I am wondering two things. First, does the occupa
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Posted On: 08/14/2019 7:02:16 AM
I am wondering two things.
First, does the occupancy test raise success in both dosages. Meaning there are patients that fail at 700 who would succeed at 525 and there are patients that fail at 525 who will succeed at 700. Hope so.
Second, I fear that because of our success, the FDA raises the bar so high, the risk of meeting the PE increases. For example, if they set PE at 70%, small risk of trial failure. If they set it at 95%, risk increases substantially.
Any thoughts?
First, does the occupancy test raise success in both dosages. Meaning there are patients that fail at 700 who would succeed at 525 and there are patients that fail at 525 who will succeed at 700. Hope so.
Second, I fear that because of our success, the FDA raises the bar so high, the risk of meeting the PE increases. For example, if they set PE at 70%, small risk of trial failure. If they set it at 95%, risk increases substantially.
Any thoughts?
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