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Post by jkendra on Jan 12, 2024 11:19:14 GMT -5
If we use common sense and logic and assuming that the 1 center didn't do any fudging (i.e. how sick are the patients, was it their last option, etc, etc, etc...) based on the adverse events of the trials for Tyvaso DPI vs. Yutrepia, the outcome very likely would be the same drop out rate or most likely even worse for Yutrepia. I think it's very unlikely they were fudging the numbers because the peer review will have asked for the data before it was accepted for the conference. What they are reporting is their experience with a new delivery mechanism for an established treatment (trepostinil) as a data point for comparison with other centers. I wouldn't disagree that having failed on Tyvaso DPI they likely will fail on Yutrepia (and vice versa), but they will still try them on the alternative because maybe it will work for them. The preference would logically be to find a working DPI solution given the satisfaction rates over nebulized delivery in both Tyvaso DPI and Yutrepia trials. As harry pointed out, more than likely (inevitably?), those patients will also drop Yutrepia. On the flip side, those who try Yutrepia and drop it, might have a better chance of succeeding on Tyvaso DPI when they try it.
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Post by Clement on Jan 12, 2024 11:34:49 GMT -5
This is an interesting conversation because UTHR previously reported that TDPI has a very high continuation rate.
Maybe the difference is start-up training and hand-holding. (reminds me of VDEX success.)
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Post by jkendra on Jan 12, 2024 11:45:52 GMT -5
The good news is the hand-holding is drastically different compared to a nebulizer. A lot of those patients had a visit from a nurse for training.
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Post by cppoly on Jan 23, 2024 15:12:09 GMT -5
Anyone know the timeline for Yutrepia approval?
I thought it was this week
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Post by prcgorman2 on Jan 23, 2024 16:01:53 GMT -5
The target due date the FDA set for themselves is 1/24/2024. The court has to lift the stay first. That may (or may not) have already been done. A good review with good links is available from agedhippie posts at: mnkd.proboards.com/post/259130/thread
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Post by agedhippie on Jan 23, 2024 16:49:37 GMT -5
The target due date the FDA set for themselves is 1/24/2024. The court has to lift the stay first. That may (or may not) have already been done. A good review with good links is available from agedhippie posts at: mnkd.proboards.com/post/259130/threadMy feeling is that the FDA will approve it. It's a lottery though and given today's price action it's possible the FDA are not going to clear it immediately. On the other hand it could just be people taking some money off the table ahead of a binary event... There is a section in Liar's Poker where Michael Lewis, who was a bond salesman at Goldman Sachs at the time, describes himself as running a full service casino. I always felt that was the best description of the stock market I have seen.
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Post by lennymnkd on Jan 23, 2024 17:07:06 GMT -5
What’s the only sure thing in life !! DEATH AND TAXES
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Post by cppoly on Jan 24, 2024 17:20:00 GMT -5
The target due date the FDA set for themselves is 1/24/2024. The court has to lift the stay first. That may (or may not) have already been done. A good review with good links is available from agedhippie posts at: mnkd.proboards.com/post/259130/threadSo what happens since the target due date hasn't been met?
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Post by agedhippie on Jan 24, 2024 17:23:07 GMT -5
The target due date the FDA set for themselves is 1/24/2024. The court has to lift the stay first. That may (or may not) have already been done. A good review with good links is available from agedhippie posts at: mnkd.proboards.com/post/259130/threadSo what happens since the target due date hasn't been met? The target date's a target, it's not guaranteed. The FDA has an 89% on-time rate.
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Post by prcgorman2 on Jan 24, 2024 17:42:12 GMT -5
Yup, the target date exists because Congress passed a law designed to make FDA more responsive, so they have to publish target dates and they get measured against them (as agedhippie illustrated with the % on-time rate).
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Post by cppoly on Jan 25, 2024 6:21:25 GMT -5
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Post by sayhey24 on Jan 25, 2024 7:00:51 GMT -5
It seems odd they would need more time. We were told this was a slam dunk.
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Post by agedhippie on Jan 25, 2024 7:40:15 GMT -5
Having done a quick bit of research My guess is that this is because of the exclusivity period for PH-ILD. There is a provision in the FDA regs on amendments that says if a drug is in an exclusivity period you cannot use the holder's own documents to get an approval without their permission. My bet would be that the FDA is looking to see if this applies (I strongly suspect it does) and is the cause of the delay. If the FDA decides that it applies they will hold off approval until March 2024 when the period expires. For LQDA the good news is it's not a CRL, the bad news is the delay. In some ways this ia a problem of LQDA's own making. They took a chance in using an amendment to the NDA before Yutrepia was approved for PAH hoping to accelerate the PH-ILD approval, but wound up delaying PAH approval instead. This will not stop approval, but it's going to delay it until the expiry of the exclusivity in March I would expect - that's my thought after 15 minutes research anyway.
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Post by cppoly on Jan 25, 2024 10:11:42 GMT -5
Aged, aside from your point causing a potential delay from PH-ILD, are there other items that can adversely affect Yutrepia approval by delay or rejection?
The orange book issue is one that you also mentioned. Any others you're aware of?
Just looking for ideas that make this approval not so much of a slam dunk.
Thanks
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Post by agedhippie on Jan 25, 2024 10:57:17 GMT -5
Aged, aside from your point causing a potential delay from PH-ILD, are there other items that can adversely affect Yutrepia approval by delay or rejection? The orange book issue is one that you also mentioned. Any others you're aware of? Just looking for ideas that make this approval not so much of a slam dunk. Thanks The only other thing I could think of is the delay while they wait for Judge Andrews to remove the stay on approval following the invalidation of the '793 patent. LQDA has filed for that but it's not yet done to the best of my knowledge. I suppose it's possible that it is that that delayed the FDA, but the PR reads more like it is entirely related to the PH-ILD amendment. Since there is no CRL they are not looking for more data or trials hence my feeling that it's related the exclusivity period and a process issue instead. There is still the trial relating to the '327 patent but I seriously doubt UTHR get an injunction given the timelines. This next comment should probably be in a different thread, but it fits here as well. My feeling at this point is that the LQDA share price is being traded for it's volatility which in turn leads to volatility and that will remain until approval. That makes it an interesting option to trade around.
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