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File NameTypeDate ProducedSizeLinkhf:file_type
125752_S3_M5_CRF_mrna 1273 p301 us3202375pdfMarch 1, 20246 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3062075pdfFebruary 1, 202410 MBpdf
125752_S1_M4.2.3.2 report body 5002400pdfFebruary 1, 202411 MBpdf
125752_S1_M4.2.3.2 report body 5002231pdfFebruary 1, 202414 MBpdf
125752_S1_M4.2.3.2 report body 5002045pdfFebruary 1, 202416 MBpdf
125752_S1_M4.2.3.2 report body 5002033pdfFebruary 1, 202425 MBpdf
125752_S1_M4.2.3.2 report body 5002034pdfFebruary 1, 202446 MBpdf
125752_S1_M4.2.3.2 report body 5002158pdfFebruary 1, 202455 MBpdf
125752_S12_M1_rsp fda cmts ir7 cmc 05oct2021pdfJanuary 2, 2024622 KBpdf
125752_S11_M1_rsp fda cmts ir6 cmc 28sept2021pdfJanuary 2, 2024717 KBpdf
125752_S15_M1_loa bla 0700 accpdfJanuary 2, 20241 MBpdf
125752_S10_M5_CRF_mrna 1273 p301 us3382284pdfJanuary 2, 20243 MBpdf
125752_S10_M5_CRF_mrna 1273 p301 us3382085pdfJanuary 2, 20243 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3082136pdfJanuary 2, 20244 MBpdf
125752_S39_M1_form 356h 0039pdfJanuary 2, 20244 MBpdf
125752_S49_M1_form 356h 0049pdfJanuary 2, 20244 MBpdf
125752_S52_M1_form 356h 0052pdfJanuary 2, 20244 MBpdf
125752_S38_M1_form 356h 0038pdfJanuary 2, 20244 MBpdf
125752_S40_M1_form 356h 0040pdfJanuary 2, 20244 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3382085pdfJanuary 2, 2024588 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3382035pdfJanuary 2, 2024588 KBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3382284pdfJanuary 2, 2024588 KBpdf
125752_S23_M1_form 356h 0023pdfJanuary 2, 20244 MBpdf
125752_S32_M1_form 356h 0032pdfJanuary 2, 20244 MBpdf
125752_S27_M1_form 356h 0027pdfJanuary 2, 20244 MBpdf
125752_S44_M1_form 356h 0044pdfJanuary 2, 20244 MBpdf
125752_S20_M1_form 356h 0020pdfJanuary 2, 20244 MBpdf
125752_S50_M1_form 356h 0050pdfJanuary 2, 20244 MBpdf
125752_S28_M1_form 356h 0028pdfJanuary 2, 20244 MBpdf
125752_S21_M1_form 356h 0021pdfJanuary 2, 20244 MBpdf
125752_S18_M1_form 356h 0018pdfJanuary 2, 20244 MBpdf
125752_S33_M1_form 356h 0033pdfJanuary 2, 20244 MBpdf
125752_S46_M1_form 356h 0046pdfJanuary 2, 20244 MBpdf
125752_S51_M1_form 356h 0051pdfJanuary 2, 20244 MBpdf
125752_S5_M1_form 356h 0005pdfJanuary 2, 20244 MBpdf
125752_S7_M1_form 356h 0007pdfJanuary 2, 20244 MBpdf
125752_S6_M1_form 356h 0006pdfJanuary 2, 20244 MBpdf
125752_S9_M1_form 356h 0009pdfJanuary 2, 20244 MBpdf
125752_S12_M1_form 356h 0012pdfJanuary 2, 20244 MBpdf
125752_S8_M1_form 356h 0008pdfJanuary 2, 20244 MBpdf
125752_S16_M1_form 356h 0016pdfJanuary 2, 20244 MBpdf
125752_S11_M1_form 356h 0011pdfJanuary 2, 20244 MBpdf
125752_S1_M1_form 356h 0001pdfJanuary 2, 20244 MBpdf
125752_S4_M1_form 356h 0004pdfJanuary 2, 20244 MBpdf
125752_S15_M1_form 356h 0015pdfJanuary 2, 20244 MBpdf
125752_S3_M5_CRF_mrna 1273 p301 us3082051pdfJanuary 2, 20244 MBpdf
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125752_S3_M5_CRF_mrna 1273 p301 us3012171pdfJanuary 2, 20246 MBpdf
125752_S9_M1_cover 0009.pdfpdfDecember 4, 20231 MBpdf
125752_S9_M1_rsp fda cmts clin 28sep2021 ir6.pdfpdfDecember 4, 2023746 KBpdf
125752_S1_M1_cover 0001.pdfpdfDecember 4, 20231 MBpdf
125752_S1_M1_form 3397.pdfpdfDecember 4, 20231 MBpdf
125752_S4_M1_cber rqstd tables.pdfpdfDecember 4, 20231 MBpdf
