|
Post by peppy on Mar 27, 2024 10:34:44 GMT -5
OK if you insist… Bloody Mary for me please. We can’t be 100% sure, but signs point to this being an amicable situation. Interesting coincidence that his replacement cut his teeth at MNKD almost twenty years ago, there probably are few employees remaining from back then when he worked his way up from audit manager to corporate controller. And it cannot be discounted that Binder has a lot riding on the continued success of the company. Looks like he will continue having a hand in things to ensure the ship is firmly sailing in the right direction before he fully departs. We saw what happens if the ship loses power and hits a Truss. Is the rebate system from the Pharmacy Purchasing manager a truss?
|
|
|
Post by peppy on Mar 27, 2024 10:23:38 GMT -5
UTHR 6 month chart daily Looks like a cup and handle since Dec 14. 6 months daily? That is like being near sided and blind. schrts.co/bPYVyiZn Now what does it look like?
|
|
|
Post by peppy on Mar 27, 2024 9:30:26 GMT -5
UTHR was flirting with break out yesterday. schrts.co/GvfIxpFX schrts.co/HdCtZHTk CNN continues to have the youngest audience among cable news networks with a Total Day median age of 67 years, -3 years younger than MSNBC (70) and Fox News (70) in January. TV Source: The Nielsen Company. January 2024 (1/1/24-1/28/24).
|
|
|
Post by peppy on Mar 15, 2024 7:17:47 GMT -5
Think of it this way. MNKD was loaned money at 2.5%. So, the lender gets that till the loan is paid off. Now the lender shorts the stock when the share price is above the conversion price of $5.21, but below the call price which in this case is 130% of the conversion price $6.77. Now they have made another profit and have all their money back to use in another venture. Only risk is if their note gets called, so you want it to stay below the call price $6.77 remember you need to be above the call price for 20 out of 30 days. (note if the lender did not get a chance to short all the shares that they can convert this is a good time to short more). So that is the thesis for the lenders wanting to keep the share price low. The problem the lenders have now is that MNKD has the cash to pay them with instead of issuing shares. So, the question is what if the lender is shorting what is their tolerance for risk. Thank you anderson . I always read what you write carefully because you give information I need. Thank you once again. Outstanding.
|
|
|
Post by peppy on Mar 14, 2024 20:32:27 GMT -5
In one of the slides Mike presented on Clofazimine it mentions expanding into other indications within the Infectious Disease Category. I present a patent by MannKind indicated for the treatment of SARS-CoV2 using Clofazimine: CLOFAZIMINE COMPOSITION AND METHOD FOR THE TREATMENT OR PROPHYLAXIS OF VIRAL INFECTIONS9. The inhalable pharmaceutical composition of claims 1-7 for use in the treatment of SARS-CoV-2 pulmonary viral infection.patents.justia.com/patent/20230248722#claimsPaper on Clofazimine and SARS-CoV2 published in Nature: Clofazimine broadly inhibits coronaviruses including SARS-CoV-2www.nature.com/articles/s41586-021-03431-4#:~:text=Overall%2C%20clofazimine%20exhibited%20broad%2Dspectrum,coronaviruses%20in%20human%20cellular%20models. Last time I checked which was two weeks ago, @200 people a week are dying of Corona Virus SARS2 a week in the USA.
|
|
|
Post by peppy on Mar 11, 2024 6:50:34 GMT -5
"In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal
One of the challenges of inhaled insulin adoption has been under-dosing when converting from injectable insulin, which causes patients to experience hyperglycemia,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
=========================================================================
MNKD used the "The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after. "
Mar 14, 2018 a. remember the dose optimization study? Mike saying, "if Afrezza is dosed correctly a second dose at 1 hour shouldn't be needed." by memory from the conference call.
.
|
|
|
Post by peppy on Mar 10, 2024 16:54:49 GMT -5
5 year study to prove that afrezza could reverse T2D? One could argue that a 5 year study of exercise and proper diet would do the same thing. It is difficult to know with type two, if that works out as true. For instance, proper diet would need to be defined. Exercise the same. Stay with me a minute. So all these fat people are because they do not have proper diet and proper exercise? Because we are all on our computers? change from 33 years ago. So here are some theories. High fructose corn syrup is one theory. The addition of seed oils another theory. Here is a theory no one will like, from a recent article, www.voanews.com/a/study-raises-questions-about-plastic-pollution-s-effect-on-heart-health-/7517261.html What did the study find? (the study is behind a paywall.) The study involved 257 people who had surgery to clear blocked blood vessels in their necks. Italian researchers analyzed the fatty buildup that the surgeons removed .from the carotid arteries, which supply blood and oxygen to the brain. Using two methods, they found evidence of plastics — mostly invisible nanoplastics — in the artery plaque of 150 patients and no evidence of plastics in 107 patients. So another theory that I can not work out the mechanism of action is these nano particles of plastic are also Obesogens. Obesogens are chemicals that disrupt the body's normal homeostatic controls in such a way as to promote adipogenesis and lipid accumulation. They are chemicals to which individuals are exposed on an almost continuous basis, in the foods and beverages they consume and the products they use. Now if that was true, why would afrezza to stop the progress of type two? Things that make me go hmmm. e360.yale.edu/digest/many-household-products-contain-obesity-promoting-chemicals-research-finds. www.sciencedirect.com/science/article/abs/pii/S000629522200106X
|
|
|
Post by peppy on Mar 10, 2024 15:06:51 GMT -5
If it can be shown through trial that afrezza really halts the progression of diabetes, thats game changing. I know we have said it and I know Al had said it and had some pilots studies showing this but if you can show in a large scale trial halting the progression of T2 diabetes that would make afrezza the new T2 standard of care. That would be so huge, I don't think the PBMs could block it at that point. The obvious question is why has Mike not mentioned such a potential? What would such a trial cost, $50M? If you could prove that Afrezza stopped the progression of T2 it would be huge and undoubtably make Afrezza the SoC choice. However, that is at least a five year trial with a lot of people so it would cost far more than $50M. I really don't like to think how much that would cost, usually only government entities run trials that big. Every party has a pooper and the pooper is you.
