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DVAX: The deciding factor for me was this morning's Jeffries report with the misleading and IMO misunderstood headline trumpeting a $5 price target.
The problem is, they're predicting a CRL tomorrow, an eventually successful retry by DVAX, and a $5 PPS in 2015!
They also did a thorough analysis of biotechs rejected in the ADCOM and then approved by the FDA. From the report:
In addition, we have found a published McKinsey analysis of FDA panel meeting votes and approval outcomes from 2001-2010. Of the 543 panel meetings held during this time, there were 190 panel meetings for new drugs, and a voting question on approval was conducted at 63 of these panel meetings. The panels voted no to 14 drugs, and not surprisingly, only 2 of these 14 drugs (14%) were actually approved by the FDA.
DVAX: All out today around $2.90. A major loss but just too risky to hold any longer.
Re this morning's Jefferies DVAX report:
I’ve already seen a couple of posts and received 2 PM’s all trumpeting the $5 price target; unfortunately, none of these people seem to have read the release.
Jeffries is predicting a CRL on Friday. They’re then going to buy on weakness. They think the company can eventually get a limited label for vaccinating chronic kidney disease patients for Hep B, then a broad label in 2015, then be worth $5.
Not on Friday!
OT: For me, a true LOL tweet by AF-
"Memo to PPHM: When you manipulate data, make it look better, not worse!"
DVAX: It has about 90% institutional ownership. IMO much of today's selling is their very conservative but prudent risk management.
This one is a real head-scratcher, it's anyone's guess re the PDUFA on Friday/Monday.
Only for the wild and crazy, daredevil risk-takers!
How did Newtown gunman Adam Lanza become a killer?
http://www.dispatch.com/content/stories/national_world/2013/02/19/what-happened.html
This article focuses mainly on the mother, and includes some details about her behavior the past few years that shows how profoundly disturbed people can slip under the radar with the help of an unwitting enabler.
From the article:
During a search of the Lanza home after the shootings, police found thousands of dollars worth of graphically violent video games.
CBS News reported last night that Adam wanted to kill more people than the 77 slain by a man in a bombing and shooting attack in Norway in 2011. CBS cited unnamed law-enforcement sources; a Connecticut state police spokesman said the report was in no way accurate.
But CBS said Adam targeted the school because he saw it as the “easiest target” with the “largest cluster of people.” Evidence also shows Adam likely was acting out the fantasies of a video game, with each death amounting to some kind of “score,” CBS said.
Nice job gathering together some DD. May I respectfully also suggest the 11/14/12 Advisory Committee Transcripts:
http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/vaccinesandrelatedbiologicalproductsadvisorycommittee/ucm288695.htm
And the transcript of the 1/7/13 CEO presentation at the J.P. Morgan Healthcare Conference:
http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=DVAX
Finally, people trading this short term should realize that the PDUFA date of Feb. 24 is this Sunday, so there's a good chance of a decision coming this Friday, Feb. 22.
Best of luck.
Why Republicans Should Embrace The Reality Of Climate Change
http://www.forbes.com/sites/matthewherper/2013/02/18/why-republicans-should-embrace-the-reality-of-climate-change/
[An excellent summary of the situation by Mathew Herper, a scientist and a science writer.]
2/18/2013
Forbes
by Mathew Herper
We have reached the point where every rational person who believes in making decisions based on science and available data should, if not fully believe that human beings are warming the planet by releasing greenhouse gases, at least recognize that this is what the data seem to suggest and that it is what the vast majority of scientists who study weather believe is the case.
Recognizing this does not force anyone to oppose pipelines, support a carbon tax, or start composting and wearing hemp shoes. It just opens us up to start aiming our fiery furnace of a political system at actually solving our problems. Go ahead, argue that the economic cost of anti-greenhouse measures doesn’t justify the benefit, especially if the planet is getting too hot. Argue that we should look for technical solutions not only to reduce carbon dioxide and methane emissions but not to suck the stuff out of the atmosphere – although then you might find yourself standing with Bill Gates and calling for more investment in R&D. If you want to wade into the science, argue that the worst-case scenarios are overstatements.
