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Post by tchalaa on Nov 11, 2015 4:32:52 GMT -5
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Post by jpg on Nov 11, 2015 5:10:06 GMT -5
Estimated Enrollment: 46
A whole 46 patients. Hmmm...
Now they need to multiply that by about 200 patients to do the real safety trial. Is Sanofi stalling on that one? You bet. How can they get out of doing it? Hmmm...
Sanofi is stalling and needs to commit to this trial asap. Mannkind should know this. If not they are simply not doing their homework, aren't being truthful or simply not very smart. Which do you think it is?
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Post by esstan2001 on Nov 11, 2015 7:42:23 GMT -5
Estimated Enrollment: 46 A whole 46 patients. Hmmm... Now they need to multiply that by about 200 patients to do the real safety trial. Is Sanofi stalling on that one? You bet. How can they get out of doing it? Hmmm... Sanofi is stalling and needs to commit to this trial asap. Mannkind should know this. If not they are simply not doing their homework, aren't being truthful or simply not very smart. Which do you think it is? Am I mis interpreting; the study was designed with, or accepted as sufficient by the FDA to show safety with a planned enrollment of 46? |
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Post by Deleted on Nov 11, 2015 7:47:53 GMT -5
If a medication is effective with few safety concerns, then a small patient pollution is sufficient.
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Post by cfield23 on Nov 11, 2015 8:29:30 GMT -5
Completely agree it's great, but this isn't the 5 year 8,000 patient study that the FUDers suggested Sanofi has yet to start. |
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Post by daduke38 on Nov 11, 2015 9:13:10 GMT -5
Completely agree it's great, but this isn't the 5 year 8,000 patient study that the FUDers suggested Sanofi has yet to start. I do believe you are correct. It's not the 5 year study, from the way I read it either. |
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Post by Deleted on Nov 11, 2015 9:26:53 GMT -5
If a medication is effective with few safety concerns, then a small patient pollution is sufficient. So if this study goes well then we are good to go and no other study with a larger N required? |
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Post by od on Nov 11, 2015 9:42:21 GMT -5
Phase 1 Pediatric - long, but important/essential, road ahead...
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Post by Deleted on Nov 11, 2015 13:18:01 GMT -5
If a medication is effective with few safety concerns, then a small patient pollution is sufficient. So if this study goes well then we are good to go and no other study with a larger N required? Correct. Then the trial for Type 2 begins. |
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Post by Deleted on Nov 11, 2015 13:21:23 GMT -5
So if this study goes well then we are good to go and no other study with a larger N required? Correct. Then the trial for Type 2 begins. Thanks, and with successful completion of the first trial, some docs will do off label for Type 2 before second trial is completed. |
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Post by Deleted on Nov 11, 2015 13:22:42 GMT -5
Correct. Then the trial for Type 2 begins. Thanks, and with successful completion of the first trial, some docs will do off label for Type 2 before second trial is completed. Its insulin.. its already approved for type 2... |
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Post by slugworth008 on Nov 11, 2015 14:50:36 GMT -5
Exactly cField - Where's the beef on that one?
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Post by jpg on Nov 11, 2015 23:13:59 GMT -5
A 46 pediatric phase 1 study is a very long way from being a 8000 patient phase 4 RCT...
Like at least 200 times less expensive. This is the issue that worries me and why I think Sanofi is stalling?
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Post by tchalaa on Dec 1, 2015 5:19:22 GMT -5
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Post by Deleted on Dec 1, 2015 7:41:49 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents.
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