The FDA approval decision date -- the PDUFA -- for Dynavax's Heplisav hepatitis B vaccine is Feb. 24. I predict approval. The FDA may place some restrictions on Heplisav initially -- patient age or other risk factors -- but those could be lifted once Dynavax submits additional clinical data in hand already. (No new clinical trials are necessary.)
"What is AF's stats in calling approvals? - If you follow Arena he is not one to trust at all."
He is widely followed and is not afraid of stepping on toes. His scientific base is limited, but he is pretty savvy when it comes to the regulatory side of the equation. He is right more than wrong and he mostly gets tripped up when FDA deviates from prior precedent. I saw his article and bought more in the premarket, still a fairly small position.
Going into the adcomm last year the presumption was a positive outcome. The FDA briefing document did not raise any red flags. The 12 month pps high is $5.34. So rolling into the PDUFA date I see momentum pushing the pps into the gap, into the high $3's as outcome expectations readjust upward. Management confidence coupled with the closeness of the adcomm vote still leads me to expect a partial approval with a clear pathway to a full approval. If that is the outcome, it will be interesting to watch the market reaction.