|
|
|
Post by peppy on Mar 10, 2024 12:05:25 GMT -5
|
|
|
Post by peppy on Mar 10, 2024 11:58:08 GMT -5
Bill continuing the conversation: “Here’s the key to circumventing PBMs and bundling. Bundling is a way the drug companies get drugs put on formulary that otherwise might not get on. Why is that? Because there are other drugs that are substitutes. This explains why Humalog and Novolog are rarely on together. They are substitutes. The Drug companies give a bigger discount to the PBM/insurance co when they put multiple drugs (bundling) from same manufacturer. It’s a form of volume discounting. In effect the manufacturer buys its way in to PBM for a drug the might otherwise be excluded because the plan might get a bigger discount from the substitute. So Lilly will give a bigger discount on its RAA when the PBM puts other Lilly drugs on formulary. Now I’m certain I don’t know half of the ways the drug companies “buy their way in.” But if a drug has no substitute AND provides “medically necessary” then it must be covered. This is why there are some insanely expensive drugs covered. There is no direct substitute and the care is medically necessary. So with Afrezza the data would establish that there is no substitute. In fact that was MNKDs strategy for getting Afrezza put into a different class (“ultra rapid acting”). If it’s the only one then no substitute. Now that’s only half the battle bc one still has to establish “medical necessity.” You could imagine a PBM/insurance co to argue that A1c can be controlled without Afrezza and that then while unique, Afrezza doesn’t really offer medically necessary care. That reasoning could be negated by showing that Afrezza allows for significantly lower A1c (with no increase in hypos and in fact a decrease in hypos). The reason that argument works for “medical necessity” is bc most patients can’t get A1c down to ADA targets. ADA has defined “medical necessity” with their targets. Last point and my apologies for the length of this. I’d also argue that Afrezza halts the progression of diabetes. The data through our experience at Vdex backs this up. So you add to the medical necessity claim and the uniqueness claim that Afrezza halts the progression of the disease. Is that medically necessary? Hell yes it is bc otherwise the disease either directly or indirectly kills most who get it. No one would dare argue against it. And the marketing and patient demand would soon overwhelm resistance. Then the PBMs would be MNKDs best friend.” ~ Bill McCullough, CEO, Vdex Diabetes Imagine, being about to market Afrezza as a cure for type 2. Thank you Bill this was the most interesting post.
|
|
|
Post by peppy on Mar 10, 2024 9:50:59 GMT -5
You previously explained the PBM bundling concept. Lets say MNKD had more than enough data which shows human insulin works, pancreatic insulin release works and afrezza mimics pancreatic insulin release. Lets say VDex has a 3rd party trial which says afrezza is the greatest thing since sliced bread. Lets say afrezza finally demonstrates superior TITR and better A1c. The assumption is we have all the data. Would the PBMs be forced to put afrezza on the insurance formularies? Based on what you previously said, MNKD would not have the other drugs to create bundles and therefore could not compete on price and the PBMs would not include it on the formulary. Please explain how you think this would play out. Thanks. If MNKD can demonstrate a superior A1c, the TIR is optional but nice to have, then PBMs would grumble but cover it. This would mirror what happened with RAA when it was introduced when insurers were arguing that it wasn't a significant improvement over Regular and NPH, and they didn't like the cost. As to costing I suspect that PBM would split Afrezza and RAA into separate classes and argue that for bundling was still valid as Afrezza isn't RAA. What would the coverage look like? I suspect that they would require a pre-auth, but there are levels of pre-auth. For example my insurer requires a pre-auth for a CGM, but nobody is ever refused and it's a simple electronic form. Today the pre-auth for Afrezza seems to involve wrestling alligators so this would be a huge improvement and pretty much universal. Essentially MNKD would need to redo the adult phase 3, and pediatrics phase 3 for superiority this time. Over the last few years, It seems to me the public has had a master class on how what we see in front of our own eyes is up for debate. The system here explained nightly. Then the integrity of the system is debated. The judges in this system come from Pharma. I am sure you get the point. Insulin is insulin. It there a superior insulin?
