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Post by pguererro on Jun 23, 2018 15:52:15 GMT -5
I believe for that data we’re revisiting the Bode Type 1 trial Novolog .41 A1c drop vs .2 something Afrezza. It was statistically similar and we reached our primary endpoint of non-inferiority with A1c drop. If this isn’t the study Dr Kendal was referring to in news release today my bad and good for us. Reading the news release I already see a nice pearl in talking about 8-8 results. That’s impactful. Anyways I know I’ve been a Debbie downer on the poster I’ve just been waiting for this trial for a long time.
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Post by agedhippie on Jun 23, 2018 15:54:36 GMT -5
Honestly, some of the spin I’m hearing is embarrassing. Half the A1C drop yet 31% less hypo is “a great way to relook at the data”. They’re directly correlated. I’m looking forward to reading entire STAT. Hopefully some great pearls to share. Also...Dr Kendall has been meeting with top Endos nationally for 3 mos now. ,,, Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. It says may because it cannot say does. In other words it may benefit them, or it may not. |
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Post by akemp3000 on Jun 23, 2018 19:38:39 GMT -5
The language is required to say "may" if one in a thousand "might" not benefit. Using the word may is standard protocol and is not a negative.
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Post by sportsrancho on Jun 23, 2018 20:27:09 GMT -5
“Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters”
“It’s Dr. Kendall‘s job to put a spin on things”
.
Somethings wrong here ...in the next couple weeks? I doubt it.
Its his job to put a spin on things.... no
I’ve been on the phone all day because people are so confused about what’s going on on this board, thanks to the people who are setting things straight!
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Post by agedhippie on Jun 23, 2018 20:40:49 GMT -5
“Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters” “It’s Dr. Kendall‘s job to put a spin on things” . Somethings wrong here ...in the next couple weeks? I doubt it. Its his job to put a spin on things.... no I’ve been on the phone all day because people are so confused about what’s going on on this board, thanks to the people who are setting things straight! Why wouldn't we see the NRx numbers rise on the back of the ADA event? We have just shown several thousand endos data and a presentation, surely some are going to act on it. They can write scripts immediately, they don't need to wait months for an appointment. A percentage of potential writers will be blocked by insurance but that is better than it was. What would a reasonable prediction be, I was thinking a couple of hundred over the next two weeks (plus one week for the reporting lag)? |
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Post by mnkdfann on Jun 23, 2018 21:29:49 GMT -5
It appears that agedhippie has been very busy posting since the ADA Convention began. Funny thing is that it seems like all of his posts come to the same conclusion. Stat study ... Afrezza... MNKD... All Still going nowhere. One could possibly get the feeling that he is short mnkd. FWIW, I disagree with Agedhippie. GLTA!! Did you read what he wrote directly above your post? So you disagree with him, and you do not believe scripts will rise (spurred on by the ADA results) by at least a couple of hundred over the next 2 weeks? |
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Post by sportsrancho on Jun 23, 2018 21:41:47 GMT -5
It appears that agedhippie has been very busy posting since the ADA Convention began. Funny thing is that it seems like all of his posts come to the same conclusion. Stat study ... Afrezza... MNKD... All Still going nowhere. One could possibly get the feeling that he is short mnkd. FWIW, I disagree with Agedhippie. GLTA!! Did you read what he wrote directly above your post? So you disagree with him, and you do not believe scripts will rise (spurred on by the ADA results) by at least a couple of hundred over the next 2 weeks? He was setting himself up to be right by creating unrealistic expectations IMO. however, this difference was not statistically significant (p=0.1022). “What that says is that if you reran the test the results could be reversed. That is why he says it MAY reduce hypos, equally it MAY increase them. Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters”. We still need patient demand. And I’m hoping Mannkind PR’s a new marketing campaign to go along with the STAT results. We usually get a bump after the ADA. I do think that the doctors will be less hesitant and won’t be turning the patients down after they’ve been educated. |
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Post by sayhey24 on Jun 24, 2018 8:12:46 GMT -5
“Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters” “It’s Dr. Kendall‘s job to put a spin on things” . Somethings wrong here ...in the next couple weeks? I doubt it. Its his job to put a spin on things.... no I’ve been on the phone all day because people are so confused about what’s going on on this board, thanks to the people who are setting things straight! Sports - while it would be great to see I think script growth will be a slow steady slog.
Dr. Kendall's next job is to take out his big stick and beat the ADA over the head to make afrezza the standard of care. Thats going to take some time and until that happens, the average endo is going to continue to follow current ADA guidance.
