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Post by agedhippie on Mar 31, 2023 10:35:01 GMT -5
This gets approved because it's perfectly standard. It is negligent to allow the number of outstanding shares to drop to low. There is nothing there to create any concern (and as Longliner will tell you I can always find a concern )
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Post by agedhippie on Mar 28, 2023 8:56:46 GMT -5
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Post by agedhippie on Mar 27, 2023 15:45:16 GMT -5
I think you are missing the point. A T2 on an antiglycemic can not do much except learn from the situation such as food eaten etc. and try and do things better tomorrow. This is how Robert Ford described the use of the CGM to CMS even for the basal insulin. Robert Ford owns "rearview mirror" not me. If you want to call it marketing talk - OK. He seems pretty good at selling CGMs and a bunch of other stuff. A T2 using afrezza can adjust near real time and make corrections now, not tomorrow. Its very similar to the radar cars now have providing warning so you can make corrections. With afrezza you can do that. With metformin, GLP1, SGLT2, etc. its a wait until tomorrow after the accident "Forward Looking Radar" is my term. If you want to call that a marketing term I would agree and I sure hope it sells more afrezza. If Mike wants to use it he certainly can. If you don't like it, what can I say. I like it as people can associate it with something they know like driving a car. TBH there is a bigger problem in the T2 non-insulin world and that's compliance. Stevil gave an example a few weeks ago of a person who he had prescribed Afrezza for coming back and asking for a weekly shot instead because he knew he would do the shot, but not meal time insulin. It's all very well coming up with cute marketing phrases, but that's not going to change things. The problem is compliance in chronic diseases that have no immediate consequences. To stick to your analogy the person isn't looking in their rearview mirror, nor looking at their forward radar, but have their foot to the floor while chatting to the passenger rather than paying attention. In a couple of minutes this will end badly when they slam into a truck, but right now they are fine. That's compliance in chronic disease in general, diabetes amongst them, where there is no immediate consequence people pay less attention than they should. A lot of things have been tried to fix this, but in the end entropy always prevails until they hit that truck.
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Post by agedhippie on Mar 27, 2023 12:00:38 GMT -5
It is interesting to wonder what shorting would look like if creditors were prevented from shorting a company whose warrants they own. Would it prevent making a legal agreement with another company to have them short the company whose warrants you own on the condition you can provide the shares at conversion, and split the proceeds in some fashion at maturity? There are two questions there: What would it do if you couldn't use the warrants to short? It would hamstring the lender's risk management. The consequence would be to increase the cost of borrowing for the borrower since the lender would need to be compensated for the increased risk to their capital. For example Deerfield would have charged truly eyewatering interest rates and MNKD would probably not have survived. Could a warrant holder have an agreement to provide stock to another company who is shorting the stock and then split any profit? That seems rather redundant since the warrant holder can short the directly without involving a third party (this is the normal practice.) I suppose they could agree to sell the stock to a third party with delivery in the future for the current price plus interest, but there are financial instruments for that already. Personally I use warrants for arbitrage. Either short or use Puts depending on whatever is cheaper to lock in the gain. Writing Calls can be effective as well, but there is always the danger that you get left with the stock if the price moves against you and you really don't want that.
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Post by agedhippie on Mar 27, 2023 11:41:09 GMT -5
It's interesting because traditionally their page has focused on T1 diabetics - insulin users. The current page has broadened that to all diabetics. This is their messaging about CGMs not just being for insulin users. OK - I guess since we have been talking about this for years it was just a matter of time. Who knows maybe the next thing they will say for the T2s is their CGM can be more than a rearview mirror. When they add afrezza they get forward looking radar. CGMs are by definition backward looking since they are recording devices. Their role is in letting you make an informed decision on your next step based on that data, that's the forward looking part of using a CGM, not the insulin used. This is the mechanism for the artificial pancreas (as well as manual management) - combine the trend from the CGM with a knowledge of the insulin curve to decide what needs to be dosed. The only difference between Afrezza and RAA is the curve. The "rearview mirror" and "forward looking radar" comes over as marketing-speak and is counter-productive in this context. While there are contexts where that sort of approach would work this is not one of them. You could use them, but they would require a more extensive explanation as to what they mean and how the evidence supports that. It risks sounding like an over-simplification and given the stakes people are probably looking for more than a slogan (that may be my T1 bias showing.)
