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Post by hellodolly on Nov 4, 2023 6:57:45 GMT -5
"Optimism doesn't wait on facts. It deals with prospects. Pessimism is a waste of time."
Norman Cousins
I dug out the above quote to remind myself that there is a defined path to both success and failure and that it takes patience to deal with prospects. Mike did say in the last healthcare presentation said [paraphrased]: Every 10,000 patients on Tyvaso DPI are worth ~$250-$300 million in revenue. Our pipeline growth is headed towards a 10X opportunity. Over the next year and a half (into 2025) we expect continued growth of patients. During this time MNKD will be known as an IPF (Idiopathic pulmonary Fibrosis) company.
Well, 2023 isn't 2025 so, my view is longer term on the PROSPECTS for MNKD. During the next 18 months, we'll all have to either be patient and let this play out or, cut bait and run. I'm willing to wait, partially rooted in: 1. The faith that what Mike said will come to fruition and Tyvaso will grow into 2025, 2. They will either be onboarding patients with NTM by the end of 2025 or at least have the BLA filed, 3. The PEDS trial data will lead to a label change allowing for children (12-17 years old ??) to use Afrezza, 4. The India trail data will be published, 5. Another drug will enter development in the pipeline, 6. An additional partner will be announced for the development of a drug coming off patent, and finally 7.The UTHR TETON study, (recently announced by UTHR) will be concluding and more will be understood as to the role MNKD will have in either a bridge study for a DPI version of TYVASO in the PPF patient population or a longer route to approval.
2025 is not a line in the sand rather, it's about where I see the pivot taking place.
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Post by poodlebytes on Nov 4, 2023 7:21:02 GMT -5
RE: IV Technosphere (TS) - not sure this would work. TS relies on the change of Ph to unravel & release the drug - would this offer any advantage over simply administering the drug via IV?
IDK
IMHO I more profitable, trendy-approach would be exploring some legal, non-FDA way of providing a buzz - like inhaled RedBull. The energy rush could be 'addicting' and the kinetics may be favorable - 2-3hrs and gone - kind of vaping w/o the smoke.
This wouldn't need regulatory approval, would have mass-market appeal and dare I say, fashionable.
JMHO
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Post by sayhey24 on Nov 4, 2023 7:46:39 GMT -5
Victoza patent expiration is next year. I wonder how liraglutide would fly on Technosphere? No shots in the diet market IMO is a blockbuster. Maybe we can sell V-Go and use the money for a pilot study. Not going to happen. Mike is very clear that the focus is orphan lung drugs which definitely does not describe GLP-1. Reread the transcript from the Morgan Stanley call, it's all in there. Should we be calling you Mike and not Aged? Or does Mike have to check in with you before he can add new items to the potential pipeline? While Mike may not have said it on the Morgan Stanley call, I am pretty sure there has been some discussion on running "at least" a pilot study to "add" afrezza to GLP1s. Makes sense, right? If you listen to the podcast from the other week he talked about being a T2 himself and seeing his BG rise to 250 after eating. He then went on talking about it not making any sense to wait until the GLP1 fails to "replace the hormone" the body is missing. One thing we know is GLP1s don't address the post prandial spike and just like metformin only provide temporary relief in A1c reduction. As Mike said - at some point you need to replace the lost hormone. We will see. With UTHR paying the bills and the expected success with clofazimine I would expect to see the potential pipeline expand and now that afrezza is personal to Mike, who knows. Nothing wrong with knocking out the 2 drugs in the pipeline but saying "that's all" Mike will ever do is kind of funny. When we have success with the GLP1 adder study whats the risk in running a small Victoza DPI pilot? I see Pfizer's one oral did not work out so well. |
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Post by mnlearner on Nov 4, 2023 11:15:03 GMT -5
Hi,
Ya know, when I got into MNKD, say ~2015/6, it was just about to explode. Great ideas, useful product, caring owners, potential... yada, yada, yada .
Repeated, in various forms through the years.
Yep, Lucy pulled the football, repeatedly.
I know I should be smarter, do more investigation, not stubbornly emotionally hopeful and if I don't like it, get out!
But sometimes it does seem like shareholder are being taken advantage of. [and need to vent]
Maybe I should jump ship and ensure it goes to the moon. The darn sales chart and income keep going steadily up to profitability......frack
Nope just gonna hang on and not get my hopes up.
Venting done.
