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Msg  64896 of 65208  at  8/14/2019 4:02:52 PM  by

Karl.B

The following message was updated on 8/14/2019 4:22:00 PM.

Question;

 Can a trial's results be re-directed to gain acceptance of a vaccine based on other criteria being met that was NOT in the original end-points?
 
This question is a slight variation of a question presented earlier.  The FDA is properly anal about allowing drugs on the market ONLY based on solid evidence of safety & effectiveness of that drug. 
I'd think getting RSVm accepted because of its pneumonia results would be unlikely...
 
But, WTF is up with a 40% breakout???
 
I've seen break-outs that are 4, 5, 6% and maybe 10%... but 40% is most unusual, even with Wainwright's target price.
 
Perhaps something is up, well beyond the Wainwright announcement???? 
I'm just wondering if that is true and what would be that truth...
 
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Replies
Msg # Subject Author Recs Date Posted
64904 Re: Question; redplate 4 8/14/2019 9:38:40 PM


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