|
Post by agedhippie on Aug 22, 2024 12:45:52 GMT -5
UTHR voluntarily dismissed, without prejudice, the complaint it had filed against the FDA so the FDA case is over for now. On the other hand LQDA is challenging the exclusivity period the FDA gave UTHR (Case No. 1:24-cv-02428). I am not really sure why LQDA did this since there is a strong chance that the exclusivity period expires before this is decided - I think it's theatre.
|
|
|
Post by agedhippie on Aug 22, 2024 12:36:55 GMT -5
I'm a complex commercial litigator and I have worked on a number of theft of trade secret and unlawful use of confidential information cases. Aged Hippie, your view is not accurate. Most folks know exactly what they are doing when they take confidential company information (whether trade secrets, sensitive business information, client lists, etc...). These are typically very smart people with future business ideas and are looking to succeed in whatever they do next. There's a reason they take the information and it's not because they are idiots. So there typically is some type of real case. The legal question is typically did they use that information and did it actually harm their prior company. I only deal with these from time to time on the clean up rather than legal side so your view is going to be far more accurate than mine. My original hypothesis was that this was related to emails, but it appears that they were on old thumb drives which makes arguing they were not deliberately copied a lot harder. On the other hand he left in 2007 which was prior to the launch of nebulized Tyvaso, rather than anything to do with LQDA's product which was always DPI. He joined LQDA in 2015. By then LQDA had already developed Yutrepia (they had licensed their DPI technology to GSK with an exception for Yutrepia in 2015) so it's hard to see how anything he can have done was relevant. This was the rejection of the move for summary dismissal and contains some interesting details. nclawyersweekly.com/2024/08/05/contract-confidentiality-provision-trade-secret-misappropriation/
|
|
|
Post by agedhippie on Aug 21, 2024 17:12:08 GMT -5
I am curious about how the Supreme Court request will go. The trade secret case is not a serious threat, filing that case was pretty standard practice. You can almost always find an ex-employee in possession of something somewhere. Wasn't the original filing accusing Liquidia of submitting the stolen blueprints to the FDA that United literally submitted to get FDA approval ? Seems kind of serious to me. I would have to refresh my memory on court documents.
...
No, nothing like that. There is no evidence that LQDA ever used any of the information (the court makes note of that, and UTHR dropped the conversion claim) the issue is purely that Roscigno was in possession of the documents while employed by LQDA. Having been on the clean up side of these cases before it usually turns out that the person copied their email when they left the company and the documents were attachments. Along comes the patent case and UTHR does discovery, basically a keyword search across everything, and gets a hit on the documents. The documents get shipped out with several hundreds to thousands of others. If these documents had actually been used used they would be known and the lawyers would have produced a reason to exclude them from the discovery - they would have remained hidden. This is why these cases are so seldom worth the effort other than for intimidation. Almost invariably the exposure turns out to have been stupidity rather than malice in my experience. The worst that would happen to LQDA is some monetary damages that will probably barely cover costs.
|
|
|
Post by agedhippie on Aug 19, 2024 17:06:28 GMT -5
Let's not forget '793 with the Supreme Court. There is also another pesky lawsuit out there regarding trade secret misappropriation. Liquidia is still driving on a very bumpy road. I am curious about how the Supreme Court request will go. The trade secret case is not a serious threat, filing that case was pretty standard practice. You can almost always find an ex-employee in possession of something somewhere.
|
|
|
Post by agedhippie on Aug 19, 2024 8:16:09 GMT -5
Well that was an option I hadn't seen coming! The FDA effectively said they will approve PH-ILD and PAH, and tossed UTHR a 3year exclusivity on the entire drug class rather than just the drug. I think the FDA comprehensively screwed this up with both sides and is attempting to extract themselves. I suspect now we will see LDQA also suing the FDA! I cannot see an LQDA lawsuit going anywhere, but I think they will file so they can go to discovery on the FDA process paper trail. What is the outcome? From an FDA standpoint there is an approval date on or near 23rd May 2025. In between there is still the '327 lawsuit but I don't think that will make much progress in 9 months.
|
|
|
Post by agedhippie on Aug 17, 2024 15:02:03 GMT -5
The FDA refiled the notice, it's not clear exactly what they did without seeing the documents but it looks like they filed a statement of their proposed actions and were asked to instead file the documents themselves (the court wanted the documents rather than notice of the documents). That is speculation based on Pacer.
