An unexpected scenario for Tuesday
Post# of 155352
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Posted On: 10/16/2020 9:15:42 AM
An unexpected scenario for Tuesday
Just had this idea. I don't think this is most likely but it would not surprise me.
There is a recommendation to change the primary endpoint or add to the primary endpoint a change in clinical status.
Nader decides to submit the interim data to the FDA anyway, still blinded to everyone but the DMSB and FDA, and asks them to grant an EUA on the basis of the CD12 interim secondary endpoint results plus the CD10 results. And of course he emphasizes that "Nobody has ever done this before".
The argument against this is that he didn't want a strike against the company for pushing the FDA on the CD10 EUA and this would be pushing it again but it's a pandemic and he knows he's in a bad position having to wait until next year for the CD12 final results. And Amarex is against taking the penalty for unblinding.
We know he's always looking for what he thinks are creative solutions so it wouldn't surprise me if he goes this route even though I think the most likely scenario is the trial simply continuing with a modified primary endpoint.
Just had this idea. I don't think this is most likely but it would not surprise me.
There is a recommendation to change the primary endpoint or add to the primary endpoint a change in clinical status.
Nader decides to submit the interim data to the FDA anyway, still blinded to everyone but the DMSB and FDA, and asks them to grant an EUA on the basis of the CD12 interim secondary endpoint results plus the CD10 results. And of course he emphasizes that "Nobody has ever done this before".
The argument against this is that he didn't want a strike against the company for pushing the FDA on the CD10 EUA and this would be pushing it again but it's a pandemic and he knows he's in a bad position having to wait until next year for the CD12 final results. And Amarex is against taking the penalty for unblinding.
We know he's always looking for what he thinks are creative solutions so it wouldn't surprise me if he goes this route even though I think the most likely scenario is the trial simply continuing with a modified primary endpoint.
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