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Post by sayhey24 on Sept 18, 2023 8:57:34 GMT -5
All this afrezza talk is off topic for this thread. But I can't resist jumping in. Some of you sound delusional. MC has said things that indicate that he has given up on pursuing afrezza for T2D. If the CEO of the company is not on board it is not going to happen. No thread stays on topic beyond the first page  How true is that but how can you separate afrezza from any MNKD activity including Tyvaso DPI? If MNKD knew how to sell afrezza maybe there would be a Tyvaso DPI but maybe not. Clearly MNKD would not need the Tyvaso DPI revenue to pay the bills. As far as Mike giving up on the T2 market thats not really the case. Mike has been trying to figure out how to return the $3B+ the shareholders have invested in afrezza with limited cash and without taking risks which could bankrupt the company. Mike, himself is a T2. He personally knows the power of afrezza and the CGM. There must have been a reason why he did not first take the GLP1 but rather took the afrezza and its probably not because he gets free afrezza. Over five years ago Mike admitted MNKD did not know how to sell into the T2 market and put it on the shelf. This was not something he tried to hide as he said it many times during conference calls the T2 market was on the shelf. I am also sure he was more than annoyed hearing from shareholders like me asking what he doing for the T2 market. Then we get V-Go. At this point he wants to wait on the India results and see how the $35 Medicare insulin pans out. He is also trying to "stabilize" V-Go as thats his baby. What we do know is the strategy selling afrezza vs selling V-Go are significantly different. |
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Post by porkini on Sept 18, 2023 9:03:13 GMT -5
So, most of the posts on the last page or so are off-topic, "Tyvaso DPI vs. Yutrepia" - is it time to lock this thread?
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Post by biffn on Oct 27, 2023 12:52:50 GMT -5
I’m not sure why the DC circuit court of appeals setting a hearing date for the Liquidia appeal of the District Court decision favoring UTHR would be good news for Liquidia and bad for MNKD and UTHR, as it’s unlikely to reverse the lower federal court decision. I would’ve thought the appeals process risk was already baked into the share prices. stocks.apple.com/Ajr-4JQDpSVuXJYdFMGtBpQ |
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Post by MnkdWASmyRtrmntPlan on Oct 27, 2023 13:19:04 GMT -5
Liquidia (NASDAQ:LQDA) rose 6.9% as a court set a December hearing in its patent dispute with United Therapeutics (NASDAQ:UTHR).
The oral hearing is scheduled for Dec. 4, according to a calendar entry for the U.S. Court of Appeals for the Federal Circuit.
The hearing comes after the U.S. Court of Appeals for the Federal Circuit in late July affirmed a district court ruling in a setback to the company’s patent dispute with United Therapeutics (UTHR). That decision came after Liquidia appealed a Delaware district court ruling that found in August 2022 that the company infringed claims related to Patent No. 10,716,793 held by UTHR.
U.S. Patent No. '793 relates to treprostinil, which Liquidia (LQDA) intends to launch as an inhaled dry powder formulation for pulmonary arterial hypertension (PAH) and UTHR markets as Tyvaso.
United Therapeutics (UTHR) markets its version of treprostinil as Tyvaso, and the FDA granted tentative approval for a generic to Liquidia (LQDA) in 2021, allowing for its potential market entry as Yutrepia for PH-ILD in March 2024.
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Post by agedhippie on Oct 27, 2023 18:03:06 GMT -5
I’m not sure why the DC circuit court of appeals setting a hearing date for the Liquidia appeal of the District Court decision favoring UTHR would be good news for Liquidia and bad for MNKD and UTHR, as it’s unlikely to reverse the lower federal court decision. I would’ve thought the appeals process risk was already baked into the share prices. stocks.apple.com/Ajr-4JQDpSVuXJYdFMGtBpQMaybe because the LQDA are not appealing the District Court decision? Rather, UTHR is appealing the PTAB decision favoring LQDA to the US Court of Appeals for the Federal Circuit. If UTHR loses their appeal (and most PTAB appeals lose) then the '793 patent becomes invalid and the District Court decision will be set aside since there will no longer be a patent LQDA could infringe. The hearing date in Q4 is considered good because there had been a strong possibility it would have been in Q1/2024. This moves up the Yutrepia launch by a couple of months if UTHR loses. |
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Post by cedafuntennis on Oct 27, 2023 18:14:19 GMT -5
How does it move it up by a couple of months if UTHR loses, as it was set for March 2024 anyways. Do you suggest Liquidia could start selling sooner, or that if the hearing would have been in January, then the March 2024 date would have been delayed? In any case, I don't see a material impact on MNKD in any case as there is enough of a market for a niche player like Liquidia to waddle in.