|
|
|
Post by peppy on Mar 9, 2024 20:34:11 GMT -5
The preliminary results from INHALE-3 showing less hypos than standard of care should be an excellent start to show proof. It was great having the presentation by a reputable source at a global conference The hope is additional excellent results are also forthcoming and will be followed by pediatric approval to provide unquestionable proof of safety. IMO, Afrezza is on the right path and the big issue is now the timing of it all coming to fruition. BPs were at the conference and have to be watching much closer now. If not, they're stupid and that's not likely. Any one of which could run with Afrezza and change the world for diabetics. Was the full presentation released somewhere? I've only seen the one slide posted here. What were the results on hypos? That one slide made it seem like in the first two hours no one in either the Afrezza group or the RAA group even returned to to pre meal levels, much less going hypo. Though I wouldn't expect hypos to show up in the first two hours.NO. The subq insulins reach there peak AT 2 hours and take 5 hours to be out of the system. The afrezza user after the two hours either needs an afrezza dose or exercise. Afrezza peaks at 30 mins and out at 90 for a 4 unit dose. Afrezza peaks at 30 mins and takes just a bit longer to clear the body for 8 unit and 16 unit respectively. Some users know how much a 4 unit dose will lower their blood glucose level. This is why Afrezza is superior. Blood glucose levels can be controlled. Also, there is food, there are beverages, candy. Blood glucose increasers.
|
|
|
Post by peppy on Mar 9, 2024 18:43:30 GMT -5
I googled it, The cost of a family restaurant meal. Unlock your healthiest body yet Promo: $99 first month, $145/month thereafter Semaglutide injection Semaglutide Medication (GLP-1) ro.co/weight-loss/semaglutide/#
|
|
|
Post by peppy on Mar 9, 2024 15:39:33 GMT -5
Well, if you don't want to watch the video maybe you would want to buy Calley Means book. I thought Carlson was the CNN Crossfire guy and the guy Fox fired. He does do some interesting interview. I thought the Jordan Belfort one is very interesting. Calley goes through the control BP has. The interview is not so much about Ozempic. I think its worth watching and Carlson usually lets the guest do most of the talking - just fast forward through Carlson. With the Putin interview I thought that was really interesting too. Moscow looks like a beautiful city probably funded mostly by oil and gas sales which Putin would rather get back to. With Carlson there was a strong rumor the Ukrainians tried to blow up his car with an UID. I don't know if its true but even Newsweek didn't really refute it 100%. Why is Ro a lot cheaper? Cheaper than what? You still need to buy the Ozempic. If we had Saxenda DPI they could be buying that a lot cheaper if we went direct. I saw Oprah was just forced off the board of weight watchers after she admitted to using Ozempic. WW could be a Saxenda DPI partner. That is what I want to know. They are making it. Is it generic? Cheaper then a person buying Ozempic because their health insurance would not cover it. I only know about Ro because a string of constant cable TV commercials, MSNBC and CNN. Do you see the humor in this? .
|
|
|
Post by peppy on Mar 9, 2024 14:55:32 GMT -5
An Afrezza commercial I see as different than other pharmaceutical commercials. I think Afrezza commercials can add to demand, as Type 1 diabetes is a chronic do or die disease that the diabetic needs to engage in to live. Other pharmaceutical commercials, I have wondered that myself as I still have cable television and it is the pharmaceutical commercials keeping it alive. I think the constant pharmaceutical commercials are to 1) make people believe these pills or shots will work. 2) get people to think it is normal to be on medications. 3) to desensitize people from the side effects. I have read that some older people can be on 10 prescription drugs or 14 prescription drugs. That is what the commercials are for. Population control and money. The final money squeeze. Did you watch the video? Money talks and in this case controls. Over the years I have watched these video's many time in and back ground of the market day. I could probably post ten you tube videos on the subject. as far as money talks, let's talk some money. Ozempic, $850 to $1000 a month with coupon. Ro is a lot cheaper, ro.co/weight-loss/?utm_campaign=homepagebodyclick It’s $99 for your initial health and medication consult, then a membership cost of $145/month for ongoing treatment support. Your monthly membership starts when ..your prescription is sent to your pharmacy. Please note that GLP-1 medication is billed separately and not covered in the program cost. Medication cost will depend on your treatment and personal insurance coverage. The cost of Afrezza is almost comparable,... 4u. Added, Oh, that video? I do not watch Tucker. I did watch parts of the Putin interview. I saw it is he had to say nice things in the grocery, because he wanted to get out of Russia on a plane. www.singlecare.com/prescription/ozempic-0-25-or-0-5-mg-dose?utm_medium=paid-search&utm_source=google-sc&utm_campaign=1798587962&utm_adgroup=72251648547&utm_term=price%20of%20ozempic&utm_content=618309531078&matchtype=e&pos=&device=c&mkwid=s%7Cdc_pcrid_618309531078_pkw_price%20of%20ozempic_pmt_e&segments=&gad_source=1&gclid=Cj0KCQiArrCvBhCNARIsAOkAGcXO3hCUZHA3AK92X1WFygCNImWVpJkicBADUuu00o6Bf2_iA1Mu3o8aAvOqEALw_wcB.
|
|