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Post by gareaudan on Jun 24, 2018 15:14:37 GMT -5
of course he said might and not would. Their is not one pills or treatment that has 100% chance of doing what it is suppose to do. Their is always some peoples that will react badly to the treatment no matter how good it is. It is not a matter of words but a matter of numbers and the numbers are there. You are trying too hard to find a bad turn to this. No, the numbers are not there or the results would be statistical significant. This is science and either the data is there to support the statement or it isn't. Lets read what Mannkind themselves said - focus on the last sentence: Significantly less total hypoglycemia was observed in the AFREZZA-Gen2 group (9.80 events per subject-month) compared to the insulin aspart group (13.97 events per subject-month; p<0.0001). The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022).
What that says is that if you reran the test the results could be reversed. That is why he says it MAY reduce hypos, equally it MAY increase them. Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters. yeah well the statistically significant p number is arbitrary determine so even if it is globally accepted, it is questionnable. For such a small n, p=0.1022 is not bad. But you are right, technicaly, it is not statisticaly significant and we should Wait. That said, im not a statisticien but im pretty sure it is not equally probable to increase the hypo. The p value only Says the your first hypothesis is valid or not. Not the possibilities of anything. |
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Post by pantaloons on Jun 24, 2018 15:44:55 GMT -5
No, the numbers are not there or the results would be statistical significant. This is science and either the data is there to support the statement or it isn't. Lets read what Mannkind themselves said - focus on the last sentence: Significantly less total hypoglycemia was observed in the AFREZZA-Gen2 group (9.80 events per subject-month) compared to the insulin aspart group (13.97 events per subject-month; p<0.0001). The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022).
What that says is that if you reran the test the results could be reversed. That is why he says it MAY reduce hypos, equally it MAY increase them. Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters. yeah well the statistically significant p number is arbitrary determine so even if it is globally accepted, it is questionnable. For such a small n, p=0.1022 is not bad. But you are right, technicaly, it is not statisticaly significant and we should Wait. That said, im not a statisticien but im pretty sure it is not equally probable to increase the hypo. The p value only Says the your first hypothesis is valid or not. Not the possibilities of anything. I'd have to agree with gareaudan's response regarding p values. That is, in clinical research, p-values equal to or less than 0.05 are (arbitrarily) considered "statistically significant". To clarify, it simply means that there is a 5% chance or less that the difference in means is due to random chance. By that vain, strictly speaking, it is not correct to state that there are equal (i.e., a 50-50 chance) probability that either Afrezza and insulin Aspart would demonstrate greater TIR in one than the other. For a p-value of 0.1022, there is approximately a 10% chance that this finding is due to random error. For every 10 times this experiment is performed, 9 of those times, Afrezza would show greater TIR, and 1 of those times, insulin Aspart would show greater TIR. As can be inferred from the very definition of p-values, there is a degree of arbitrariness and therefore, it is prudent to also consider the various contexts in which these numbers are presented. Randomized clinical trials are considered the highest standard of clinical data (aside from meta analyses and in contrast to case studies/series, which are the least rigorous), but it is also important to note that this is but a single (yet insightful) trial with a modest sample size. With that said, the results are promising, but this is just the beginning and what will be important in the coming months will be the interpretation of this data by endocrinologists (and health insurance payers), as they will ultimately be prescribing and funding these treatments. A compelling shift in the standard of care will likely require clinical trials on the order of hundreds if not thousands, depending on the power of the study and how well measurable the effect of the novel treatment is. Nonetheless, it is noteworthy that this initial study has shown promise and surely will be the nidus for many subsequent, impactful studies spearheaded by a world-class expert (Kendall). |
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Post by gareaudan on Jun 24, 2018 16:46:24 GMT -5
yeah well the statistically significant p number is arbitrary determine so even if it is globally accepted, it is questionnable. For such a small n, p=0.1022 is not bad. But you are right, technicaly, it is not statisticaly significant and we should Wait. That said, im not a statisticien but im pretty sure it is not equally probable to increase the hypo. The p value only Says the your first hypothesis is valid or not. Not the possibilities of anything. I'd have to agree with gareaudan's response regarding p values. That is, in clinical research, p-values equal to or less than 0.05 are (arbitrarily) considered "statistically significant". To clarify, it simply means that there is a 5% chance or less that the difference in means is due to random chance. By that vain, strictly speaking, it is not correct to state that there are equal (i.e., a 50-50 chance) probability that either Afrezza and insulin Aspart would demonstrate greater TIR in one than the other. For a p-value of 0.1022, there is approximately a 10% chance that this finding is due to random error. For every 10 times this experiment is performed, 9 of those times, Afrezza would show greater TIR, and 1 of those times, insulin Aspart would show greater TIR. As can be inferred from the very definition of p-values, there is a degree of arbitrariness and therefore, it is prudent to also consider the various contexts in which these numbers are presented. Randomized clinical trials are considered the highest standard of clinical data (aside from meta analyses and in contrast to case studies/series, which are the least rigorous), but it is also important to note that this is but a single (yet insightful) trial with a modest sample size. With that said, the results are promising, but this is just the beginning and what will be important in the coming months will be the interpretation of this data by endocrinologists (and health insurance payers), as they will ultimately be prescribing and funding these treatments. A compelling shift in the standard of care will likely require clinical trials on the order of hundreds if not thousands, depending on the power of the study and how well measurable the effect of the novel treatment is. Nonetheless, it is noteworthy that this initial study has shown promise and surely will be the nidus for many subsequent, impactful studies spearheaded by a world-class expert (Kendall). very well said! |
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Post by sellhighdrinklow on Jun 24, 2018 17:09:53 GMT -5
,,, Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. It says may because it cannot say does. In other words it may benefit them, or it may not. It says, "may" because we're dealing with insulin. Insulin lowers blood sugar which "can be" dangerous. It's a legal safety net. |
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Post by mannmade on Jun 24, 2018 18:01:58 GMT -5
My "take"on the stat study has been determined in part on the actual results, which by and large seem actually pretty good, but also on what I consider to be the promise of what it has shown us and for which Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes.
