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Post by agedhippie on Jun 6, 2023 19:02:35 GMT -5
Funnily enough the source of Ozempic's popularity was social media, specifically TikTok. A quick look and there are 1.1B view for #ozempic. Of course Elon Musk praising it and crediting it with his weight loss didn't do any harm either, but this was primarily driven by social media posts. they could TiK Tok all they wanted, if it wasn't for the weight loss, who would care. One thing that catches women attention is weight loss. We all want to be twiggy. And women are willing to pay to play that game. I have never looked so good in clothes, weehaw. Absolutely. TikTok was focused entirely on weight loss and Ozempic as a wonder drug for weight loss. As a matter of interest I looked up last month's TRx - 2.5M prescriptions.
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Post by agedhippie on Jun 6, 2023 17:15:08 GMT -5
Ozempic is very popular. All of us who have never used the drug should probably stop claiming the side effects are terrible and/or horrible. Every drug data sheet lists every potential side effect, including Afrezza. The reality is that many people like it. The reality is it comes with a very serious Black Box Warnings, along with serious potential side effects and also horrific post marketing adverse events. I have not seen a single social media post praising this drug. I know why. Funnily enough the source of Ozempic's popularity was social media, specifically TikTok. A quick look and there are 1.1B view for #ozempic. Of course Elon Musk praising it and crediting it with his weight loss didn't do any harm either, but this was primarily driven by social media posts.
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Post by agedhippie on Jun 6, 2023 17:00:02 GMT -5
Why not do the work needed and target the kids who are obese? Once the kids start taking it, the adults will, too. 1 INDICATIONS AND USAGE OZEMPIC® is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. www.novo-pi.com/ozempic.pdfPerhaps I miss understood what was being asked. That work has already been done for kids. The trial (NCT04102189) wrapped up in January so I would be shocked if the application for a label change isn't already filed with the FDA.
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Post by agedhippie on Jun 6, 2023 16:44:48 GMT -5
I think there’s a study showing IV administration of GLP-1 restores first phase insulin secretion. Administration via inhalation using MannKind’s inhaler with Technosphere GLP-1 it would mimic intra-arterial administration and have the same restoration of the first phase like that in the IV study. Maybe even better results. The author said, GLP-1 made by the body in the body lasts minutes.The drug has been made to not deteriorate. The half life has to be long. I'll look. Here it is, 10 OVERDOSAGE In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of OZEMPIC® of approximately 1 week.
" Administer OZEMPIC® once weekly, on the same day each week, at any time of the day, with or without meals. • The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours). • If a dose is missed, administer OZEMPIC® as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. www.novo-pi.com/ozempic.pdfThe GLP-1 drugs on the market today are GLP-1 analogs engineered for an extended half life rather than actual GLP-1.
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Post by agedhippie on Jun 5, 2023 20:04:37 GMT -5
Mike was sending a message to share holders to sell by selling for "tax obligations ". He was looking out for us share holders. He cares about us. I've had RSUs before. Selling for tax is pretty much standard. Postponing the sale to occur after the India results would be insider trading if he has had any sort of readout. It's the whole point of the 105b sales - they happen at a predetermined point in time regardless of events. Trying to get cute with this sort of thing seldom pays unless you have really expensive lawyers which rather defeats the purpose of marginal gains.
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Post by agedhippie on Jun 5, 2023 16:44:12 GMT -5
...
On a separate topic (i.e., the topic of this thread), a family member started Ozempic over the weekend and only threw up 3 times (so far). The doctor told her that the nausea and vomiting typically goes away after a few days and at most a few weeks.
agedhippie (and/or others) is there any reason to believe an inhalable version of GLP-1 would reduce the nausea and other side-effects?
Ugh. It's one of the reasons I never took it when my endo prescribed it, I preferred to just take more insulin. I would be interested to know if it does go away and on what timescale. I don't know why it would reduce the side effects because those are mostly related to the gut and I can't see why the delivery would matter. The only test so far was a single shot to see if it hit the blood stream and at what level. It cleared fast so it may not have had time to cause problems before it was gone. There would need to be some engineering to the molecule to make it hang around longer (GLP_1 naturally clears fast), but that's solved science, at which point you would find out about the nausea. Reaching that point would cost money though and Mike might not see that as the best use of resources as there is a risk that you find that it doesn't solve the nausea issue, hence the GLP-1 + Afrezza idea.
