Dynavax Technologies Corp (DVAX)

[oldberkeley]

I'd strongly suggest that all current and any prospective DVAX investors listen to yesterday's presentation by the CEO at the J.P. Morgan Healthcare Conference.

http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=DVAX

Some highlights (my own quick transcription, so please forgive any errors):

*Continuing to work on EMA filing, anticipate approval next year.
*Strong cash position w/ moderate spending & significant revenues.
*Will solve U.S. patent situation either by negotiation or litigation [duh]

Most important, and the majority of the presentation dealt with this:

*Continuing talks with the FDA. Discussions are going well but they can't predict the outcome and most likely will not know before the Feb. 24 PDUFA date. "We are engaged in a certain amount of finger-crossing." [I can imagine.]
*Re HEPLISAV: stressed positive safety date equal to existing vaccines; much greater reliability than existing vaccines for high-risk population; will replace current HBV vaccines over time.
*Will focus on immunization of older (40+) diabetic population.
*No question that HEPLISAV is seen as highly-desirable by those people responsible for purchases because it offers higher, faster and more convenient immunization (2 injections over a month.)

Finally, this is somewhat of a subjective interpretation, but he seemed to suggest that they expect one of two things re the PDUFA: general population approval or restricted approval, not a CRL.