|
Post by dreamboatcruise on Apr 19, 2018 15:49:39 GMT -5
Pep, sorry for this basic question : What do you guess this may mean? As always, thank you for your insights. Also, anyone with an idea, what is up? If there is no news, like today, I wouldn't rule out that it is simply traders pushing the price around of this highly volatile stock in order to generate short term trading profits.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 15:45:31 GMT -5
Yes, many seem to ignore the fact that any information that is targeted at patients is under scrutiny of FDA. Usually companies seek guidance before making it available to the public rather than risk fines afterwards. The FDA is also the reason we're never going to see Afrezza users on the company's websites extolling the virtues of our product. Some people fail to realize or fail to accept that in the FDA's eyes anecdotal evidence is not allowed. That has certainly been my understanding, though recently some have posted here that at least one patient is under the assumption that their anecdotal experience is to be posted on a soon to be unveiled new Afrezza website. I'll give them benefit of the doubt that this is their understanding, but also will be a bit skeptical until I actually see it.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 15:14:30 GMT -5
Well I now have the Libre sensor in my arm and Afrezza in the refrigerator. That went quicker than I thought. I believe Mannkind had it delivered the next day. The Libre sensor doesn't read for the first 12 hours per the instructions. Also I must have hit a capillary because it bled up thru the sensor. I've read about this happening and some say it will read better but if it doesn't read correctly Abbott will replace it. I was surprised that it required a prescription. I'm going to hold off on the Afrezza and get a feel for what my body is currently doing with Glucose before I start adding Afrezza to the mix. That was suggested by a person or two here and seems to make sense. I got the Afrezza pack with 30-4 units and 60-8 units for $143....note this is uninsured assisted. It should stay fresh in the fridge for a while I'm hoping. My doctor (PA rather) has been real cool about this and said she hopes it works well because she has a couple other patients that she thinks would love inhaled insulin. That is a good price given it is without insurance. Looking forward to hearing the results. I assume Libre can give you time in range. Please post some before and after numbers. Cheers.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 15:10:10 GMT -5
I don't believe these two are the sole sources to borrow shares from. Perhaps there aren't many brokers other than these two that offer to let retail clients like myself participate in loaning, but I suspect most institutional investors or hedge funds would be set up to loan shares out. These are simply my assumptions of how this works so take with a proper dose of salt. Oh, and I'm also assuming that just because I got shares returned doesn't mean there were necessarily returned shares from shorts. Call me a cynic, but I would suspect that if a more important customer of Schwab (i.e. more money than me) wanted to put shares out for loan, Schwab would probably take theirs and return mine. The large number of shares I hold worked against me. As I stated the other day, if Fidelity gets a large number of shares returned, they will first credit them back to the largest holders, if they think they can loan them back out quickly. It is easier for them to return shares to 10 accounts rather than 100 smaller accounts. My husband owns far fewer shares than I but his shares were not returned and are still 100% loaned out. Mine are only about 70% loaned out. Interestingly, when Schwab returned shares to me recently it was the two accounts with fewer shares rather than the one with significantly more shares. Guess they have different methods to their madness. I'm at 60% on loan now.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 15:05:17 GMT -5
peppy ... yes, definitions for levels of hypoglycemia are new. Needing medical treatment is definitely the most severe level. This is an interesting new development for Afrezza and RAA's. I am not going to look it up. Talk on the afrezza trial, it was the same person claiming hypoglycemia. Talk that the individuals claiming hypoglycemia during the Afrezza trial only needed to state, "they felt it." "The ADA has now defined these new metrics and relevant thresholds (target range, level 1, 2, 3 hypoglycemia, etc.), but there is still work to be done to determine relevance to treatment regimes." The vdex white paper is not opening for me. www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdfNotice the phrase target range. ? Afrezza trials were before it was feasible to have CGMs. One might imagine that soon the FDA will require that CGMs be part of any trial intended to determine hypoglycemia frequency, and they'd presumably use the new thresholds from the ADA to determine frequency of occurrence of each level.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 15:00:40 GMT -5
