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Msg  61755 of 66329  at  4/18/2019 1:04:52 PM  by

redplate


 In response to msg 61751 by  goirish1776
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Re: They said this

Good presentation. Data is good but depends on expanded data set being accepted by FDA.
A few data points to consider. Antibody titers reveal a lot. The mothers titers have a sharp peak, and decline, and this determines the amount transferred to child, and therefore the post birth outcomes. The transferred Ig has a half life that determines efficacy out after day 60 . This is where the observed efficacy and timing of the vaccination relative to birth shows a ‘logical story’ to explain different outcomes in the data. I think this supports the approval language be used to tightly control the vaccination window. Functional immunogenicity data explaining /supported by mechanism of action will be helpful for FDA to approve with ph4 follow up using modified vaccine timing limits.

I think a better data set than first pass and greater than fifty fifty FDA likes it.


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Replies
Msg # Subject Author Recs Date Posted
61756 Re: They said this Wily.Coyote 10 4/18/2019 1:21:51 PM
61757 Re: They said this arkenfisher 1 4/18/2019 1:22:04 PM
61758 Re: They said this phition42 0 4/18/2019 1:27:52 PM


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