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Actionable news in DVAX: Dynavax Technologies Corporation,

My Latest Take On Dynavax Technologies - Read Before Market Open Tuesday 0 comments

"Fear cannot be banished, but it can be calm and without panic; it can be mitigated by reason and evaluation." Vannevar Bush

My "mailbag" has been dominated over the past 72 hours around questions concerning small cap biotech Dynavax Technologies (NASDAQ:DVAX). This stock dropped over 30% on Friday after the Ad Comm panel for the company's hepatitis B vaccine in Mid-November was unexpectedly cancelled. I added a third to my position at $11 a share late in trading Friday as this seemed a substantial overreaction. I think I will be hitting myself tomorrow for being so timid.

(click to enlarge)

Another contributor and PhD, Theodore Cohen, posted this today on an article of mine around Dynavax after reading through Dynavax's announcement around the decision that came out Sunday. It is a good take on the Ad Comm decision I think.

Summary:

1. Review is proceeding apace. The VRBPAC meeting was cancelled and remaining questions will be addressed between Dynavax and the review team via the normal process.
2. The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.
3. FDA will review the overall immunogenicity data from HBV-23, the company's most recent pivotal Phase 3 trial, to support the proposed indication for adults 18 years of age and over.
4. The Agency has decided it will not review immunogenicity data related to sub-populations...


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