You can't fix stupid II

[joeypotsandpans]

I understand why BD locked the previous thread so posters please refrain from the name calling as I get my points across, thank you!

From this am, and Bob Stert once again please post the full response and do not take out of context, (DBC please try to follow along, I am the dark blue from yesterday's response to SO, and the light blue is my response today):




Bobstert

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What potsie wrote:

Q2 net revenue with your thesis on STAT _Q2 will most likely not feel any direct effect as the quarter will be basically over by then so given we are just about halfway through it _4.2M____

Q2 net revenue without your thesis __4.2M______

Q3 with __6.2M______

Q3 without __4.5M_____

Q4 with ____8.5M_____

Q4 without ___5.5M______

11 May 2018, 12:21 AM Report Abuse Reply0Like


Bob, you left out quite a bit, so let's put into the proper full context, again please do not selectively edit, because the way you edited it, Spencer replied that I was calling for a miss which couldn't be further from the truth,  thank you "potsie"

SO: Tell me....what are your projections? Have the courage to put them down, AND put down what they would be without STAT, etc. Are you courageous enough to put numbers on the table? I HIGHLY DOUBT IT. What will you say when your numbers are not being met. I bet you will offer any number of excuses.



"Potsie": I don't make excuses, no need to, but if you go back a couple of years or so I was one of the first to state that until the insurance issue got taken care of scripts would never get off the ground...I didn't need to write two years of articles to foresee that as I was one of the first denied frustrated patients who was in touch with the then rep that was as equally frustrated, they left SNY and are now with DEXCOM btw. So let me patronize you and appease your egocentric modeling for the purposes of entertaining you:





I will make it easy. Fill In The Blanks



Q2 net revenue with your thesis on STAT _Q2 will most likely not feel any direct effect as the quarter will be basically over by then so given we are just about halfway through it _4.2M____



Q2 net revenue without your thesis __4.2M______



Q3 with __6.2M______



Q3 without __4.5M_____



Q4 with ____8.5M_____



Q4 without ___5.5M______





Now the bigger question to you: Where do you think the SI will be by the end of Q4, and what do you think the sp will be if your projection is correct or if mine is? I do believe that the company will meet the lower end of its guidance between net rev and other rev., I know you do not forecast that in your models.



Read more: mnkd.proboards.com/thread/9946/fix-stupid?page=3#ixzz5FCs8iTNd


Spencer Osborne, Contributor

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Author’s reply » Since guidance is $25m in net afrezza sales he is calling for a miss


No Spence, again your messenger only brought you a selected part of the context, see above and it would be nice if you could respond to my question to you regarding SI and sp


11 May 2018, 07:51 AM Report Abuse Reply0Like



Matt_PK

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With respect to STAT and other limited scope studies, investors need to learn how levels of evidence are used in medical practice. Physicians are now well-trained on relying on Level I evidence and to be skeptical, but open minded, to Level II evidence. STAT is Level III evidence.

In order to be Level I the evidence must have been developed in a randomized controlled trial. Level II evidence is from a controlled trial without randomization, cohort study from multiple centers, or multiple time series. Since STAT only tests post-prandial adjustments using a single agent, Afrezza, it is not a controlled study.

Think about it. What STAT does is equivalent to a marksmanship contest where the competitors shoot from 100 feet. After the initial shot, the contestant is allowed to see the target and if he missed the bulls-eye he is allowed to try again, this time from a closer distance. If he gets closer to the bulls-eye on the second try, that is a "success".


Thank you Matt, because if you asked the physicians which marksman they would put their money on to hit the bulls-eye every time in the end, which one do you think they would bet on ?


STAT measures post-prandial glucose. If it is not in range, the subject gets to try and adjust it with a spray of Afrezza. Would it be surprising that more patients hit the target range after an adjusting dose? Indeed, it would be shocking if 100% of the patients did not get an improved result. When the outcome is known before the trial starts, the success is not going to be very convincing and for that reason it is not going to be very persuasive for marketing purposes.


