WASHINGTON: In a new twist to the ImClone tale, the FDA is close to allowing embattled biotech company to resubmit its clinical trial data for Erbitux, a treatment for colon cancer.As soon as the FDA announces its decision, the Colorectal Cancer Network (CCN), a nonprofit group composed of colorectal cancer survivors and their loved ones, is prepared to restart its communications efforts to move the drug through clinical trials.
Priscilla Savary, executive director of the CCN, said, "We want to make sure that everyone diagnosed with colon cancer is educated about whether clinical trials are something they should look into or not."
The much-hyped Erbitux was dealt a blow when the FDA refused to accept its letter of application for phase II clinical trial. Congress and the Justice Department then investigated whether the company had committed any improprieties.
Before the controversy, the CCN was promoting the treatment, sending its members to Capitol Hill to speak with Congress, writing letters and testifying before the FDA, and talking with the media.
The group has hundreds of volunteers whose purpose is to help raise awareness of colon cancer among the public. Savary is also looking for volunteers with media relations skills.
See feature, p.19.