Here is my 10 reasons for my approval opinion/speculation on Dynavax's Heplisav-B.
- Higher rate of protection
- Better regime/compliance. Two dose one month vs. three dose six month.
- Immune-compromised patients.
- CpG is safe. REMS plan in place.
- Safety is less a problem. Safety.
- Competitor is still years away. Sci-B-Vac
- TLR9 will be part of history, as the immuno-stimulatory component of Bacteria BCG
- 100% Vaccine in NDA stage are eventually approved
- Two months after AdComm cancellation still no complete response letter.
- Market sentiment is so negative. FDA will surprise everyone.
The main concern right now is the potential imbalance of "new onset" autoimmune events. Overall efficacy and safety profile of Heplisav-B will suggest approval.