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Post by agedhippie on Oct 28, 2023 3:17:28 GMT -5
How does it move it up by a couple of months if UTHR loses, as it was set for March 2024 anyways. Do you suggest Liquidia could start selling sooner, or that if the hearing would have been in January, then the March 2024 date would have been delayed? In any case, I don't see a material impact on MNKD in any case as there is enough of a market for a niche player like Liquidia to waddle in. The '793 patent doesn't expire until May 2027. The March 2024 date is the expiry of the PH-ILD exclusivity granted by the FDA and not under dispute. From the market standpoint UTHR is losing a monopoly (why they have been fighting so hard) and it's unclear how LQDA will price Yutrepia. LQDA don't have a profit split like UTHR and MNKD so it's possible they will set their price lower to capture market. The LQDA CEO was the COO and co-CEO of UTHR for 18 years, almost from foundation, so he knows The UTHR play book and how to launch drugs. |
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Post by cppoly on Oct 28, 2023 6:10:28 GMT -5
I’m not sure why the DC circuit court of appeals setting a hearing date for the Liquidia appeal of the District Court decision favoring UTHR would be good news for Liquidia and bad for MNKD and UTHR, as it’s unlikely to reverse the lower federal court decision. I would’ve thought the appeals process risk was already baked into the share prices. stocks.apple.com/Ajr-4JQDpSVuXJYdFMGtBpQMaybe because the LQDA are not appealing the District Court decision? Rather, UTHR is appealing the PTAB decision favoring LQDA to the US Court of Appeals for the Federal Circuit. If UTHR loses their appeal (and most PTAB appeals lose) then the '793 patent becomes invalid and the District Court decision will be set aside since there will no longer be a patent LQDA could infringe. The hearing date in Q4 is considered good because there had been a strong possibility it would have been in Q1/2024. This moves up the Yutrepia launch by a couple of months if UTHR loses. What happens if UTHR wins, how long would that set back LQDA? If you had to take a guess, what are the odds UTHR wins? |
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Post by agedhippie on Oct 28, 2023 6:43:09 GMT -5
What happens if UTHR wins, how long would that set back LQDA? If you had to take a guess, what are the odds UTHR wins? If UTHR wins then the patent remains valid and LQDA cannot enter the PAH market until May 2027. Based on historical outcomes from US Court of Appeals for the Federal Circuit PTO appeals UTHR has around a 20% chance of winning. Like much of the legal system it depends on who the judge is. |
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Post by cppoly on Oct 28, 2023 7:43:26 GMT -5
What happens if UTHR wins, how long would that set back LQDA? If you had to take a guess, what are the odds UTHR wins? If UTHR wins then the patent remains valid and LQDA cannot enter the PAH market until May 2027. Based on historical outcomes from US Court of Appeals for the Federal Circuit PTO appeals UTHR has around a 20% chance of winning. Like much of the legal system it depends on who the judge is. Thanks! Well let's hope UTHR brings their A game. I'm sure they will. |
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Post by beardawg on Oct 30, 2023 14:09:24 GMT -5
What happens if UTHR wins, how long would that set back LQDA? If you had to take a guess, what are the odds UTHR wins? If UTHR wins then the patent remains valid and LQDA cannot enter the PAH market until May 2027. Based on historical outcomes from US Court of Appeals for the Federal Circuit PTO appeals UTHR has around a 20% chance of winning. Like much of the legal system it depends on who the judge is.This is sad. It shouldn't be this way. A law should be the same regardless of who is presiding. |
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Post by mcbone on Oct 30, 2023 15:41:24 GMT -5