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Post by agedhippie on Jun 5, 2023 16:36:31 GMT -5
Wow - I did not realize that you were a pump rep for Medtronics. Time will tell. I believe in the power of moms but it all depends on just how good afrezza is with the kids. It seems pretty good, maybe better than good. We will see once the trial numbers are in. Who knows, maybe afrezza can help reduce the amount of PTSD in the parents. ... A Medtronics pump rep because I cited a paper using their data? I guess if you can't disprove the data you try calling the poster names and see if that distracts people. Remember - the trial is not against AID pumps, it was against pens. The response will go exactly as I described it; Afrezza is good, but that was not against AID pumps and those are better since they manage your levels all the time and not just when you dose. Endos in my hospital group don't mess around, they put you on a pump at diagnosis even in the pre-AID days (even dumb pumps give better results than pens.) My PTSD concern if for the kids rather than the parents. Since you seemed to have missed that here it is again; " The primary motivator used to secure the child's compliance is fear (do exactly this or you will die horribly if you deviate in any way at all) so the end result is predictable. There is a paper out there to be research on the incidence and levels of PTSD in adults who were child diabetics."
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Post by agedhippie on Jun 5, 2023 9:59:39 GMT -5
IDK - IMO with the kids its more about the moms and less about the endos. Its really about how good afrezza is with the kids. If the kids are seeing great success word will spread quickly through social media support groups. Moms not the endos will make this happen. My granddaughter is 8 and I would have absolutely no concerns with her using afrezza on her own. My five year old grandson I would have no issues taking but he would require supervision. It really depends on the kid and they are all different but the moms know. BTW - no need for pumps as a backstop when you have the CGM. Sports posted about pump sales reps already spreading the word with endo's that afrezza is being discontinued. I see that as great news for afrezza as they must already be concerned about the pediatric impact. The last time we saw this type of rumor spreading was 2014/2015 when Al was telling everyone afrezza would be the greatest selling drug of all time. I have met few moms who really enjoy having their kids wear pumps.... Based on my experience with the parents of T1 kids I feel you are overestimating how willing parents will be to overrule their kid's endo but time will tell. They follow everything obsessively, but they are very reluctant to go counter to the endo (I have tried on things I saw as no-brainers.) The argument is going to go like this: Parent: Look at these wonderful trial results, I want my kid on this. Endo: Ah, but they are comparing Afrezza to shots. We don't suggest using shots any more because pumps a vastly superior, look at this real world data are against shots and I wouldn't suggest using shots we have moved past that, they should be on a pump because that is far better. Parent: Do you have anything to support that? Endo: Sure, look at this real world data for the Medtronics pump ( Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users) and remember this is kids in the real world when you cannot be standing over them. This is why we believe pumps are better and they continue to improve. That's hard to argue with. Beyond that I don't believe a kid should be making life or death decisions even if they appear able, I have seen the psychological fall out from that and it is not pretty. The primary motivator used to secure the child's compliance is fear (do exactly this or you will die horribly if you deviate in any way at all) so the end result is predictable. There is a paper out there to be research on the incidence and levels of PTSD in adults who were child diabetics.
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Post by agedhippie on Jun 5, 2023 8:09:25 GMT -5
My expectation after pediatric availability is that sales in that sector will expand to a bit less than the percentage share that Afrezza has in the adult market. Things to remember though; the adult market is far bigger than the pediatric market, and that I think Afrezza for kids below ten is a hard sell (do you trust a kid that age to always have their Afrezza on them and to always use it when they snack?) The endos are already heavily pushing pumps for kids because it backstops responsibility for managing their diabetes from the kid. The weak link for Afrezza is that management and it will more than balance out Afrezza's superior performance in the endo mind.
