Naturecell applies to US FDA for 'JointStem' Phase 2b/3a clinical trial plan

[Asia Economy Reporter Geum Bo-ryeong] Naturecell announced on the 18th that it has applied to the US FDA (Food and Drug Administration) for a Phase 2b/3a clinical trial plan for severe degenerative arthritis JointStem in the United States.

Naturecell stated, "According to the US Biotechnology Innovation Organization, the probability of clinical trial drugs receiving final approval as pharmaceuticals by the FDA from 2006 to 2015 over a 10-year period is about 10%, with the likelihood of passing each clinical phase being 30.7% for Phase 2 and 58.1% for Phase 3. There is a possibility that the results during the clinical trial and product approval process may not meet expectations, and accordingly, there is also a possibility of changing or abandoning commercialization plans."

The clinical trial is planned to be conducted on a total of 140 patients (70 in the experimental group and 70 in the control group).

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