We know the outcome, it is very questionable whether those in attendance know the outcome for if they did we would absolutely have higher scripts, why wouldn't we if they knew they could get their patients in range "100% of the time" as you stated. You're answering the question of why the STAT study combined with the lower incidence of hypo risk WILL make a difference, so thank you for that


11 May 2018, 08:25 AM Report Abuse Reply1Like



Spencer Osborne, Contributor

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Author’s reply » Matt....

Thank You. You hit the nail on the head.
Yes he certainly did, you just can't see the forest through the trees but then again that would be asking me to compare you to the former global affairs scientist for Lilly diabetes and well that just wouldn't be fair for an aspiring journalist would it?

The data will appear good because there is essentially no way that it cant. The trail was small (60 people if my memory serves) and fast (a matter of months).

Is it positive? yes. Will it become a driver of sales? Not really in my opinion.
Again, if I were the physician and saw the difference, I would put my money on the marksman that will hit the bulls-eye 100% of the time, wouldn't you Spence? (Thanks again Matt for pointing that out)
11 May 2018, 10:50 AM Report Abuse Reply0Like

[agedhippie]

Probably a title like "You can't fix stupid" is not a great start. It's an implicit statement that anyone who disagrees is stupid and that's inevitably going to get people rise to the bait. It would be better to pick a more descriptive and less combative title.

[joeypotsandpans]

Aged, I have been in business over 35yrs. and have learned over that period of time there are some employees/individuals/customers that you just "can't fix" so forgive me if I carried that over but it is the same thought process regarding not just one particular individual but many that fall into the same "arena". Maybe I feel it's stupid to have to respond on another medium because the one that is selectively biased causes me to do so, would you agree that is pretty childish, amateur, and stupid? You are choosing/assuming to apply to one individual, but it is a general statement regarding not just one individual but a whole wrath of ridiculous sentiment that surrounds that situation, ie., stupid/lazy physicians, pharmacies, competing sales reps, you can pick who you want to fall under the label of that which cannot be "fixed" but I am speaking from direct experience of having to deal with same in all the examples I mentioned above. Again, the frustration is more so from a satisfied user of the product that I believe should be in more PWD arsenal towards fighting the disease but isn't because of "stupid" barriers to entry they have been saddled with. I get that you are happy and content to stick yourself, but as Liane pointed out, that is a personal choice/perspective that cannot be assumed that a majority of others share. Wishing you the best, going forward -J

[digger]

"Again, if I were the physician and saw the difference, I would put my money on the marksman" -- I think Spencer's point is that all the physicians already know the results because similar studies using RAAs have been done in the past. They aren't going to be surprised that checking glucose at 1 and 2 hours after eating and then dosing is going to improve time in range, etc.

More important to Mannkind, in my opinion, is that the STAT trial will mean nothing to insurers who couldn't care less about time in range when making tier decisions. Like it or not, they want to see long term improvement in A1c. To get to tier 2, MNKD will have to show afrezza does either a better job or an equivalent job for less money than the other RAAs.

[lennymnkd]

A less invasive approach adopted by new type1s and type two’s ... who are afforded the option of inhalation will make compliance greater therefore garnering the attention of insurers/ one thing I can’t belive / is the job shorts ; paid bashes ; BP has done to midigate our belief in the advantages in the inhalation over injections ... almost to the point it doesn’t matter at all . Getting us to take it for granted... I STILL SAY ITS A BIG PART OF THE SUCSSESS OF THE EQUATION !

[cjm18]

Hi insurers....Less hypos. Less hypos. Less hypos.

[dreamboatcruise]

May 11, 2018 11:11:48 GMT -5 joeypotsandpans said:

Aged, I have been in business over 35yrs. and have learned over that period of time there are some employees/individuals/customers that you just "can't fix" so forgive me if I carried that over but it is the same thought process regarding not just one particular individual but many that fall into the same "arena". Maybe I feel it's stupid to have to respond on another medium because the one that is selectively biased causes me to do so, would you agree that is pretty childish, amateur, and stupid? You are choosing/assuming to apply to one individual, but it is a general statement regarding not just one individual but a whole wrath of ridiculous sentiment that surrounds that situation, ie., stupid/lazy physicians, pharmacies, competing sales reps, you can pick who you want to fall under the label of that which cannot be "fixed" but I am speaking from direct experience of having to deal with same in all the examples I mentioned above. Again, the frustration is more so from a satisfied user of the product that I believe should be in more PWD arsenal towards fighting the disease but isn't because of "stupid" barriers to entry they have been saddled with. I get that you are happy and content to stick yourself, but as Liane pointed out, that is a personal choice/perspective that cannot be assumed that a majority of others share. Wishing you the best, going forward -J

