Replies to post #123667 on Biotech Values

[biomaven0]

>>DVAX

I assume this will be enough to preclude FDA approval

Not what the company said on their call. They claim this was not a manufacturing issue as evidenced by the fact that the mean immunogenicity response was fine and later data points for that lot were also fine. Instead they say they underestimated the standard deviation of the response for this population.

They also claimed that Prevnar 13 was approved despite similar issues in some titers (they cited the FDA review documents) and some other approved vaccines also allowed a wider range.

They seemed to be claiming that it is likely the FDA will give them a pass here, and if not they can run a confirmatory trial without pushing back their previous timeline for the NDA.

Hard for me to know how much is spin as I'm not a vaccine guru. Does it really even matter if some folks have a greater response to a particular lot than normal at one time point but have a consistent response at later time points?

I suspect this will prove to be a buying opportunity. This vaccine with a decent partner should take the market.

Peter

[biomaven0]

>>DVAX

I assume this will be enough to preclude FDA approval

As I commented at the time, I disagreed with this assessment and said the weakness would prove to be a buying opportunity:

FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots

Companies:Dynavax Technologies Corporation
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DVAX 2.43 0.00

Press Release Source: Dynavax Technologies On Thursday July 28, 2011, 8:00 am
BERKELEY, CA--(Marketwire -07/28/11)- Dynavax Technologies Corporation (NASDAQ: DVAX - News) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."

According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected, the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we just announced. With their concurrence, we can now move forward towards our goal of preparing a BLA for submission by the end of the year for hyporesponsive populations aged 40 and older."

[DewDiligence]

GILD, GlobeImmune ink collaboration to develop therapeutic vaccine for HBV:

http://finance.yahoo.com/news/Gilead-and-GlobeImmune-bw-1970275793.html?x=0&.v=1