Where is the door? How does Eddie open that big red door? I have been focused on EMA for the last year+ and FDA for 4 years now, I have paid little to no attention to Asia.
Hey guys, what do we know about Asia? I was poking around, trying to find some information and found very little. FDA is what it is, EMA is on the horizon, but what about asia? There was a phase 3 trial run over there- article below:
BERKELEY, CA -- (MARKET WIRE) -- 03/13/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that results of an early Phase 3 trial (HBV-04) of HEPLISAV™ investigational hepatitis B vaccine were published online in the journal VACCINE. The article concludes that HEPLISAV was well-tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine.
The article, entitled "Demonstration of Safety and Enhanced Seroprotection Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B® in 412 adults 40-70 years of age. The seroprotection rate at one month after the second dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p
Did you call it, or what... for #$%$ sake!
You see the block trades going through? This aint retail my friend! A slice indeed!!!
Should shake the short tree! Someone is buying the AH's sell... Eddie is moving fast! He has a plan... Sail is set!
I'm glad I tagged onto your trade and added to my position. Things are looking good. Should be one news release after another for the next 6 months to a year sending us gradually higher. Eddie put on a great CC...
Does this #$%$ work? You spout off nonsensical #$%$ with an obvious attempt to make yourself sound illiterate... Are you trying to sway DVAX investors? Are you a short? I cannot imagine you have ever invested in anything in your life... You are so #$%$ terrible at what you are doing! I imagine most people feel as I do, you are a joke! A caricature! Possibly a 14 year old white male that watches reruns of "What's Happening" for source material! Do you honestly think any of us would SELL based on your words -- well, whatever they are... just give it a rest! Maybe every 4 days... not post after post! You are wasting your time!
He continually says (today as well) - "we will be exploring ALL possibilities" - in reference to funding! I am right there with you Jack!
Sentiment: Strong Buy
I don't know how I missed this new job post here in the US posted 9/25/13.
Manage and lead all aspects of more than one Phase 1 to 4 clinical trials including, but not limited to protocol development to final report, regulatory filing and/or publications, trial start-up, conduct, and close-out activities in order to achieve program objectives and goals. This level may lead the efforts with clinical service provider selection.
The incumbent will use professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective ways as well as effectively build and maintain partnerships with stakeholders internally and externally. This position will act independently to determine methods and procedures on new assignments and provides guidance and oversee the activities of team members and support staff. Works on complex problems in which analysis of situations or data requires an evaluation of intangible variables and exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Perhaps we are getting to close to an announcement!
A lot of things are coming together! It is that time!
Jack, you have been the backbone of this board for some time now -- thanks for all of the info. -- Remember, every day is one day closer to EMA!
Hey Black, SHUT THE #$%$ UP ALREADY! This is a stock message board, you #$%$ fruit! Take your wife, and your home sale, and now your kid going to the library and your #$%$ BLOOD DONATIONS (are you kidding me) and shove them up your #$%$! STOP talking about moronic #$%$ and to moronic people about NOTHING having to do with DVAX! Do they not have some FRUITY #$%$ BOARD somewhere that you can ramble on about picking tulips and farting with bulls? This aint it! I mean for #$%$ sake, you are such a #$%$ drag on this board, I cannot believe it! Now your fruity friends, lawquaneshianita and the #$%$per man are holding your hands!!! #$%$ fantastic!!! They are multiplying! You attract idiots and morons,.. WHY might you ask? BECAUSE YOU HAVE NOT TRIED THE COCAINE! You need a drug habit more than anyone I know! Just shut up about EVERYTHING that is not related to DVAX! Do some coke, take your Vietnamese wife, your son, your home sale proceeds, your library card, your blood donations and your feed the needy campaign to your local church and confess your cocaine habit to a priest! Take your time, for #$%$ sake!
9/24/2013 Job opening: DE-NW-Düsseldorf
This position is for a Process Engineer Downstream Processing, reporting to the Director of Process Engineering. The Process Engineering group’s mission is to apply engineering expertise to implement, maintain, and improve Equipment, Facilities, and Utilities systems capabilities to enable reliable manufacture and release of drug substance. The department is tasked with the overall process Validation program, the CPV program and monitoring and trending of process data.
The process engineer will work on cross-functional project teams, providing engineering leadership and support in the delivery of expense/capital projects and engineering services at the Düsseldorf Manufacturing Facility.
The Process Engineer will provide engineering support to the Downstream Processing part of the HepB commercial manufacturing scale process.
The process engineer will be involved throughout the project life cycle of launched equipment as well as initiation, design, construction, implementation, commissioning and qualification of new equipment
The FDA has established goals that it shoots for when making decisions: currently 10 months for a standard review and six months for an accelerated review. There’s lots of back and forth between the agency and the drugmakers during that time.
The EMA, on the other hand, issues questions to drugmakers during the review process, which stops the clock. The agency shoots for a decision within 210 days — about seven months, excluding clock stops.
The FDA elicits the help of outside experts during advisory-committee meetings, but it isn’t bound to the recommendations the committee makes. The EMA relies on the Committee for Medicinal Products for Human Use, or CHMP, but don’t be fooled by the “committee” part: CHMP doesn’t play the same role as an FDA advisory committee.
In fact, CHMP is essentially the equivalent of the FDA. Technically, CHMP makes recommendations to the European Commission, but the EC’s decision is nothing more than a rubber stamp. The only example I know of where the EC didn’t ratify a CHMP recommendation is Johnson & Johnson’s (NYSE: JNJ ) antibiotic Zeftera, where new information came up between the recommendation and the EC approval. CHMP revisited its decision, eventually recommending against approval.
In 2008, Merck’s (NYSE: MRK ) Cordaptive was approved by the EMA based on its ability to lower cholesterol levels, but before approving the medication, the FDA asked Merck to run an outcomes trial, which the company is still in the process of completing.
The FDA rejected InterMune’s (Nasdaq: ITMN ) Esbriet because the drug worked in only half of the phase 3 trials. CHMP recommended approval and the EC concurred; apparently the lack of treatment options for idiopathic pulmonary fibrosis patients trumped the lack of concrete data.
If the FDA and the EMA were teenage girls, the EMA would be the head cheerleader and the FDA would be that scary goth girl no one talks to. Put bluntly, the EMA’s standards are a little more lax than the FDA’s.
Cookies... the inside word is that Daum expected a basket of freshly baked cookies... and a foot massage before panel discussions commenced... So, what is DVAX and it's 160 employees doing, you ask? RECIPES and MASSAGE OIL! Do you know how many choices there are? It blew my friggin mind -- Jack, I call and email IR every 30-90 days to poke and prod! Not a lot to report... Obviously no details or breaking news. We all get the good stuff at the same time! All we can do is speculate! Is Eddie working with the FDA as I type, agreeing on protocols? Is Eddie stalling the FDA, pending EMA news? Is the FDA the one dragging it's feet (realizing they want the drug, and need a way around the panel and Daum)? Knowing a bit about Eddie, I am still betting that he is going ALL IN on Europe! That is his backyard. You know his resume as well as anyone on this board - EMA is still the key! While we are all waiting, perhaps a few "dip" buys are in order! Shaft has the right idea! We all want some news - but let me ask you this - would a press release saying, "We are still working out the protocols with the FDA, more to come later" - be good news? The speculators and critics would have a field day. Silence is not always a bad thing! We either have a certain amount of trust/respect in Eddie and the Board and HOLD, or we don't and we SELL or short! I am holding all of my shares! A little #$%$ off... but holding none the less!!!