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Post by agedhippie on May 6, 2024 22:15:48 GMT -5
Anyone else wondering why there's such a delay from the FDA with Yutrepia? It's because LQDA didn't split PAH and PH-ILD. That means approval is hung up on whether UTHR get an injunction for PH-ILD or not. The hearing for the injunction was last week so there may be a ruling this week. My feeling is that UTHR will not get the injunction, but if they do UTHR will have to file a bond for damages (probably $200M at a guess) to be paid to LQDA if the "327 patent is invalidated. There is a separate case with UTHR suing the FDA but I don't think that goes anywhere. The judge told them that they cannot sue on a hypothetical so they will have to wait for the FDA to approve and then sue the FDA. |
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Post by agedhippie on May 31, 2024 16:09:00 GMT -5
Anyone else wondering why there's such a delay from the FDA with Yutrepia? It's because LQDA didn't split PAH and PH-ILD. That means approval is hung up on whether UTHR get an injunction for PH-ILD or not. The hearing for the injunction was last week so there may be a ruling this week. My feeling is that UTHR will not get the injunction, but if they do UTHR will have to file a bond for damages (probably $200M at a guess) to be paid to LQDA if the "327 patent is invalidated. There is a separate case with UTHR suing the FDA but I don't think that goes anywhere. The judge told them that they cannot sue on a hypothetical so they will have to wait for the FDA to approve and then sue the FDA. Well that was a couple of weeks later than I predicted! The judgement is finally in and UTHR lost again - there will be no injunction in the '327 patent case so LQDA can launch for PH-ILD (PAH was not in scope for this lawsuit) when the FDA approves Yutrepia. How long the FDA take is anyone guess, but I suspect after this it may be reasonably soon. There were a couple of interesting comments. The judge found that in the PH-ILD market Yutrepia was unlikely to impact Tyvaso sales since by 2030 UTHR only expected to serve half the available market. The other was UTHR's claim that Yutrepia's entry into the market would likely force UTHR to reduce their price by 20% to 30%. |
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Post by ktim on Jun 1, 2024 15:51:17 GMT -5
It's because LQDA didn't split PAH and PH-ILD. That means approval is hung up on whether UTHR get an injunction for PH-ILD or not. The hearing for the injunction was last week so there may be a ruling this week. My feeling is that UTHR will not get the injunction, but if they do UTHR will have to file a bond for damages (probably $200M at a guess) to be paid to LQDA if the "327 patent is invalidated. There is a separate case with UTHR suing the FDA but I don't think that goes anywhere. The judge told them that they cannot sue on a hypothetical so they will have to wait for the FDA to approve and then sue the FDA. Well that was a couple of weeks later than I predicted! The judgement is finally in and UTHR lost again - there will be no injunction in the '327 patent case so LQDA can launch for PH-ILD (PAH was not in scope for this lawsuit) when the FDA approves Yutrepia. How long the FDA take is anyone guess, but I suspect after this it may be reasonably soon. There were a couple of interesting comments. The judge found that in the PH-ILD market Yutrepia was unlikely to impact Tyvaso sales since by 2030 UTHR only expected to serve half the available market. The other was UTHR's claim that Yutrepia's entry into the market would likely force UTHR to reduce their price by 20% to 30%. Will be interesting how well UTHR can manage the market impact of Yutrepia. Seems UTHR has the upper hand in dealing with insurance formularies, but I think our current share price is pricing in a real though unknown magnitude Yutrepia threat. |
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Post by cretin11 on Jun 1, 2024 18:03:16 GMT -5
We are lucky UTHR is calling the shots on all that. I believe the odds are good they will have solid strategy on it.
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Post by mayday on Jun 1, 2024 19:34:37 GMT -5
Amen to that!
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Post by jkendra on Jun 18, 2024 19:17:15 GMT -5
Aerovate's shares plummet as inhaled version of Novartis' Gleevec misses the mark in PAH trial
Aerovate Therapeutics’ attempt to use an inhaled formulation of Novartis’ cancer med Gleevec as a treatment for pulmonary arterial hypertension (PAH) didn’t pan out.
After the drug missed the mark in a phase 2b study, Aerovate’s stock price plummeted 93.3% during Monday’s trading.
