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Posted On: 08/14/2019 8:56:10 AM
Post# of 149513
Re: Stramboat19 #6094
If they structure the protocol that way, what the occupancy test will do is reject any candidates where even a 700 mg dose will not block all or most CCR5 receptors. This ensures HIV will get shut down.
From what I've seen the FDA sets the efficacy level based on the current efficacy of approved drugs. They would not change that level based on our own drug. Drugs that come to trial after us may have efficacy levels partially based on leronlimab. Sad for them
Quote:
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
From what I've seen the FDA sets the efficacy level based on the current efficacy of approved drugs. They would not change that level based on our own drug. Drugs that come to trial after us may have efficacy levels partially based on leronlimab. Sad for them
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