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It is a nice deal but PLX has a take out premium I believe so it may go down on this news
So are you saying that aria will be able to run an open label study?
when was the last time you saw that if there was an approved drug for an indication
It is amazing that everyone assumes that ariad will be able to do an open label study for the CML drug.
Chemgenex was able to do the open label study for the t315i mutation because there was no drug approved for that mutation.
If omapro is approved in early March for the t315i mutation the fda will not accept an open label study by ariad.
I own ariad because the upcoming data will probably be good but their trial will probably have to be used in conjunction with Omapro
all the better because their drug with omapro may actually turn into some cures.
thank you for the call info
Read the article and then click the you tube post.
INSIDE WASHINGTON: Stream of WH health care visits
INSIDE WASHINGTON: Lobbyists, health care heavyweights visited White House early and often
Dubai debt fears hit world markets hard
Dubai debt fears, dollar slide hit world stock markets hard
By Pan Pylas, AP Business Writer
On 11:54 am EST, Thursday November 26, 2009
LONDON (AP) -- World stock markets tumbled Thursday as investors fretted over the debt problems at Dubai World, a government investment company, and the continuing slide in the dollar, which earlier fell to a 14-year low against the yen.
Markets are usually relatively quiet when Wall Street is closed for a holiday, as it is Thursday for Thanksgiving Day. Not so today, as the rest of the world digested the stunning news from Dubai that the government's flagship investment company was in financial trouble.
European markets followed Asia lower with the FTSE 100 index of leading British shares closing down 170.68 points, or 3.2 percent, at 5,194.13, having been out of action earlier for over three hours because of technical problems.
Germany's DAX fell 188.85 points, or 3.2 percent, to 5,614.17 while the CAC-40 in France was 129.93 points, or 3.4 percent, lower at 3,679.23.
Sentiment in stocks was dented by the news that Dubai World, which is thought to have debts totaling around $60 billion, has asked creditors if it can postpone its forthcoming payments until May. That stoked fears of a potential default and contagion around the global financial system, particularly in banks and emerging markets.
"Fear of sovereign default in the Middle East rattled the markets," said Jane Foley, research director at Forex.com.
Banks bore the brunt of the selling in Europe, amid fears of potential exposure to Dubai. In London, Royal Bank of Scotland PLC was down nearly 8 percent, making it the biggest faller on the FTSE. In Germany, Deutsche Bank was the biggest faller on the DAX, down around 6 percent.
Investors were also keeping a close eye on associated developments in the currency markets after the dollar slid to a new 14-year low of 86.27 yen, while the euro pushed up to a fresh 15-month high of $1.5141.
By late afternoon London time, the dollar had recouped some ground and was trading at 86.55 yen, down 0.9 percent on the day, while the euro was 1 percent lower at $1.4988.
The continued appreciation in the value of the yen continued to dent Japanese stocks as investors worry that the rising currency will have a detrimental effect on the country's exports. Japan's Nikkei 225 stock average fell 58.40 points, or 0.6 percent, to 9,383.24.
Kit Juckes, chief economist at ECU Group, said the developments in Dubai and in the currency markets are related as the fall in risk appetite has pushed money into government bonds and into safe haven currencies such as the Swiss franc and the yen.
This, he said, is "testing the tolerance of central banks to see their currencies cause further damage to their economies."
Already there have been unconfirmed reports that the Swiss National Bank has intervened to buy dollars to prevent the export-sapping appreciation of the Swiss franc.
Meanwhile, Japanese Finance Minister Hirohisa Fujii tried to assure the market he was closely monitoring the situation and would "take appropriate steps if foreign exchange rates move abnormally." But that did little to ease investor worries.
Across all markets, there is a growing awareness that investors may use the upcoming year-end to lock-in whatever profits have been made over the last 12 months.
Gold has been one of the biggest high-flyers over the last few months, having gained over 10 percent in November alone. It continued to rise Thursday as investors bought it up as a safe haven.
It hit a new record high earlier of $1,196.8 an ounce, before falling back modestly. By late afternoon London time, gold was down 0.4 percent at $1,182.50 an ounce.
Oil also fell alongside stocks -- the two have traded alongside each other for much of this year. Benchmark crude for January delivery was down $1.85, or 2.4 percent, at $76.11 a barrel. On Wednesday, it rose $1.94.
Earlier in Asia, the Shanghai index tanked 119.19 points, or 3.6 percent, to close at 3,170.98, its biggest one-day fall since August 31, while Hong Kong's Hang Seng shed 1.8 percent to 22,210.41.