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Post by agedhippie on Nov 4, 2023 11:28:09 GMT -5
Not going to happen. Mike is very clear that the focus is orphan lung drugs which definitely does not describe GLP-1. Reread the transcript from the Morgan Stanley call, it's all in there. Should we be calling you Mike and not Aged? Or does Mike have to check in with you before he can add new items to the potential pipeline? Just read the transcript. He lays out the options they considered, why the arrived at the strategy they have, and what they intend to do. It's all about orphan lung drugs, and GLP-1 is mentioned only as being irrelevant to MNKD since he says, "There's always these weight loss crazes that happen, and eventually they die down." Does that make his view on GLP-1 clear enough? There is a strategy, GLP-1 is not part of it, no he cannot arbitrarily add GLP-1 as companies don't work like that (especially listed companies). |
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Post by sayhey24 on Nov 4, 2023 15:56:25 GMT -5
Should we be calling you Mike and not Aged? Or does Mike have to check in with you before he can add new items to the potential pipeline? Just read the transcript. He lays out the options they considered, why the arrived at the strategy they have, and what they intend to do. It's all about orphan lung drugs, and GLP-1 is mentioned only as being irrelevant to MNKD since he says, "There's always these weight loss crazes that happen, and eventually they die down." Does that make his view on GLP-1 clear enough? There is a strategy, GLP-1 is not part of it, no he cannot arbitrarily add GLP-1 as companies don't work like that (especially listed companies). Yes. I will be saving this post. I find it amazing how sure you are. Afrezza has been a very long road. We will finally start moving the ball in 2024. With UTHR paying the bills its time to start looking toward the future. Adding afrezza to GLP1s is a no-brainer. Seeing how Victoza flies is not a big investment. If its really a $90B market Mike would be a fool not to at least give it a try and pick up where Richardson left off. Remember, Richardson did not have a proven analog. Mike does. In fact Trulicity is expiring in a few years too. |
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Post by agedhippie on Nov 4, 2023 17:43:02 GMT -5
Just read the transcript. He lays out the options they considered, why the arrived at the strategy they have, and what they intend to do. It's all about orphan lung drugs, and GLP-1 is mentioned only as being irrelevant to MNKD since he says, "There's always these weight loss crazes that happen, and eventually they die down." Does that make his view on GLP-1 clear enough? There is a strategy, GLP-1 is not part of it, no he cannot arbitrarily add GLP-1 as companies don't work like that (especially listed companies). Yes. I will be saving this post. I find it amazing how sure you are. I am not sure what is amazing. Did you read the transcript? |
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Post by letitride on Nov 4, 2023 18:30:40 GMT -5
When I listen to the Morgan Stanley conf call Mike is very clear on his focus on orphan lung being clofazimine and nintedanib. GLP-1s are explained as prolonging the need for insulin by a couple of years and that they are very hard to tolerate. In my opinion Mike is making the right call here given the depth of the current competition. Think the Afrezza battle could easily justify why not to do this again.
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Post by sayhey24 on Nov 5, 2023 7:32:49 GMT -5
It would be interesting to know if VDex has any experience adding afrezza to PWDs taking a GLP1 and what the results have been.
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Post by anderson on Nov 5, 2023 20:56:47 GMT -5
RE: IV Technosphere (TS) - not sure this would work. TS relies on the change of Ph to unravel & release the drug - would this offer any advantage over simply administering the drug via IV? IDK IMHO I more profitable, trendy-approach would be exploring some legal, non-FDA way of providing a buzz - like inhaled RedBull. The energy rush could be 'addicting' and the kinetics may be favorable - 2-3hrs and gone - kind of vaping w/o the smoke. This wouldn't need regulatory approval, would have mass-market appeal and dare I say, fashionable. JMHO To characterize FDKP pharmacokinetics, an absorption, distribution, metabolism, and excretion (ADME) study was conducted in healthy human subjects utilizing 14C-radiolabeled FDKP administered by both intravenous and oral routes (study 1) www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000PharmR.pdfPDC-PC-2002-20005: A Pharmacological Assessment of Intravenous Administration of Technosphere®/Insulin Formulations on the Cardiovascular System of the Conscious Telemetered Beagle Dog [By Study No. 93554] Following the IV administration, FDKP was highly bioavailable and systemic clearance approximated the GFR. Following the SC administration, FDKP was also highly bioavailable. On the other hand, following the PO administration, the relative bioavailability of FDKP was about 3% compared to the SC administration. There was no evidence of any sex-related differences in the PK of FDKP in dogs It also looks like in the Rat study they were injecting subcutaneously. www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000PharmR.pdfStudy title: Insulin Impurities: A 28-day Subcutaneous Toxicity Study with a 14-Day Recovery Period in Spraque-Dawley Rats |
