Skew the Truth?
CEO bought 25k last year
And in o13
Oct 30, 2013 PHILLIPS PEGGY V
93,023 Direct Purchase at $1.08 per share. 100,464
Oct 30, 2013 KISNER DANIEL L
10,000 Indirect Purchase at $1.08 per share. 10,800
Oct 30, 2013 ORONSKY ARNOLD L
186,047 Direct Purchase at $1.08 per share. 200,930
Does this count?
Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did not fundamentally address the shortfall in the safety database. It was concluded that to do so would unnecessarily restrict the patient population that could benefit from HEPLISAV's approval;
The additional safety data collected would facilitate review for an indication in adults 18-70 years of age.
Briefing documents posted by the regulatory agency failed to demonstrate a mechanistic link between the company’s TLR-9 agonist and autoimmune response: Pooled results from two pivotal late-stage trials demonstrated the relative risk of developing a serious adverse event in patients treated with Heplisav was no greater than the group injected with the comparator vaccine Engerix-B, marketed by GlaxoSmithKline (GSK).
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.
The Advisory Committee voted 8 to 5 that the safety data is insufficient. So there were 5 members that voted clearly for the approval. From the 8 members that voted against the safety data, there were some that voted that a further test could be made POS-approval. I do not know the exact number who voted for that, but I remember to see at least 2 of them. If from 8 members, 2 voted against but accept a POS-approval test, that means that 5+2=7 member are for the approval of the vaccine even if a test is further necessary. That would mean that at maximum 8-2=6 members requested tests pre-approval. In other words the result of the voting was at least 7 for the approval and at maximum 6 against the approval.
NOW, about WOOTANG
This is his post to bfsworld just a year ago
• Jan 16, 2014 8:45 PM
Just joking .....
I know you are bored .
I am bag holder at 1.678.... I am not worried.
What 's you real position ? Should I continue talking non-sense to you?
Evaluation of New Vaccines: How Much Safety Data?”
American Journal of Public Health
Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service
Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines.
Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered.
The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions.
Summary: It was further proposed that a standard be set for minimum sample sizes in prelicensure randomized, controlled trials of any new vaccine (with new antigens) for which universal use is likely to be recommended and that 10,000 participants (vaccinees in combination with controls) might be the appropriate standard; sample sizes in studies focusing on vaccines used in the prevention of milder diseases might be higher.
Guys you know I'v made no bones about it, I'm long this stock have been for years. I can't speak for others but I'v done the DD and know the risk reward here. And I'm supporting my investment thus I am as you said the "Optimus"
On the other hand Character assassinations do not need to be true. 'Mud sticks' as they say and an accusation of wrong-doing is enough to sow the seeds of doubt in the minds of others.
Sly innuendos to dragging skeletons from old and hidden closets I can only guess are for the purpose of , anger , trading , shorting ?
May be " Fear " was a bad choice
Doubt might be better
I would suggest you read our going forward statement, you might get a few to " Doubt " their investment with that one
No Sir, I'm quite confident that combined our three phase III studies and the number of patients will appease the FDA
When your "Reporting Data" Is it ok to respond?
Are you pointing out that you fear the study size is not adaquate?
Thursday, January 15, 2015 at 10:00 a.m. Pacific Time (1:00 p.m. Eastern Time).
Eddie Gray, Chief Executive Officer of Dynavax, will provide a company overview and (update)