Elsewhere in Asia, markets in Australia, Singapore, Taiwan and Indonesia closed lower.
AP Business Writer Jeremiah Marquez contributed to this report from Hong Kong.
Copyright © 2009 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten, or redistributed without the prior written authority of The Associated Press.
the article doesn't mention that Bear Stearns was taken over by JP Morgan because it owed Goldman Billions, Lehman wasn't rescued because it didn't Goldman money, and AIG was bailed out because it owed Goldman billions.
Goldman was paid back 100 cents on the dollar because of these transactions, and I am pretty sure they must have had a big short position in Lehman, so they made money on that trip to zero.
finasteride
I have bph and I am taking finasteride because it has lowered my PSA, reduced the size of my prostate, and to prevent cancer.
MNTA Key Points:
· Central Tenet To Our Investment Valuation Has Changed: M-enoxaparin royalties will be lower than what we had estimated (17%), and lower than St. estimates of between 12-20%. During investor meetings with management late last week, we confirmed M-enoxaparin royalties will start in the high single digits and will increase to mid-teens as sales increase. While we do not know the sales threshold for increasing royalty rates, investors should conservatively assume the lowest rate because of potential competition from multiple generics.
· M-Enoxaparin Approval Still Expected: We continue to remain confident of M-enoxaparin’s approval in 1H 2010, and management reiterated that approval was still possible this year. Because of the lower royalty rate, we believe share movement on approval (and in conjunction with approval of Teva’s generic) may be muted.
· Markman Hearing Probably Not In December: The Markman hearing for Copaxone litigation, which has been anticipated for December, has not been scheduled yet and may occur in January.
Conclusion:
Upon potential M-enoxaparin approval in 1H 2010 we believe upside from the binary event is limited based on a 9% royalty rate, and therefore lower our rating to Neutral from Buy. Upside beyond our new price target of $12 depend on sole M-enoxaparin approval (20% odds), a positive ruling from Markman (hard to call), and M-118 partnership (probably a 2H 2010 event).
unintended consequences
In the nineties the democrats were upset that CEO's were making so much money. They enacted legislation forcing a special tax on companies that paid their employees more than a million dollars a year.
To get around it companies issued stock options. This caused companies to look for short term gains instead of running the business for the long term.
In the case of the insurance industry, it gave the companies greater incentives to make enormous profits, and raise rates at a higher rate every year. Health insurance executives that used to make a few millions a year for companies that made good profits, now make hundred's of millions a year because by raising rates, they make great profits, their stocks go up, and their option gains increase.
I believe our healthcare cost problems started with this law.
Maybe the heathcare cost problem could solved by limiting options at the executive pay level for this one industry, instead of changing the entire healthcare industry.
pico was supposed to be less toxic which would allow for more cycles, which would increase efficacy with reduced side effects
their pfs was actually less then the carboplatin.
without the small cell lung cancer approval they will not be able to partner the drug. any money that they raise will be highly dilutive unless they do something overnight today because dummies bought the stock on the data they released which wasn't very good.
the data today that made the stock go up is a rehash of data from asco.
the data didn't impress me in April and it means less now.
i think the drug is dead
PARD is holding a CC at 8am ET Monday to announce the phase-3 results in SCLC:
From the volume activity, the timing if not the result of the trial was leaked on Friday.
Longs and shorts were able to hedge their positions with the use of short term options.
View By Expiration: Nov 09 | Dec 09 | Mar 10 | Jun 10 | Jan 11
CALL OPTIONS Expire at close Fri, Nov 20, 2009
Strike Symbol Last Chg Bid Ask Vol Open Int
2.50 FQRKZ.X 5.10 0.00 N/A N/A 60 904
5.00 FQRKA.X 3.10 0.00 N/A N/A 606 13,265
7.50 FQRKU.X 1.20 0.00 N/A N/A 1,197 23,147
10.00 FQRKB.X 0.55 0.00 N/A N/A 1,653 12,943
12.50 FQRKV.X 0.20 0.00 N/A N/A 1,056 8,522
15.00 FQRKC.X 0.10 0.00 N/A N/A 10 2,973
PUT OPTIONS Expire at close Fri, Nov 20, 2009
Strike Symbol Last Chg Bid Ask Vol Open Int
2.50 FQRWZ.X 0.15 0.00 N/A N/A 25,095 98,889
5.00 FQRWA.X 0.50 0.00 N/A N/A 1,390 30,267
7.50 FQRWU.X 1.20 0.00 N/A N/A 2,482 5,546
10.00 FQRWB.X 2.95 0.00 N/A N/A 50 677
12.50 FQRWV.X 5.30 0.00 N/A N/A 52 153
15.00 FQRWC.X 8.40 0.00 N/A N/A 2 2
Highlighted options are in-the-money.
