0001102624-16-002591.txt : 20160425 0001102624-16-002591.hdr.sgml : 20160425 20160425080133 ACCESSION NUMBER: 0001102624-16-002591 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160425 FILED AS OF DATE: 20160425 DATE AS OF CHANGE: 20160425 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLICEL LIFE SCIENCES INC. CENTRAL INDEX KEY: 0001205059 STANDARD INDUSTRIAL CLASSIFICATION: GOLD & SILVER ORES [1040] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50112 FILM NUMBER: 161587915 BUSINESS ADDRESS: STREET 1: SUITE 2020 - 401 WEST GEORGIA STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6B 5A1 BUSINESS PHONE: 604-248-8730 MAIL ADDRESS: STREET 1: SUITE 2020 - 401 WEST GEORGIA STREET CITY: VANCOUVER BC STATE: A1 ZIP: V6B 5A1 FORMER COMPANY: FORMER CONFORMED NAME: NEWCASTLE RESOURCES LTD. DATE OF NAME CHANGE: 20081128 FORMER COMPANY: FORMER CONFORMED NAME: PAN AMERICAN GOLD CORP DATE OF NAME CHANGE: 20040521 FORMER COMPANY: FORMER CONFORMED NAME: TRI LATERAL VENTURE CORP DATE OF NAME CHANGE: 20021109 6-K 1 replicel6k.htm REPLICEL LIFE SCIENCES INC. 6-K replicel6k.htm


 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
 
For the month of April 2016
 
Commission File Number 000-50112
 
 
RepliCel Life Sciences Inc.
(Translation of registrant’s name into English)
 
 
Suite 2020 – 401 West Georgia Street, Vancouver, British Columbia V6B 5A1
(Address of principal executive office)
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.     Form 20-F [X]     Form 40-F [   ]
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1) [   ]
 
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
 
 


 
SUBMITTED HEREWITH
 
RepliCel Life Sciences conducts formal consultation review with Japan's PMDA and receives unprecedented review fee reduction
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
RepliCel Life Sciences Inc.
 
 
/s/ Brooke Hurford                           
Brooke Hurford, Secretary
Date: April 25, 2016
 

 


 
EX-99.1 2 exh99_1.htm EXHIBIT 99.1

Exhibit 99.1
 
 
NEWS RELEASE
 
RepliCel Life Sciences conducts formal consultation review with Japan's PMDA and receives unprecedented review fee reduction
 
Japan's Pharmaceuticals and Medical Devices Agency reviews RepliCel's pre-clinical, quality, and manufacturing data for its non-bulbar dermal sheath (NBDS) platform

VANCOUVER, BC – April 25, 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced that it met this month with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo. The meeting was a formal consultation review of the company's pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology.  This review is a required step in the process to obtain PMDA consent to perform a clinical trial in Japan.

"We have been very encouraged by the PMDA's collaborative approach and yet the absolute high standards of safety they maintain", stated R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. "The conduct of this consultation meeting moves the clinical-stage products (RCT-01 tendon repair; RCS-01 skin rejuvenation) being developed from our NBDS platform closer to the launch of Japanese clinical trials and partnerships", he added.

Furthermore, each consultation performed by the PMDA at the formal request of a potential clinical trial sponsor, carries with it associated fees which are lowered for academic institutions, hospitals, and small/medium enterprises. Additionally all documentation created for the consultation must be provided in Japanese.

Without any known precedent for doing so, RepliCel, on the advice of CJ Partners Inc., applied for the reduced-fee designation based on its small size and the pre-revenue nature of its business. The company was successfully awarded a reduced fee status which represents approximately one-tenth of the otherwise applicable fees.

"To the extent that CJ Partners knows, this is the first time that a foreign regenerative medicine company has qualified for the reduced price status with the PMDA", commented Colin Lee Novick, Managing Director of CJ Partners Inc.

"RepliCel continues to pioneer foreign participation in cell therapy development in Japan", said Buckler. "We are committed to early commercialization of our products in Japan and entering into a Japanese-based partnership for each product in our cell therapy portfolio."

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Company's product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries.


All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. The Company has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications.  Please visit www.replicel.com for additional information.

For more information, please contact:

CORPORATE:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

MEDIA/INVESTOR RELATIONS:
Jacqui Specogna
Telephone: 604-248-8730 / js@replicel.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements
Certain statements in this press release related to the Program are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "may", "should", "will", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe" or "continue", or the negative thereof or similar variations. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the number of Warrant Holders that may participate in the Program, the use of proceeds and final regulatory approval. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



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