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Post by agedhippie on Mar 25, 2023 23:24:36 GMT -5
Can I short a warrant? This means you can only take a long position in a call or a put warrant by buying such standard warrant and close out such long position previously established by selling such standard warrant – that is, you cannot short sell such standard warrant. I have messed around with warrants in the past. There is a standard arbitrage where you hold the warrant and short the stock to lock in the current gain. It's low risk because you know you will have the stock to cover when the warrant converts and you know exactly what it will cost. This works when the warrant is at a discount to the stock which is often the case in loans. It relies on the warrants being registered so they can be traded, but that's often a condition of the loan. Shorting a warrant itself? I am with you there - never heard of it!
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Post by agedhippie on Mar 25, 2023 9:50:18 GMT -5
Agree. Ironically, it is called BlueHale which implies exphiration, not inspiration. Make the little bugger capable of reading BG on exhale and dose reading on inhale, and it could be a lot more interesting to consumers. That would be really nice, but technically challenging. I think it's enough that it registers thata dose is taken. You can see an analogy on the insulin pen side in InPen from Medtronics, and the Unity system from Bigfoot which connect the insulin pen over bluetooth. Interestingly my insurer will cover InPen as of this year. The point of these systems is that they overcome the longstanding issue of people not recording their insulin bolus. Doctors would dearly like to have the time and dose information. Trial data says that connected systems reduce HbA1c.
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Post by agedhippie on Mar 25, 2023 9:39:46 GMT -5
That page is really interesting. Notice that the focus was entirely on managing diabetes and nowhere, other that the disclaimers around connected insulin pumps, did it mention any type of treatment for diabetes; insulin, GLP-1, metformin, or even diet and exercise. Why is that interesting? We know Dexcom wants to sell CGMs. Aside from needing insulin treated patients for Medicare payment they want to sell to everyone including Wegovy users which may become a big market. It's interesting because traditionally their page has focused on T1 diabetics - insulin users. The current page has broadened that to all diabetics. This is their messaging about CGMs not just being for insulin users.
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Post by agedhippie on Mar 24, 2023 22:03:01 GMT -5
Any of you financial and market experts have any thoughts on why UTHR CEO has been selling her shares for weeks? It doesn't seem to look good unless the CEO has insight on the future of her company or the world economy and was able to predict the decline of the stock price. 10b5-1 trading plan. Read the filing.
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Post by agedhippie on Mar 24, 2023 21:59:06 GMT -5
Effortlessly see your glucose levels and where they’re headed, so you can make smarter decisions about food and activity in the moment to take better control of your diabetes. DEXCOM CGM That page is really interesting. Notice that the focus was entirely on managing diabetes and nowhere, other that the disclaimers around connected insulin pumps, did it mention any type of treatment for diabetes; insulin, GLP-1, metformin, or even diet and exercise.
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Post by agedhippie on Mar 24, 2023 15:26:30 GMT -5
"Sharing the data would require patient consent - I know a lot of diabetics (me amongst them) who refuse to let their data be shared. I will share very specifically, but not an open ended agreement like any doctor they chose."
Well, lets look again what Mike said, "...and the patients can share with their doctors and their caregivers..."
Don't try to read into this too much agedhippie . Mike shares your concerns, too. Nobody will lose any control over their data and this is a non-issue once PWDs are provided with the details and how it is designed to fully integrate with the CGM to their advantage. "I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device."Does FDA approval pose some sort of problem? MNKD lives in a regulatory environment and I'm pretty sure they don't see it as any sort of issue. Besides, it's likely they received some sort of feedback or guidance from the FDA very early on, even though nobody really knows if it's a "thing" or just a formed imaginary guess that we so often see posted. I like the idea of the integration as it makes dosing a lot simpler if it's properly integrated. It's more complex than it seems because simply recording when you took a dose is not terribly useful IMHO because you want to know what the future looks like as the CGM tells you what's happening right now. This means you need to generate a predictive curve and that's the bit that gets the FDA worked up. For some reason (I have no idea why) the FDA really doesn't like bolus assistants and has blocked them from meters in the US - it's deeply annoying. Generally though I think this is a good idea. In an ideal world I would say integrate it into xDrip+ because that will get a lot of visibility amongst early adopters.
