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Post by straightly on Sept 22, 2019 14:36:29 GMT -5
Since this isn't new data, it's not surprising that there isn't any share price reaction. This is another step in the direction of making the case for Afrezza, but most everyone (short and long) knows it will be a slow process of changing minds within the mainstream medical community to accept that Afrezzas unique attributes have meaningful positive clinical relevance. I'm quite curious about slide 12. What causes hypoglycemia to seem to be minimized at a dose of 30-35 daily units for RAA, and yet a slight peak at the comparable 2x dose for Afrezza? Maybe just a meaningless artifact from noisy data, but the magnitude seems that it is something statistically significant. I wonder if that FDA approved glucose/pancreas physiology simulator would generate comparable outcomes. Wonder if data about defensive eating was recorded for this trial and might have played a factor in the non unimodal hypoglycemia dose response curve. You sages of the board, do we have enough supporting evidence now to apply for superiority labeling? Something like ludicrous fast? |
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Post by radgray68 on Sept 22, 2019 15:05:39 GMT -5
All the negativity!!! Could one of the science critics please let me know in a short paragraph, just what it is that AL MANN MISSED IN THE SCIENCE... that led him to put one BILLION dollars of his own money INTO .. Technosphere/AFREZZA and me basing my investment decision on his knowledge .. I’ll be waiting (the science) He missed how hard it would be to change the scientific beliefs of the medical community. Also managed to miss getting the "unit" for Afrezza correct. Of course the latter is really one of the causes of the former. To some extent he also didn't seem to have anticipated AP systems getting as good as they are, though he also probably assumed Afrezza would have been well established in the market before APs were viable. Just a couple of thoughts. Al said at approval that they, the FDA, would not let them titrate aggressively enough in the big P3 trials. I believe that after the CRL's and decades of investor suffering, Al was simply trying to appease the FDA just to get Afrezza out there to patients and paying for itself until he could run the trials he wanted. Everybody's still hesitant to dose like Al said they should way back then. About Afrezza's safety, I remember him saying: "They'd have to be trying to get a hypo." Without CGM, Al was seeing things before his time. Unfortunately for his legacy, and more so for the diabetic community, his time ran out too soon. One can easily place blame on several of the players during development, FDA, Skreli, Margaret H., Al, Matt, Hakan, Brandicourt, stupid Sanofi agreement requiring us to spend all our up-front money on additional Fill/Finish lines and a ridiculously HUGE insulin supply contract instead of advancing either Afrezza or Technosphere. And how about De Sisto? What was that about? Damn short sellers, market sentiment, insulin cartel, finicky capital markets, etc. etc. etc. all culminating in our current situation. However, I believe it's going to change. Mike and crew have been trying to change the scientific bias and lack of completely convincing data from the ground up. It's simply going to take more trials like the small ones we've done, the professional publications like this current one, the U.S. pediatric trials and the India trials coming up. I hope many of you remember that Al had an infectious laugh. I picture hearing him having a big huge laugh when we get stellar superiority figures from the coming data. All JMHO, of course. |
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Post by dh4mizzou on Sept 22, 2019 16:53:36 GMT -5
Since this isn't new data, it's not surprising that there isn't any share price reaction. This is another step in the direction of making the case for Afrezza, but most everyone (short and long) knows it will be a slow process of changing minds within the mainstream medical community to accept that Afrezzas unique attributes have meaningful positive clinical relevance. I'm quite curious about slide 12. What causes hypoglycemia to seem to be minimized at a dose of 30-35 daily units for RAA, and yet a slight peak at the comparable 2x dose for Afrezza? Maybe just a meaningless artifact from noisy data, but the magnitude seems that it is something statistically significant. I wonder if that FDA approved glucose/pancreas physiology simulator would generate comparable outcomes. Wonder if data about defensive eating was recorded for this trial and might have played a factor in the non unimodal hypoglycemia dose response curve. You sages of the board, do we have enough supporting evidence now to apply for superiority labeling? Something like ludicrous fast? Compliments on the Spaceballs reference. |
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