When the stat study first came out I was expecting more positive comments from people. I am not a true science person so I was a bit confused at what I thought was the underwhelming response to the study, espcially given a few people on this board whom I respect for their science background that did not see the merits as very positive..
But upon further study and hearing more comments it is now my personal beleif that the stat study results are quite positive and lay the groundwork for the new mannkind and the new conversation about Afrezza that goes with it. That conversation imho is as follows:
1. Stat study showed how Afrezza can accomplish exactly, if not better control, as what an RAA can accomplish in less time with less hypos. To me, this in and of itself is good news. You can debate whether or not the numbers are statiscally relevant. Does it make Afrezza superior? I beleive it does.
2. Now the promise... what the study did not do is show how Afrezza can work to keep better control and TIR at significanntly lower levels of fasting BG which would require in many cases higher does of basal insulin and/or adjusments to prandial dosing. But as we know from the many anecdotal posters on social media, they are getting non diabetic numbers in the 5's and even more of them in the low to mid 6's for Hba1c's using Afrezza by targeting lower fasting BG at anywhere from 120 to 140.
So why didn't the stat study show this as a goal? because imho it could not as a first of its kind study with a comparison to RAA's as its basis, since doing so would require dosing that most docs will not do with traditional RAA insulins as it would drive pwd into more severe hypos. (The stat study targeted 160 for fasting BG.) A separate study targeting lower BG will likely have to be done under more direct management if a comparison is done or with Afrezza only.
THIS is the NEW story that could not be told now without the stat study... Remember that the ADA recently raised the acceptable Hba1c level to 8 from 7 or so because it has been too hard to get pwd to the lower levels without hypos and compliance is difficult with all that it entails for a T1. Afrezza changes all of this. Just think if you can now get pwd to a range of 5.5 to 6.5 with the same or less hypos... You don't think this would have to be the new SOC?
And this is what Dr. likely meant when stating that Afrezza should be the SOC.
Now again I do not have diabetes and I am not a science person so someone with a better understanding may be able to correct me if I have mispoken and hope they will but what imho I beleive is the true value of the stat study is the conversation Dr. K and the reps can now have with other docs that they had no basis for prior to the stat study...
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Post by uvula on Jun 24, 2018 22:49:53 GMT -5
mannmade, excellent post.
The STAT study by itself won't make Afrezza the SOC. However, it is enough ALL BY ITSELF to make people question whether it makes sense to raise the acceptable AIC goal to 8 when everyone knows 8 is not healthy.
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Post by sayhey24 on Jun 25, 2018 5:42:03 GMT -5
Mann - Well said - "Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes"
On Friday, all I was reading on this board was how disappointed most were in the results. Spencer even rushed to publish an article on how bad they were to which I had one response - "Good Grief". At the same time STAT exceeded my expectations. With Dr. Kendalls press release and the simple statement "8.0 to 6.8" the world has flipped.
Now Dr. Kendall has one job, making afrezza the "SOC for MDI". He should be able to do this based on the STAT and "lost studies" within six months. He then needs to make afrezza the SOC for T2. I would like to see Step 1 but I think getting Step 2 is doable. He should be able to do this in 18 months. IMO, now knowing what we know, everyday the ADA does not make afrezza the "SOC for MDI" they are committing medical malpractice, "8.0 to 6.8" says it all.
Maybe thats what the T-Shirts should say "8.0 to 6.8 ADA Just Do It"
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