- Dynavax (DVAX -9.7%) bulls are feeling a bit "penned in" this morning on the heels of an article just published by TheStreet's Adam Feuerstein delving into the prospects for FDA approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] after it canceled the Advisory Committee meeting to review the company's Biologics License Application (BLA). Normally, Ad Comm reviews are done ~45 - 60 days before the agency's action date (PDUFA). A positive vote by the majority of Committee members typically portends approval. The PDUFA date for the HEPLISAV-B BLA is December 15.
- On occasion, Ad Comm meetings are canceled, normally a bearish development, but there have been strong opinions on both sides of the aisle in this case. Mr. Feuerstein wondered if a historical look at previous cancellations would be informative on HEPLISAV'B's potential fate. An unnamed investor did just that.
- Going back to 2008, the FDA has canceled 15 previously scheduled Ad Comm meetings, 13 of which were eventual rejections. In the two cases where drugs were approved, Bristol-Myers Squibb's (BMY +1.2%) Yervoy (ipilimumab) and Celgene's (CELG +0.9%) Pomalyst (pomalidomide), the agency stated in its announcements that "...the issues for which the FDA was seeking scientific input of the committee have been resolved." Clear language implying that the agency had no lingering questions that needed answering before giving its nod to the products.
- The FDA's wording is a bit different for the rejections, mentioning the need to "review and resolve outstanding issues." Investors may feel like "China watchers" as they try to decipher the agency's intentions, but even the most ardent of bulls may want to put a hedge in place before mid-December.