The study, called IMPACHT, tested three different doses of a dry powder inhaled version of imatinib in PAH patients. While the drug was well tolerated, it didn’t cause an improvement in pulmonary vascular resistance compared to placebo, Aerovate reported in a press release.
www.fiercepharma.com/pharma/aerovate-therapeutics-shares-plummet-after-inhaled-version-novartis-gleevac-misses-phase-2b
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Post by cppoly on Jun 27, 2024 15:07:07 GMT -5
I know the FDA moves slow, but this is now a 6 month delay for Yutrepia. Can something else be holding LQDA up?
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Post by agedhippie on Jun 27, 2024 18:52:18 GMT -5
The FDA and LQDA filed a motion to dismiss the UTHR / FDA lawsuit this week. UTHR have responded, and the FDA and LQDA filed their response to UTHR this week. Main argument is that the UTHR action is speculative since the FDA have not approved anything (this was the argument they used to defeat the UTHR injunction). My guess, and it is just a guess, is that FDA want to see if they can get the case dismissed before approval as that would be cleaner. However, I think if it isn't dismissed the FDA will move to approve anyway because at that point they have no reason to delay further. As to timeline, it's in the lap of the judge!
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Post by agedhippie on Jul 1, 2024 16:36:38 GMT -5
The FDA and LQDA filed a motion to dismiss the UTHR / FDA lawsuit this week. UTHR have responded, and the FDA and LQDA filed their response to UTHR this week. Main argument is that the UTHR action is speculative since the FDA have not approved anything (this was the argument they used to defeat the UTHR injunction). My guess, and it is just a guess, is that FDA want to see if they can get the case dismissed before approval as that would be cleaner. However, I think if it isn't dismissed the FDA will move to approve anyway because at that point they have no reason to delay further. As to timeline, it's in the lap of the judge! I should have been a bit clearer on this. I don't think the FDA win their dismissal (getting a case dismissed is always a stretch), but I think the FDA will approve regardless after the motion to dismiss is ruled. It's just that through choice they would rather have the dismissal as it would be cleaner. |
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Post by ryster505 on Jul 1, 2024 20:27:50 GMT -5
The FDA and LQDA filed a motion to dismiss the UTHR / FDA lawsuit this week. UTHR have responded, and the FDA and LQDA filed their response to UTHR this week. Main argument is that the UTHR action is speculative since the FDA have not approved anything (this was the argument they used to defeat the UTHR injunction). My guess, and it is just a guess, is that FDA want to see if they can get the case dismissed before approval as that would be cleaner. However, I think if it isn't dismissed the FDA will move to approve anyway because at that point they have no reason to delay further. As to timeline, it's in the lap of the judge! I should have been a bit clearer on this. I don't think the FDA win their dismissal (getting a case dismissed is always a stretch), but I think the FDA will approve regardless after the motion to dismiss is ruled. It's just that through choice they would rather have the dismissal as it would be cleaner. Liquidia does not have the right to ILD…Please explain to me how Liquidia trying to “bundle” with their approval goes with the FDAs own rules regarding this. |
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Post by Clement on Jul 2, 2024 6:47:22 GMT -5
Hey you legal wizards, tell me if the following makes sense:
If UTHR loses here, then they have a strong argument for T-DPI for IPF being "bundled " without an extra trial when TETON trials are completed.
So, losing now would actually be a big win later. (I'm guessing UTHR has done their homework with proper patenting for the IPF indication.)
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Post by agedhippie on Jul 2, 2024 6:57:08 GMT -5
Liquidia does not have the right to ILD…Please explain to me how Liquidia trying to “bundle” with their approval goes with the FDAs own rules regarding this. I am curious why you think LQDA doesn't have a right to ILD as the exclusivity period the FDA granted UTHR has now expired. As for explaining why the FDA and LQDA did not break the rules the best idea is for you to read the FDA response to UTHR's reply in the motion to dismiss the suit as it is explained in detail. For the curious with more time than is good for them here is a link to the whole docket:  www.courtlistener.com/docket/68267106/united-therapeutics-corporation-v-food-and-drug-administration/ |
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