The company said the agency did not raise concerns about the clinical trial data, safety or label for lebrikizumab, a monoclonal antibody for treatment of atopic dermatitis, or eczema. Lilly said it will work closely with the manufacturer and the FDA to address the issues cited by the regulator in its so-called complete response letter.
Creating hard tech is no walk in the park. The process is complex, the costs are high and the challenges are plentiful. But despite all that, it s still worth pursuing.