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Post by agedhippie on Dec 8, 2023 19:01:08 GMT -5
What is the outcome you are looking for from marketing to the school nurses? At a minimum, awareness of Afrezza as a safer, more effective, prandial insulin and differences in administration as compared to pumps, pens, and syringes.
A bonus would be minor modifications of the school district (or school) Section 504 plan to include reference to inhalable insulin and administration of Afrezza as appropriate in Section 3 "Student's Level of Self-care and Location of Supplies and Equipment", and Section 7 "Checking Blood Glucose Levels, Insulin and Medication Administration, and Treating High or Low Blood Glucose levels".
The key is awareness. The modifications, if any, to a Section 504 plan would just be for completeness with regard to information of importance mainly to school nurses or any non-medical school staff members in the role of Trained Diabetes Personnel (TDP).
I certainly think they should modify the language in the plan to include inhaled insulin. For example change to "Insulin and/or other diabetes medication will be administered at the times and by the route (e.g., syringe, pen, inhaler, or pump) prescribed on the student’s DMAF". I would argue that this aligns with the ADA SoC and thus should be modified to reflect that. Mostly though, the 504 document doesn't specify delivery or form and just say insulin. What I am trying to figure out is given that the nurse is absolutely bound to deliver the plan and only the plan, and in the manner prescribed in that plan, what can they do to promote Afrezza? I do agree that they need to know how to handle Afrezza, so does MNKD have a plan in place to undertake that education as soon as it is cleared for pediatrics? It's not absolutely necessary since the plan spells this out, but if they are aware ahead of time there is likely to be less push back.
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Post by agedhippie on Dec 8, 2023 15:26:07 GMT -5
We agree and I'm suggesting a low-effort approach to marketing to an important and influential segment of the healthcare community supporting pediatric prandial insulin users. What is the outcome you are looking for from marketing to the school nurses?
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Post by agedhippie on Dec 8, 2023 13:30:08 GMT -5
...
You do make me wonder, do school nurses have "emergency" insulin supplies, or do they 100% rely on whatever a child or their parent provided? Just wondering if a few cartridges and inhalers could be in a school nurse diabetes care safety kit.
In my (limited) experience the nurse will store whatever the patient gives them, but cannot substitute insulin or deviate from the pupil's treatment plan. They are there to administer the plan. This is the ADA advice, but who can administer insulin and if they can vary the dose varies wildly from state to state. Anyone can administer glucagon thankfully. diabetes.org/advocacy/safe-at-school-state-laws/tips-for-school-nurses
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Post by agedhippie on Dec 8, 2023 10:58:12 GMT -5
... Your comments remind me that one of the valuable things that may be learned from the on-going Pediatric trial is an answer to the question of, “how important and desirable are 2U cartridges?”. Oddly this is one of the places where the fact that unit for unit Afrezza is a lot weaker than RAA will work to it's advantage. You are not going to need 2u Afrezza cartridges because the 4u will approximate to that. For pediatrics that will be good.
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Post by agedhippie on Dec 6, 2023 8:48:24 GMT -5
I think its that simple. We have to wait for the decision and then we will know. I have read what you have posted on this and that you have given LQDA an 80% chance of winning. If after listening at the 2:10 mark you don't want to adjust that down a bit seems a bit surprising. If you have lost one judge maybe you have 2. Two out of three seems like 66%. To be honest, UTHR is not that interesting to me. Right now they serve a useful purpose by paying the bills and extending the runway. Mike better figure out how to sell afrezza and needs to take a shot at the GLP1 market. Waiting for the decision is the way to go, but in the interval we can speculate. It's always fun seeing if you can get the outcome right. If you lose one judge that's not a 66% chance of success, that's a majority verdict and 100%. Even if it wasn't the case 66% is a gross over simplification since no judge is 100% certain to vote either way so it never comes to a 66% chance hence I think 80% is more realistic. I agree with you about UTHR in that this is a problem for UTHR, but everyone here seems pretty convinced LQDA is not going to get a big share. So 10% of a small share is lost, is that a big deal?
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Post by agedhippie on Dec 5, 2023 22:40:02 GMT -5
Or knew it was likely and perhaps engaged in pump-and-dump. Not that I'm paranoid or anything, but the ex-convict Martin Shkreli promoting LQDA always made me leery. That is far more probable. It looks to me like they ran it up from mid-November with a view to dumping it immediately after the case opened and shorting it back down. There is always volatility around these events which makes them good targets.
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Post by agedhippie on Dec 5, 2023 22:34:59 GMT -5
If you listen starting at the 2:10 mark as you suggest it sounds like LQDA is doomed but with any trial you just never know until the decision is filed. Right now I would be concerned if I were LQDA. It's not that simple. You are fixing on Judge Reyna and ignoring the other two judges. I would say there is a 10% chance this gets sent back to the PTAB which means a year delay to the launch, a 10% chance UTHR gets their reversal, and an 80% chance LQDA wins. Read the original link I posted. I doubt LQDA see themselves as doomed.
