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The current air quality nightmare in Beijing says it all about the difficulties facing a society that is fundamentally pre-industrial age trying to bridge the gap to the 21st century in one heedless, reckless, negligent and myopic leap.
Re DVAX, some possible strategies: Currently at $3.25. William Blair analysts just predicted a limited approval on Feb. 24 with a price target of $5.
http://seekingalpha.com/article/1109311-william-blair-analysts-are-gaining-comfort-ahead-of-dynavax-s-heplisav-pdufa
IMHO, FWIW: one month run-up to at least $4 is likely, so it's a darn good trade from here. At that point, I’d have my finger on the trigger. Would not hold through PDUFA! If limited approval, sell that day ($4.50 - $5 ???). If no approval, it’ll drop but not drastically (that already happened after the November ADCOMM meeting) probably to the high $2’s.
At that price it would be a great longer-term hold, because after one more safety study it should be fully approved in 2014, target $8 - $10.
DVAX: William Blair analysts predict restricted-label approval with price target of $5.
http://seekingalpha.com/article/1109311-william-blair-analysts-are-gaining-comfort-ahead-of-dynavax-s-heplisav-pdufa?source=feed
FWIW, I agree.
William Blair Analysts Are Gaining Comfort Ahead Of Dynavax's Heplisav PDUFA
http://seekingalpha.com/article/1109311-william-blair-analysts-are-gaining-comfort-ahead-of-dynavax-s-heplisav-pdufa?source=feed
Their opinion is that the most likely outcome is a restricted-label approval with a price target of $5. FWIW, I agree.
Thanks much.
Perhaps OT, and I'm not singling out ARQL here, but I think that there's a lot of truth to AF's tweet about excuses and rationalizations for failed studies.
ARQL: Do you see this as a buying opportunity, and will you be buying? TIA.
you have got this one down path!
And you deserve a path on the back!
Mouton- I eagerly await your comprehensible translation of this. And at all costs, avoid the use of the word cabined.
OT: Why don't the courts stop pussyfooting around and go back to issuing all their opinions in Latin like they really want to do, it would be even more unfathomable.
GILD has been an absolute monster lately and it's a fantastic addition to a person's long-term portfolio.
They're the company that bought YMI last month. Also, they're doing a 2-for-1 split in a couple of weeks.
DVAX: Could not agree more. Total uncertainty (CEO said the other day that they themselves were crossing their fingers!) As you say, it's all about the FDA run-up. Also going to sell before the PDUFA date, no way I'd hold through.
Best of luck.
DA- No, I'm not currently in any specific flu play, although from what I've been reading and seeing on TV that angle could certainly be a lucrative one!
The only thing that immediately comes to mind is the most widely-used vaccine, Tamiflu by Gilead (GILD).
DVAX is usually on the list of bird flu stocks. They're working on a Universal Flu vaccine that offers protection against various strains and increases the efficacy of standard vaccines when combined with them. Novartis is supplying the standard vaccine, DVAX the proprietary component.
This is all Phase I stuff, not the current bone of contention and PPS-driver which is their Hepatitis B vaccine HEPLISAV, PDUFA date of Feb. 24.
I might be wrong on this, but weren't both Bonds and Clemens legally exonerated on the steroids charges?
I agree with you that baseball should have anticipated this, but it's a slippery slope when we start mixing actual athletic accomplishments and statistics with morality judgments (Ty Cobb was a racist, Babe Ruth was a philanderer, etc.)
As a lifelong baseball fan, going back to the '50s Yankees, I have very mixed feelings about today's voting.
I just watched a short segment on PBS about the issue. A columnist from The Washington Post pointed out that while the players in question obviously and undeniably are all-time greats and would normally be first round inductees, baseball is the only sport that includes character in its Hall of Fame criteria.
I may be wrong, but I believe that OJ Simpson is still enshrined in Canton!
Again, not sure what to think about this.
I apologize for any misunderstanding that we may have had earlier.
I think that we both can agree that indeed it is looking very strong, and that it should continue rising until the PDUFA date.
Whether it gets a CRL, restricted approval or full approval is anyone's guess, and as the CEO himself said yesterday, "We've all got our fingers crossed."
Best of luck.
No, I've never owned the stock, if that's what you mean. I just read the board occasionally because I'm interested in biotech, and in general investor behavior and psychology.
OT: I was a Realtor, broker and owner for many years. Glad for you that business is picking up.
Basing Food Safety Standards on Science and Prevention
https://blogs.fda.gov/fdavoice/
January 8, 2013 by FDA Voice
By: Margaret Hamburg, M.D.
Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.
That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.
The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination.
These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.
These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.
In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad [bolding mine]. We need a strategy that will address all of these complexities and challenges.
In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.
We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.
I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.
FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.
Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.
Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration
I was literally just about to post the same thing.
They're serial offenders, bastardizing a process intended to protect public health for the sole purpose of delaying drug approval.
DVAX: 4+ million volume today. This will have some ups and downs as it's traded, but I'm expecting a gradual move up into Feb. 24 PDUFA date.
OT:
Anyone likes to comment?
I do, but it's usually just some smart-ass remark.