If you can convince 8 to 10% of a population opinion shifts very rapidly. Thats because almost every one forms opinion based on an unconscious algorithm that weight opinions of others highly - this make sense because most of the time the majority opinion is correct and those who rely on it survived in greater numbers than those who did not. If we create memes for Affrezza asserting its known virtues and ridiculing the more egregious slanders we can reach a large number of people.Meme are not just words and picture, a sucessful meme is retained in memory, changes host behavior and self replicates. In other words, you remember to try Afrezza and spam your contact list with a sucessful meme. Busy elsewhere ATM but will try to create some demos - the most important thing is that the message is true, and it assert the truth visually in an unexpected way. I would challenge the notion that merely creating something is going to mean it will reach large numbers of people. Most people will not view pharmaceuticals as being interesting enough to share on social media no matter how clever it extols virtues or ridicules slanders. We've had a lot of impressive or clever Afrezza content generated and put on social media, but it is lucky to break 100 viewers in general.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 14:50:21 GMT -5
Still looks the same and then I found this annoyance on the FAQ page where the question is "What should I do if I develop a cough while taking afrezza"-- "In studies, cough was reported in about 27% of patients using AFREZZA; 2.8% of patients gave cough as a reason for stopping AFREZZA. Talk to your healthcare professional if you develop a persistent or recurring cough or breathing difficulties while taking AFREZZA." They couldn't have included some suggestion of trying a sip of water or some other useful advice? By itself like that makes it sound like they're warning the patient they might be developing some serious lung disease. digger FWIW, I wouldn't be surprised to find out that the odd wording was recommended to MNKD by the FDA. I had a brief DM Twitter exchange with Mike C about other wording on their site and that's the response I got, i.e., The odd wording was not ours, it was the wording recommended by the FDA. Yes, many seem to ignore the fact that any information that is targeted at patients is under scrutiny of FDA. Usually companies seek guidance before making it available to the public rather than risk fines afterwards.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 14:43:22 GMT -5
peppy... yes, definitions for levels of hypoglycemia are new. Needing medical treatment is definitely the most severe level.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 14:16:51 GMT -5
Press release excerpt:
“We are very pleased with the opportunity to present the STAT Study results at the 78th Scientific Sessions of the American Diabetes Association”, stated Dr. Satish Garg (Barbara Davis Center for Diabetes, University of Colorado Denver), senior author and principal investigator of the collaborative multicenter randomized study.
“MannKind welcomes the opportunity to share the results of this collaborative clinical trial and looks forward to pursuing additional analyses to assess the clinical use of Afrezza therapy for mealtime glucose control,” stated David Kendall, MD, Chief Medical Officer of MannKind Corporation. “We believe that the STAT Study results will offer important insights into ways that individuals with diabetes can potentially improve their experience and outcomes by using mealtime inhaled insulin ’in the moment.‘ Our long-term goal is to establish inhaled human insulin as both a useful option and a potential treatment of choice for those individuals with diabetes requiring mealtime glucose control.”
---
It really comes down to how you interpret CMO Dr. Kendall's remarks. Will he join Dr. Garg to "share the results of this collaborative clinical trial" at the ADA Scientific Sessions? The answer is entirely speculative at this point, but it is clear that MannKind plans to share the trial results. Perhaps MannKind's CEO and/or CMO will shed more light on their participation in the two STAT presentations when they speak at May 16 Annual Shareholders Meeting.