SO has no influence over what doctors and insurance companies do.  He seems skeptical that they will change.  You seem to be having a heated personal debate with him as if convincing him is going to change the stupid behavior of doctors and insurance companies.  It is SO you are calling stupid with your title (or at least anyone reading the thread would assume so), not the barriers that he seems to think will be difficult to remove.  Most of us longs thought the barriers wouldn't exist at all... most of us thought they'd disappear much sooner.  I'm hopeful that things are finally lining up, but I certainly wouldn't call anyone stupid for looking at the past few years and being skeptical about that.  MNKD made some missteps, the FDA screwed us, SNY screwed us and that left us perceived as dead and struggling for life in a somewhat broken medical industry.  Is someone really evil or stupid just because they might believe the barriers are still real and significant?

Obviously there are still many smart people on Wall Street that aren't bought into the risk-reward proposition of MNKD.  Maybe you should spend your time trying to convince GS, or the chief strategist of whichever broker you use, of your point of view.  If you swayed them it would make a difference.  Convincing SO will mean nothing.


  

[dreamboatcruise]

May 11, 2018 11:25:30 GMT -5 digger said:

"Again, if I were the physician and saw the difference, I would put my money on the marksman" -- I think Spencer's point is that all the physicians already know the results because similar studies using RAAs have been done in the past. They aren't going to be surprised that checking glucose at 1 and 2 hours after eating and then dosing is going to improve time in range, etc.

More important to Mannkind, in my opinion, is that the STAT trial will mean nothing to insurers who couldn't care less about time in range when making tier decisions. Like it or not, they want to see long term improvement in A1c. To get to tier 2, MNKD will have to show afrezza does either a better job or an equivalent job for less money than the other RAAs.

1) I'm curious about these studies showing improved TIR with follow up RAA dosing.  Can you provide links to those?  I'm actually unaware of many trials that have used CGMs, which is the only way to measure TIR practically other than within a clinical setting for a very small cohort.

2) Even under the current A1c focused regime doctors do consider other metrics such as incidence of hypos and weight gain... and cardiovascular implications of spikes.  Some doctors will simply treat to ADA guidelines, but some are certainly smart enough to understand the implications of better weight neutral TIR, which will hopefully be demonstrated by STAT.

3) Sadly, I think you are correct that insurers will not care about TIR.  I think you are incorrect in assuming they care about long term A1c.  They care about short term profits.

[traderdennis]

May 11, 2018 13:18:17 GMT -5 dreamboatcruise said:

May 11, 2018 11:25:30 GMT -5 digger said:

"Again, if I were the physician and saw the difference, I would put my money on the marksman" -- I think Spencer's point is that all the physicians already know the results because similar studies using RAAs have been done in the past. They aren't going to be surprised that checking glucose at 1 and 2 hours after eating and then dosing is going to improve time in range, etc.

More important to Mannkind, in my opinion, is that the STAT trial will mean nothing to insurers who couldn't care less about time in range when making tier decisions. Like it or not, they want to see long term improvement in A1c. To get to tier 2, MNKD will have to show afrezza does either a better job or an equivalent job for less money than the other RAAs.

1) I'm curious about these studies showing improved TIR with follow up RAA dosing.  Can you provide links to those?  I'm actually unaware of many trials that have used CGMs, which is the only way to measure TIR practically other than within a clinical setting for a very small cohort.

2) Even under the current A1c focused regime doctors do consider other metrics such as incidence of hypos and weight gain... and cardiovascular implications of spikes.  Some doctors will simply treat to ADA guidelines, but some are certainly smart enough to understand the implications of better weight neutral TIR, which will hopefully be demonstrated by STAT.