dewophile
do you realize that amgen got dmab from their deal with abgenix. Amgen was trading at 40 when the dmab data came out. It is the only thing keeping amgn from going into the thirties
The foreign matter includes stainless steel, rubber, and fiber-like material.
looks like someone accidently dropped a tire in the bioreactor.
It must have been Wallstarb before starting a short position in the stock
However the Chemgenix drug will rapidly become obsolete in CML once ARIA's drug is approved
I am glad you can be so sure of that before anyone has seen any data about ariad's drug. This must be the first drug that has gotten 100 percent chance of approval based on a press release.
Once Omacetaxine is approved it could be used with a tki because it has a different MOA. So far it is the only drug to kill the cancer in the stem cells so it is a possible cure if given early enough.
FOR IMMEDIATE RELEASE
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (10 November 2009) –
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug
Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro™
(omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who
have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. The NDA
has also been granted Priority Review. A Priority Review designation is given to drugs that offer
major advances in treatment or provide a treatment where no adequate therapy exists, and generally
denotes that the FDA review period is reduced to approximately six months. ChemGenex submitted
the NDA on 8 September 2009.
“We are pleased that the FDA has accepted our NDA for Omapro and granted the filing Priority
Review status which underscores the critical need for a treatment option for the CML T315I+ patient
population,” said Greg Collier PhD, ChemGenex’s Chief Executive Officer and Managing Director.
“We look forward to working closely with the agency over the next several months as they review our
filing. If approved, we plan to launch Omapro in the U.S. as the first therapy specifically indicated for
CML T315I patients.”
Omapro has received Orphan Drug designation in the U.S. and in the European Union, and has
received Fast Track status from the FDA. Omapro demonstrated clinical benefit in the pivotal Study
202 in CML patients who had failed imatinib and have the T315I mutation.
About Omapro™ (omacetaxine mepesuccinate)
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may
have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global
phase 2/3 clinical trials for CML and has been granted Orphan Drug designations by the U.S. Food
and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status
by the FDA.
Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range
of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to
the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and
Grants the Filing Priority Review Status
Page 2 of 3
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100
Email: chemgenex@chemgenex.com ABN 79 000 248 304
upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical
research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin,
Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to
be insensitive to TKIs.
About Chronic Myeloid Leukemia (CML) and the Bcr-Abl T315I Mutation
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of
approximately 200,000 patients. The bone marrow is responsible for the production of specialized
cells that constitute blood; these cells include red blood cells (to carry oxygen around the body),
thrombocytes (to help stop bleeding) and certain white cells (part of the body’s defense system
against infection). In patients with CML the cell production system is diseased and defective. Cells
multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.
The majority of CML patients initially respond well to treatments with drugs called tyrosine kinase
inhibitors (TKIs). However, a significant proportion of patients fail, or become intolerant to, one or
more TKIs. In many of these situations the cause of failure can be traced to the emergence of Bcr-Abl
mutations. A common mutation called T315I renders CML resistant to all currently approved TKIs,
and has created a significant unmet medical need in the management of CML.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with
new mechanisms of action to treat malignancies with significant unmet medical needs. The company
is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic
Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A
New Drug Application has been submitted to the U.S. Food and Drug Administration for CML patients
with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize
omacetaxine independently in North America and to establish commercial partnerships in the rest of
the world. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS"
For additional information on ChemGenex Pharmaceuticals, please visit the company’s website at
http://www.chemgenex.com.
