Novan, Inc. is eyeing an additional pivotal trial for its investigational treatment for acne vulgaris, SB204. The company concluded a guidance meeting with the FDA regarding SB204 in which the agency advised that an additional pivotal trial should be conducted. Given the need for the additional clinical study, the agency treated this meeting as a guidance meeting rather than a pre-NDA meeting. The Company anticipates receiving written minutes of the meeting within the next 30 days.
“We had a productive guidance meeting with the FDA regarding SB204. The meeting provided important clarity with regard to design for any future pivotal trial,” stated Kelly Martin, Novan’s interim Chief Executive Officer. “We intend to update the marketplace as to the next steps for SB204 after having had the chance to review and verify the final FDA minutes and incorporate that input into the overall Novan plan.“