|
|
Post by compound26 on May 17, 2017 20:43:41 GMT -5
He clearly said per month. Can anyone else comment on that price? The announcer said "that's over $32,000 per year", so that really shines a bad light on Afrezza. I'm not even sure this is good advertisement for Afrezza. Could that really have been a mistake? (month vs. year)? It is possible. But, if that is true, he will be using A LOT of insulin. Using the price offered on International Pharmacy (which I think is on high end compared with other retailers), $2,700 will get him either 3 boxes of titration pack, totaling 540 cartridges, i.e. 18 cartriges a day or 6 cartridges a meal (if he eats three meals a day, like most of us). or 6 boxes of regular packages, again, totaling 540 cartridges, i.e. 18 cartriges a day or 6 cartridges a meal (if he eats three meals a day, like most of us). internationalpharmacy.com/products/afrezza-inhalation-cartridges-insulin-regular |
|
|
|
Post by compound26 on May 11, 2017 14:15:46 GMT -5
I just look at the continuous glucose monitors. It seems pretty clear cut. that is why this whole endo thing is unclear.
Then I read that users are so happy, and people that want it like sweedee's dad who loved it can not get it with the medical coverage he has. Then I see happy users example Laura K. She seems like a likable sophisticated person living in a nice home, rides in a nice boat, with a continuous glucose monitor. "It is Magic" Sam was in south America loving afrezza, and Eric, he and his family, they try to tell us and Erics last piece, afrezza vs subq analog. Insulin is expensive.
Things that make me say hmmmm.
It would seem some employers in general offer more/better/different insurance coverage than others.
Had it not been for me my dad would have never heard of Afrezza ... nor would he have had the support and knowledge I gave him ... I served as an advocate against docs who don't want to change or take the extra time ..
Then we have Sam who was in the trials... and is a self advocate , not just relying on docs to make decisions about his own health.... that seems to be true for many of the successful Afrezza users
Unfortunately many PWD don't advocate for themselves and only listen to what the doc says .. and have never heard of Afrezza .. and if they have don't know what it is... so many things to consider ..
And also insurance coverage varies for every for person.. Medicare patients don't have the very best of medical care... that is what I have seen.. and that is due to lack of government monies to cover all of these programs ..
Afrezza is absolutely ahead of its time .. and so misunderstood .. change happens very slowly in our current medical system ..
The CC yesterday shows that MNKD is taking the right steps to put things in place .. time and money .. the big question is where will the money come from to keep progress moving forward.... If we can continue to find the cash we can do this...
The juvenile market will be a great target.. younger generation is tech savy .. My dad doesn't even have a cell phone... he couldn't stand a CGM or the hassle that would create for him ... yet Afrezza was a healthier option for him .. He is now on a larger dose of injectable.. the more insulin they give him the more weight he gains... its killing him .. he isn't the same person he was anymore.. trips and falls a lot .. no energy.... hard to watch .. specially when I know there is an answer that docs seem to not want to hear about .. so in the mean time people die.. and yes this will kill my dad ..
Based on this CC, Mannkind now has contract with MedImpact, which Mike describes as working with many medicare plans. Wondering if it is now possible for your dad to somehow get Afrezza covered? |
|
|
|
Post by compound26 on May 10, 2017 17:36:07 GMT -5
Overall pretty good call. We all know that the scripts are not that good. So that is expected before the call.
I do like the fact that they are lowering the cash burn to less than $8M (to be exact, 7.4M) a month from $10M a month. I would also believe that the July $10M note payment probably will be extended. So that means, without counting any future financing (which Matt noted will probably be in the form of debt, if possible), we have enough cash to run through at least Sept. 30, 2017.
Recall that, last year, quite a few people on this board were in the view that Mannkind will not survive Thanksgiving 2016. So put things in perspective, things are not that bad (in terms of financials).
I do think that things are progressing and tide is turning. As Mike has pointed out, diabetics in the know are using Afrezza and appreciate its benefits. With increased awareness, we will reach a tipping point at some point.
Think about it, in addition to the users like Sam, Eric and others we have been hearing from frequently, we also have in our existing user pool:
Chief medical officer of JDRF;
Two main editors of DiabetesMine;
Dr. Steven Elemen and Dr. Jeremy Pettu;
Laura: author of a popular diabetes book;
Daniele Hargenrader, author and blogger on diabetes;
Damon Dash;
...........