Details on the clinical trials can be accessed from the following websites:
http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and
http://www.tkiresistantcmltrials.com
Omapro™ is a trademark of ChemGenex Pharmaceuticals Limited
ChemGenex Announces FDA Accepts NDA for Omapro™ (Omacetaxine Mepesuccinate) and
Grants the Filing Priority Review Status
Page 3 of 3
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100
Email: chemgenex@chemgenex.com ABN 79 000 248 304
Contacts:
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Australia): +61 419
897501
Cell (USA): +1 650 200 8145
Email:
gcollier@chemgenex.com
Rebecca Wilson
Buchan Consulting
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)417 382 391
Email: rwilson@bcg.com.au
Remy Bernarda
Blueprint Life Science Group
Tel: +1.415.375.3340 x 2022
Cell: +1.415.203.6386
Email:
rbernarda@bplifescience.com
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) that use
the words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify
forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve known and unknown risks and uncertainties which could cause the actual
results, performance or achievements of the company to be materially different from those which may be
expressed or implied by such statements, including, among others, risks or uncertainties associated with the
development of the company’s technology, the ability to successfully market products in the clinical pipeline, the
ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated
technologies, the ability to enter into additional collaborations and strategic alliances and expand current
collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development,
the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary
technology, potential limitations on the company’s technology, the market for the company’s products,
government regulation in Australia and the United States, changes in tax and other laws, changes in competition
and the loss of key personnel. These statements are based on our management’s current expectations and are
subject to a number of uncertainties that could change the results described in the forward-looking statements.
Investors should be aware that there are no assurances that results will not differ from those projected.
###
You will take a shot twice a day to extend your life.
Nothing is a hundred percent. Chemgenex has been on a tear and I haven't sold. That could be a mistake if they don't get priority review.
If it doesn't get priority review then I would agree with you that the data isn't as good as I think it is. I am almost positive that they will get it. If they don't I will have to eat crow and lose a lot of money.
Chemgenex hasn't been discussing Berger or Ariad with me. Berger has a very long history of misleading investors. I have been at many conferences and discussed the company, and the managers I speak with say they won't go near him
a couple of years ago I was at a breakout and the fellow I was sitting next to kept asking how long the money will last, because it was running low, and Berger said he wasn't concerned about cash. He did a raise less than a month later.
He didn't technically lie. He wasn't concerned about cash because he knew he was going to raise it, and he wasn't going bankrupt.
And unless you have seen his data, I don't know how you can say that Chemgenex will get its clock cleaned.
Have you seen the data?
Chemgenex was able to do the open label study in the t315i mutation because there was no drug approved that treated it. Once Omacetaxine is approved, he would have to do a study versus, or with Omacetaxine, he won't be able to run an open label study so it won't be that easy to recruit.
If Omacetaxine is approved early next year Ariad would probably have to run a trial of his tki with omacetaxine vs. his tki alone imho
That is okay with me
That is me saying that, not chemgenex.
So up the penalty or, better yet, make it a mandatory three-year waiting period for people to get health insurance after they first become eligible. (And five years after that.) Believe me, folks wont want to roll the dice for three years.
Why dont you tell us what percentage of Massachusetts residents are now insured compared to the percentage before the law went into effect?
Bladerunner
by saying that people need a 3 year waiting period to get health insurance after they become eligible you have just accepted the need for pre existing conditions. Instead of doing all this other garbage why didn't they just pass a law saying that and keep the current process in effect?
cycc
is the market cap 20 million when you take into consideration the preferred stock?
There has got to be a way to put people with pre existing conditions for things like pregnancy on a federal plan, without changing insurance for ninety percent of people that are fairly satisfied with their plans.
if private insurance had to pick up pre existing conditions for people that didn't want to pay for insurance until they needed it the premiums would be much higher.
You don't wait to buy auto insurance until after you have a car accident, do you?
berger has a reputation for being a lying POS
GlaxoSmithKline and XenoPort Announce Extension of GSK1838262 (XP13512) FDA Review Date to February 9, 2010
XNPT was up $1.60 today so there were no leaks
Press Release
Source: XenoPort, Inc.
On 8:15 pm EST, Friday November 6, 2009
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)--GlaxoSmithKline (NYSE: GSK - News) and XenoPort, Inc. (Nasdaq: XNPT - News) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.
The FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary for GSK1838262. In response to FDA’s request, GSK submitted a proposed REMS. The FDA accepted this submission as a solicited major amendment to the GSK1838262 NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate in partnership with Astellas Pharma Inc. and GSK. XenoPort’s product candidates are being studied for the potential treatment of restless legs syndrome, gastroesophageal reflux disease, migraine headaches, neuropathic pain, spasticity related to spinal cord injury and Parkinson’s disease. To learn more about XenoPort, please visit the Web site at www.XenoPort.com.
GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
XenoPort Forward-Looking Statement
This press release contains "forward-looking" statements, including, without limitation, all statements related to the PDUFA goal date extension. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort' s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the uncertainty of the FDA approval process and other regulatory requirements; XenoPort' s dependence on its current and additional collaborative partners; and the therapeutic and commercial value of the company' s compounds. These and other risk factors are discussed under the heading "Risk Factors " in XenoPort' s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2009. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
how come the fda didn't have the same middle of the night awakening issues with nvd's product as they did with Transcept's
It still shows hints of many of the toxicities seen for Amiodarone - more in fact than Dronedarone (another Amiodarone redo - but with lesser efficacy than Amiodarone). (Note the word 'hints' because from the data released so far it is hard to tell anything other than that it probably still has some kind of tox for thyroid and liver - both of which are significant for Amiodarone, although I can't, for instance, find median blood data for such Amiodarone SAEs) In contrast Vernakalant(sp?) appears to have fewer side effects.
Not a comment, just a question. You are saying there is probably tox in the liver and thyroid based on the data presented. What data that was presented gives you that idea?
Wallstarb is either right or wrong in IDIX
why does trying to convince him have to take up half the board?
I own a little achn, may buy more soon.
Re: CYCC
Quote:
--------------------------------------------------------------------------------
the ceo got the stock to move from the twenty cent range by showing that his drug was better than Genzyme's and Vion's that were in front of the FDA with open label phase 2 data, and he intimated he could do the same thing.
--------------------------------------------------------------------------------
I haven't compared CYCC data to Genzyme and Vion yet. Can you summarize a comparison of the data for me if you know it off-hand? Otherwise, I'll find it.
I think this data is better than genzyme's and definitely Vion's the issue is that Simos was saying he could run a small open label trial that would be cheap and he wouldn't have to partner. Now he has to partner and will not get data for a long time
Quote:
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when the odac panel meeting was exposed showing that the fda advised genzyme that they didn't want open label phase 2 data in the first place I was surprised that cycc was able to stay near a dollar
--------------------------------------------------------------------------------
It's still just a $25 million market cap, which is nothing. If there's any legitimate potential for this compound at all, a $25 million market cap starts to look very, very intriguing.
you are right it is cheap, but what if the bio window closes. what do they do without the funds to get a trial done?
Quote:
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It is going to take a long time to run a randomized phase 3 study. They will have to dilute quite a bit. Not sure how the preferred stock effects the equation.
--------------------------------------------------------------------------------
So, you don't believe CYCC will be able to land a partner with this data? Any particular reason why? You may be right. I'm just curious.
I am not saying that I just do not know.
re:Fed Ending Treasury Purchases That Helped Cap Yields (Update1)
I was wondering why the dollar was strengthening for no reason last week
I am sure this news was no surprise to Soros. He was unwinding his short, and going long last week on the news that must have been leaked to him
cycc
the ceo got the stock to move from the twenty cent range by showing that his drug was better than Genzyme's and Vion's that were in front of the FDA with open label phase 2 data, and he intimated he could do the same thing.
when the odac panel meeting was exposed showing that the fda advised genzyme that they didn't want open label phase 2 data in the first place I was surprised that cycc was able to stay near a dollar
It is going to take a long time to run a randomized phase 3 study. They will have to dilute quite a bit. Not sure how the preferred stock effects the equation.
. Amgen spells out FDA's D-mab demands
By John Carroll Comment | Forward
Amgen has opened up about the FDA delay it faces on denosumab, and analysts seem to agree with the biotech's CEO that the company can handle requests for new information without seriously damaging its near-term revenue prospects.
Regulators want Amgen to spell out a formal plan detailing how it will communicate safety issues to patients and doctors, and they want to take a look at updated safety data that Amgen has collected on the blockbuster drug, which will be marketed as Prolia once it gains an approval. The FDA also wants Amgen to mount new clinical trials further investigating the use of the therapy in women with breast and prostate cancer - a separate request from the marketing approval it is seeking for the broader population of women with osteoporosis. Researchers will have to demonstrate that denosumab does not spur tumor growth or reduce survival times.
Analysts were encouraged to see evidence that Amgen can get an approval on denosumab for women with osteoporosis shortly after it satisfies the FDA on safety issues. "It's a bit disappointing that the FDA will require more studies on denosumab breast and prostate cancer, but the treatment-induced bone-loss market is small," Eric Schmidt, an analyst at Cowen & Co., noted to Bloomberg.
- the D-mab info is buried deep in Amgen's release on Q3 results
- check out the story from Bloomberg
Racing Toward Disaster?
Soaring budget deficits threaten the economy and the stock market, says veteran fund manager Bob Rodriguez.
