Tag Archives: CRL

10 Reasons Why FDA Will Approve Dynavax’s Heplisav-B

Here is my 10 reasons for my approval opinion/speculation on Dynavax's Heplisav-B.

  1. Higher rate of protection
  2. Better regime/compliance. Two dose one month vs. three dose six month.
  3. Immune-compromised patients.
  4. CpG is safe. REMS plan in place.
  5. Safety is less a problem. Safety.
  6. Competitor is still years away. Sci-B-Vac
  7. TLR9 will be part of history, as the immuno-stimulatory component of Bacteria BCG
  8. 100% Vaccine in NDA stage are eventually approved
  9. Two months after AdComm cancellation still no complete response letter.
  10. 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.