Below follow some of the main objections that have come up over the past year or so when I discussed this issue with conservative friends who do not believe in global warming – and the reasons why I think those objections have been covered.
But warming stopped.
No it didn’t. The global temperature is rising, but it also bounces around a lot. Between 1998 and 2005, average global temperature did not increase. But that’s because 1998 was really hot. An abnormally strong El Nino caused heat to move from the ocean into the atmosphere. Besides being cherry-picking, this also ignores warming in the ocean, scientists say.
The Earth is getting warmer, but it’s too much of a leap to say that human beings are the reason. There are plenty of natural climate cycles and I believe in being skeptical.
Fair enough. But this is science, and skepticism has to come within the framework of what we already understand. The scientific method does not simply mean coming up with an idea, or hypothesis, and testing it to see if it is true.
Hypotheses are supposed to be based on our existing body of understanding – based on our current theory. These get tested before wilder and crazier ideas. We don’t just leap to testing whether aliens are using the planet as a dump for the heat from their warp drives.
It’s certainly true that climate can change dramatically over time, and has. There have been ice ages and hot periods. But right now, there are not obvious candidates for other explanations of current warming. For instance, the sun seems to be cooling.
“There’s no way of explaining what’s happened in the last 50 years through natural cycles,” says Donald Wuebbles, the Harry E. Preble Professor of Atmospheric Science at the University of Illinois.“We have no evidence of a natural cycle that can do anything like this. It also exactly fits with all our knowledge of what happens with carbon dioxide and greenhouse gases. We’ve known about greenhouse gases since 1824! We know the oceans are warming, the atmosphere’s warming, the land is warming. It’s all happening in tune with each other.”
Wuebbles says “there’s no basis for trying to make up something because you’d like that to be true” and that “you can’t dream up natural cycles as if that will work.”
A natural cycle still seems more likely than the idea that we’ve made the atmosphere into a giant heat tent.
The main reason for believing that the atmosphere is a giant heat tent is that this has been the basis of climate science for nearly 200 years. Joseph Fournier, the great mathematician, first made calculations about how the atmosphere keeps the Earth warm in 1824. John Tyndall, a physicist, established that particular gasses, including water vapor but also methane and carbon dioxide, resulted in heat being trapped in the atmosphere. The Swedish scientist, Svante Arrhenius, showed in 1896 that more carbon dioxide would mean warming and predicted that industrial output could eventually warm the planet. The greenhouse effect is the main explanation for why Venus is super-hot – the hottest planet in the solar system – and Mars is super-cold. So this isn’t an out-there idea. It’s an outgrowth of our basic theory, our understanding, of how the warming of planets works, and it has been tested again and again. These are not new ideas, and they are not based entirely on computer models.
Scientists are just trying to get government money.
Dangling grant money is a great way to shift the priorities and perspectives of scientists, but it doesn’t tend to lead them to make things up. Most of the scientists who are arguing for global warming could probably make more money if they went to work for industry. Also, controversial ideas get published all the time, and there would be a Nobel Prize in proving that warming isn’t happening.
Everything Al Gore says is wrong.
In our interview and during a press conference at the annual meeting of the American Association for the Advancement of Science in Boston this weekend, Wuebbles actually agreed that misstatements by Gore had led to a backlash.
“Most of what is pretty good but there’s a few comments that are over-exaggerations,” says Wuebbles. “That’s typical Al. I’ve known him for years. He gets it, he understands it, but he has the ability to overstate it and some of those overstatements are where he gets in trouble.”
Go ahead. Hate Al Gore. Put his face on a dart board. Al Gore is not a climate scientist, and even stopped clocks are right twice a day.
For years scientists said that no individual weather event could be traced to global warming. Now they are blaming heat waves and Hurricane Sandy on climate change. I think this is all politics.