By Manuel Schiffres
September 2, 2009
You'd think that a money manager who races Porsches at speeds of up to 160 miles per hour for a hobby would be a daredevil when it comes to investing his clients' cash. But nothing could be further from the truth when the manager-racer in question is Bob Rodriguez, who has run FPA Capital fund for more than a quarter of a century.
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Rather than take big chances, says Rodriguez, he has always tried to handle his clients' money as if it were his own. So if too few companies meet his strict price criteria, he'll hold wads of cash in FPA Capital (symbol FPPTX), a concentrated stock fund. And he marches to his own drummer even if consultants tell him a stock fund should always be fully invested in stocks, and even if his customers don't like his approach and respond by withdrawing money. Rodriguez, 60, has taken a similar in-your-face tack with FPA New Income (FPNIX), a bond fund that, like Capital, he has managed since July 1984.
But as cautious as he is, Rodriguez wasn't able to escape the stock market's carnage in 2008. Despite having as much of 45% of Capital's assets in cash last year, the fund lost 35%, victimized by its heavy concentration in energy stocks and a series of purchases that began in the fall -- a few months too soon, as it turned out. Still, Capital's loss was two percentage points less than the decline of Standard & Poor's 500-stock index.
Capital, which is closed to new investors, has rebounded strongly this year, gaining 33% through September 1. And its long-term record is superb. From the time Rodriguez took over the reins on July 1, 1984, through September 1, the fund returned 14.5% annualized, beating the S&P 500 by an average of more than four percentage points per year. New Income earned 4.3% last year and has gained 2.4% so far in 2009.
After years weathering the vicissitudes of markets and the fickleness of his clients, Rodriguez is cutting back. At the end of 2009, he will begin a one-year sabbatical that will allow him and his wife to admire the winter beauty of Lake Tahoe, near their home in Nevada, then embark on an extended tour of Latin America and perhaps elsewhere. Dennis Bryan and Rikard Ekstrand will become co-managers next January and retain the title when Rodriguez returns in a supporting role in 2011.
Never one to mince words-- he moved to Nevada in 2006 in part to protest California politicians' "total lack of fiscal discipline"-- Rodriguez was his usual outspoken self when we visited him recently in FPA's Los Angeles offices. What follows is an edited version of the interview with Rodriguez and Ekstrand.
KIPLINGER'S: The stock market is up more than 50% from its March low, and many, if not most, economists think the recession has ended. Are we out of the woods?
RODRIGUEZ: No. I like to remind people that in the 20 years from 1989 through the early part of 2009, the Japanese stock market had 11 rallies of 20% or more and three that were 50% or more, yet the Nikkei Index set a new 26-year low this year. Essentially, the Japanese market experienced a lot of false starts. I expect similar false starts in the U.S. stock market.
So the question is, What are the fundamentals in this country that justify this stock-market rally? I don't believe the fundamentals have improved in the consumer area, nor, especially, with regard to the fiscal status of the federal and state governments. The U.S. government is adding to the federal debt at the rate of nearly $5.5 billion per day. The consumer has a large amount of retrenching and rebuilding to do, and that has significant implications for the U.S. economy.
So I think that the expectations for long-term earnings growth are too optimistic. It took us more than three decades to get into this mess. To think that we are going to get out of it in less than a year is both arrogant and foolish. So what's going on now is just an interlude; it's a rally in a bear market. As a result, we are still very much defensive. We haven't bought any stocks since early March.
Where are we in the economic cycle, in your view?
Rodriguez: We see it as a caterpillar economy, one that goes up, then comes down, then goes up, comes down and so on. The end result is that the economy doesn't go forward very fast. We couldn't continue the rate of economic decline that was occurring during the second half of 2008 and the first quarter of 2009, so we were bound to get some recovery or stabilization.
But we believe that consumer spending will be retarded for many, many years to come. This was a devastating downturn to the balance sheet of consumers and, more importantly, of high-end consumers. The middle-income guy got hammered because of declines in the value of his real estate. But this is the first time high-end consumers have been hit with both declining employment and declining asset values, especially in their investment portfolios, which for the wealthy usually represents a much higher percentage of their assets.
So this is a totally different decline than anything we've seen in the post-World War II period. Because of this, I believe we will experience substandard growth in gross domestic product over the next decade, in the neighborhood of 2% a year or less in real terms, unless we expand our exports.
What does that mean for stocks?
Rodriguez: With substandard GDP growth of 5% or less per year-that figure includes inflation -- we will be lucky to get annual returns of 6%, including dividends. It will take about ten years for the S&P 500 to get back to its 2007 peak.
