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Post by agedhippie on Mar 2, 2024 16:09:00 GMT -5
IMO......if you BUILD IT....They WILL COME. Once insurance cos. see the Superior Data and realize this will LOWER THEIR COSTS...they will come ONBOARD. Then it will snowball down to the doctors and make their lives easier. IT'S ALL ABOUT THE DATA. How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions.
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Post by agedhippie on Mar 1, 2024 15:26:29 GMT -5
Just as MNKD has been held down, strangled, manipulated for years, LQDA has been manipulated Upward by the same bunch. LQDA's potential with Tyvaso is an absolute joke compared to MNKD's DPI. For those of holding LQDA, NOW would be a good time to unload it and move those funds to MNKD. Don't know if will be weeks, months or a year or more, but LQDA will likely be cut in half (or more). Might be good to get out while the getting"s good. The party in MNKD is just starting. LQDA isn't going to get hammered until they actually release the drug. That is awkward time when projections and reality collide and they have to deliver. A lot depends on their pricing model. Insurance is actually going to be pretty easy since that market is primarily driven by clinical centers rather than PBMs. Beside, right now UTHR is doing a solid marketing job for LQDA.
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Post by agedhippie on Feb 23, 2024 13:03:05 GMT -5
If you check the LQDA thread, UTHR's Tyvaso DPI is doomed as compared to Yutrepia (and therefore MNKD's deal with Sagaard must be a masterful stroke of genius). Of course, I completely discount nearly all of the cheerleading for Yutrepia (while at the same time respecting that LQDA might be a good investment and with no disrespect intended to LQDA investors). I expect Tyvaso-DPI to get the bulk of the PH-ILD and PAH markets because they will have first mover advantage and, more importantly, I don't see LQDA having the manufacturing capacity to meet all the demand. I suspect LQDA will be just fine with that.
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Post by agedhippie on Feb 23, 2024 9:28:37 GMT -5
Aged, will you please change your emoji. I worked with a brit company for long enough that it's an irritation...apologies to your brother. I'm a flag guy, I like the worn flag (even British) but that vampire mouse really sucks. Hey! That's Snowball from the Secret Life of Pets. A personal hero.
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Post by agedhippie on Feb 22, 2024 23:15:23 GMT -5
Aged, what do you think the chances are that the UTHR / FDA lawsuit uncovers a repeat of the Chang (FDA)/Hamburg/Brown Renaissance era (prison, well...you know the rest)? Shkreli being involved with Lqda certainly adds an interesting twist eh? I find these things are far more often screw ups than malicious. In this case the FDA changed the rules and either they didn't convey that adequately, or UTHR took their eye off the ball. I am curious to see how this goes but I don't think it will impact LQDA judging by the market reaction. UTHR's problem is that once Yutrepia is approved for PAH the horse is out of the stable. In the worst case for LQDA their salesforce couldn't sell Yutrepia for PH-ILD, but they could continue publishing research on PH-ILD and Yutrepia and let that be the marketing. The doctors would just use it off-label since these are large clinics and they use whatever they think the patient needs.
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Post by agedhippie on Feb 22, 2024 16:35:57 GMT -5
If only that IDIOT Mike would start loading AI onto FDKP!!! Ya hear that Mike??? Ohhh MIKE? Lol couldn’t help myself. Sometimes I crack myself up. ... Give Afrezza for free to NVDA and in then issue a PR saying that we are an NVDA supplier.
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Post by agedhippie on Feb 21, 2024 19:10:01 GMT -5
At $99 I am pretty sure they are getting paid more than the PBMs are paying them. I am also not aware of a limit on the $99 boxes and there are bigger boxes you can buy for more. ... Always look at the professionals site and not the marketing site. Read the asterisk. afrezzahcp.com/patient-support/If it's that cheap why is there a limit? Because it isn't that cheap.
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Post by agedhippie on Feb 21, 2024 15:06:39 GMT -5
UTHR should just buy out MNKD and all of it's assets, convert them to a division under the UTHR umbrella focusing on orphan lung diseases and dry powder treatments. LQDA won't be the only show with dry powder formulations taking away market share. It would be a nice bolt on to their existing lung focused mission. I think that using the '327 patent on LQDA is a tactical error. The '327 patent is very weak, but it's in the Orange Book now so anyone wanting to challenge it will have a year or two delay to work through it. Throwing it at LQDA is pointless because LQDA is the one case where that doesn't work since they predated the Orange Book filing and thus there is no delay possible. What it does do is force LQDA to invalidate the '327 patent so UTHR is burning a patent that could be used against another competitor in this space for zero return.
