Index of /ipfs/QmVqhZZa2u5oqzbtduVwCLpnvJGBwYm7zxL2RPVaUNLWuk/Pfizer Documents/Batch 3 - 13 Dec 2021
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BATES-FDA-CBER-2021-5683-0002372_adc19ef-ve-cov-7pd2-eval-sas.txt
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8.7 kB
 
BATES-FDA-CBER-2021-5683-0002373_adc19ef-ve-sev-cov-7pd2-eval-sas.txt
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8.7 kB
 
BATES-FDA-CBER-2021-5683-0002374_adc19ef-ve-sev-cov-7pd2-wo-eval-sas.txt
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9.3 kB
 
BATES-FDA-CBER-2021-5683-0002375_addv-sas.txt
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4.7 kB
 
BATES-FDA-CBER-2021-5683-0002376_relrec.xpt
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580 kB
 
BATES-FDA-CBER-2021-5683-0002377_supppr.xpt
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74 kB
 
BATES-FDA-CBER-2021-5683-0002378_ta.xpt
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8.7 kB
 
BATES-FDA-CBER-2021-5683-0002379_te.xpt
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3.4 kB
 
BATES-FDA-CBER-2021-5683-0002380_ti.xpt
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38 kB
 
CRFs-for-site-1055.pdf
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6.7 MB
 
STN-125742_0_0-Section-2.5-Clinical-Overview.pdf
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4.4 MB
 
STN-125742_0_0-Section-2.7.3-Summary-of-Clinical-Efficacy.pdf
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3.3 MB
 
STN-125742_0_0-Section-2.7.4-summary-clin-safety.pdf
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6.8 MB
 
signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf
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212 kB