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Post by peppy on Jun 17, 2018 19:28:09 GMT -5
As we approach the start of ADA (at roughly the midpoint of 2018) I thought it might be good to recap what we have to look forward to this year both pro and con: A. The Pros 1. ADA Stat Study and Hypo Study 2. Term sheet (possibly China?) 3. Possible second term sheet (Mexico or Canada?) 4. Trep T Partner (upfront cash payment?) 5. One Drop partnership for direct pay subscription 6. Better Insurance Coverage 7. Gradual trend of increasing scripts and revenue 8. Mike’s assurances we will meet guidance 9. RLS, anyone??? 10. Approval of AFREZZA for Brazil 11. Possible Fast track of AFREZZA in India 12. Start of Trep T Phase 3 13. Reduction of Deerfield Debt w final payment in 2019, leaving only Mann Group as a major debtor 14. New Commercial and more commercials 15. Dr. K continued publishing and outreach w his advisory board 16. Continued growth of cgm penetration and with it the growth of importance of TIR, which helps us B. The Cons 1. Need for cash: Dilution on it before August? Or something non-dilutive? Likely dilution 2. Payment to Deerfield in July with stock also dilutive 3. Scripts and revenue do not grow as expected 4. Dilution in 1st Q 2019 I would say the Pros outweigh the The Cons imho at this point in time. Please note if I have left anything out either Pro or Con please feel free to add. This is only meant to be an outline to start a conversation about what we might expect over next six months until end of year. Also I have only included those items both pro and con which imho are real possibilities and have tried to avoid the truly speculative with no basis or reference points making them worth inclusion on either list. Items 4 & 12 may not happen this year, but maybe 1st quarter and 2nd quarter 2019 respectively. The PR released on the completion of the phase 1 trial stated, "Based on these data, MannKind is preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH." This next "phase of development" sounds to me like another phase 1 trial, this time in PAH patients rather than healthy subjects. If this is so, the phase 1 studies may not complete until November or December, which likely means that a partnership deal might not materialize until 1st or 2nd quarter next year, with the phase 3 study following (unless MNKD decides to fully fund the phase 3 trial itself.) I just read over the last earning call transcript last week, mike said TreT to move into phase three. MNKD wants a TreT partner. |
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Post by peppy on Jun 17, 2018 19:31:15 GMT -5
So Andrea Leone-Bay has been involved in "hooey" all this time? Really? And the million bucks Mannkind received from RLS, while not much in the overall scheme of things, was also hooey? I got the impression last time or so that Mike spoke publicly about RLS to answer a question about it, it seamed to me he even kind of like tilted his head upward, rolled his eyes, shrugged his shoulders and threw his hands out out to his sides palms up and said something like who knows. Not really, but that’s the impression I got. July 2018, Marijuana to be legal in Canada. I heard a new repost federal legalization under tRump being considered. Oh my sessions. |
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Post by peppy on Jun 17, 2018 19:33:19 GMT -5
As we approach the start of ADA (at roughly the midpoint of 2018) I thought it might be good to recap what we have to look forward to this year both pro and con: A. The Pros 1. ADA Stat Study and Hypo Study 2. Term sheet (possibly China?) 3. Possible second term sheet (Mexico or Canada?) 4. Trep T Partner (upfront cash payment?) 5. One Drop partnership for direct pay subscription 6. Better Insurance Coverage 7. Gradual trend of increasing scripts and revenue 8. Mike’s assurances we will meet guidance 9. RLS, anyone??? 10. Approval of AFREZZA for Brazil 11. Possible Fast track of AFREZZA in India 12. Start of Trep T Phase 3 13. Reduction of Deerfield Debt w final payment in 2019, leaving only Mann Group as a major debtor 14. New Commercial and more commercials 15. Dr. K continued publishing and outreach w his advisory board 16. Continued growth of cgm penetration and with it the growth of importance of TIR, which helps us B. The Cons 1. Need for cash: Dilution on it before August? Or something non-dilutive? Likely dilution 2. Payment to Deerfield in July with stock also dilutive 3. Scripts and revenue do not grow as expected 4. Dilution in 1st Q 2019 I would say the Pros outweigh the The Cons imho at this point in time. Please note if I have left anything out either Pro or Con please feel free to add. This is only meant to be an outline to start a conversation about what we might expect over next six months until end of year. Also I have only included those items both pro and con which imho are real possibilities and have tried to avoid the truly speculative with no basis or reference points making them worth inclusion on either list. The Stat and HYPO most important now and then increased insurance coverage. then scripts. build it and they will come. people in USA turning 18 every day. |
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Post by goyocafe on Jun 17, 2018 20:13:48 GMT -5