What has changed is that new techniques have been created to analyze the factors that went into a particular weather event, and to figure out whether the totality of weather events – for instance, patterns of droughts or heat waves – would have happened without global warming. There is still debate on this topic, but many scientists do believe they can now link “weird weather” to global warming. But it’s entirely likely that the furor of the current debate is leading to bad thinking on both sides. That’s exactly why we need to turn down the heat.
the clock is ticing my friend
Yep, just ticing and tocing the time away.
Thanks, misunderstood your first post re antibiotics but still interested in your reply.
I'm going to be selling my DVAX position next week no matter what the PDUFA outcome (OT: for me, it's been a perfect illustration of the old Wall Street line "an investment is a trade gone bad") and I'm planning on buying GERN.
Best of luck.
M.- Re TSRX: It's currently one of my largest holdings. Not saying that it's going to be "the next PCYC" (everyone's getting tired of that phrase, especially those who missed the boat! ) but I think that it has tremendous potential.
You refer to other names in the antibiotic space that you prefer, would you mind sharing? TIA.
Here's a blog by Jeff Sharman about nutritional supplements and cancer treatment. He's a hematologist/oncologist at the Willamette Valley Cancer Institute in Eugene, Oregon, and directs the lymphoid malignancy (CLL/NHL) research efforts for US Oncology, a community-based research network with sites throughout the United States.
Just one of the clearest, no-nonsense essays about the subject that I've ever read.
http://www.cll-nhl.com/2013/02/nutritional-supplements.html
There are many good, solid, impartial sources of real info about DVAX--both bear and bull--available.
Won't be posting here again, but best of luck to all longs.
Shocking final paragraph summary in a SA article discussing various FDA decision dates:
While an approval decision will most likely cause a spike in their stock prices, a rejection has the possibility of causing a dramatic drop in price.
OT: Small near-Earth asteroid 2012 DA14 will be closest to Earth in about 10 minutes. NASA TV providing great video.
http://www.nasa.gov/multimedia/nasatv/index.html
OT: Small near-Earth asteroid 2012 DA14 will be closest to Earth in about 10 minutes. NASA TV providing great video.
http://www.nasa.gov/multimedia/nasatv/index.html
DVAX: Talk about a range-bound stock, it just can't escape the $3.20 area. As soon as it does, large selling.
I'm assuming that the FDA decision is announced on Friday, Feb. 22. Since Monday is Presidents' Day, there's not many trading days left. I'm not so sure that the anticipated pre-PDUFA run-up will really happen. Comments welcome.
Dynavax trade tries to time rebound
http://finance.yahoo.com/news/timing-rebound-dynavax-155919193.html
By David Russell (david.russell@optionmonster.com)
Feb 14, 2013, 11:43AM EST
One investor is looking for Dynavax Technologies to come back from a brutal selloff last year.
optionMONSTER's Heat Seeker monitoring program detected the purchase of 2,000 July 4 calls for $0.75 and the sale of an equal number of March 6 calls for $0.12. Volume was below open interest in the 6s, so there are two possible explanations of the activity.
One is that an existing position was rolled down in price and further out in time. That gives the investor a greater chance to profit, but for an additional cost of $0.63.
The more likely possibility is that both trades were opened as part of a bullish diagonal spread. In that case, the investor has locked in a purchase price of $4 through the summer while agreeing to sell the stock for $6 if it goes above that level during the next month.
In this case, should DVAX remain below $6 through March expiration, the trader can sell more calls at the higher strike to further reduce the cost basis. (See our Education section for more on how options can be used to manage trades.)
DVAX is down 0.25 percent to $3.21 in morning trading. It lost almost half its value on Nov. 16 after a Food and Drug Administration advisory panel voted against approval of its Heplisav hepatitis B vaccine. Since that drop, however, the shares have been trying to rebound.
Total option volume is twice the daily average so far in the session, with calls outnumbering puts by 51 to 1.
Just my guess...a leak of dilution heading our way.
Ewwww.
