Press Release Telesta Announces Type A Meeting Results and Strategic Option Review
Monday, April 18, 2016
Telesta Announces Type A Meeting Results and Strategic Option Review
07:00 EDT Monday, April 18, 2016
MONTREAL, April 18, 2016 /CNW Telbec/ - Telesta Therapeutics Inc. (Telesta) today announced the outcome of its Type A meeting with the U.S. Food and Drug Administration (FDA), which was held via teleconference on Friday, April 15 th. Telesta's questions for this meeting were centered on whether the FDA would permit Telesta to resubmit their BLA for MCNA1 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 has 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 our 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.
Commenting on this strategic option process, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted:
"Since we received our Complete Response Letter with the U.S. FDA in February, we have been working closely with our board of directors, to identify strategic options that will deliver value for our shareholders in the event that commercial approval for MCNA in the United States would require another long term clinical study. This strategic option review includes the sale and/or merger of the company, the sale and/or licensing of our assets and the acquisition of commercial and/or pre-commercial healthcare assets that could be developed leveraging our current cash and human resources. This process is ongoing and will accelerate now that we have a definitive ruling from the FDA and may involve the engagement of an investment bank to assist and facilitate this review process.
My management team and our board of directors are acutely aware that one of our key assets is our current cash position of approximately C$44 million. As such, we continue to review and will implement additional cost reduction strategies in the near term and in the future as they are identified. A further report on these efforts will be made in conjunction with the release of our third quarter results expected the week of May 9 th."