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To: smileyface; bitt

I take it that the “Biologics License Application” is separate from the full FDA approval?

The priority review that Pfizer and BioNTech are asking for pegs approval occurring around November 2021 instead of March 2022.


1,671 posted on 05/10/2021 10:13:39 AM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000))
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To: WildHighlander57

Biologics (BLA) is a different path than small molecule (NDA).

From a bio source. Different generic rules to protect proprietary biotechnology and bioproducts.


1,762 posted on 05/10/2021 1:32:29 PM PDT by smileyface ("The illuminati's whole philosophy demands the use, abuse, sacrifice and consumption of children.")
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