So what Mike said is true. Diabetics in the know are using Afrezza. They have seen the results and appreciate its benefits!
To the vast diabetes population, Afrezza is a well-concealed secret, waiting to be discovered. As Mike has put it, as long as we take care of (and therefore retain) the first 20,000 patients on Afrezza, the rest will be history.
|
|
|
|
Post by compound26 on May 9, 2017 14:13:10 GMT -5
Yes, to compare to the 1st arm of the trial, as both arms dose before meals: "Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals." I think they had no choice. Perhaps they had no choice, perhaps because the method of administration must be the same for both which is the same as the protocol for the FDA trials. There should be two more arms for a "fair trial". Should have requested an arm that follows the recommended "10 minutes after eating" for both Afrezza and injected. We know how that would turn out and it SHOULD BE PUBLICIZED. Of course the suppliers of the injected would say that is not the correct protocol. Tough cookies. Dosing Afrezza any earlier than the first bite of food may cause users with a starting blood sugar around 80 to go low. That is not a fair trial protocol. Freakin' BOZOS! I guess if Afrezza is dosed right before meal (not 10 or 15 minutes before meal) and then any correction dose is administered relatively early (like whenever the BG level hits 120 and is rising), the result should be OK. Seems like Anthony Hightower is using this method of dosing and he has an A1C of 4.7/4.8 to back it up. $MNKD Prior 2 Titration Pack, My Doc ONLY Knew 90 units of 4, 8 &/or 12 Mixed, all B4 MEALS! Now ADD 90 More Units 4 AFTER MEALS! HOME RUN! View Message: stocktwits.com/message/79045530 Sent by Rick H (@rckhrrr) at Apr. 14 at 3:32 PM @livingandlearning @schtik 23/24 Days! I Inhale Before & After Meals & More If Needed For Bigger Meals! View Message: stocktwits.com/message/80262679 Sent by Rick H (@rckhrrr) at Apr. 2 at 1:03 PM @livingandlearning Anthony is the one who showed me the importance of Not Just Before Meals, But After as Well! 👍😍 View Message: stocktwits.com/message/79049813 |
|
|
|
Post by compound26 on May 2, 2017 16:00:32 GMT -5
There were some great discussions on the safety of Afrezza in this update given by DRs. PETTUS, BODE & McGILL (ENDO 2017 Townhall - Updates on Inhaled Insulin, Reaching for the Stars in Post Prandial Glucose Control). goo.gl/EJCUXWDr. Jeremy Pettus: Question: So next one is - Are Lung Function Tests required - Full FPTs or just FEV 1. Reply Dr. Janet McGill: Just FEV1 Reply Dr. Bruce Bode: So in the development phase, they did full function initially, and realized, the FDA realized this, the Pulmonologist consultants said, you don't need to do this, just an FEV1, and that is very quick. Obviously, Primary Care Doctors do it, obviously Pulmonologists have them all the time. But Endocrinologists don't have them, they think it's a very big thing. It's so easy, it's a very inexpensive kit. You can buy hand held ones that are very inexpensive / disposable. But why do you want something disposable when you can buy something for $1000 and you can use it on hundreds and hundreds of patients. You get reimbursed, but its not much, it's $30, I don't know, it's about $30 or $40, but you will have it it payed for almost immediately. So we do about these. It only takes our staff 3 minutes. What's the length of doing that. Typing in the name and the date of birth and their weight. They do it 3 times and get the average. Question: Safety of Inhaled Insulin (AFREZZA) Reply: Dr. Bruce Bode: One thing, I think, is the safety. Most ENDOs won't prescribe because of the safety. I have been around enough of these lung biologists and experts, because I've been involved with them for the last 10 years. They'll convince you "it's perfectly safe". And the other thing, this drop of 40 mililiters, it's like me sitting here and I go back like this, I drop 40 mililiters of my FEV1 by just lying down. That's less that one per cent, one and a half per cent of your FEV1 overall. Lung Function: That's the safety. But that's hard for people to get over. And then the big thing is: People are, especially Type 1s, that are stuck on their 4 and 8 units; "I use the half unit here, the 2.5 units there. Tell them, it's in and out so quickly, it's gone so quickly. The hypoglycemia is related to, from Hour 2 to Hour 5. People going low before lunch all the time, people going low in the afternoon, people going low early in the bedtime and they are eating, they are going low at bedtime ad they eat a bunch of food. They are high and they are taken insulin, and they are over-correcting and they go low. This (AFREZZA) is in and out so quickly. Initially on the market back in the 1920s, nobody would have ever taken a SubQ Insulin for