Okay, undermine and ridicule others if you must,
It is pretty amazing to me that PPHM didn't fall more today
DVAX,a few thoughts:
1. The PPS certainly seems pegged to $3.20: it can't escape the gravity of that number.
2. Lots of selling into morning runs. A trader on Twitter has speculated (no more than that) that it's an institution unloading before what they feel will be a total non-approval. Again, just his speculation, and I'm currently going with the restricted label scenario.
3. The PDUFA date is Feb. 24, but since that's a Sunday I'm looking at Friday, Feb. 22. Since the market is closed Monday for Presidents' Day, after today there are only five more trading days left. Is the pre-PDUFA run-up over before it ever began, or is there still time?
Comments welcome, best of luck to all.
TA is non-sense.
LTG is simply restating one possible, widely-held thesis on this stock: the FDA will not go against the ADCOM rec and will not approve. It's a simple, basic argument but it has historical precedence behind it and it may be correct.
This view puts less value on a more objective, scientific analysis of the actual efficacy and safety data presented in the briefing docs, something which the FDA has been doing. Based on the data alone, the FDA should approve. This is a somewhat more complex argument (it's not a true binary event, the possibility of a restricted label must be considered) but it's still fairly basic and it may be correct.
It's a risky crapshoot. As I've stated before, if I wasn't already the holder of a large underwater position I probably would pass on this.
Best of luck to all.
there are far better plays on the docket
How did they get passed the FDA?
Fassed talking?
LTG: The ADCOM results have been posted here and many other places since November, but thanks anyway.
It's unclear what you mean by "what have they done?" They've been in talks with the FDA, but the data are the data, no additional submission between the ADCOM and the PDUFA date.
What you seem to be driving at (OT: IMHO it's always clearer to simply state your position) is a belief that the FDA will not approve HEPLISAV. You very well may be correct.
This has been widely discussed on many sites, on many forums, in many blogs and articles: some say yes, some no. The bull & bear arguments can be found in an hour or so of careful reading.
FWIW, I somewhat agree with you, but perhaps for different reasons. The safety data are more than adequate, but I can't see the FDA totally going against their own advisory committee. Because of that, I'm expecting a compromise: a restricted label with post-marketing studies. Approved for use by high-risk groups: intravenous drug users, diabetics, those over 60, those traveling to areas where Heb B is endemic, etc.
Don't even get me started about the PPS after each potential scenario! It's a very dicey situation, again IMHO not a good risk/reward trade, and if I wasn't holding a sizable underwater position I'd most definitely stay away, there are safer bets.
Best of luck in all your trades. -OB
You're still shortchanging the post by leaving out crucial info.
It includes bolding; uses the words Swiss, hottest, and huge; the chart is bouncing and…wait for it…there’s a doctor on the advisory board.
A sure winner.
StockCall Review on Dynavax and GlaxoSmithKline: Pharma Stocks Bet on Drug Approvals
http://www.marketwatch.com/story/stockcall-review-on-dynavax-and-glaxosmithkline-pharma-stocks-bet-on-drug-approvals-2013-02-12?siteid=nbsh
DVAX: 13G Ownership Filed, State Street Corp, 5.1% stake
http://investors.dynavax.com/secfiling.cfm?filingid=1519058-13-48
13G Ownership Filed, State Street Corp, 5.1% stake
http://investors.dynavax.com/secfiling.cfm?filingid=1519058-13-48
Re DVAX FDA date: 24th is a Sunday, most likely decision on Friday, Feb. 22.
Biotech Stock Mailbag: Dynavax, ImmunoCellular, Celldex and Medgenics
http://www.thestreet.com/story/11835902/1/biotech-stock-mailbag-dynavax-immunocellular-celldex-and-medgenics.html?kval=dontmiss
New Adam Feuerstein article in The Street:
Joe P. emails, "Just curious to know what your take is on Dynavax's (DVAX_) Heplisav. I feel a lot of blogs and even Twitter have been preoccupied with other names lately, though the Heplisav PDUFA is steadily approaching. I find it interesting the journey this vaccine has taken from a clinical trial hold, to Dynavax proposing an indication of patients aged 40-plus but then the FDA expanding it to patients 18-plus, then the negative advisory committee vote and now the PDUFA. Has there ever been a negative safety advisory committee vote that progressed to an FDA approval? I read the negative safety vote as a wild card: It was a close vote and the actual discussion was in my opinion off topic and based on theoretical risks of a novel adjuvant."