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Post by agedhippie on Dec 4, 2023 16:56:11 GMT -5
It's the legal system, it's seldom a slam dunk! Even if there is an 80% chance that LQDA wins that still means that there is a 20% chance that UTHR wins and 20% isn't nothing!
I haven't listened to it as I am not a lawyer and wouldn't understand what and how they were arguing.
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Post by agedhippie on Dec 4, 2023 9:16:21 GMT -5
We should have a category called "realism" - then just post the graph of the share price from the beginning on Nasdaq to present - it will say all that is needed! This should be a fantastic company and the sp should reflect it but - it has become a pos stock for all that invested a long while ago! The YTD graph is negative compared to the IBB, but the 2 and 5 year graphs are positive. Granted, the range from the launch of Afrezza is awful. It's easy to cherry pick timeline and say it's good or bad.
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Post by agedhippie on Dec 4, 2023 9:05:27 GMT -5
For all the pessimists here....sorry, I'm on the wrong thread! Please sell...soon! We are becoming profitable, the sooner you sell so the tutes can get their allotment the better for me! Buy bye Tutes can get all they want right now, they just don't want and that's the problem
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Post by agedhippie on Dec 2, 2023 18:25:28 GMT -5
This is a review of the pending appeal from someone who actually is a lawyer (and yes, he is long LQDA) www.valoremresearch.com/p/the-lionel-hutz-substack-is-now-valoremI have read his work for a while and find it well written and easy to understand. I also like that he talks about both the strong and weak points in a case. He also brings up an outcome that I hadn't considered; the court could send it back to the PTAB for review. This is definitely worth a read.
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Post by agedhippie on Dec 2, 2023 10:36:22 GMT -5
^ That is pretty much one of the best summaries I have seen on this.
I expect the legal challenges to keep coming because Martine is essentially buying first mover advantage. Compared to the revenue at stake the legal bills are peanuts. Even if UTHR loses the appeal (which is by no means certain, as a 80% probability of a loss still has a 20% probability of a win) I would expect more law suits.
Speculating on motive; I think UTHR expect to lose the appeal (there are comments on the call about competitors for DPI), and Martine has moved on to focusing on protecting the PH-ILD market. That makes sense because the PAH market is relatively crowded compared to the PH-ILD, plus there is the impact Merck looks like it will have on the PAH market with Sotatercept given results that seem to reverse PAH rather than the current palliative approach. It is worth noting though that in the Stellar trial Sotatercept was used with a background PAH drug. Although there is talk of Sotatercept being launched in 2024 my expectation would be 2025.
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Post by agedhippie on Dec 1, 2023 19:51:09 GMT -5
What's that old saying Aged? No honor among ? Pharmas?
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Post by agedhippie on Dec 1, 2023 19:49:03 GMT -5
I think the grey area here is, LQDA had been notified that the patent claims for '327 had been approved for the patent grant, and they stated they were evaluating the claims before they filed for PH-ILD. In reading the orange book guidelines, LQDA will have to amend its application to include a patent certification statement addressing the '327 patent, though I do not know what that means as far as a 30 month stay goes. I agree that the rules state UTHR is not entitled to a mandatory 30 month stay at that point. However, I believe UTHR could make a good argument based on the intent of the law, versus the technicality of the wording. LQDA knew about the patent approval and claims well before they filed for PH-ILD, and the law is intended to protect patent holders from infringement on known, valid, patents. I agree about the grey area. The key thing LQDA seem to believe is that since they filed the NDA prior to the patent issue and being posted into the Orange book they are in the clear from the standpoint of a stay. I think both sides are quite capable of dragging this out for the foreseeable future, but without a stay it's a bit pointless for UTHR from a practical point of view.
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Post by agedhippie on Dec 1, 2023 19:30:00 GMT -5
Since the expiration of protection for ILD has not expired (march 31, 2024). Uthr is well within their rights to seek injunction. U.S. Code § 156 - Extension of patent term I have to add that the original NDA for Yutrepia was for PH class 1 and did not include PH-ILD. LQDA subsequently submitted a supplemental NDA to include PH-ILD which is in review with the FDA currently and has not been issued. UTHR actually had no standing until the supplemental NDA was filled and the patent was approved. Looks like it can drag out for 30 months but it may all be mute if UTHR is successful on the case on Monday. Enjoy the weekend! (All the above is thanks to Itza) I will add that some time ago Martine stated that she didn't believe Yutrepia would reach the market before 2027 (if ever). I would love to know what went into her calculation. Who knows? In addition to a 30 month stay, maybe a citizen's petition is in Liquidia's future. The FDA will not approve Yutrepia for PH-ILD until the exclusivity expires in March so a lawsuit is unnecessary. I am fairly certain this is just about spreading FUD and I confidently await the citizen's petition, or a lawsuit for animal cruelty - whichever comes first The important thing as I understand it was that the NDA was filed before the patent was in the Orange book, it doesn't need to be approved but LQDA needs to be able to say that at the time of filing there was no patent in the Orange book which they did. The stay is issued only if the patent is filed before the NDA.
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