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Post by dreamboatcruise on Mar 21, 2018 15:50:37 GMT -5
in Q2 they should have at least 2 announcements (One Drop collaboration and International agreement). I bet they'll have even more than 2 announcements. What they'll be is always hard to predict, but historically speaking we usually get more than 2 in a quarter... deals, new employees, debt restructurings, selling shares, etc. I think another private placement is highly likely in Q2.
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Post by dreamboatcruise on Mar 21, 2018 15:43:23 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. I think that was in reference to the old Affinity trials, the data for which was presented on a slide right after that 35% reduction comment. That was a published study, so to the limited extent studies can be talked about that didn't make it into the label, that data has been out there.
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Post by dreamboatcruise on Mar 21, 2018 14:02:13 GMT -5
Here is some history. Al assumed afrezza would be approved on the first submission. After all, he was only asking for human insulin which was already approved to be re-approved for administration through the inhaler. What Al did not appreciate was there was huge BP pressure on the FDA not to improve. Pfizer helped the cause by throwing the lung cancer "red herring" into the mix and pulling Exubera from the market. After approval on the first submission, the plan was to qualify the dreamboat; re-submit for FDA approval; sign the partner; re-do some of the lost studies with the dreamboat; build out the factory; and get the FDA approval. Well, that did not happen. The first CRL happened and then the Shkreli CRL happened and then it took 2 more years before approval. Al's health started to fail, the target partner had manufacturing concerns, Vienbacher stepped to the plate and signs the deal, and then Vienbacher gets canned. Al's health goes down hill fast, Brandicourt is focused on Toujeo, Stefan Schwartz sees its going to take a different approach selling to the T2 market and starts Onduo, its announced DeSisto is taking over, then Sanofi bails, then Desisto bails, the market assumes the "closed" sign is going and Jason Karp puts his 15cent pps target, Mike shows up out of the blue, Matt starts having health issues with his eyes and everything is a big mess. For some period of time there was no CMO, then we had Ray who was not a diabetes guy, then we had no CMO again. Then we have Mike giving interviews and says a few things which seem odd, like he never read the old studies. Then we have a few old time investors ask about the old studies, Mike finds them, gives them to Dr. Kendall and the next things you know Dr. Kendall comes to MNKD. Full disclosure - some of the time-line may not be 100% accurate but its pretty damn close. I just think Mike was not aware of all of Al's work. He had no history with the company and Al was not there to let him know. Unlike Dr. Kendall's due diligence which was reading the studies, Mikes due diligence before coming to MNKD was talking with the original afrezza users and social media.To be clear, these are things you are guessing, correct? Or do you actually have first hand knowledge of what each of them did and did not do?
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Post by dreamboatcruise on Mar 21, 2018 13:48:45 GMT -5
I see bits and pieces of thoughts about this subject but have not seen a thread devoted to it. So here it is. Who has the best guess of why we’ve not heard about them until very recently and why they are thought to be of importance? Perhaps it’s only one or a small amount of these studies of the alleged 60 that had something inside that created an epiphany? My head is often like a sieve, I don’t even recall what Mike’s exact words were when he first mentioned this subject. Perhaps there are conspiracy theorists on board here that think someone inside MNKD was in cohoots with BP and hid these out of view? Just joking about this last question, I think. We've known that there were lots of studies. They weren't a secret nor lost. MNKD went above and beyond in doing various safety studies related to cancer risk, immunological, etc. To me they seem pretty compelling. One of the reasons I took such a financial risk on MNKD. However, they aren't long term, large population trials, such as the FDA is requiring post market. Those that are more conservative, and those that are against Afrezza (the competition), will argue that it's not definitive until the long term safety trials required by FDA are completed. We also know that there were efficacy trials that were not accepted by the FDA for Afrezza because they were done with an older inhaler. I imagine right after the FDA approval MNKD management probably assumed things would go great with SNY and that a whole round of new trials with dreamboat and optimally designed to show superiority would ensue. I think we're left "rediscovering" these old studies because MNKD hasn't been able to afford new ones. If Dr. Kendall manages to convince FDA to consider some of the pre-dreamboat data to improve the current label I will be very impressed. There might be some small chance of that. There is new management at the FDA and policies/priorities can change. To me it appears that dosing and titration was still not fully understand even after Afrezza approval, so I would think that new studies with optimal dosing, use of CGM, etc. would be even better than any of these old results. I wouldn't put too much stock in the idea that everyone here on proboards knows more about Afrezza than did Matt, Urbanski and Mike. I'm not saying they aren't putting in place a strategy to try to better leverage these old studies, but as for what Mike has said, keep in mind that he is always trying to present new reasons to be optimistic (it's his job). Remember, there was an awful lot of talk of the label change and how important that was going to be. It's important, but obviously it wasn't a holy grail. These old studies aren't the holy grail either.
