06:33:29 EDT Thu 18 Apr 2024
Enter Symbol
or Name
USA
CA



Telesta Therapeutics completes pre-BLA meeting with FDA

2014-12-01 09:36 ET - News Release

Dr. Michael Berendt reports

TELESTA THERAPEUTICS ANNOUNCES KEY CLINICAL & CORPORATE UPDATES

Telesta Therapeutics Inc. remains on track with its internal objective of filing a biologics licence application (BLA) for marketing approval with the U.S. Food and Drug Administration (FDA) for MCNA 1 prior to March 31, 2015. Two recent key accomplishments include the completion of both a pre-BLA meeting with the U.S. FDA and a mock-audit of Telesta's MCNA manufacturing facility. As the result of the pre-BLA meeting, Telesta received written answers and verbal feedback to a number of clinical, manufacturing and regulatory items related to the filing of their BLA while the manufacturing "mock-audit" saw a third party firm complete a detailed and exhaustive review intended to simulate the type of audit that Telesta is expected to be subject to, by the FDA, during the course of a BLA review process.

Commenting on these achievements, Dr. Michael Berendt, chief executive officer and chief scientist, noted that: "We will continue to challenge ourselves and our expert consultants to ensure that the BLA that we ultimately file, will be the best BLA that we can produce. At this critical juncture in our history, nothing is more important than achieving our ultimate goal of delivering to non-muscle invasive bladder cancer patients who have failed first line BCG therapy, a new and efficacious therapeutic option."

In parallel, Telesta expects to conclude their third party assessment of the market opportunity for MCNA, in the United States, in the weeks to come. This market assessment, where qualitative and quantitative primary market research was conducted with payers (managed care organizations/decision makers both from the private and public sector) and urologists (community urologists and key opinion leaders), will address issues such as market size, pricing/pricing strategy and market access context/reimbursement potential for MCNA. These data will be key in assisting Telesta to make informed decisions concerning overall market potential and optimal licensing/partnering and/or commercial development strategy.

Telesta also announced today that its board of directors has accepted the resignation of Greg Gubitz as a director of the company. James Rae, chairman of the board of directors stated: "While Greg was a positive and thoughtful voice at the board and board committee levels, the board must acknowledge the voting results of the Nov. 12, AGM. We will be conducting a search for a new director in the weeks to come."

From today, going forward, Telesta Therapeutics will trade on the Toronto Stock Exchange under the new ticker TST. Telesta Therapeutics will also be announcing the launch of its new website in the weeks to come.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.