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Posted On: 09/15/2020 7:39:56 AM
Post# of 148948
Questions: (don’t know if this board has already covered it)
This from another board with regard to phase 3/12...
Query:
Am I wrong saying the FDA already knows the death rate in the Phase 3 severe trial? They would also know if it was from the placebo arm or the leronlimab arm.
Answer:
I addressed that issue today, below. One reply said yes, every death in a clinical trial is reported to the FDA with unblinded info also. Another confident reply said no, no way and that the FDA is only advised of SAE caused by the drug being tested.
1. Is there an expert that can way in on this issue?
2. If people (including Nader) have the info when did they have it and how do people think it colors the request for additional compensation?
3. How much efficacy ( as simple as possible ie out of a hundred severe patients this many survived vs placebo) on severe needs to be proven before the FDA must take action?
4. Worst case how long could it take to have concrete numbers?
This from another board with regard to phase 3/12...
Query:
Am I wrong saying the FDA already knows the death rate in the Phase 3 severe trial? They would also know if it was from the placebo arm or the leronlimab arm.
Answer:
I addressed that issue today, below. One reply said yes, every death in a clinical trial is reported to the FDA with unblinded info also. Another confident reply said no, no way and that the FDA is only advised of SAE caused by the drug being tested.
1. Is there an expert that can way in on this issue?
2. If people (including Nader) have the info when did they have it and how do people think it colors the request for additional compensation?
3. How much efficacy ( as simple as possible ie out of a hundred severe patients this many survived vs placebo) on severe needs to be proven before the FDA must take action?
4. Worst case how long could it take to have concrete numbers?
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