3) Sadly, I think you are correct that insurers will not care about TIR.  I think you are incorrect in assuming they care about long term A1c.  They care about short term profits.

Insurers care much about a1c in terms of how it reduces cardiovascular risk in T2.  Reducing risk here increases both short and long term profits.  Thats why statins are given out like candy.

[dreamboatcruise]

traderdennis... you're more charitable in your view of insurers than am I.

[dreamboatcruise]

May 11, 2018 14:02:49 GMT -5 traderdennis said:

May 11, 2018 13:18:17 GMT -5 dreamboatcruise said:

1) I'm curious about these studies showing improved TIR with follow up RAA dosing.  Can you provide links to those?  I'm actually unaware of many trials that have used CGMs, which is the only way to measure TIR practically other than within a clinical setting for a very small cohort.

2) Even under the current A1c focused regime doctors do consider other metrics such as incidence of hypos and weight gain... and cardiovascular implications of spikes.  Some doctors will simply treat to ADA guidelines, but some are certainly smart enough to understand the implications of better weight neutral TIR, which will hopefully be demonstrated by STAT.

3) Sadly, I think you are correct that insurers will not care about TIR.  I think you are incorrect in assuming they care about long term A1c.  They care about short term profits.

Insurers care much about a1c in terms of how it reduces cardiovascular risk in T2.  Reducing risk here increases both short and long term profits.  Thats why statins are given out like candy.

As for A1c vs TIR... there is now beginning to be solid clinical evidence that postprandial spikes are a CV risk factor separate from A1c... read: "TIR does matter".

www.endocrinologyadvisor.com/type-2-diabetes/hyperglycemia-in-type-2-diabetes-related-to-heart-disease/article/628385/

Surprisingly, however, "beginning" is the operative word.  If one googles "diabetes cardiovascular prandial" you can find lots of articles with conflicting results and ones fairly recently before the one cited here saying the evidence that glucose spikes are a separable CV risk is questionable.  One limitation is that pre-CGM era looking at PPG spikes was not easy to do for a large trial.

There is definitely a need for more studies, however.  It would be ideal if MNKD could do big long term CV studies, but they can't.  However, if controlling PPG spikes (equivalent to TIR if titration of insulins is adjusted to yield a threshold acceptably low hypo incidence) is shown by other studies to have CV benefits independent of controlling A1c, and MNKD can demonstrate Afrezza offers better PPG control (within acceptable hypo risk) they would have some significant ammo.  STAT hopefully does the latter, with the caveat of being a small trial. 

[babaoriley]

I feel as if I've been watching one of those old wrestling tag-team matches (the orchestrated ones), this particular variety featuring three on a team.

[thekindaguyiyam]

May 11, 2018 15:05:26 GMT -5 babaoriley said:

I feel as if I've been watching one of those old wrestling tag-team matches (the orchestrated ones), this particular variety featuring three on a team.

You've got that right.
As Forrest Gump's Mother use to say "stupid is as stupid does".
Here we have proof.  These guys think they are wearing invisible clothing.

[dreamboatcruise]

The Gumps of the world certainly aren't smart enough to understand scientific papers. Too many of the Gumps think they can stumble into success... probably because of that movie (It wasn't real life BTW).

[babaoriley]

May 11, 2018 15:15:18 GMT -5 dreamboatcruise said:

The Gumps of the world certainly aren't smart enough to understand scientific papers. Too many of the Gumps think they can stumble into success... probably because of that movie (It wasn't real life BTW).

You know, DBC, long, long ago I use to repeatedly make the point that the shorts were sharper than the longs in stocks like this (I got plenty of lizard dung for thinking that).  It does not surprise me that you know a lot of stuff about this subject matter, because if you did not, it would be someone else doing what you're doing here.  Digger, the Trader and Matt know plenty of stuff, too.  I mean, the interests backing you guys up aren't going to have any old idiot on here representing their cause, they have hundreds of millions at stake. 

However, for all your knowledge on diabetes and related topics, you don't have the sense to realize how transparent you all are.  I guess it's likely that you actually do know, but just don't care and figure you're effective regardless (hey, I wrote "effective" without having to think about it!!).