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Post by agedhippie on Feb 21, 2024 12:30:13 GMT -5
UTHR had to pay for clinical trials to get to sell Tyvaso in the PH-ILD space. LQDA did not. UTHR did the heavy lifting and LQDA gets a free pass in PH-ILD. Aged, I bet you understand this and I hope you will explain it. Happy to explain. The FDA gives you a two year exclusivity for doing that work from the filing point. UTHR burnt most of that exclusivity period not progressing the trial so it all happened at the end and now only has a month left. If UTHR had done the work earlier then the patent would have been in the Orange book, there would have been a 30 month stay, and UTHR wouldn't be trashing around. Basically UTHR dropped the ball. It doesn't help that in Roger Jeffs UTHR is up against the person who wrote most of their playbook!
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Post by agedhippie on Feb 21, 2024 11:38:24 GMT -5
It actually sounds like standard business practice (unfortunately). It will also cost Liquidia to pay to defend themselves and anything that costs Liquidia money helps uthr. In this case it doesn't cost LQDA anything this is between the government (FDA) and UTHR. LQDA is not involved.
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Post by agedhippie on Feb 21, 2024 11:34:26 GMT -5
This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit). Aged, maybe you can provide more? 1. Your comment, " If it was real they would have done this far earlier", seems too simplistic. Why preempt questions about LQDA on the call? They could've provided an answer that can mitigate any concerns about market share and/or the proceedings with, "We have a better product and we don't expect to recognize any significant decline in revenues and are not making any changes to our guidance." Sooner or later they're going to be asked again and my bet is the answer will likely be the same or similar now as it will be later. 2. Why poke the bear first and sue the FDA? A direct lawsuit against LQDA would be the logical "first course" of legal action. I'm sure after careful consideration and researching prior litigation, UTHR feels they have a legal foundation from which they can make their case. Like I said, maybe not the preferred route, but they're willing to go to all sorts of expenses to protect this asset. 3. I'd rather say, at the bare minimum, (piggy backing off your theory), this is just another attempt at a delay tactic to which a judge may impose another Order delaying the Yutopia sales while UTHR converts more patients, to stall and buy time, behind another legal proceeding. UTHR could have filed this months ago, but instead they waited for their earnings call. It's dead catting. UTHR already have a court case with LQDA but since UTHR didn't have a patent in the Orange Book it's pretty useless since they cannot get an injunction. That means they need to prevent the FDA from allowing LQDA to cover PH-ILD, and since the FDA said months ago they would allow it their only option is to sue the FDA. It's unlikely to work, but it's the only option. Yes, this is just a delaying tactic to slow LQDA into the PH-ILD market. It has no impact on the PAH market, but PH-ILD is the one everybody is after. If you want to see what the market thinks of UTHR's chance of success look at the LQDA share price.
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Post by agedhippie on Feb 21, 2024 9:22:03 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved. ... This goes nowhere. If it was real they would have done this far earlier. They want to preempt questions about LQDA on the earnings call and that is the purpose of this PR (and lawsuit).
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Post by agedhippie on Feb 21, 2024 9:18:38 GMT -5
If you need more than one box at $99 you'll need more at $35, too. To me, the $64 dollar consumer question (difference in price), do I prefer the simplicity, convenience and hassle free options with Afrezza or, do I go el cheapo and stay with the same routine that can cause swings, aggravation and anxiety? I'll pony up $64 more dollars and take Box Number 1. The problem for MNKD is that the insurance rate is $35 for all you can eat. The MNKD price is per box and you will need at least two. My suspicion is that they are making a loss on that $99 price given that they limit the number of boxes you are allowed to buy (if they were making a profit why the limit?) So really you are looking at $200 vs. $35. The insurance will pay for a pump though and you can see from the article the effect that has in dealing with level issues.
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Post by agedhippie on Feb 21, 2024 9:12:40 GMT -5
That still doesn't fix the nighttime numbers as you pointed out before. If they go to bed at 90 - 100 the highs are not going to be that high. Its not the highs keeping the moms up its the lows. If they are really seeing highs its probably more right before they wake but the CGM will tell them. Now this is going to sound crazy for me to say and I wouldn't do it but they could always give them low dose metformin before bed. I am going to guess that you have never dealt with T1 kids from that reply. If they go to bed at 90-100 they can spike quite happily overnight if their body decides it a good time to dump some growth hormones (and it does). Since it's night time everyone is asleep and if you had ever been woken by a dexcom alarm you would know exactly how jarring it is. Now the parent needs to go and wake up the kid, get a confirmation finger stick, and persuade them to inhale properly. The metformin idea is a non-starter. Metformin doesn't deal with spikes.
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Post by agedhippie on Feb 20, 2024 23:04:44 GMT -5
That was the protocol used for STAT-1 and it failed to deal with the nighttime highs. That was the point the mother was making about disrupted sleep for both her and her child to deal with those. That said a daily basal plus Afrezza would be the go-to protocol for kids using Afrezza. You're confusing me. (Not hard to do.) Why would this be the go-to protocol if it doesn't deal with nighttime highs? Thank you. For kids using Afrezza? Because it's pretty much the only option in that case. It's very hard to get a pump AND bolus insulin (Afrezza) because insurers see it as double dipping.
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