(Total Views: 514)
Posted On: 03/22/2021 12:11:54 PM
Post# of 154883
Re: Number1Stocker #83845
No CD16... Yes, that's where I hope this is going.
And connecting the dots, EUA for critical/under 65 (or perhaps all critical).
And OLE to continue to add data.
If we hear this afternoon that an EUA has been filed with the FDA then the above scenario will be in play. Until we hear something definite about an EUA. Or the initiation of CD16.
* * *
The above thoughts are based on my understanding that you can't have a placebo arm in a clinical trial where mortality is at stake while at the same time conducting an open-label extension for the same drug in the same indication. It would condemn a certain percentage of the placebo arm to an avoidable death.
Am I wrong here? Any bioethicists in the house?
Its a genuine question and I'd like to hear an answer if anyone can speak with some authority on this.
Thanks in advance,
--Sherlock--
And connecting the dots, EUA for critical/under 65 (or perhaps all critical).
And OLE to continue to add data.
If we hear this afternoon that an EUA has been filed with the FDA then the above scenario will be in play. Until we hear something definite about an EUA. Or the initiation of CD16.
* * *
The above thoughts are based on my understanding that you can't have a placebo arm in a clinical trial where mortality is at stake while at the same time conducting an open-label extension for the same drug in the same indication. It would condemn a certain percentage of the placebo arm to an avoidable death.
Am I wrong here? Any bioethicists in the house?
Its a genuine question and I'd like to hear an answer if anyone can speak with some authority on this.
Thanks in advance,
--Sherlock--
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