12:11:17 EDT Sat 13 Jul 2024
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or Name
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Telesta Therapeutics Inc
Symbol TST
Shares Issued 301,556,586
Close 2016-02-02 C$ 0.09
Market Cap C$ 27,140,093
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Telesta's cancer candidate needs more testing, says FDA

2016-02-02 12:09 ET - News Release

Dr. Michael Berendt reports

TELESTA THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM FDA

The U.S. Food and Drug Administration (FDA) has issued a complete response letter to Telesta Therapeutics Inc.'s biologics licence application (BLA) for MCNA. In this letter, the FDA communicated that an additional phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.

Dr. Michael Berendt noted: "We are very disappointed with the FDA's decision. Since we began our dialogue with the FDA in February, 2014, we have clearly communicated that we believe that MCNA is a safe and efficacious agent for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed front line BCG therapy. The FDA decision, at this point, to require an additional clinical trial is a setback for underserved bladder cancer patients, our dedicated staff and our investors who have funded our efforts to obtain MCNA approval in the United States. MCNA would have been the first new bladder cancer therapeutic to reach the market since 1998.

"We will, over the next few months, work closely with the FDA, our advisers and our development partners to analyze the clinical and regulatory path forward in the United States and Europe, as well as the current competitive landscape, and the costs and timelines to conduct a second phase 3 trial for MCNA. In parallel, with our board, investors and advisers, we are carefully analyzing the multiple strategic options that can best leverage our financial and human resources to create value for our shareholders. The current climate of uncertainty in the financial markets has created opportunities for well-capitalized companies that were simply not available even a few months ago."

Telesta Therapeutics will be reporting its second quarter financial results for the six-month period ending Dec. 31, 2015, on Feb. 12, and will at that time confirm the timing and details of a management conference call to provide a corporate update.

We seek Safe Harbor.

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