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Post by dreamboatcruise on Mar 21, 2018 13:29:10 GMT -5
agedhippie Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. I was asked by a self-insured company to help put on an internal employee only diabetes fair. In discussion with them they told me their number one health expense is diabetes. That was not including some diabetes related complicates including heart disease which they had not related to diabetes. It seems employees over 45 tend to hang around awhile and some are not leaving until 70. Thats a pretty long time. When they have health issues and good insurance its tough getting these people out the door. The government says over 8 years for those 45-55 www.bls.gov/news.release/pdf/tenure.pdf But diabetics stay longer. Its the 45 year olds you want to identify early and treat early with afrezza. They aren't going anywhere in five years. I asked them how would they feel if in some cases we could stop the progression and potentially reverse some beta cell damage. The self insured market has the biggest incentive to use afrezza if it can actually stop progression and they can get it for less than $400 a box. 40% of the insurance market is self insured. I assume this company does not cover Afrezza? Will certainly be good news if you can convince them to.
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Post by dreamboatcruise on Mar 21, 2018 13:25:30 GMT -5
"It's one thing to read this and another to be living it"...was great to read joeypots! No doubt challenges will remain. IMO, the education of doctors and insurance providers will start moving up rapidly following the release of the STAT study. Whereas Al Mann showed the PK/PD profile graph to everyone he met, the graph Peppy shows in this thread should become the new document that everyone can share once the STAT study shows how Afrezza can enable diabetics to achieve non-diabetic BG results. The lone attempt to downplay Mike's presentation by saying there was nothing new obviously missed the portion where Mike referenced the STAT study results. This was not only new, it was a defining moment in diabetes history that should be chronicled in the eventual movie We've known about the STAT study for a long time, and based on the titles from the ADA presentation we know that it met it's endpoints. I guess I had way more confidence that they'd be able to show better time in range than you did, because the apparent success of STAT doesn't seem new to me. Mike did throw in some hype/hyperbole as I remember, but good lord hyping things is certainly also not new for MNKD management... they've had an embarrassment of rich hype over years. As I'd expect... not knocking management tooting their own horn at every opportunity. I do hope STAT will make a difference, but there was nothing new in this presentation. I'm very skeptical it alone would be enough to change attitudes at insurers, which are more about short term profitability than patient health. Hopefully it will get noticed at ADA by practitioners.
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Post by dreamboatcruise on Mar 21, 2018 13:13:43 GMT -5
A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? agedhippie Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. The point is it doesn't pay to be one of the few that is extra generous since there would then not be this balance. You'd tend to get more new people that had poorly treated diabetes for which you're now responsible for the complications while sending relatively healthy people out the door. Your paying not only the near term costs of better treatment but also the cost of the poor treatment being offered by your competitors. If everyone in healthcare looked at the overall long term costs it would be great, but they don't. Case in point, look at stories here on proboards of people whose insurance rations the amount of monthly insulin they get or the number of test strips they can use.
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Post by dreamboatcruise on Mar 21, 2018 11:42:41 GMT -5
What did Mike say about when they'd next need to raise capital? I don't remember anything concrete other than the implication that we'll barely skate by the end of this quarter with the necessary $25M in cash, but would burn through that in Q2 and need to replenish from somewhere, likely meaning dilution in Q2. I must have mis-heard him. I thought he indicated that organic growth and (other events, my interpretation) would take us through the end of 2018 and that further dilution was not on the table for the balance of 2018. I'm going to listen again. I've been in the MNKD desert too long, I'm seeing and hearing things. Update: Time: 24:52 of presentation. Nothing expected to be needed to meet Deerfield threshold in the near term, but it sounds like the door is still open for something (dilution) to happen this year. Near term as in getting us through Q1. It is interesting how easy it is to hear things that we wish to hear when it's really not there.
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Post by dreamboatcruise on Mar 21, 2018 11:18:03 GMT -5
That was far and away Mike's best presentation on behalf of MannKind! Smooth and confident, all the way through! Terrific job, Mike! As to some of his feelings re script counts and how long our money will last before needing to tap markets, well, let's just say I hope that Mike is able to make my pessimism seem short-sighted and unenlightened. Mike, I need to warn you, I've known MannKind far longer than you have. What did Mike say about when they'd next need to raise capital? I don't remember anything concrete other than the implication that we'll barely skate by the end of this quarter with the necessary $25M in cash, but would burn through that in Q2 and need to replenish from somewhere, likely meaning dilution in Q2.
