ETFs & Funds
View as an RSS Feed
Dynavax Technologies (
premarket after the FDA
its hepatitis B vaccine Heplisav, citing the need for additional safety data in healthy adults. DVAX says it's confident it can meet the request for more information, but
it may also fast-track a refiling
by first seeking approval for sick patients.
View news story
Not a good business strategy for DVAX to go to court.
Remember, in addition to the more safety data for adults, FDA also has asked to supervise additional data from DVAX's process validation program and to clarify information on DVAX's manufacturing controls and facilities related to the assurance of the quality of the commercial product.
Feb 28, 2013. 07:22 AM
Link to Comment