Even the 6% return number I view as being quite optimistic because corporate profit margins were enhanced in this past cycle by excessive leverage and financial manipulation of earnings. Excessive leverage in the U.S. financial system allowed corporations to achieve higher levels of revenues than they otherwise would have. This led to record corporate profit margins, which were unsustainable. An example of this is in the housing arena, when home builders were able to report incredible earnings numbers from 2004 through 2006 before the rug was pulled from beneath them.
You run a bond fund, too. If you're so pessimistic about stocks and if interest rates are so low, where do you go to get good returns?
Rodriguez: I think a well-diversified portfolio will be a loser over the next several years, so you're really going to have to target where you deploy your capital. The destruction of the finances of the federal government is just an abomination. The fiscal mess we're in is accelerating. When you get concerned about the borrower, what do you do? You shorten maturities.
How do you explain Treasury bonds yielding 3.5% to 4%? There seems to be plenty of demand for them.
Rodriguez: [Federal Reserve Chairman Ben] Bernanke and the Fed have taken interest rates down to force people to take on more risk, whether it's buying junk bonds or stocks or long-term Treasuries. To stay at the short end of the curve right now truly hurts. But to protect capital, we will keep maturities short in the New Income fund-its duration [a measure of interest-rate sensitivity] is just over one year. If our investors don't like it, they can leave.
But where do you go to make money?
Rodriguez:I said you have to be targeted.
But what are the targets?
Ekstrand: We had been about 45% in cash in the Capital fund before deploying one-third of it from October 2008 through the first quarter. And two-thirds of that cash went into the energy area, primarily oil-services and exploration-and-production companies. We bought those companies because, first of all, the valuations were extremely depressed. We were able to buy them at about one-third of the replacement cost of their assets. On top of that, we think the fundamentals are very good for energy and much better than the fundamentals in other areas.
The natural decline rate for natural-gas fields in the U.S. past peak production is 30% a year. For oil, the rate is 9%. The recession has probably reduced demand for oil by about 2% to 2.5%. But that's not that large a number, especially when you factor in lower capital expenditures because of lower energy prices. As a result of these decline rates and lower capital spending, we believe we will face very high energy prices again when the world economy recovers.
Rodriguez: We want to be in the land of the tall trees, and only a few industries fit the bill. We also want companies with a large international component, although that, too, has its risks. In my opinion, the U.S. has to take exports from approximately 12.9% of GDP to something on the order of 18% over the next decade. If the U.S. doesn't, we will have another headwind against economic growth because we won't have something to offset the contraction in consumption.
What sectors of the economy are best positioned to lead the export charge?
Ekstrand: The second-largest sector in Capital is technology. We own Arrow Electronics and Avnet, the 800-pound gorillas of electronics distribution, and they derive about 50% of their sales through export. We also own Western Digital, a manufacturer of disk drives, which we added quite a bit of in the fourth and first quarters.
Rodriguez: Let me make it perfectly clear: There is virtually nothing we are buying right now. In fact, we have been selling into this rally.
What is Capital's current cash position?
Rodriguez: It's about 25%, up from 20% a month ago.
Last March, when the market was 55% below its record high, you couldn't find anything else to buy?
Rodriguez: The problem is that after the Fed arranged the rescue of Bear Stearns in March 2008, we crossed the Rubicon; we entered a new economic era with a new regulatory landscape. We do not know what the ground rules are or the shape of the playing field.
So even though 450 to 460 stocks met our criteria for cheapness last fall, we wouldn't buy them because we didn't know what the system was going to be like for financial services, or for the consumer, or for anything else. I wouldn't throw money at them. That's not investing. That's speculating. At least on the energy side, regardless of what happened, we felt there was some predictability.
Ekstrand: To give you a sense of why we focused on energy, take a look at Pride International, one of the stocks we were buying when the price was in the teens. It provides services to oil and gas exploration-and-production companies. We were basically getting the company at about 25% of the replacement cost of its assets, which include 12 semi-submersible rigs and about 25 jack-up rigs, half of them operating internationally under contracts with private or state-owned companies. It also owns two deep-water drill ships and four more that are being built.
The kicker is that when we were investing in this company, it had a contracted backlog of $9.6 billion. In this business, the legal precedents are that if the customers don't want to take the contract, the oil-services companies win in court. So that is a very firm backlog. And what's the value of that? Well, the value of the free cash flow the company will be accumulating from the backlog is right around $15 a share-about what we were paying for the stock.
