquidia to develop LIQ861.
|
|
|
Post by boca1girl on Aug 11, 2021 19:16:09 GMT -5
Final decision in a year?
|
|
|
Post by neil36 on Aug 11, 2021 19:21:18 GMT -5
Final decision in a year? That would be my guess. Just posted this because it is relevant to the process, but still trying to get my head around the implications
|
|
|
Post by markado on Aug 11, 2021 19:26:06 GMT -5
Good find Neil, and that stinks. But it seems the share price didn’t move dramatically on that announcement (though it’s been down big recently, maybe it was leaked?). And I think/hope that the $170 price Boca mentioned is a glitch as I mentioned above. This is pick and choose snoozy news. UTHR has the upper hand and will likely be first to market. It's still uncertain if Liquidia will be allowed to get there, given there are three patents involved in the suit. We don't help our stock price by over-interpreting the (non)importance of select(ively) negative news items.
|
|
|
Post by neil36 on Aug 11, 2021 20:03:44 GMT -5
Good find Neil, and that stinks. But it seems the share price didn’t move dramatically on that announcement (though it’s been down big recently, maybe it was leaked?). And I think/hope that the $170 price Boca mentioned is a glitch as I mentioned above. This is pick and choose snoozy news. UTHR has the upper hand and will likely be first to market. It's still uncertain if Liquidia will be allowed to get there, given there are three patents involved in the suit. We don't help our stock price by over-interpreting the (non)importance of select(ively) negative news items. I posted the development without comment. But anyone with any serious money invested here (which is most of us), needs to be aware of every headline and development that can affect future revenue streams. I’m not overly concerned by this, but i definitely want to bring it into my scan of things to be aware of.
|
|