As we approach the start of ADA (at roughly the midpoint of 2018) I thought it might be good to recap what we have to look forward to this year both pro and con: A. The Pros 1. ADA Stat Study and Hypo Study 2. Term sheet (possibly China?) 3. Possible second term sheet (Mexico or Canada?) 4. Trep T Partner (upfront cash payment?) 5. One Drop partnership for direct pay subscription 6. Better Insurance Coverage 7. Gradual trend of increasing scripts and revenue 8. Mike’s assurances we will meet guidance 9. RLS, anyone??? 10. Approval of AFREZZA for Brazil 11. Possible Fast track of AFREZZA in India 12. Start of Trep T Phase 3 13. Reduction of Deerfield Debt w final payment in 2019, leaving only Mann Group as a major debtor 14. New Commercial and more commercials 15. Dr. K continued publishing and outreach w his advisory board 16. Continued growth of cgm penetration and with it the growth of importance of TIR, which helps us B. The Cons 1. Need for cash: Dilution on it before August? Or something non-dilutive? Likely dilution 2. Payment to Deerfield in July with stock also dilutive 3. Scripts and revenue do not grow as expected 4. Dilution in 1st Q 2019 I would say the Pros outweigh the The Cons imho at this point in time. Please note if I have left anything out either Pro or Con please feel free to add. This is only meant to be an outline to start a conversation about what we might expect over next six months until end of year. Also I have only included those items both pro and con which imho are real possibilities and have tried to avoid the truly speculative with no basis or reference points making them worth inclusion on either list. The Stat and HYPO most important now and then increased insurance coverage. then scripts. build it and they will come. people in USA turning 18 every day. Kids turning 4 every day. 😁 |
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Post by mnkdfann on Jun 17, 2018 20:30:50 GMT -5
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Post by peppy on Jun 17, 2018 20:34:34 GMT -5
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Post by sweedee79 on Jun 17, 2018 20:38:21 GMT -5
peppy .. I love Trudeau too.. He is really a class act!!!!!! I've been trading CGC and Aphria.. and yes the legalization has been delayed a bit..
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Post by mannmade on Jun 17, 2018 21:19:12 GMT -5
With respect to the artificial pancreas note the following as I beleive it may have limits for the general population of PWD (although I am not a diabetic)
1. The Santa Barbara trials by Samsun used Afrezza for prandial
2. Would be more difficult to use current prandials I would think as they do not react as fast in or out as Afrezza
3. It is a mechanical device that people would still have to be hooked up to which means the inconveince of tubes, and moving the infusion spot every week or two
4. Patch pump with Afrezza and cgm possibly just as effective in controlling TIR and less expensive
5. More to go wrong with AP (True story, know a 19 year old T1 who almost died twice because of hypos. Turned out his pump was not calibrated properly. At anyrate went to an endo who gave him Afrezza and three months later he dropped his pump and yes his Hba1c is now in low 6's)
6. Harder to travel with AP if it malfunctions
7. Can you swin in the ocean with AP?
8. Am guessing younger generation would rather not be hooked up to an AP
9. As someone else mentioned earlier AP much more expensive
Just my thoughts...
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Post by babaoriley on Jun 18, 2018 1:31:55 GMT -5
Wow, you guys love details!! And, believe me, the devil's not in the details, the details are the devil! Here's the way I look at MannKind as an investment: Pros: The share price may go up. Cons: The share price may go down. Over the years, we've had any number of supposedly good events coming, some actually do come, and some come in slightly different form than we think (the Bizarro World of MannKind, remember Bizarro from the old Superman comics?). But the share price doesn't do much but, if it does anything, it goes lower, save the wonderful financing at $6 - short-lived, to be sure, but a lot of fun for about a week or so! Right now, one of the key indicators is where we stand financially, unfortunately we are not on solid ground there and haven't been since the "Embarrassment of Riches" era (kinda short for an era, but what the heck). You'll notice that our share price reflects this lack of stability. Another indicator is script count - it's been disappointing, in parallel with our share price. So, in conclusion, if the share price goes up, and the rise does not culminate in a money raise after which the share price recedes like the shore line before a tsunami, I will assume one or more of the pros in mannmade's excellent list have occurred, if the share price goes down, I'll assume not enough good stuff is happening or likely to happen. The above is for simple-minded folk like I, so make sure you want to be considered that if you agree.  |
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Post by tingtongtung on Jun 18, 2018 2:10:30 GMT -5
Wow, you guys love details!! And, believe me, the devil's not in the details, the details are the devil! Here's the way I look at MannKind as an investment: Pros: The share price may go up. Cons: The share price may go down. Over the years, we've had any number of supposedly good events coming, some actually do come, and some come in slightly different form than we think (the Bizarro World of MannKind, remember Bizarro from the old Superman comics?). But the share price doesn't do much but, if it does anything, it goes lower, save the wonderful financing at $6 - short-lived, to be sure, but a lot of fun for about a week or so! Right now, one of the key indicators is where we stand financially, unfortunately we are not on solid ground there and haven't been since the "Embarrassment of Riches" era (kinda short for an era, but what the heck). You'll notice that our share price reflects this lack of stability. Another indicator is script count - it's been disappointing, in parallel with our share price. So, in conclusion, if the share price goes up, and the rise does not culminate in a money raise after which the share price recedes like the shore line before a tsunami, I will assume one or more of the pros in mannmade's excellent list have occurred, if the share price goes down, I'll assume not enough good stuff is happening or likely to happen. The above is for simple-minded folk like I, so make sure you want to be considered that if you agree. That's the news from Lake Babagon :-) Like a clockwork, there's that pearls of wisdom from Baba around Sunday midnight! Hahahaha.. After all this is MNKD. MNKD acts like crazy, it's followers are crazy, and it's fun. Great to be part of this journey. As we used to say "Keep Portland weird", MNKD is weird :-) |
