0000000000-19-016064.txt : 20200323 0000000000-19-016064.hdr.sgml : 20200323 20191203145742 ACCESSION NUMBER: 0000000000-19-016064 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20191203 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: FIBROGEN INC CENTRAL INDEX KEY: 0000921299 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 409 ILLINOIS STREET CITY: SAN FRANCISCO STATE: CA ZIP: 94158 BUSINESS PHONE: 415-978-1200 MAIL ADDRESS: STREET 1: 409 ILLINOIS STREET CITY: SAN FRANCISCO STATE: CA ZIP: 94158 PUBLIC REFERENCE ACCESSION NUMBER: 0001564590-19-004979 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4-)>+CS],-"CD@,"!O8FH-/#PO3&EN96%R:7IE9" Q+TP@,S,U M,#(O3R Q,2]%(#(X,S0R+TX@,B]4(#,S,C U+T@@6R T-34@,30Y73X^#65N M9&]B:@T@(" @(" @(" @(" @(" @(" @#0HQ-B P(&]B:@T\/"]$96-O9&50 M87)M7!E+UA2968O5ULQ(#(@,5T^/G-T,C17,% PM% P-U&P ML=%W2BQ.=%#(, @P 8!0VPPT*96YD)RU6%MSVD84?N=7G,D3F0%%JRM*G[ -*6V-'4/2R4Q> M%FDQVPH)[PH3?DC?_5-[5C=TPPU-"\. 5N?ZG:MXZCV!-=)!O4N_7?ZAI%1H38TX;IP6+>"S@,_<9W LF><"B!&@4P/6&LS5,>40CG],0[M9K)!+=HD>ZYC9% M3V=7#WS +0Q[%7,(B$8PEWF#OVXJ)232'=#-4 =/. 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Form 10-K for the Year Ended December 31, 2018 Filed February 27, 2019 File No. 001-36740 Dear Mr. Cotroneo: We have reviewed your filing and have the following comment. In our comment, we may ask you to provide us with information so we may better understand your disclosure. Please respond to the comment within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to the comment, we may have additional comments. Form 10-K for the Year Ended December 31, 2018 ITEM 1. BUSINESS PAMREVLUMAB FOR THE TREATMENT OF FIBROSIS AND CANCER Clinical Development of Pamrevlumab , page 28 1. Please address the following regarding your disclosure of certain serious adverse events (SAEs) experienced by patients in the clinical development of Pamrevlumab: You disclose on page 31 that there have been 45 SAEs in 31 patients, four of which were considered possibly related by the principal investigator to study treatment. Further, on page 34, you disclose that there were 99 TSAEs; six of which were assessed as possibly related by the principal investigator, and 93 as not related to study treatment. Please provide us proposed disclosure to be provided in future filings identifying each treatment related SAE "possibly" related to Pamrevlumab. Pat Cotroneo FIBROGEN INC December 3, 2019 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Sasha Parikh at 202-551-3627 or Rolf Sundwall at 202-551-3105 if you have any questions. FirstName LastNamePat Cotroneo Sincerely, Comapany NameFIBROGEN INC Division of Corporation Finance December 3, 2019 Page 2 Office of Life Sciences FirstName LastName