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Post by agedhippie on Mar 23, 2023 22:21:56 GMT -5
Hopefully, they will put together the app that he referred to integrating bluetooth with dexcom and providing the info to give to medical providers, etc. Or, will that take another year or so? Good question, pollworthy even (since we need something to entertain us during these doldrums), how long will it take? How long should it take? I think, but am not certain, that if they do that integration the app needs FDA approval because it would be a medical device. Sharing the data would require patient consent - I know a lot of diabetics (me amongst them) who refuse to let their data be shared. I will share very specifically, but not an open ended agreement like any doctor they chose.
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Post by agedhippie on Mar 22, 2023 17:57:45 GMT -5
On that slide presentation page 4, I wonder why Mike said this We ended 2022 with:
– 2 marketed products on our platform (Afrezza & Tyvaso DPI)+ V-Go®
I think he should have said, 3 marketed products. I know I can count to three, but you never know.... Better emphasis would be: – 2 marketed products on our platform (Afrezza & Tyvaso DPI) + V-Go® or phrased as: – 2 marketed products on our platform (Afrezza & Tyvaso DPI), and V-Go®
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Post by agedhippie on Mar 22, 2023 11:06:40 GMT -5
FYI: The Cipla deal was done five years ago. The Brazil deal was done years ago---and they haven't purchased any Afrezza in more than two years ago. The "supposed" clinic trial was designed for a little over 200 patients--18-65 years of age. The "supposed" clinic trial was designed to last for 24 weeks for those patients enlisted in the trial FYI:Cipla has a website for their corporation. On their website they have a search link. Put in the word Afrezza and it tells you they have no references for this topic. They is something about this deal that doesn't match up with Cipla really having any interest in spending their money on developing Afrezza for India. I hope I'm wrong! With five years passing and they can't find 200 patients in of all places--India with a zillion citizens there is something "rotten in Denmark and now India" A lot of FYIs there - BIOMM have suspended Afrezza purchases. Their minutes say it's temporary but I suspect not. I think that deal is dead. - The India clinical trial exists and is registered in the CTRI database - ctri.nic.in/Clinicaltrials/showallp.php?mid1=45751&EncHid=&userName=Cipla - The data was last updated at the start of the year and is active with 216 people. - The trial is paid for by Cipla. From the SEC filings: " Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla." Clinical trials take time. People are started as they sign up and pass the vetting criteria defined in the trial filing. The result is that a 24 week trial can easily last a few years (you can see this even with the big pharma drug trials) It's likely that COVID imposed delays as well, it certainly did with US clinical trials.
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Post by agedhippie on Mar 21, 2023 17:32:46 GMT -5
I find the lag is between 15 to 20 minutes. It's why if your levels are changing fast you use a finger stick, which only lags by 5 minutes, rather than a CGM. Exercise is one of those things that induces big swings. CGMs attempt to reduce the apparent lag with predictive algorithms, but generally this video from Abbott explains the issue: www.youtube.com/watch?v=I3tQ80NXvGkMakes sense to me, the CGM is measuring the glucose level of interstitial tissue. "The interstitial space that lies between blood vessels and cells provides the fluid and structural environment surrounding those cells. Under most conditions in most tissues, fluid from the vascular space continually filters from the microvessels into the interstitial space and is not reabsorbed " What they don't mention are fun things like compression lows. If you lie on a sensor it pushes the interstitial fluid away which reduces the glucose in the area and as a result the sensor thinks you are low. Having that happen in the middle of the night is no fun because the alarm is loud!
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