Telesta Submits Type A Meeting Request To FDA; Cuts Staffing Levels

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Telesta Therapeutics Inc. (TST.TO, BNHLF.PK) said it has submitted a request to meet with the U.S. Food and Drug Administration.

Telesta also said that it has conducted a review of its discretionary staffing and expenditures. As a result, the company has reduced staffing levels by 15 percent, with most of these departures coming from Telesta's Montreal manufacturing facility.

Telesta noted that the "Type A" meeting request includes specific questions concerning the regulatory path forward for Telesta's therapeutic MCNA in the U.S.

MCNA is a biologic therapy developed to provide high-risk, non-muscle invasive bladder cancer or NMIBC patients who are refractory to or relapsing from first line therapy with Bacillus Calmette-Guérin or BCG, with a therapeutic alternative to surgery.

Based on FDA guidance, Telesta expects that the meeting or teleconference will be held within 30 calendar days at the FDA's discretion. The company intends to obtain clarity on what the FDA will require to consider commercial approval of MCNA for high-risk non-muscle invasive bladder cancer patients who have failed front-line BCG therapy.

Monique Champagne, Vice President Clinical and Regulatory, said, "Depending on the FDA's written responses to our questions, it may or not be necessary to hold the actual meeting with the FDA. It is also possible that the answers received to our first set of questions will require the preparation for and scheduling of a second meeting with the agency in order to be confident that the regulatory pathway in the U.S. is actionable for us or for a future partner for MCNA."

Further, the company said it has also reduced internal and consulting expenditures in order to ensure that cash reserves are conserved as the company conducts a full review of its strategic options.

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