I feel that when kids become more responsible as they get older will be Afrezza's sweet spot. They will still have the same insurance headwinds though. Initially there is going to be a sharp ramp up as people start to onboard, but if I was modelling this I would expect it to run about 30% of the adult market after a year or so when the pent up demand is met. (In case it's not obvious that 30% is a SWAG.)
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Post by agedhippie on Jun 3, 2023 18:26:40 GMT -5
P-man I was referring to 1995 when “marketing began “ 😀 To be clear on that one - marketing began in the US in 1995, but in the rest of the world since at least 1958 (UK launch). It has been the standard of care for Type 2 outside the US since the early 1970s. The GLP-1 drugs are the same - released in Europe in 2011, in the US in 2015.
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Post by agedhippie on Jun 3, 2023 10:06:26 GMT -5
What great drug succeeded (modern day ) without commercial advertising.. in a big way ? Advertising drugs is illegal in most countries outside the US so pick any drug where the FDA is being even slower than usual... Metformin has been widely used outside the US since the early 1970s even if it took the FDA another 20 years to approve it in the US. This is not atypical.
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Post by agedhippie on Jun 2, 2023 12:59:33 GMT -5
Al Mann defined this for us years ago - MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing. The reality is MNKD was running out of money and Mike started grasping at straws. Then when he had UTHR covering the bills he still did not know how to sell afrezza so he picked up V-Go so he had something to put in the sales reps "bag". I would say V-Go will go back into the dumpster in time. TS GLP1 needs to be prioritized. He needs to get Martine to announce another TS based drug. He also needs to find partners for the other TS drugs in the pipeline and afrezza. If MNKD is a manufacturing company which licenses Technosphere based products to BP for sales and marketing then it needs more customers to avoid being seen as being overly dependent on a single customer. Without that the share price gets penalized for that business risk. V-Go is a wasting asset. It's sales are steadily dropping YoY which is why Zealand sold it.
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Post by agedhippie on Jun 2, 2023 12:38:50 GMT -5
I think part of the problem for Wall Street is that it's unclear what Mannkind sees as it's core business. Are they a drug delivery platform for pharmas (UTHR), or are they a pharma in their own right developing and selling drugs (Afrezza, maybe clofazimine), and what the hell are they doing in medical devices (V-Go and, one day maybe, bluhale)? Right now it looks to Wall Street like they will just swing at any pitch.
This is not saying that anything needs to be shut down, but rather that Mannkind needs to define what it does and then Wall Street can quantify it and price it accordingly. If you want a repricing which is what we are talking about you need to provide a clear basis for that repricing. That clarity is a measurable strategy with focused execution. Absent that the share price will do ok, but not as well as it could because the management will be seen as tactical.
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Post by agedhippie on Jun 2, 2023 9:46:12 GMT -5
OK - no GLP1s. Too bad. We will just need to wait for Mike's trial. Based on Mike's comment he suggested a 1.5-2% A1c reduction. So while CIPLA may not have tried to prove superiority it seems they may have fixed the under dosing issue and their results will be better than Affinity-2. Maybe they will release some preliminary finding during ADA2023 in 3 weeks. If Mike is correct, its a big deal. I am curious about Mike's statement because the dosing instruction haven't changed. The trial is about using a protocol that has already failed (the selection criteria require that) vs. adding another step which is Afrezza in this case. If you can't seriously reduce the A1c under those circumstances something is badly wrong with your drug. This is why nobody cared about the Type 2 trial results before (plus (0.8% reduction was rather underwhelming). RAA and GLP-1 already get results around the range Mike is talking about (averaging around 1.4% reduction)
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Post by agedhippie on Jun 2, 2023 9:05:41 GMT -5
...I just wish Mannkind would announce another "UTHR like" partnership with BP. MC has alluded to this desire in the past but not so much recently. Hopefully, there are always on going talks and negotiations. The impact would probably be huge. I would echo that. While UTHR is their only customer the MNKD share price will suffer because the market views it as luck rather than strategy (one swallow does not make a spring). Get two or three customers and the market will start to believe that spring has arrived. They cannot be indiscriminate about the partner though - the resulting drug must be a success.
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