That may restart the three day clock, or the court may just say they have known the outcome for three days at this point (I suspect the latter.) Since both sides have their lawyers lined up at this point I think the judge will give his final resolution of the request for an injunction. Previously he had refused an injunction but had asked to be informed before approval was granted, and this is almost certainly approval being granted to at least PAH.
When is this announced? That's an interesting question. Probably Monday, but maybe not until Wednesday or Thursday. When does it get settled? That's a bigger question since it is not impossible that the judge slaps an injunction on the sale of the drug since UTHR got over their skis on this suit and sued before there was the context for a suit, hence the notification clause for when the context did exist. An injunction seems unlikely - however, this is the US legal system so anything is possible...
|
|
|
Post by agedhippie on Aug 16, 2024 10:50:36 GMT -5
With afrezza, coping without insulin is old school thinking. The goal is to stop the meal time spike not looking at a 3 month A1c. If the to be mom is going over 140 and staying there over 2 hrs get her the afrezza. There is no need to cope anymore. Get her down and to baseline. Now if the to be mom is not taking another med which will interfere, the liver will prevent the hypo. In most cases its not an issue. I think VDex has a paper with some nice CGM reports of taking afrezza without eating. If the patient is reliably over 140 2 hr after meals then they will be put on insulin today - end of story. If they are not (again, as 85% are not) then they will not be put on insulin. This is really simple. To be honest, I am not really replying to you in what follows, but rather to point out to anyone stumbling across this thread by accident that all insulin can cause hypos and that includes Afrezza. The idea that Afrezza does not cause hypos is laughable. I don't know about Vdex, but in their own clinical trial Mannkind had the Type 1 arm shutdown because of the number of hypos. Read the data here: clinicaltrials.gov/study/NCT00747006I wait to see your trial data showing Afrezza cannot cause hypos
|
|
|
Post by agedhippie on Aug 16, 2024 9:49:46 GMT -5
The FDA approval (or not) for Yutrepia should happen today. Place your bets for the outcome. I think they approval PAH and delay PH-ILD. The PAH approval would not be controversial since they granted tentative approval three years ago so any issues would have long since been cleaned up so I think that gets granted. The PH-ILD approval is the point of this law suit so I think that will be a lot less certain but I think it still gets approved because once it is approved for PAH it can be used off-label for PH-ILD. The FDA are not going to want that area sitting outside their scope.
|
|
|
Post by agedhippie on Aug 15, 2024 22:28:49 GMT -5
Yes, because they need to see if they can cope without insulin and that could change at any time. Thats the beauty of afrezza. If they are borderline give them the afrezza. It will reduce the BG to near normal levels and they won't get the hypo. With afrezza all this worrying and wondering about coping is a thing of the past. I think misunderstand what I meant by cope. If they can cope without insulin (and 85% can) then they will not be given it because it's unnecessary. Worry and cope in the sense I think you meant it is different. Oh, and Afrezza can give hypos - the trial data shows that.
|
|
|
Post by agedhippie on Aug 15, 2024 16:13:04 GMT -5
I really like Afrezza for the GDM space. Mostly because it has a much higher level of management from the physician. As far as size, just getting 5% of the 15% of the 250,000 cases per year is still 2500 patients for 3-5 months of the year. Also, if safety superiority with Afrezza can be established then the % of GDMs given Afrezza will get much higher. Are GD patients given a CGM? Yes, because they need to see if they can cope without insulin and that could change at any time.
