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Msg  3461 of 4701  at  7/13/2020 10:41:50 AM  by

euphorbus


 In response to msg 3455 by  luckijack
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Re: News -FDA request more info HIV BLA PDUFA

<On the Interim look which the PR says is coming.>
 
The PR does not say this is an interim look, rather it is a "Periodic public safety review by the Data Safety Monitoring Committee."  That means that the committee has to look at data from the trial and ensure that Leronlimab is not doing more harm than good in a life-threatening disease.
 
We will get more color this afternoon, but one of three things is likely to happen. 
 
(1)  The DSMC recommends that the trial continue.  This does not necessarily mean that the drug is working, only that it is not causing harm.  We might get a PR to this effect. 
 
(2) The DSMC recommends stopping the trial because it is working so well. This is very rare in my layman's experience.
 
(3)  The DSMC halts the trial because of safety signals.  This can mean adding safety protocols to the trial, which will entail a long hiatus.  Or it can mean stopping the trial altogether because the drug is increasing mortality rather than decreasing it.
 
With respect to (3) we already know that Leronlimab is unusually safe, so that possibility does not enter my thinking.
 
 


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Msg # Subject Author Recs Date Posted
3475 Re: News -FDA request more info HIV BLA PDUFA luckijack 2 7/13/2020 1:18:25 PM






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