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Post by hellodolly on Jul 15, 2024 8:20:46 GMT -5
Wow, so the Federal Circuit Court judges erred and went beyond the scope of the complaint to apply prior court decisions, without properly hearing the evidence as 'de novo' (when a court hears a case “de novo,” it is deciding the issues without reference to any legal conclusion or assumption made by the previous court) and thus violated the plaintiffs rights to a fair trial based solely and only on the facts of the new arguments.
Long story short, the courts went beyond the scope of their judicial authority.
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Post by sayhey24 on Jul 15, 2024 13:38:21 GMT -5
Am I understanding this correctly that this decision seems like its going to take awhile, maybe a year for a decision?
If so LQDA is burning $40m a quarter and had $158M at the end of 1Q2024. I would think they will need to do at least a $100m raise.
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Post by prcgorman2 on Jul 15, 2024 16:27:33 GMT -5
The article posted ealier today indicated the Supreme Court "long conference" in September is when the court may remand the case back to the circuit court. If the case is remanded, I have no idea how long it takes to conduct the "further proceedings". This will be a good topic to ask agedhippie about.
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Post by agedhippie on Jul 15, 2024 16:29:28 GMT -5
The article posted ealier today indicated the Supreme Court "long conference" in September is when the court may remand the case back to the circuit court. If the case is remanded, I have no idea how long it takes to conduct the "further proceedings". This will be a good topic to ask agedhippie about. Agedhippie has no idea!
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Post by agedhippie on Jul 15, 2024 16:43:05 GMT -5
Wow, so the Federal Circuit Court judges erred and went beyond the scope of the complaint to apply prior court decisions, without properly hearing the evidence as 'de novo' (when a court hears a case “de novo,” it is deciding the issues without reference to any legal conclusion or assumption made by the previous court) and thus violated the plaintiffs rights to a fair trial based solely and only on the facts of the new arguments. Long story short, the courts went beyond the scope of their judicial authority. This isn't going to be a problem just for LQDA. What the Supreme Court may do here is change the rules and that is going to hit all the Federal Circuit patent judgements. The patent cycle could become even more of a mess than it is already.
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Post by cppoly on Jul 16, 2024 4:56:45 GMT -5
Aged, is it possible to take a guess here as to how this impacts LQDA's timeline?
Minimum 3 months delay? Maximum delay =?
Best case for LQDA, I don't see how they have any market penetration in 2024.
Worst case, how far does this go in 2025?
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Post by Clement on Jul 16, 2024 5:54:53 GMT -5
From a Zacks article. Roll eyeballs, then read: " Earnings GrowthEarnings growth is arguably the most important factor, as stocks exhibiting exceptionally surging profit levels tend to attract the attention of most investors. For growth investors, double-digit earnings growth is highly preferable, as it is often perceived as an indication of strong prospects (and stock price gains) for the company under consideration. While the historical EPS growth rate for United Therapeutics is 20.6%, investors should actually focus on the projected growth. The company's EPS is expected to grow 25.5% this year, crushing the industry average, which calls for EPS growth of 14.3%. Cash Flow GrowthCash is the lifeblood of any business, but higher-than-average cash flow growth is more beneficial and important for growth-oriented companies than for mature companies. That's because, high cash accumulation enables these companies to undertake new projects without raising expensive outside funds. Right now, year-over-year cash flow growth for United Therapeutics is 33.3%, which is higher than many of its peers. In fact, the rate compares to the industry average of -3.9%. While investors should actually consider the current cash flow growth, it's worth taking a look at the historical rate too for putting the current reading into proper perspective. The company's annualized cash flow growth rate has been 10.7% over the past 3-5 years versus the industry average of 5.1%. " finance.yahoo.com/news/united-therapeutics-uthr-solid-growth-164507102.html
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Post by jkendra on Jul 16, 2024 9:04:22 GMT -5
We are coming up on four years since Yutrepia tentative approval.
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Post by prcgorman2 on Jul 16, 2024 9:11:14 GMT -5
Ironically, LQDA is (was) up big today. ¯\_(ツ)_/¯
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Post by casualinvestor on Jul 16, 2024 10:22:55 GMT -5
Am I understanding this correctly that this decision seems like its going to take awhile, maybe a year for a decision? If so LQDA is burning $40m a quarter and had $158M at the end of 1Q2024. I would think they will need to do at least a $100m raise. LQDA burned $40M Q1 2024, as compared to an average of $20M per Q in 2023. It was even less in 2022. Looks like they were ramping up something, most likely for volume production. If they need to, I'd bet that they can tighten their belt and last 2 years...whether they will or not is another guess. Any significant delay for LQDA is a good thing for UTHR and a huge win for MNKD. Getting both closer to PH-IPF approval, where I think UTHR has exclusivity?
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Post by Clement on Jul 16, 2024 10:46:50 GMT -5
^ orphan drug designation "Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 9, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF. FDA recently cleared United Therapeutics' investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. This exclusivity would also benefit Treprostinil Technosphere®, United Therapeutics' next-generation dry powder inhalation form of treprostinil, upon FDA approval of that product for the IPF indication." ir.unither.com/press-releases/2020/12-09-2020-014550224
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Post by agedhippie on Jul 16, 2024 11:01:46 GMT -5
Aged, is it possible to take a guess here as to how this impacts LQDA's timeline? Minimum 3 months delay? Maximum delay =? Best case for LQDA, I don't see how they have any market penetration in 2024. Worst case, how far does this go in 2025? Let's have the disclaimer up front - I am not a lawyer, and in particular not a Supreme Court lawyer. Happily the process here is well defined and boils down to this: - UTHR files a request - The court requests LQDA replies within 30 days (this is where the August 30th date comes from) - The court then asks UTHR for a rebuttal withing 30 days (UTHR can request a 30 day extension which it would likely get, extensions beyond that are harder) - These briefing get rolled up into a conference where the justices decide which cases they will take. (I think I saw Late September mentioned as a likely date) - Any justice can request that a case is put on the discuss list. If no justice wants to discuss a case it dies here. - Once the case makes it to the discuss list then at least four of the justices must vote to accept the case, if not it dies here. - If they decide to accept the case the you are off to the races. The vast majority of cases never make it onto the discuss list and die there, so probably September/October. They only take about 80 cases per year. They can remand the case back to the lower court via GVR. This is possible because of the Loper Bright case, but I think that case is sufficiently different for it not to apply. This is why the LQDA share price hardly budged, what has happened so far is exactly what the process says should happen so there are no surprises. The most likely outcome is that this dies in the Supreme Court at the discuss list stage, but with this Supreme Court who knows! Where do I get all of this from? Mostly some friends who are lawyers, and from this: www.citizen.org/wp-content/uploads/opposingcertguide-1.pdf
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Post by phdedieu12 on Jul 17, 2024 11:17:51 GMT -5
LQDA getting crushed today with a low at $11.15.... almost down 10% at the time of this post
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Post by hellodolly on Jul 17, 2024 18:08:45 GMT -5
LQDA getting crushed today with a low at $11.15.... almost down 10% at the time of this post Comments in substack today that this legal battle went from less than 1% of heading to the Supreme Court to ~20%. That was a screen shot someone sent me today.
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Post by phdedieu12 on Jul 19, 2024 7:11:35 GMT -5
LQDA getting crushed today with a low at $11.15.... almost down 10% at the time of this post Comments in substack today that this legal battle went from less than 1% of heading to the Supreme Court to ~20%. That was a screen shot someone sent me today. Thank you for the info. Something tells me this will go on for some time and the next earnings call will reflect widening losses. They ramped up on the expectations of going to market and they're going to bleed money for some time.
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