6:02AM Dynavax Technologies receives FDA Complete Response Letter on HEPLISAV Biologic License Application; indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group (DVAX) 2.97 : Co announced that it received a Complete Response Letter (CRL) from the FDA regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events. However, the Agency indicated its willingness to continue discussions regarding a more restricted use of HEPLISAV. Co plans to discuss the CRL with the FDA to identify the most expeditious path to approval for HEPLISAV, particularly in adults who may receive the greatest benefit from HEPLISAV. Furthermore, the FDA requested additional data from Dynavax's process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product. Dynavax believes it can provide the information but the exact timeframe for its response cannot be determined until it has met with the Agency. Co plans to meet with the FDA to discuss the steps necessary for potential approval of HEPLISAV and currently believes the meeting can take place within 6 weeks.
DVAX in the beginning wanted to submit BLA only for age group 40+ but FDA insisted them to submit for 18-170. DVAX is victim of GSK's dirty politics, you can not beat powerhouse like GSK. Would like to see GSK buy DVAX