Of coarse we can precede or progress from here
A twofer!
Thats my worst case senario
Yep, wouldn't be a pretty sene.
DVAX: Good, very positive CEO presentation at yesterday's J.P. Morgan Healthcare Conference. Seemed to suggest (unclear on this) that they're expecting either a full approval or a restricted approval by the FDA on Feb. 24, not a CRL.
I'm starting to change my opinion on that possibility, think it's a pretty decent risk/reward at around $3
Re DVAX: Good, very positive CEO presentation at yesterday's J.P. Morgan Healthcare Conference. Seemed to suggest (unclear on this) that they're expecting either a full approval or a restricted approval by the FDA on Feb. 24, not a CRL.
I'm starting to change my opinion on that possibility, think it's a pretty decent risk/reward at around $3.
DVAX: My own quick summary of yesterday's presentation at the J.P. Morgan Healthcare Conference.
http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=DVAX
*Continuing to work on EMA filing, anticipate approval next year.
*Strong cash position w/ moderate spending & significant revenues.
*Will solve U.S. patent situation either by negotiation or litigation [duh].
Most important, and the majority of the presentation dealt with this:
*Continuing talks with the FDA. Discussions are going well but they can't predict the outcome and most likely will not know before the Feb. 24 PDUFA date. "We are engaged in a certain amount of finger-crossing." [I can imagine.]
*Re HEPLISAV: stressed positive safety date equal to existing vaccines; much greater reliability than existing vaccines for high-risk population; will replace current HBV vaccines over time.
*Will focus on immunization of older (40+) diabetic population.
*No question that HEPLISAV is seen as highly-desirable by those people responsible for purchases because it offers higher, faster and more convenient immunization (2 injections over a month.)
Finally, this is somewhat of a subjective interpretation, but he seemed to suggest that they expect one of two things re the PDUFA: general population approval or restricted approval, not a CRL.
IMHO, FWIW, seems like a decent bet at around $3 PPS.
Seems to me that there's going to be a decent pop going into the PDUFA date, whether or not things actually work out. IMHO, FWIW, $3 looks like a good price.
Best of luck.
I'd strongly suggest that all current and any prospective DVAX investors listen to yesterday's presentation by the CEO at the J.P. Morgan Healthcare Conference.
http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=DVAX
Some highlights (my own quick transcription, so please forgive any errors):
*Continuing to work on EMA filing, anticipate approval next year.
*Strong cash position w/ moderate spending & significant revenues.
*Will solve U.S. patent situation either by negotiation or litigation [duh]
Most important, and the majority of the presentation dealt with this:
*Continuing talks with the FDA. Discussions are going well but they can't predict the outcome and most likely will not know before the Feb. 24 PDUFA date. "We are engaged in a certain amount of finger-crossing." [I can imagine.]
*Re HEPLISAV: stressed positive safety date equal to existing vaccines; much greater reliability than existing vaccines for high-risk population; will replace current HBV vaccines over time.
*Will focus on immunization of older (40+) diabetic population.
*No question that HEPLISAV is seen as highly-desirable by those people responsible for purchases because it offers higher, faster and more convenient immunization (2 injections over a month.)
Finally, this is somewhat of a subjective interpretation, but he seemed to suggest that they expect one of two things re the PDUFA: general population approval or restricted approval, not a CRL.
lovethatgreen: DVAX is continuing talks with the FDA going into the Feb. 24 PDUFA date. See my next post.
All IMHO, FWIW of course: I'd say a 75% - 80% chance of no approval this time around, a 20% - 25% chance of limited approval for the high-risk group.
At this point, for the most part, no approval is already built-in to the PPS. Yes, there would be some drop (depending on the extent of the false-hope run-up!) but certainly nothing like the November debacle.
An unexpected limited approval will cause a pop--again, the extent would depend on how high it was on that day--but I think that the street will immediately recognize two things: first, the potential market is now drastically smaller, and second, DVAX will have to run a long-term, very large, very expensive clinical trial that will almost certainly require new financing. Both these factors will severely limit the upside.
I've made no secret of the fact that I played this one completely wrong. I was looking for a modest gain off of what I and many experts considered a safe bet. Perhaps in biotech there is no such thing.
B.- $3.75 to $4, yes.
But in my previous post I tried to stress that it will not go there because it actually will be approved, IMHO this is highly unlikely.
It will go there because of many buyers' mistaken hopes, and many traders using this to their advantage.
As I said, a dollar is a dollar, truth or illusion, the color is still green.
In this exchange of posts, #msg-82653461 , SwingKing and I are basically in agreement.
Best of luck! -OB
Re NYSE Continued Listing Standards:
http://usequities.nyx.com/regulation/listed-companies-compliance/continued-listings-standards
"Price Criteria: Average closing price of a security is less than $1.00 over a consecutive 30 trading-day period."
The company then gets a deficiency notice, they have 6 months to cure the deficiency.
The latest conspiracy is that the dosage fowl up was done on purpose
Those kind of cock-ups are not pheasant.
Yesterday's action perfectly highlights another problem for long-term holders who bought in because of fundamentals: every single step of the way, there's going to be relentless pressure from profit-taking by traders.