0000000000-21-006324.txt : 20210707 0000000000-21-006324.hdr.sgml : 20210707 20210519113007 ACCESSION NUMBER: 0000000000-21-006324 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20210519 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: CytoDyn Inc. CENTRAL INDEX KEY: 0001175680 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 753056237 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 BUSINESS PHONE: 360-980-8524 MAIL ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 FORMER COMPANY: FORMER CONFORMED NAME: CYTODYN INC DATE OF NAME CHANGE: 20031114 FORMER COMPANY: FORMER CONFORMED NAME: REXRAY CORP DATE OF NAME CHANGE: 20020617 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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P(&]B:@H\/"]&:6QT M97(O1FQA=&5$96-O9&4O5'EP92]/8FI3=&TO3&5N9W1H(#(R-2]&:7)S=" R M.2].(#4^/G-T8 %/F2VY<;8,YUV"-D.4?&+V1?$KR^3_69XR6 ^'7J!"UC>^ MX%1I(U^+C>LXOE2ALU[-?1T:YUNU=7[FH[OW3Z'*\-W\07IW3=SE$ET^"M?^ ML7G$FPS8S$#Z TSMB7L*96YD()%=!!%C9,Q;#.3F760 M@?__ 1ND">D*96YD'0M-2XT+C4* TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo May 19, 2021 Michael Mulholland Chief Financial Officer CytoDyn Inc. 1111 Main Street, Suite 660 Vancouver, Washington 98660 Re: CytoDyn Inc. Form 10-K for the Fiscal Year ended May 31, 2020 File No. 000-49908 Dear Mr. Mulholland: We have limited our review of your filing to the financial statements and related disclosures and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments 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 comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Form 10-K for the fiscal year ended May 31, 2020 Note 2 -- Summary of Significant Accounting Policies Inventories Procured or Produced in Preparation for Product Launches, page 84 1. We note your response to prior comment 1. Please expand your proposed disclosures to clarify that, due to their RTF letter, the FDA has not yet commenced their review of your BLA, including leronlimab's safety and efficacy. Ensure you also discuss and update the risks and uncertainties surrounding market acceptance and salability of leronlimab in your future periodic reports. 2. We note your response to prior comment 4 from our letter dated February 18, 2021. Given the significant delays in resubmitting your BLA, please expand your disclosures to provide detailed disaggregated information related to the remaining shelf lives of your inventory. As of each balance sheet date, please quantify the remaining shelf life of your raw materials, finished drug product in vials and bulk drub substance. To the extent material, separately quantify raw material that has a 12 month shelf life from raw materials with longer shelf lives. Please also disclose the point at which inventory may no Michael Mulholland CytoDyn Inc. May 19, 2021 Page 2 longer be accepted by potential customers due to limited remaining shelf life. In closing, 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 Jeanne Baker at (202) 551-3691 or Terence O'Brien at (202) 551-3355 with any questions. FirstName LastNameMichael Mulholland Sincerely, Comapany NameCytoDyn Inc. Division of Corporation Finance May 19, 2021 Page 2 Office of Life Sciences FirstName LastName