Where's the stock now?
Ekstrand: It's moved up to $25. But still, when you think about the value of the backlog and a replacement value, net of debt of $60 a share, it is still undervalued.
This is a stock you continue to hold?
Rodriguez: Correct, we have not been selling it.
What is your outlook for inflation?
Rodriguez: Over the near term -- say, one to two years -- very subdued because of weak economies and excess capacity around the world. Inflation can come about because of a decrease in supply and an increase in demand for goods, but it can also result from printing too much money.
It's the latter issue -- the monetization of our debt -- that is my big concern. I don't trust the Fed, the Treasury, nor the executive and legislative branches of government, and I think some of our counterparties are nervous. Thus, there is risk to the dollar, which also has inflationary implications. Over the next five to seven years, the piper will have to be paid for our deficits. Should present trends continue, we see inflation likely rising to about 5%. Should U.S. finances get even more unbalanced, inflation could be even higher.
And yet Treasury-bond yields remain in the gutter.
Rodriguez: There is a bubble in Treasuries. I wouldn't lend money to the U.S. government for ten years at 3.5%.
How does the debate about health-care reform figure into your big-picture analysis?
Rodriguez: It's insanity. Before this country takes on another entitlement, we should deal with Social Security, Medicare, Medicaid and the prescription-drug program. If Congress enacts an expanded health-care program, I fear this would further raise anxiety among our foreign providers of capital, and it would probably encourage me to move a large percentage of my net worth out of the country.
That's strong stuff. Are you making a partisan statement?
Rodriguez: No, it doesn't matter which party is in power. Washington is fundamentally broken. Both the Democrats and the Republicans are fiscally irresponsible. The current administration, though well intentioned, is attempting to make major changes in how this country runs, and if it's wrong, there is little margin for error.
President Obama is trying to emulate the first 100 days of the Roosevelt administration. The difference is that when FDR came in, the ratio of outstanding federal debt to GDP in the U.S. was about 16%. This year it will rise to about 85%, and this does not include the present value of entitlement liabilities--Social Security, Medicare, Medicaid and prescription drugs -- or guarantees, such as those for Fannie Mae and Freddie Mac debt, that total an additional $5 trillion-plus. The words cut and eliminate are foreign to both parties. Our elected officials should be ashamed of themselves for what they are doing to the young and to future generations to come.
Although you've moved to Nevada, your firm is still based in California. Would you invest in California municipal bonds?
Rodriguez: I can look at the numbers and say that California general-obligation bonds are fine. But I also could have looked at Chrysler's numbers and said, "I'm a secured creditor; I'm fine." Yet the rights of secured creditors were thrown overboard in the Chrysler bankruptcy. So when the ground rules change in the middle of the game, you have nothing to hang on to. So, at this point in time, I wouldn't lend a dime to the state.
Corporate junk bonds have had a huge run-up this year. Is it too late to buy?
Rodriguez: High yield is a highly speculative area, and this year those who speculated won. But I go back to what I just said: If I can't determine what the ground rules are, how can I invest? If you can overthrow creditors' rights, as was the case with Chrysler, you add more risk to what is already a risky asset class.
Bob, you've criticized the fund industry over a number of issue, including the idea that funds need to hew to a particular style and be fully invested at all times.
Rodriguez: I have dealt with this issue for over 25 years and have tried to gain as much flexibility as possible. Nowadays, if you stray too far from a particular style box or hold too much cash, the consultants attack you for tracking error. And that makes it more difficult for you to raise money.
I've had investors redeem assets from FPA Capital because I let cash build to 45%. I had redemptions because I had too high a concentration in energy stocks, and the sellers wanted a more diversified fund. If it were up to me, there would be no style boxes, and the client would hire you to use your best judgment. But that is not the case in this industry today, and I do not see it changing anytime soon.
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vermillion used to be ciphergen
Noble financial is getting people into the stock
I think some of the girls on fox news are pretty hot
so your liberal bias even clouds you view of the world outside of politics
I wasn't disagreeing with you on everything you said, I was just making a comment that I believe this management has handled negotiations well previously.
> My guess (based upon personal experience within an entirely different industry), is that biotech management stinks at negotiations just like the technical teams I know. <
Actually Paul Goddard was a senior executive on the other side of partnership discussions when he was at Smithkline, and John Varian is a top notch executive who has handled many negotiations from the sale of Neurex, to the sale of Genset, on very good terms.
thank you senior