125752_S4_M1_cover 0004.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_cover 0005.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_form 3674.pdfpdfDecember 4, 20231 MBpdf
125752_S5_M1_rsp fda cmts clinical 17sept2021.pdfpdfDecember 4, 2023730 KBpdf
125752_S5_M1_rsp ir1 14sept2021.pdfpdfDecember 4, 2023690 KBpdf
125752_S6_M1_cover 0006.pdfpdfDecember 4, 20231 MBpdf
125752_S6_M1_rsp ir1 14sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S7_M1_cover 0007.pdfpdfDecember 4, 20231 MBpdf
125752_S7_M1_rsp fda cmts ir2 clinical 17sept2021.pdfpdfDecember 4, 2023782 KBpdf
125752_S7_M1_updated rsp ir1 14sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S8_M1_cber rqstd tables batch2.pdfpdfDecember 4, 20232 MBpdf
125752_S8_M1_cover 0008.pdfpdfDecember 4, 20232 MBpdf
125752_S8_M1_rsp fda cmts clinical 23sept2021.pdfpdfDecember 4, 20233 MBpdf
125752_S20_M1_rsp fda cmts clin 28oct2021.pdfpdfDecember 4, 20231 MBpdf
125752_S20_M1_rsp fda cmts ir11 cmc 22oct2021.pdfpdfDecember 4, 2023866 KBpdf
125752_S21_M1_cover 0021.pdfpdfDecember 4, 20231 MBpdf
125752_S11_M1_cber req tables mrna 1273.pdfpdfDecember 4, 20232 MBpdf
125752_S11_M1_cover 0011.pdfpdfDecember 4, 20231 MBpdf
125752_S11_M1_rsp fda cmts ir3 cmc 23sept2021.pdfpdfDecember 4, 2023665 KBpdf
125752_S11_M1_rsp fda cmts ir5 group1 24sept2021.pdfpdfDecember 4, 2023769 KBpdf
125752_S12_M1_cover 0012.pdfpdfDecember 4, 20231 MBpdf
125752_S15_M1_cover 0015.pdfpdfDecember 4, 20231 MBpdf
125752_S16_M1_cover 0016.pdfpdfDecember 4, 20231 MBpdf
125752_S16_M1_rsp fda cmts ir5 group3 24sept2021.pdfpdfDecember 4, 20231 MBpdf
125752_S18_M1_cover 0018.pdfpdfDecember 4, 20231 MBpdf
125752_S18_M1_rsp fda cmts clin 22oct2021.pdfpdfDecember 4, 2023850 KBpdf
125752_S20_M1_ce mapping.pdfpdfDecember 4, 20231 MBpdf
125752_S20_M1_cover 0020_.pdfpdfDecember 4, 20231 MBpdf
125752_S21_M5_real world effect study v3.pdfpdfDecember 4, 202327 MBpdf
125752_S40_M1_cover 0040.pdfpdfDecember 4, 20231 MBpdf
125752_S23_M1__rsp fda cmts safety 10nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S23_M1_cover 0023.pdfpdfDecember 4, 20231 MBpdf
125752_S27_M1_cover 0027.pdfpdfDecember 4, 20231 MBpdf
125752_S28_M1_rsp fda cmts info req24 30nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S32_M1_cover 0032.pdfpdfDecember 4, 20231 MBpdf
125752_S32_M1_rsp fda cmts clin 19nov2021.pdfpdfDecember 4, 20231 MBpdf
125752_S33_M1_cover 0033.pdfpdfDecember 4, 20231 MBpdf
125752_S33_M1_rsp fda cmts info req30 10dec2021.pdfpdfDecember 4, 20231 MBpdf
125752_S38_M1_rsp fda cmts ir32 cmc 10dec2021.pdfpdfDecember 4, 2023693 KBpdf
125752_S39_M1_cover 0039.pdfpdfDecember 4, 20232 MBpdf
125752_S39_M1_rsp fda cmts info req36 16dec2021.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_draft labeling text patient info clean.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_draft labeling text patient info redline.pdfpdfDecember 4, 20232 MBpdf
125752_S51_M1_rsp fda on info req48 26jan2022.pdfpdfDecember 4, 20231 MBpdf
125752_S52_M1_cover 0052.pdfpdfDecember 4, 20231 MBpdf
125752_S52_M1_draft labeling text patient info clean.pdfpdfDecember 4, 2023911 KBpdf
125752_S52_M1_draft labeling text patient info redline.pdfpdfDecember 4, 2023984 KBpdf
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