0000000000-20-004924.txt : 20200714 0000000000-20-004924.hdr.sgml : 20200714 20200602172833 ACCESSION NUMBER: 0000000000-20-004924 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200602 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Akers Biosciences, Inc. CENTRAL INDEX KEY: 0001321834 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 201 GROVE RD CITY: THOROFARE STATE: NJ ZIP: 08086 BUSINESS PHONE: 856-848-8698 MAIL ADDRESS: STREET 1: 201 GROVE RD CITY: THOROFARE STATE: NJ ZIP: 08086 FORMER COMPANY: FORMER CONFORMED NAME: Akers Biosciences Inc DATE OF NAME CHANGE: 20050325 PUBLIC REFERENCE ACCESSION NUMBER: 0001493152-20-009733 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]4>7!E+UA/8FIE8W0O0V]L;W)3 M<&%C92]$979I8V5',Z%$;3 BU,"VEA6J % M6J %6J %6J %6J %6O ]*WOEK(,D*\X#9H:[]P]6<&19EAU+^GP>RR(B(B(B M(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B+_-A\?'^_O[V]O;Z^OKR\' MGI^?GP[$AY="%(AB43AV^=.M%A$1$1$1$9$?2,H4S\_/CX^/]_?WOP[<'=E- MR6+L]?OW[ZCAZ>GI]?5504-$1$1$1$1$+N;M[>WIZ>GAX6&_WS<"Q:]?O^[O M[^.KQW.(\K]__VZJBLJ1,EY>7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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MS1Y.QEK+ QY8VY:'YFVP(C1Y-9,POL3DQ#2(3M[^*"ECY'MM6K^>2!![VM,] M;3"/#!Y?VF;.)9V$"8G9[ L^Z/K*RS[#K<. M?*6BHF("[^2F$]H_G:]U;0IE;F1S=')E86T*96YD;V)J"C$Q(# @;V)J"CP\ M+U1Y<&4O0V%T86QO9R]086=E6-E*2]07!E+T]B:E-T;2].(#4O3&5N9W1H(#(R-B]&:7)S=" R M.2]&:6QT97(O1FQA=&5$96-O9&4^/G-TR<5?!"] R&0G4BYDU+9"CKQZNKR=&0\TB9V>[<\D.$]O%XR_C M/[P\*?TGD!:._8A8ZX;=(+=-8>Z;^]=O4]I*FUILM)D:IQ]XU1U:W^5;YF4@,30O1FEL=&5R+T9L871E1&5C;V1E M/CYS=')E86T*>)QC8&#X_Y^1@9^!@9%)DH&!B8&#@0E$,#.F'()P64 $ V.! M&I#(ZH2(,3+F\P*Y^=8,(/#_/P _P@_"F5N9'-T')E9@HR.3 R. HE)45/1@H! end TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo June 2, 2020 Christopher Schreiber Executive Chairman Akers Biosciences, Inc. 201 Grove Road Thorofare, NJ 08086 Re: Akers Biosciences, Inc. Registration Statement on Form S-3 Filed May 22, 2020 File No. 333-238631 Dear Mr. Schreiber: We have limited our review of your registration statement to those issues we have addressed in our 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 this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Registration Statement on Form S-3 filed May 22, 2020 Prospectus Summary Overview, page 2 1. We note your disclosure that Premas Biotech PVT Ltd, your partner company, has successfully completed its COVID-19 vaccine prototype. Please update your disclosure to clarify the current clinical or pre-clinical stage of development of the vaccine product candidate and the jurisdiction. Make clear the possibility that the FDA may not accept clinical trials performed in other jurisdictions and may require additional testing. Please also balance your disclosure by stating that you will need to submit an IND to the FDA and complete all phases of clinical trials before you can apply to receive marketing approval for this product candidate. Christopher Schreiber Akers Biosciences, Inc. June 2, 2020 Page 2 2. If true, please also clarify that Premas has responsibility to develop the product candidate through proof of concept. 3. Please disclose the scope, jurisdiction and expiry date for each of the patents that are related to the COVID-19 vaccine product candidate. To the extent that neither you nor Premas have any patents related to the COVID-19 product candidate, please disclose. 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. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Alan Campbell at 202-551-4224 or Celeste Murphy at 202-551-3257 with any questions. Sincerely, FirstName LastNameChristopher Schreiber Division of Corporation Finance Comapany NameAkers Biosciences, Inc. Office of Life Sciences June 2, 2020 Page 2 cc: Rick A. Werner, Esq. FirstName LastName