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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Comment by JD2016on May 28, 2016 9:58am
228 Views
Post# 24912750

RE:Is there anything left after the FDA rejection....

RE:Is there anything left after the FDA rejection....Read the following excerpt from Telesta's MDA as at March 31st, 2016. This will give you a quick analysis of the Companys position. Telesta was formed on September 1, 1999 through an amalgamation of Bioniche Inc., Renaissance Life Sciences Inc. and Vetrepharm Animal Health Inc., pursuant to articles of arrangement issued under the Canada Business Corporations Act. The Common Shares have been traded on the TSX since February, 1992. Company shareholders approved a name change on November 12, 2014 and on November 24, 2014, the Company was rebranded as Telesta Therapeutics Inc. from Bioniche Life Sciences Inc. While at its formation the Company was primarily an animal health company, some of the Companys proprietary technologies were found to have potential human health applications. Following a strategic decision to focus on Human Health and the engagement of a new Chief Executive Officer and Chief Scientist, in November 2013, Telesta has successfully executed on this strategy. It sold its Animal Health business in April 2014 to Vtoquinol SA and it engaged a specialized U.S. broker, PharmaBioSource, Inc. (PharmaBioSource), to sell its vaccine business (One Health Inc.) and associated property and manufacturing facilities located in Belleville, Ontario, as more fully described below. The Company has established a corporate office together with associated administrative functions in Montreal, Quebec near where the manufacturing site for its bladder cancer drug MCNA1 , is located. Substantially all of Telestas administration and operations are now localized in Montreal, Quebec and all of the Companys business is focused on Human Health. In July, 2014, the Company announced that the U.S. Food and Drug Administration (FDA) provided written guidance on the regulatory pathway for potential MCNA approval in the United States. This guidance permitted the submission of a MCNA Biologics License Application (BLA) for U.S. marketing approval based on the Company's existing clinical trial data set. In accordance with this feedback Telesta engaged a regulatory consulting firm that assisted in the review and final preparation of the BLA. The BLA was submitted to the FDA on June 29, 2015, and the BLA was accepted for filing by the FDA and designated for Priority Review on August 28, 2015. At the same time, the FDA indicated that they would be organizing an advisory committee to review the BLA and initially set February 27, 2016 as their review goal date or the date by which the FDA was targeting to render its final decision concerning the approval of MCNA for commercial sale in the United States. The FDA subsequently changed the review goal date to February 26, 2016. On September 28, 2015, Telesta announced receipt of a notice from the FDA confirming that they had organized an advisory committee to review Telestas BLA to be held on Wednesday, November 18th. On November 19, 2015. Telesta announced the results of the FDAs advisory committee organized to discuss the safety and efficacy of Telestas BLA for MCNA where panel members voted 18 no to 6 yes, with no abstentions, on the following question: Does MCNA have an overall favourable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing? On February 1, 2016, the FDA issued a Complete Response Letter in response to Telestas BLA for MCNA. In this letter, the FDA communicated that at least one additional clinical trial for MCNA would be necessary to adequately establish MCNAs efficacy and safety. Telesta subsequently requested a Type A meeting, which was held on April 15, 2016. Telesta's questions for this meeting were centered on whether the FDA would permit Telesta to resubmit their BLA for MCNA under Accelerated Approval, with a more restricted label. Based on their review of Telesta's regulatory filing and the additional information provided by Telesta in the briefing package prepared for the Type A meeting, the FDA ruled that any potential commercial approval of MCNA would require an additional Phase 3 clinical trial to be completed prior to resubmission of the MCNA BLA. Telesta currently estimates that U.S. Regulatory approval for MCNA could not be obtained for a period of at least 5 years and possibly longer depending on the exact clinical trial design and required patient follow-up period. As a result, and in the interest of building earlier value for shareholders, Telesta has determined that it will not pursue another Phase 3 clinical trial on its own. Rather, the Company will seek a partner for the future development of MCNA in the U.S. and accelerate its review of other strategic options in order to best preserve and utilize its strong cash position. As part of this succession plan for MCNA, Telesta will continue to work with the FDA in the months to come to precisely define the exact parameters of the clinical trial that will be acceptable to the U.S. FDA so that the exact costs and timeline of the trial can be quantified for the eventual partner or third party. Telesta is reviewing the Companys strategic options that will best leverage the Companys expertise, assets, and financial and human resources to create value for shareholders.
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