meals, never! But unfortunately, everybody is used to SubQ Insulin, and that's all they know. They have this precise carb in ratio on their pumps. And in our Hybrid Closed Loop development, the group out of Santa Barbara, did a trial using inhaled insulin (AFREZZA) versus rapid acting insulin Lispro in the Artificial Pancreas Project. In the inhaled insulin, totally flattened out the meal rise and it did not have any reactive hypoglycemia. Question: Give the latest post marketing data on lung cancer: Dr. Bode, Reply: "As far as I know, there's no reported (cases). The ones' who had lung cancer, there were a total of four, 2 during and 2 afterwards. These people - 2 of them had long standing history of smoking. One person only used it (AFREZZA) a very short time, less than a few weeks. So you know, obviously, so many people think this rate of lung cancer of these 4 cases is so unexpected. They also showed that when they looked at the Chest xRay, 2 out of the 4 had changes on their xRay that was misdiagnosed unfortunately. So there's no way that inhaled insulin can cause cancer within. You know, 10 weeks, 20 weeks, and this thing (AFREZZA) doesn't hang out in the lungs. There's no activity in the lungs. So it just either gets absorbed. If your's silly, bring it back up and cough it out when you swallow". |
|
|
|
Post by compound26 on Apr 27, 2017 17:35:27 GMT -5
|
|
|
|
Post by compound26 on Apr 26, 2017 11:14:46 GMT -5
The extra expenditures is probably a wash with the extra savings. MNKD is saving a lot not operating out of the velencia space that was sold and also they are saving from not trying to get drugs approved R and D. But yes I also want to know what the current burn rate is.. I suspect about the same or lower then 10 mil monthly I think the actual burn rate of the fourth quarter of 2016 is bit over $8 million a month. Think that will be the going rate as we move forward. |
|
|
|
Post by compound26 on Apr 24, 2017 18:30:56 GMT -5
If Deerfield forces Mannkind into BK, they will face a few risks.
1. Afrezza's relaunch will basically be suspended again and lose whatever momentum they have at the time of BK. This will reduce the value of the Afrezza and TS assets.
2. Once it is in BK process, there is no guarantee it will be quick and smooth process for Deerfield to get out as the owner of the afrezza assets. What if it takes a few years? The afrezza assets will further depreciate as patents approch expiration and other competing technologies get developed.
3. Deerfield is not a BP or drug company themselves, so it will take time and probably some risk for them to successfully money-tize the Afrezza assets. Will it be foreced to run itself or try to find a buyer? There will be some risks and unforceability in either option.
|
|
|
|
Post by compound26 on Apr 24, 2017 18:09:23 GMT -5
No guaranteed alignment for sure. However, it is not that easy or cheap for Deerfield to take private Manndind either given that Mann trust/foundation owns significant portion of the equity. And if Deerfield forces Mannkind to bankruptcy, there is no guarantee that it will be made whole either.
We are about 10 weeks in this current relaunch. So it is still in the early stages. Deerfield is probably still waiting to make a decision on whether the launch will get traction if given some additional time (say the rest of the year).
|
|
|
|
Post by compound26 on Apr 24, 2017 17:40:21 GMT -5
I understands that Deerfield still holds about $90 million notes after the recent debt restructuring. Also, I do not think that Deerfield sold short immediately before they got the 5 million shares. So assuming they still holds the 5 million shares, Deerfield now holds 5% equity stake and 90 million notes.
If the above assumption is correct, I think Deerfield’s interest is quite aligned with Mannkind at this moment. (If Mannkind is forced to BK, there is no guarantee that Deerfield will be made whole. On the other hand, if Mannkind survives and succeeds, Deerfield will benefit handsomely. )
IMHO, Mannkind’s PPS dropped recently probably for the following reasons: (a) limited and diminishing cash reserve; (b) basically flat scripts; (c) unresolved July debt payment; (d) panicked longs selling; and (e) continued short selling.
Since the May notes payment has already been addressed and there is no immediate payment to be made by Mannkind in the next few weeks, I think Deefield is now in a watching mode. If the scripts show a continued upward trend in the next 4-6 weeks, say, if the scripts go over 300s and then 400 in the next few weeks, it is not unlikely that Deerfield may choose to extend the July note payment date (right now, $10 million needs to be paid) and provide an additional financing of $25 to $30 million (which will represent about 25% additional investment for Deerfield).