Take a look at this patent that UTHR obtained in August: UPSN 11,730,710. Looks like another obstacle for Liquidia. patentimages.storage.googleapis.com/15/e0/cd/76d3b5b9a53d37/US11730710.pdf Btw, that trade secret misappropriation lawsuit (including other claims like unfair trade practices, etc.) is still ongoing against Liquidia and Roscigno. I'm guessing there are other chairs UTHR has thrown in Liquidia's path. Tyvaso DPI is "bet the farm" big for UTHR. I'm sure Martine and her team of lawyers are on it. MC can tend to the manufacturing and otherwise just hold onto Martine's skirt. |
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Post by agedhippie on Oct 30, 2023 16:55:43 GMT -5
Take a look at this patent that UTHR obtained in August: UPSN 11,730,710. Looks like another obstacle for Liquidia. patentimages.storage.googleapis.com/15/e0/cd/76d3b5b9a53d37/US11730710.pdf Btw, that trade secret misappropriation lawsuit (including other claims like unfair trade practices, etc.) is still ongoing against Liquidia and Roscigno. I'm guessing there are other chairs UTHR has thrown in Liquidia's path. Tyvaso DPI is "bet the farm" big for UTHR. I'm sure Martine and her team of lawyers are on it. MC can tend to the manufacturing and otherwise just hold onto Martine's skirt. That patent is irrelevant to LQDA because LQDA had filed for PH-ILD use before the patent was in the Orange Book. Likewise the trade secret case is pretty much irrelevant as well as it's not going to result in a stay which is what UTHR need. Entertainingly Roger Jeffs, the LQDA CEO was the COO and co-CEO at UTHR for 18 years so I dare say he knows where a few bodies are buried. The only thing standing between UTHR and them being forced to compete with LQDA in the open market is the hearing in December. |
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Post by sayhey24 on Oct 30, 2023 17:21:18 GMT -5
Take a look at this patent that UTHR obtained in August: UPSN 11,730,710. Looks like another obstacle for Liquidia. patentimages.storage.googleapis.com/15/e0/cd/76d3b5b9a53d37/US11730710.pdf Btw, that trade secret misappropriation lawsuit (including other claims like unfair trade practices, etc.) is still ongoing against Liquidia and Roscigno. I'm guessing there are other chairs UTHR has thrown in Liquidia's path. Tyvaso DPI is "bet the farm" big for UTHR. I'm sure Martine and her team of lawyers are on it. MC can tend to the manufacturing and otherwise just hold onto Martine's skirt. That patent is irrelevant to LQDA because LQDA had filed for PH-ILD use before the patent was in the Orange Book. Likewise the trade secret case is pretty much irrelevant as well as it's not going to result in a stay which is what UTHR need. Entertainingly Roger Jeffs, the LQDA CEO was the COO and co-CEO at UTHR for 18 years so I dare say he knows where a few bodies are buried. The only thing standing between UTHR and them being forced to compete with LQDA in the open market is the hearing in December. Why do you think LQDA will be much competition for UTHR? Do you think they have a better mouse trap or salesforce? The last I checked it did not seem their solution had the same deep lung penetration as technosphere. |
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Post by agedhippie on Oct 31, 2023 7:11:07 GMT -5
Why do you think LQDA will be much competition for UTHR? Do you think they have a better mouse trap or salesforce? The last I checked it did not seem their solution had the same deep lung penetration as technosphere. If they weren't a threat UTHR would not have spent the amount of time, money, and effort trying to stop them as they have and instead would have just rolled right over them. So are they competition? UTHR appears to think so, but the question is how big. I think that UTHR still gets the majority of the market by virtue of it's salesforce. Deep lung penetration (or not) is irrelevant. What matters is the outcomes and from the trials those are broadly comparable. Don't fixate on the technology at the expense of the outcomes, the outcomes are what doctors care about. There is still UTHR's appeal against the PTAB. If UTHR win that then superiority, sales, and everything else won't matter. |
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