|
|
|
Post by agedhippie on Aug 15, 2024 9:32:46 GMT -5
I feel sorry for those that invested in LQDA thinking UTHR can buy them out. The really should read the MNKD UTHR agreement. I would love to see UTHR buy LQDA and see Tyvaso DPI right fall back to MNKD. That would make our stock price soar. Or how much do you think MNKD would ask UTHR (besides shelving LQDA's product) for to amend the contract to allow UTHR to buy LQDA? I don't think anyone expects UTHR to buy LQDA, they are well covered with Tyvaso DPI. The buyer would have to come from elsewhere. That said, I seriously doubt there would be a buyer until LQDA has established that it can sell into the PH-ILD and PAH markets.
|
|
|
Post by agedhippie on Aug 15, 2024 8:47:37 GMT -5
Afrezza can be prescribed for use during pregnancy today, the label doesn't forbid it. This trial is about quantifying the impact with a meal. I would expect a far bigger trial if they wanted to seriously get traction in GDM because insulin requirements vary wildly during pregnancy. Initially you require less insulin, and later you require twice as much insulin. For that reason I would expect a trial to last most of the term to prove that it can be adequately titrated throughout.
I am interested in this in the existing diabetic case. Your endo will want your A1c at or below 6.5 before you become pregnant, and then to keep below 140 for the whole term. This is not easy, but it can be done (I know a few people who have managed it). I feel that Afrezza would be ideal because it hits that post meal spike, and while normally you don't really care about it in pregnancy it matters. This is why Carol Levy is so interested in it - she deals with a lot of women who are or want to be pregnant.
The GDM market is large, but only 15% of women with GDM need insulin.
|
|
|
Post by agedhippie on Aug 13, 2024 16:55:21 GMT -5
Aged, speaking of UTHR / LQDA, what's the latest from your perspective? It really is amazing that we are coming up on an 8 month delay for Yutrepia (hey I'm not complaining). It seems every time there's some general consensus that it'll be approved within a week, that week turns into several months. So..... what's the latest and greatest?? That letter should be the three day warning the FDA was required to give the court so look for a PR Friday It is likely to be at least a partial yes. I think the PAH indication is pretty much certain, and the that the PH-ILD indication is likely but not certain (a SWAG in the region of 90%?) If it is an approval, and the court doesn't issue an injunction, then I would expect LQDA to immediately start selling since there would be no legal restriction. They have sales staff visiting the major clinics already so i would expect a short transition. This will be fun to watch as there is going to be a mad scramble to get out of short positions. Usually there is a bit of time to unwind these positions so it's not to bad, but in this case they must be out by the end of Friday so they have to get clear in three days.
|
|
|
Post by agedhippie on Aug 13, 2024 16:37:57 GMT -5
I expect Boehringer-Ingelheim to wait until nearer launch before they sue. I would also watch for spurious patents like the UTHR '327 patent coming from Boehringer-Ingelheim to protect and extend the Ofev exclusivity and provide the basis for more frivolous suits. Basically the BP playbook that UTHR is using with LQDA. Aged, how does it compare re: UT/Liq as Ofev is NOT dpi? I see how United is fighting liquids against identical delivery/makeup etc. Not sure how Boeringher would compare to Mannkind techno. They don't need a valid case they just need a case (see UTHR). This is about delaying, not winning, to the point where MNKD either go away, or pay to be allowed to play. The best result here would be if BI decide that they don't care about this market and just let it go. The down side is that they would not do that if the market was significant (again, see UTHR).
|
|
|
Post by agedhippie on Aug 13, 2024 8:55:32 GMT -5
I thought of another reason for MannKind to consider partnering with Boehringer-Ingelheim on nintedanib DPI (could be known as Ofev DPI). This was probably obvious to many others but it hit home for me yesterday after a short conversation with an attorney who knows a thing or two about drug company litigation, and who said something along the lines of "drug companies routinely file (suit) when an FDA decision doesn't go there way either to permit sales or prevent sales of a drug". ... I expect Boehringer-Ingelheim to wait until nearer launch before they sue. I would also watch for spurious patents like the UTHR '327 patent coming from Boehringer-Ingelheim to protect and extend the Ofev exclusivity and provide the basis for more frivolous suits. Basically the BP playbook that UTHR is using with LQDA.
|
|