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Post by akemp3000 on Jun 26, 2018 15:02:20 GMT -5
The STAT study WAS very statistically significant and ground breaking in diabetes care. Negative spin doesn't help diabetics. Afrezza does. The world is about to learn.
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Post by harryx1 on Jun 26, 2018 15:25:37 GMT -5
No idea re: cash on hand...but absolutely insane that in the past few weeks we have come out with another drug in our pipeline that has passed Phase 1 trials (with a big market) and had Afrezza validated by STAT study to prove its the best mealtime insulin on the PLANET..and yet our SP hasn’t moved!!! It’s hard not to be completely frustrated...based on the conversations I was reading this weekend re: STAT results, never in a million years did I think this is where we would be at closing bell on Tuesday.. A study with a small sample size with a lot of results that were NOT statistically significant. Perhaps I am too pessimistic, but I don't see how such a study will meaningfully drive share price let alone change SOC. So what would your professional opinion be on what the size of the study should be done? 100, 250, 500, 1000, 5000, 10000 participants?  ? |
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Post by mango on Jun 26, 2018 15:32:04 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate.
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Post by harryx1 on Jun 26, 2018 15:37:43 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. EXACTLY!!   |
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Post by agedhippie on Jun 26, 2018 15:50:33 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. It was a pilot clinical trial according to the filing. The explanation of a pilot clinical trials (from the AHA): Pilot trials are exploratory studies limited in size and scope that give insight into the actions, efficacy, and safety of a drug or device but cannot provide definitive support for specific mechanistic or therapeutic claims.Pilot trials live outside the formal Phases and are there to guide the configuration of a full trial. While they cannot provide a definitive statement alone they can be incorporated into later full studies. |
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Post by mnholdem on Jun 26, 2018 16:37:54 GMT -5
The STAT study WAS very statistically significant and ground breaking in diabetes care. Negative spin doesn't help diabetics. Afrezza does. The world is about to learn. Statistically significant or not, the trial provides MannKind with more information to communicate to prescribers. IMO, the Number 1 reason that doctors aren't prescribing Afrezza in large numbers is that they simply want more information about this new insulin. CMO Kendall will be providing that information to healthcare professionals in the coming weeks and months utilizing a variety of communication channels.
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Post by traderdennis on Jun 26, 2018 16:40:30 GMT -5
A study with a small sample size with a lot of results that were NOT statistically significant. Perhaps I am too pessimistic, but I don't see how such a study will meaningfully drive share price let alone change SOC. So what would your professional opinion be on what the size of the study should be done? 100, 250, 500, 1000, 5000, 10000 participants? ? To get to a 95 or 97 percent confidence interval. I create metric reports for A/b tests at my company. The number of observations needed for an event that happens a very low percentage of time (hypoglycemia) need a few hundred occurrences in each group before you can get the confidence level to 95%. With a short study and 60 participants on a side I doubt there were more than just a few severe hypo events and no where near enough to get a 95% confidence band. |
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Post by mnkdfann on Jun 26, 2018 17:34:32 GMT -5
So what would your professional opinion be on what the size of the study should be done? 100, 250, 500, 1000, 5000, 10000 participants? ? To get to a 95 or 97 percent confidence interval. You may want to reword or qualify that, seeing as any size of study can give you a 95 to 97 percent CI. Just not necessarily a particularly useful one. |
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Post by mnkdfann on Jun 26, 2018 17:38:30 GMT -5
The STAT study WAS very statistically significant and ground breaking in diabetes care. Negative spin doesn't help diabetics. Afrezza does. The world is about to learn. No, a couple of the reported results had p < 0.05. Some had p > 0.05, p > 0.10, and IIRC one had p > 0.24. None of those latter values are convincing at those levels (not according to common practice, anyway). Some of the results did not even give the associated p-values, suggesting that those results were probably not strong at all. Negative spin doesn't help diabetics (or MNKD investors). Neither does hopium. |
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Post by harryx1 on Jun 26, 2018 17:48:11 GMT -5
You guys can spin it all you want but reducing time spent in hypoglycemia (i.e., <70 mg/dl) by 41% and increasing time-in-range by an average 12% per day is a big deal over years of a diabetics life.  |
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Post by sayhey24 on Jun 26, 2018 18:46:33 GMT -5
STAT was a Phase 4 investigator initiated study. Participant size was sufficient and adequate. It was a pilot clinical trial according to the filing. The explanation of a pilot clinical trials (from the AHA): Pilot trials are exploratory studies limited in size and scope that give insight into the actions, efficacy, and safety of a drug or device but cannot provide definitive support for specific mechanistic or therapeutic claims.Pilot trials live outside the formal Phases and are there to guide the configuration of a full trial. While they cannot provide a definitive statement alone they can be incorporated into later full studies. Exactly. The STAT provides the insight into why 3 year clinical use is showing the results it is. It also perfectly mirrored the 171 result in the non-compliant group. In addition, Dr Kendall has the lost study results and more than enough ammunition to change the SOC for T1s. He can start with bullet 2 of PHARMACOLOGIC THERAPY FOR TYPE 1 DIABETES care.diabetesjournals.org/content/41/Supplement_1/S73
Then again we can say, naw we need another study and then we just need one more study and another after that. I don't think so. afrezza is working exactly as Al said it would, maybe better.
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Post by sayhey24 on Jun 26, 2018 19:57:29 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951 |
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Post by kc on Jun 26, 2018 20:14:00 GMT -5
You guys can spin it all you want but reducing time spent in hypoglycemia (i.e., <70 mg/dl) by 41% and increasing time-in-range by an average 12% per day is a big deal over years of a diabetics life. |
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Post by mango on Jun 26, 2018 20:25:09 GMT -5
You guys can spin it all you want but reducing time spent in hypoglycemia (i.e., <70 mg/dl) by 41% and increasing time-in-range by an average 12% per day is a big deal over years of a diabetics life. And from severe hyperglycemia. |
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Post by careful2invest on Jun 26, 2018 20:29:39 GMT -5
And one more thing, the "8.0 to 6.8" was from the the Affinity 1 which had 518 participants which should be enough to stop the whiners about STAT only having 60 and not being big enough. clinicaltrials.gov/ct2/show/NCT01445951Bashers, and soft bashers will do what they do and say what they say no matter what facts are in front of them. We are finally on a solid path toward success with a competent and stellar team at the helm. IMHO, Whiners (bashers/shorts) opinions should be taken with a grain of salt at this point. GLTA Longs!! |
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