Selecta Biosciences’s Reports the US FDA's Clinical Hold on the P-I/II Clinical Trial of SEL-302 for the Treatment of Methylmalonic Acidemia
Shots:
- The US FDA has placed a clinical hold on the P-I/II clinical trial of SEL-302 in patients with MMA
- On Nov 23, the US FDA notified the company of the clinical hold via a letter & recommends the updates of additional information on the chemistry, manufacturing, and controls related to the MMA-101 product
- The company plans to work closely with the US FDA to address the requests for additional information and will provide an additional update in 2022
Ref: Selecta Bioscience | Image: Selecta BIoscience
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