No problems with approval
The TLR science has been proven valid.
The presence of Merck, GSK and AstraZ ALL validate that the TLR science is genuine.
GSK, Merck, AstraZ Become prospective Buyers or royalties will be
Without A control arm I believe there is only a month in the interim between first and second shots and the 1 year follow up should commenced.
The FDA should be willing to allow for interim analysis of the safety data.
We should get A peak at the safety data soon .
If we went by the world's definition of who We are supposed to be because We appear weird...
'Well, surely, this guy can't have a productive life, surely, he doesn't have a sense of humor. Surely, he can't love life.'
We stereotype people in this world. And so... if the world thinks you're not good enough, it's a lie, you know.
Get a second opinion.
Did you buy back in ?
"That hadn't been Performed"
It was more like " UHA, I don't know"
It was a Sad Day for sure*
If a study of only one gender or minority group or subpopulation is proposed, there must be a scientific justification for limiting the diversity of the study population, such as high prevalence of the condition, unique disease characteristics, or gaps in knowledge in the select population.
The risk of African-Americans contracting HBV is three times greater than that of whites. Committee chair Robert Daum, MD, expressed concern “that there’s not enough data from different ethnic groups to be sure the immunogenetic response [of heplisav] is adequate.”
On average, the ethnicities in the two phase-3 trials containing 4,800 participants were White (87.8%); Black (8.8%); and Hispanic (4.3%). However, it’s important to remember that last year blacks and those of Hispanic or Latino origin comprised only 13.1% and 16.7% of the U.S. population, according to U.S. Census Bureau data.
2nd Phase 3 trial is "out of the woods" with no case of Wegeners SAE
Just a feel good point to counter your post.
Key catalysts for DVAX’s stock are,
“1) the first of three DSMB safety assessments of the Phase III HBV-23 study of vaccine Heplisav in hepatitis B during fourth quarter 2014;
2) top-line data from the Phase I IST study evaluating SD-101 in relapsed lymphoma patients anticipated in late 2014 or early 2015;
3) the second of three DSMB safety assessments of the Phase III HBV-23 study expected in first half 2015; 4) the third of three DSMB safety assessments of the Phase III HBV-23 study expected in second half 2015; 5) proof-of-concept data for AZD1419 in asthma expected during second half 2015; and 6) top-line results from the HBV-23 study expected in fourth quarter 2015.”
Rave asks WHY?
There are two great days in a person's life - The day you are born and the day you discover WHY
I'm more curious of timing?
The Father of Hep-Lisa-V announced Resignation And just 4 Working days later Grey PR's a new study.
Just another move in the Challenging game of Dynavax.
You must have chips to play*
Good Morning *
Why are we here?
In short, attempts to explain the nature of the universe, its origins, and what’s really going on require an understanding of how the observer, our presence, plays a role. According to the current paradigm, the universe, and the laws of nature themselves, The story goes something like this: From the Big Bang until the present time, we’ve been incredibly lucky. This good fortune started from the moment of creation;
There is no way to remove the observer — us — from our perceptions of the world … In classical physics, the past is assumed to exist as a definite series of events, but according to quantum physics, the past, like the future, is indefinite and exists only as a spectrum of possibilities.”
You hang out at the Dolla Store?