I understand that in the fourth quarter, Mannkind’s cash burn is around $8 million, if I calculated correctly. If Mannkind can further reduce its cash burn to around $6-7 million a month, $25 to $30 million, plus whatever revenue it can generate, will enable Mannkind to make through the rest of 2017.
With Damon Dash’s diabetes network, Reversed show and anticipated label update to arrive in the third quarter, if Mannkind can maintain continued scripts growth through-out 2017, reaching scripts to around 1,000 by the end of 2017, refinancing and/or partnership will be more likely by then.
|
|
|
|
Post by compound26 on Apr 24, 2017 14:04:49 GMT -5
Someone on TS also suggested "Afrezza - Pancreas in your pocket".
|
|
|
|
Post by compound26 on Apr 24, 2017 9:15:52 GMT -5
Is this like lets see how many are short and how many are long on this message board? because that would be nice to know the percentages of shorts and longs posting here. It appears the longs are out numbered by the shorts at least in terms of posts they are producing on this board.  |
|
|
|
Post by compound26 on Apr 21, 2017 18:14:11 GMT -5
I can try and take a picture and send it to mnholdem:-) I was thinking you probably can take a picture for OOG. |
|
|
|
Post by compound26 on Apr 21, 2017 17:22:06 GMT -5
I have a question for the group. When Sanofi originally launched Afrezza, the number of cartridges in one prescription (one script) was 90. This was made up of 4 and 8 unit cartridges. Is this correct? Then MannKind took over sales and marketing. In February 2016, MannKind launched a 180 cartridge titration pack made up of 4s and 8s. Then recently, a new titration pack was launched that is made up of 180 cartridges of 60 each 4s,8s and 12s. Mike Castagna tweeted today the following statement: If you can look at total cartridges shipped and number of insulin units dispensed you get a better picture. It got got me to thinking about comparing apples to apples. If Sanofi at its peak sold 600 scripts in one week times 90 cartridges, that would be 54,000 cartridges at the peak. And those would have been 4s and 8s which meant that people had to refill more often. Meaning less people were actually patients but refilling more often. Today we we had close to 300 reported for last week. I would figure all those script numbers would be for the 180 cartridges pack for a total of 54,000 cartridges. It's the same as the Sanofi peak. And, it more patients than Sanofi had because people had to refill more often. Is my math off here or is MannKind currently selling as many cartridges as Sanofi did at its peak? CCI, I think what OOG and Liane have posted probably answers your question, at least roughly. Based on the chart, basically, our current week's 281 TRx translates into about 400-500 TRx in the Sanofi marketing era? Let's just pick an arbitrary number, 450. That probably is in the ball park of things. |
|
|
|
Post by compound26 on Apr 21, 2017 9:31:58 GMT -5
Here is my take of this Deerfield debt restructuring. My thinking is that the whole purpose for this restructuring is for Deerfield to take a 5% stake in Mannkind right now.
a. The main purpose is not to extend Mannkind’s cash runway. Mannkind is to repay $4 million (out of the total of $5 million) of the notes that is due in May. If the main purpose is to extend the cash runway, the whole $5 million of May notes should be swapped for equity. But it is not the case, only $1 million of the May notes is swapped for equity.
b. Why only $1 million of the May notes is swapped for equity? Deerfield control over $100 million of the notes. By swapping only $1 million of the May notes for equity, plus $5 million of the July notes for equity, Deerfield is basically swapping about 1/16 of the Tranche B notes and the other notes that Deerfield controls. So this probably is mainly due to Deerfield wants to allocate the shares to different tranches of note holders on a more pro rata basis.
c. Why Deerfield chooses to swap $6 million of the notes and leave another $10 million of the July notes un-swapped? I think this is because $6 million of the notes translates to about 5 million shares at current share price and gives Deerfield 5% stake.
d. Why Deerfield chooses to take only 5% stake (not a bigger stake)? One of the reasons could be that Mannkind and Mann Trust may only want Deerfield to take 5% at this time. The other reason could be that Deerfield just wants to take a 5% right now.
e. What does this suggest? It at least suggests that Deerfield at this stage wants to assert some control (in addition to its rights as the main debt holder) that a major shareholder has and wants to send a public message out that it now owns a major stake in Mannkind (as it has to file for such ownership).
|
|
