Biotech Values

[DewDiligence]

(RVNC)—More details on Evolus’ manufacturing setback:

https://www.fiercepharma.com/manufacturing/fda-finds-issues-daewoong-plant-will-make-evolus-botox-biosimilar

A highly redacted copy of the Form 483 shows the FDA noted a number of issues during its November inspection. The FDA raised concerns about the extent of the Daewoong plant’s investigation into black particles found in some batches of the sterile drug candidate, as well as its endotoxin method verification and its monitoring of aseptic process areas. There was also an observation about the potential for employees to access some computer programs and potentially alter or delete data.

Emphasis added. The above refers to the manufacturing plant in Korea owned by Daewoong, the company who makes DWP-450 for Evolus.