SEC Comment Letter for FIBROGEN INC (FGEN) (CIK 0000921299) (KYNB) — Feb 14, 2020
FIBROGEN INC (FGEN) (CIK 0000921299)
Date: Feb. 14, 2020 · CIK: 0000921299 · Accession: 0000000000-20-001454
AI Filing Summary & Sentiment
File numbers found in text: 001-36740
Letter
February 14, 2020 Pat Cotroneo Senior Vice President and Chief Financial Officer FIBROGEN INC 409 Illinois Street San Francisco, CA 94158 Re:FIBROGEN INC. 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 January 31, 2020 response to our comment letter 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. Unless we note otherwise, our references to prior comments are to comments in our December 20, 2019 letter. 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.We note your response to prior comment 1 and your definition of the term “safety signal.” Please provide us proposed disclosure for use in future filings that identifies all serious adverse event (SAE) determined by the principal investigator to be related to, or possibly related to Pamrevlumab. Alternatively, please disclose clearly that upon investigation it is your belief that there is no causal relationship between the investigational drug and these SAEs.
FirstName LastNamePat Cotroneo Comapany NameFIBROGEN INC February 14, 2020 Page 2 FirstName LastName Pat Cotroneo FIBROGEN INC February 14, 2020 Page 2 You may contact Sasha Parikh at 202-551-3627 or Rolf Sundwall at 202-551-3105 if you have any questions. Sincerely, Division of Corporation Finance Office of Life Sciences
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February 14, 2020
Pat Cotroneo
Senior Vice President and Chief Financial Officer
FIBROGEN INC
409 Illinois Street
San Francisco, CA 94158
Re:FIBROGEN INC.
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 January 31, 2020 response to our comment letter 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. Unless we note otherwise, our references to prior comments are to comments in
our December 20, 2019 letter.
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.We note your response to prior comment 1 and your definition of the term “safety
signal.” Please provide us proposed disclosure for use in future filings that identifies all
serious adverse event (SAE) determined by the principal investigator to be related to, or
possibly related to Pamrevlumab. Alternatively, please disclose clearly that upon
investigation it is your belief that there is no causal relationship between the
investigational drug and these SAEs.
FirstName LastNamePat Cotroneo
Comapany NameFIBROGEN INC
February 14, 2020 Page 2
FirstName LastName
Pat Cotroneo
FIBROGEN INC
February 14, 2020
Page 2
You may contact Sasha Parikh at 202-551-3627 or Rolf Sundwall at 202-551-3105 if
you have any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences