The PR does not inspire confidence. We know the DS
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Posted On: 10/19/2020 12:53:30 AM
Re: Good to go #61905
The PR does not inspire confidence. We know the DSMC will not be recommending a halt for safety issues or lack of efficacy. It would be either continuation or halt for efficacy and submitting an EUA. "a potential regulatory pathway forward" could refer to either one. What weighs against a halt for efficacy is delaying any announcement until a conference call.
But we live in unusual times. FDA guidelines and DSMC rules may have gotten thrown out the window due to the pandemic. There is a small chance the FDA actually has the data, the DSMC may decide to abrogate the preliminary conditions for halt. It's anyone's guess. Either way I'm here for the long run so waiting for Tuesday is just a small irritant to me.
But we live in unusual times. FDA guidelines and DSMC rules may have gotten thrown out the window due to the pandemic. There is a small chance the FDA actually has the data, the DSMC may decide to abrogate the preliminary conditions for halt. It's anyone's guess. Either way I'm here for the long run so waiting for Tuesday is just a small irritant to me.
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