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Post by sayhey24 on Nov 6, 2023 11:31:39 GMT -5
RE: IV Technosphere (TS) - not sure this would work. TS relies on the change of Ph to unravel & release the drug - would this offer any advantage over simply administering the drug via IV? IDK IMHO I more profitable, trendy-approach would be exploring some legal, non-FDA way of providing a buzz - like inhaled RedBull. The energy rush could be 'addicting' and the kinetics may be favorable - 2-3hrs and gone - kind of vaping w/o the smoke. This wouldn't need regulatory approval, would have mass-market appeal and dare I say, fashionable. JMHO This company has been working on a TS buzz for years. I am not sure whatever happened with them. Maybe someone knows. www.receptorlife.com/ |
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Post by peppy on Nov 6, 2023 11:47:27 GMT -5
RE: IV Technosphere (TS) - not sure this would work. TS relies on the change of Ph to unravel & release the drug - would this offer any advantage over simply administering the drug via IV? IDK IMHO I more profitable, trendy-approach would be exploring some legal, non-FDA way of providing a buzz - like inhaled RedBull. The energy rush could be 'addicting' and the kinetics may be favorable - 2-3hrs and gone - kind of vaping w/o the smoke. This wouldn't need regulatory approval, would have mass-market appeal and dare I say, fashionable. JMHO This company has been working on a TS buzz for years. I am not sure whatever happened with them. Maybe someone knows. www.receptorlife.com/This was my favorite. NOV 1, 2022 | Press Release Receptor Life Sciences Opens Second Investigational New Drug (IND) Application with FDA for RLS103 (Inhaled Dry Powder CBD) for the Treatment of Rapid Epileptic Seizure Termination (REST) SEATTLE - Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, is expanding the potential clinical utility of RLS103 into epilepsy. A proof-of-concept clinical safety and efficacy study in epilepsy will be conducted under a second, recently opened IND application. The Phase 1b randomized, double-blind, placebo-controlled, crossover study will evaluate RLS103 in patients with photosensitive epilepsy as a model for REST. RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of psychiatric and neurological disorders. Epilepsy study startup is underway "As the parent of a child with epilepsy, I recognize the need for a product that can terminate a seizure as soon as possible, without sedation," said Mark Theeuwes, President and CEO of Receptor Life Science. "RLS103 could address that need as the first non-scheduled, non-sedating seizure rescue therapy. Advancing our lead drug candidate, RLS103, into a second proof-of-concept clinical study demonstrates our continued commitment to treating central nervous system conditions in collaboration with FDA." "Many patients with epilepsy have recognizable auras that precede a seizure," said Orrin Devinsky, MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine. "A treatment capable of terminating a seizure at the aura stage would be a life-changing therapy for these patients. This study is designed to be the first proof-of-concept clinical trial of RLS103 in epilepsy; and will be a study of significant interest for epileptologists and patient communities.". |
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Post by MnkdWASmyRtrmntPlan on Nov 6, 2023 12:59:39 GMT -5
RE: IV Technosphere (TS) - not sure this would work. TS relies on the change of Ph to unravel & release the drug - would this offer any advantage over simply administering the drug via IV? IDK IMHO I more profitable, trendy-approach would be exploring some legal, non-FDA way of providing a buzz - like inhaled RedBull. The energy rush could be 'addicting' and the kinetics may be favorable - 2-3hrs and gone - kind of vaping w/o the smoke. This wouldn't need regulatory approval, would have mass-market appeal and dare I say, fashionable. JMHO This company has been working on a TS buzz for years. I am not sure whatever happened with them. Maybe someone knows. www.receptorlife.com/RLS was founded in 2015 and entered into a collaboration agreement with MNKD in Jan, 2016. Their first product, "Cannabidiol Inhaled Dry Powder for Acute Anxiety in Social Anxiety Disorder", is in Phase 1b/2a. I would say this company is in no hurries. I wonder, is this these employee's day jobs? Like, has RLS been paying them all this time? They do have 2 other products in their pipeline: DPI for Rapid Epileptic Seizure (IND) and an Oral for Autism (Phase 1) |
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Post by sayhey24 on Nov 6, 2023 13:24:04 GMT -5
IDK, Mike made a comment awhile back that nothing was coming from it anytime soon. Maybe if someone is friendly with Andrea Leone-Bay they could reach out to her and find out if they are still doing anything. Traci Carman is still listed as the CFO. She was part of the old MSFT team which included Kevin Johnson that was rumored to have provided initial capital. You would think Johnson has some time after getting the $50M to leave Starbucks.
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Post by MnkdWASmyRtrmntPlan on Nov 6, 2023 13:44:30 GMT -5
I posted the following on the RLS website:
Hi, I am a share-holder of Mannkind stock. I was around when RLS and MNKD first signed a collaboration agreement in Jan 2016. Your pipeline still lists your anxiety product as in Phase 1b/2a. Could you tell me any expectations you have for it's future?
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