The FDA approval decision date -- the PDUFA -- for Dynavax's Heplisav hepatitis B vaccine is Feb. 24. I predict approval.[bolding mine] The FDA may place some restrictions on Heplisav initially -- patient age or other risk factors -- but those could be lifted once Dynavax submits additional clinical data in hand already. (No new clinical trials are necessary.)
Last November's advisory committee meeting wasn't as bad as the headlines suggested. Remember, the panel strongly supported Heplisav's efficacy. The vaccine works. On the safety question, the panel voted 5-8 against but only due to theoretical concerns about rare side effects that might appear in some patients. To me, this was just busting chops for the sake of busting chops. I hope (expect) FDA won't be nearly as shortsighted.
At the J.P. Morgan Healthcare Conference last month, Dynavax executives told investors that it was in discussions with FDA about the Heplisav review. This may or may not have included submission of additional data for the agency to review. FDA could have easily extended the Heplisav review period by three months. The fact that the approval decision date is still set for Feb. 24 suggests to me that agency has the data it needs and that approval is more likely than a rejection.
The risk to being bullish on Heplisav's near-term approval: Heplisav is not an unmet medical need. Other hepatitis B vaccines are already on the market, so the sense of urgency for FDA to approve is missing.
Dynavax shares shouldn't drop too far on a Heplisav rejection as long as the only requirement for resubmission is clinical data the company already has compiled. Worse case is FDA asking for an entirely new clinical trial, but that seems very unlikely.
DVAX: Still looking for a run-up into the PDUFA, but will definitely not be holding through.
Best of luck!
Cramer had a lightning round caller last night who asked about DVAX, Cramer quickly said that he wants to "stay long."
10 second segment, IMHO it illustrates the worst thing about that show. I very much doubt that Jim could have given a complete bull & bear analysis of the story and a specific rationale for his rec.
I was originally thinking a CRL, but have changed to a 60-40 chance of a restricted label. Some informed folks seem fairly sure—based mainly on the briefing docs—of a full approval, but that means the FDA goes against the ADCOM rec which usually doesn't happen.
Regardless, considerable damage has been done to the PPS, perhaps for the foreseeable future, and I'm not sure that any flavor of approval will significantly move the dial while a CRL might move it from $3 back to $2.
I'm underwater here, just looking for a bit of a run-up next week to sell into. Will definitely not hold through!
DVAX, just a reminder: The official PDUFA date is Feb. 24, a Sunday. Expecting the decision on Friday, Feb. 22.
Dude, you vasilate more than most.
Perhaps an erudite reference to Vasil Spasov, the Bulgarian chess grandmaster, known for his complex endgame strategy.
Nah.
Clinical Cancer Advances 2012: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.
http://www.cancerprogress.net/pdf/CCA_2012.pdf
I'm carefully reading through this, trying to improve my layman's knowledge. I was really struck by this passage in the section about central nervous system cancers:
This year brought important validation for two novel clinical trial designs that are increasingly being used in CNS cancer research. The new designs allow trials to be completed with fewer patients, saving time and resources and, most importantly, helping patients benefit from new treatments faster.
The first, called the Bayesian-based trial design, uses accumulating study data in real time to guide the course of the trial. This flexibility increases the probability that patients will be assigned to treatment cohorts that show evidence of efficacy. To determine if Bayesian-based design would require fewer patients to answer a scientific question (eg, whether an experimental drug is better than placebo) than a traditional trial design, researchers retrospectively applied adaptive randomization to patient data from four phase II trials in patients with recurrent glioblastoma.4 They determined that if Bayesian design had been used in those studies, 30 fewer patients (approximately one third) in each trial would have been needed to achieve the same scientific results.[bolding mine]