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Post by #NoMoreNeedles on Jun 18, 2018 3:44:28 GMT -5
Add: Global Expansion in Europe which will require new trials
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Post by agedhippie on Jun 18, 2018 8:15:59 GMT -5
With respect to the artificial pancreas note the following as I beleive it may have limits for the general population of PWD (although I am not a diabetic) 1. The Santa Barbara trials by Samsun used Afrezza for prandial 2. Would be more difficult to use current prandials I would think as they do not react as fast in or out as Afrezza 3. It is a mechanical device that people would still have to be hooked up to which means the inconveince of tubes, and moving the infusion spot every week or two 4. Patch pump with Afrezza and cgm possibly just as effective in controlling TIR and less expensive 5. More to go wrong with AP (True story, know a 19 year old T1 who almost died twice because of hypos. Turned out his pump was not calibrated properly. At anyrate went to an endo who gave him Afrezza and three months later he dropped his pump and yes his Hba1c is now in low 6's) 6. Harder to travel with AP if it malfunctions 7. Can you swin in the ocean with AP? 8. Am guessing younger generation would rather not be hooked up to an AP 9. As someone else mentioned earlier AP much more expensive Just my thoughts... Some good points there. 1) Afrezza was used to model an AP with fast insulin. Afrezza cannot be used in an AP because they are closed loop which requires that the AP administers all insulin. Well, that's not strictly true, there is still a role as an occasional rescue insulin although it's probably easier just to tell the AP to give you more. 2) The current insulins undoubtably are not ideal. The fix that they are using is ti dribble insulin continually. The problem is that the AP then needs to be able to look forwards to where you are going to be and some times it gets that wrong. There is the same problem with CGMs, when you get a reading off a CGM it is it's best guess at where you will be in 20 minutes. 3) No argument there. Sometime drop a pump when it is attached - it pulls up short of the tube and yanks the site (ouch). There are patch pumps like the Omnipod or, I think, the new Lilly pump. There are other patch pumps in development. 4) The answer to this one is probably not. The patch pump would still be as advanced as a regular pump (ie. an Omnipod) so the cost would be there, ditto the CGM. I think the cost would be a wash at best. 5) I am not pro-pump, I don't use one any more. Not because of the mechanicals, but because I don't like the attachment. 6) As a diabetic you always travel with back up. When I was on a pump I always took an insulin pen as well. Never ever go without back up, what happens if you have a bad batch of insulin? 7) Possibly, depends on the design. 8) I am not so sure. Kids want to fit in and be the same, taking insulin screws that up. Also as a parent would you rather your kid had a devices which was going to get it right, or rely on a distracted 8 year old to do so? 9) The cost will be the same. The only thing that differs between a T:Slim pump and an AP is the software. The T:Slim is already dual chambered for glucagon when Zealand release it. |
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Post by oldfishtowner on Jun 18, 2018 8:58:52 GMT -5
Items 4 & 12 may not happen this year, but maybe 1st quarter and 2nd quarter 2019 respectively. The PR released on the completion of the phase 1 trial stated, "Based on these data, MannKind is preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH." This next "phase of development" sounds to me like another phase 1 trial, this time in PAH patients rather than healthy subjects. If this is so, the phase 1 studies may not complete until November or December, which likely means that a partnership deal might not materialize until 1st or 2nd quarter next year, with the phase 3 study following (unless MNKD decides to fully fund the phase 3 trial itself.) I just read over the last earning call transcript last week, mike said TreT to move into phase three. MNKD wants a TreT partner. Thanks, you are correct. A mental lapse on my part in not recalling slide 25 from the earnings CC, which you encouraged me to look at again.
Just ignore my original post.
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Post by lakon on Jun 18, 2018 9:46:26 GMT -5
Ok - I admit if my A1c was over 10 I would definitely care more as well. I think maybe it comes down to what each person sees as trying, and what the trade off is. I am luck, I don't try much and my A1c hovers around 7, mostly under, and when I use a CGM my TIR is around 75% (deviations tend to the upside) with a low standard deviation which is good (I target SD more than TIR). On the other hand I know people who work really hard and still end up in the 8s and 9s. It's a bit of a lottery. Imagine how well you could be doing IF you tried Afrezza...you might even care more too... |
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Post by agedhippie on Jun 18, 2018 16:52:52 GMT -5
Ok - I admit if my A1c was over 10 I would definitely care more as well. I think maybe it comes down to what each person sees as trying, and what the trade off is. I am luck, I don't try much and my A1c hovers around 7, mostly under, and when I use a CGM my TIR is around 75% (deviations tend to the upside) with a low standard deviation which is good (I target SD more than TIR). On the other hand I know people who work really hard and still end up in the 8s and 9s. It's a bit of a lottery. Imagine how well you could be doing IF you tried Afrezza...you might even care more too... The thing is I don't feel I need to do better. I am sure I am not alone in that. |
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