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Post by dreamboatcruise on Mar 21, 2018 11:03:12 GMT -5
The skeptic in me thinks the lost data none of us have seen is similar to the agreement with RLS that was worth up to $100M. Standard mnkd playbook. Sales are down because underperforming sales reps were fired but don't worry because this issue was solved. Everything is wonderful now. Really? History would suggest a short time price spike followed by dilution followed by a price crash. I hope I'm wrong. I think you're wrong... IMO, they'll be no short term price spike based on talk of old studies. STAT probably has more potential to peak investor interest.
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Post by dreamboatcruise on Mar 21, 2018 10:53:48 GMT -5
IMO, Mike's presentation yesterday at the Oppenheimer Conference was the biggest turning point in a generation for global diabetes care when he confirmed what many of us had hoped and expected; the STAT study ( STudy of insulin Aspart versus Technosphere) results will shock (diabetes) doctors as they have never seen a medicine work like Afrezza. He explained that Dr. Kendall is currently summarizing data from 65 prior Afrezza studies that included 5,000 trial patients which will answer many questions that had not been sufficiently answered previously. The coming release of these studies will make it easier for diabetes doctors to be comfortable prescribing Afrezza, i.e. confirming there should be no concern with lung issues. With this information and the new CGMs (continuous glucose monitors), doctors will now be able to personally witness results in their own diabetes patients as they keep their blood sugar within range of a non-diabetic person with a healthy pancreas. While this is not a cure for diabetes, it's pretty damn close. Mike also explained the recent slow down in scripts, that many non-performing sales reps have recently been replaced with new hires, some coming from Dexcom, and that the Mannkind reps had recently been brought in for additional training. It was good to hear that Mike now expects scripts to begin rising soon. While there's much work to be done, the STAT study results being released at the coming ADA should be the proverbial shot-heard-round-the-world. IMO, yesterday Mike confirmed the coming paradigm shift to Afrezza becoming the standard of care and we now know why Dr. Kendall left a global executive position at Lilly to join Mannkind. GLTA There really was no new information in this presentation vs recent previous ones. I think Mike did a good job of presenting, as many others have said, but presenting old material hardly seems to constitute a turning point.
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Post by dreamboatcruise on Mar 21, 2018 10:47:06 GMT -5
By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. First down a bit of a rabbit hole... I think the problem with the nickel sized sensor is going to be the battery. If you look at the Dexcom sensor today the bulk of the sensor is taken up with the holder for the transmitter and the sensor proper is in the subcutaneous fat. The Dexcom transmitter, I suspect specifically the larger battery to cope with the bluetooth drain, is the big object. With the G4/5 Dexcom made the transmitter larger and halved the battery life from the Dexcom Seven. I don't see how they get this to $10 retail, sensors today without any electronics or smarts are over $30. Now to time in range. Analysis of the DCCT study showed that only 11% of the risk of microvascular complications is due to absolute glucose level (HbA1c) and, while there is some debate, it seems probable that fluctuation may be a major contributor to the missing 89%. The insurers are not going to pay to mitigate this risk because it's years away and statistically you are unlikely to be their problem when complications strike. I believe the G5 is based on classic Bluetooth technology. There is now a low energy version that is a significant advance in reducing the required battery size for applications just like this that require very modest amounts of data to be transmitted (compared to audio, the original purpose of bluetooth). To me (worked in wireless tech industry for much of my career) it seems plausible to have something roughly the size being proposed... nickle sized but thicker. As for sensor cost, it likely could be driven down considerably with higher production volumes. As for insurance payment I agree that insurers are not going to get out ahead with regard to trying to avoid long term complications due to exactly what you say. However, if solid science comes out showing how CGMs can significantly reduce reduce long term complications and advocacy groups like ADA get behind demanding insurance make them available, I think payers can be pressured into doing it even if it doesn't benefit them financially in the short term. It's not going to happen over night though.
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Post by dreamboatcruise on Mar 20, 2018 22:41:51 GMT -5
Anything new said about RLS? I haven't listened yet but the slide is the same as the previous one, no new RLS info on slides. Buying more shares next week. Wish there was a way to fast-track the pedi trials. What was said about the Bluhale? Nothing new on RLS. Bluhale seemed to be primarily positioned as a device to teach patients how to properly inhale. Didn't really say whether it was available in doctors offices for that purpose.
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Post by dreamboatcruise on Mar 20, 2018 14:57:02 GMT -5
Good performance, though wish they'd finally get their slide deck cleaned up.
Nothing new, so no big market reaction.
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Post by dreamboatcruise on Mar 19, 2018 16:36:33 GMT -5
What falling share price? We've been in this $2.50 - $3.50 range for awhile now. But, interest is definitely in for Afrezza and also for MNKD stock. In a few months, we are leaving this range and going to galaxies far beyond.
As far as you cutting your nose to spite your face??? Sorry, but you already ran out of nose. I've had my space suit ready for a long time now. Though I certainly have learned that the course of MNKD stock is not something I have the ability to predict. I'll leave that to you and Michael K.
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