I've participated in a lot of conferences and having multiple speakers for one presentation is not normal. Though, I would assume he'll be at the conference and talking to lots of people about the STAT results. Personally I don't think this is a big deal one way or the other. If the STAT study results are credible and impressive (I think they will be) then people will pay attention regardless of who presents (assuming some level of competency of the speaker). Actually, searching the Advanced Program now, nothing for "Garg" turns up. Has someone seen the STAT study listed in the Advanced Program? Is it perhaps only a poster presentation?
|
|
|
Post by dreamboatcruise on Apr 19, 2018 14:04:28 GMT -5
This is actually setting up pretty well for Mannkind as the cgm companies now can take the lead on data for beyond a1c as the new soc. Mnkd should already have enough studies to step in and show Best in class for beyond a1c needs. Especially if ADA is now willing to consider the 60 or so studies recently “unearthed.” May be a little early still but shorts really do need to start thinking about how to get out as this ship is starting to turn. The stars may finally be aligning in our favor. Not say will happen overnight but imho this is the starting point for real change of opinion Re AFREZZA. None of MNKDs studies provide the link from these "beyond A1c" metrics to clinical outcomes that would prompt major change to standard of care... i.e. cardiovascular and other long term complications. The ADA has now defined these new metrics and relevant thresholds (target range, level 1, 2, 3 hypoglycemia, etc.), but there is still work to be done to determine relevance to treatment regimes... e.g. changing the progression through the stages of treatment protocol based on time in range rather than A1c. There is also the complication that only a small portion of patient population has CGMs to facilitate collection of time in range data. Even with T1 population that has much higher rates of CGM use, it is not universal. If they do start considering replacing A1c with time in range or some variant, how will they accommodate the reality of CGM availability? Just wondering what people are reasonably expecting we might see from ADA over the next year or two. Seems the ship has been turning for years according to some. Perhaps that was the problem... we ended up sailing in circles. Maybe we need to straighten the course out.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 13:42:55 GMT -5
I still suspect that there isn't a huge amount of covering and that the shift in loan rates has more to do with additional shares ending up in hands willing to loan... possibly from the recent share offering. If that is the case, who other than Fidelity and Schawb are peddling the shares from the recent share offering? I don't believe these two are the sole sources to borrow shares from. Perhaps there aren't many brokers other than these two that offer to let retail clients like myself participate in loaning, but I suspect most institutional investors or hedge funds would be set up to loan shares out. These are simply my assumptions of how this works so take with a proper dose of salt. Oh, and I'm also assuming that just because I got shares returned doesn't mean there were necessarily returned shares from shorts. Call me a cynic, but I would suspect that if a more important customer of Schwab (i.e. more money than me) wanted to put shares out for loan, Schwab would probably take theirs and return mine.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 12:25:24 GMT -5
I don't remember that, but I think that is because it is incorrect information. The study wasn't conducted by Mannkind. The lead author was Dr. Satish Garg of Univ of CO who will presumably be the one presenting. Where did you read/hear that Kendall would be presenting? I believe MNKD has one additional verbal presentation at ADA. Kendall. What is he presenting? I can't find him in the advanced program.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 12:14:14 GMT -5
I am showing at fidelity that the rate is: MANNKIND CORP COM NEW BORROW RATE 16.875 %Wow, so Fidelity is only making 2% on the spread! I bet the rate paid will drop further. Too bad we can’t get a real squeeze that so many of us have dreamed about! I still suspect that there isn't a huge amount of covering and that the shift in loan rates has more to do with additional shares ending up in hands willing to loan... possibly from the recent share offering.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 12:12:12 GMT -5
Just like I said before, the shorts have no more idea than we do if we’re going to need more dilution by the end of the year depending on the upfront money we get, if we do, so why would they stay in? What’s their catalyst at this point in time...:-) We all should realize that odds are more dilution will be needed before end of the year. Hopefully it will be at higher price than this last one. Unlike the need for dilution, it's very difficult to predict the price movement of MNKD shares.
|
|
|
Post by dreamboatcruise on Apr 19, 2018 12:02:45 GMT -5
And don’t forget who is presenting at ADA on behalf of Mannkind. Our very own Dr. K. Perhaps this was MK third catalyst? I don't remember that, but I think that is because it is incorrect information. The study wasn't conducted by Mannkind. The lead author was Dr. Satish Garg of Univ of CO who will presumably be the one presenting. Where did you read/hear that Kendall would be presenting?
|
|