Seneca Biopharma Announces Results of Meeting with FDA Regarding the Design of Phase 3 Trial for NSI-566 in ALS
Seneca Biopharma, Inc. (SNCA)
Company Research
Source: PR Newswire
GERMANTOWN, Md., April 9, 2020 /PRNewswire/ -- Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today announced that the company held a Type C meeting with the Office of Tissues and Advanced Therapies at the FDA on March 10, 2020 to discuss future clinical development plans for NSI-566, the company's leading neural stem cell therapy candidate, for the treatment of patients with amyotrophic lateral sclerosis (ALS). As a result of the discussion and feedback received from the FDA, Seneca believes that the existing phase 1 and 2 trial results support moving into a phase 3 clinical study for ALS. "This represents a major step forward in getting our potentially beneficial therapy to patients who suffer from this devastating disease," said David Recker, M.D., Chief Medical Officer for Seneca. "We received significant guidance from FDA regarding an acceptable trial design and are
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