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Post by liane on Jul 20, 2015 19:20:03 GMT -5
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Post by compound26 on Jul 20, 2015 19:28:14 GMT -5
Believe this is a rehash of the data from the same phase III Type 1 Diabetes trial used for the FDA approval. |
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Post by liane on Jul 20, 2015 19:35:01 GMT -5
Yes, it's the PIII trial - but now it's in journal print.
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Post by compound26 on Jul 20, 2015 19:46:00 GMT -5
Yes, it's the PIII trial - but now it's in journal print. Then that's a good thing. Hope the less hypos data will get emphasized. |
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Post by liane on Jul 20, 2015 20:17:05 GMT -5
Yes, it's the PIII trial - but now it's in journal print. So now some docs might actually read about it. |
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Post by dreamboatcruise on Jul 21, 2015 9:58:57 GMT -5
Yes, it's the PIII trial - but now it's in journal print. Then that's a good thing. Hope the less hypos data will get emphasized. If only the trial had really been designed to look at hypos. The data on "severe" hypos at first glance appears even better than "all" hypos, but there were so few severe hypos in either group that the results are deemed statistically "not meaningful". The results on "all" hypos are also tempered by the fact that A1c average was lower for RAA group, so argument could be made that the trial is simply showing the tradeoff between A1c and hypo incidence, and if Afrezza dose was titrated to achieve equiv A1c it may very well have been equivalent hypos. Of course we longs know that it was poor protocols that resulted in failure of showing a simultaneous reduction in A1c with less hypos. Bottom line is that it appears to reflect what we expected in it... and sadly no silver marketing bullet. They do clearly state the expected result that hypos hours after dosing do not occur with Afrezza, so when one gets into the details that may present a clinically meaningful result as I'm sure there are some patients for whom those delayed hypo events may constitute a meaningful problem and Affinity shows that Afrezza eliminates them. |
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