(Total Views: 729)
Posted On: 09/01/2020 4:04:10 PM
Post# of 153827
Quote:That is incorrect. The FDA asked for the Integrated Assessment of the CD03 Mono trial that I believe finished in July.
THE ORIGINAL TIMELINE. Critical to this answer was 700mg dosing safety which came from the interim M/M trial “safety review.”
Also incorrect is that there has never been an "interim M/M trial safety review".
And if you're talking about the DSMC safety review of the CD12 S/C trial -- that has nothing to do with the Combo HIV BLA filing, and we have not been notified that the FDA has officially asked for it in that context.
Regarding all of the other timing issues you discuss, which may or may not be correct, I am now bowing out of this topic and will let others, or Dr.NP, provide commentary.
We all have to try harder to get our facts straight.
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