Sorry for the typo...

Elmore = gossip, tale, rumor....

TEVA - There are Elmore that teva may get FDA nod for its generic version of lovenox tomorrow or sometime next week. Does anyone hear the same thing from the shorts?

Thanks!
WID

I use my iPhone reading the hub everyday and sometime I can reply to other msg as well. So, iPhone is working--just let you know.

MNTA - Court Decision on SNY PI

"Sanofi objects to the FDA's finding that Sandoz' generic has the same active ingredient as Lovenox because it didn't fully analyze the complete structure of the drug. "FDA has determined that parts of Sandoz's product are the same as [Lovenox]. For the rest, FDA is making an assumption," Henn wrote in a brief."

That is one of the reasons the judge needs more time to consider a decision--I think he may need couple months to see if there is any safety issues the mL.

Other than that, I don't see SNY will prevail on this lawsuit against the FDA.

Hi all,

Thanks a lot for your prompt response! I indeed loaded more shares today as well.

All the best!

PS: I also loaded up some SGEN too. SGEN will report P3 top line for SGN-35 in the next couple months.

Hi all,

I want to know if any of you did actually sell or cut your holding in MNTA? And how much credit you give to Tim Anderson of Sanford Bernstein?

Thanks!
WID

Does anyone know why MNTA keeps bleeding everyday? Just wonder!

Thanks!
WID

Did anyone listen to the IDIX presentation today in UK?

For some reason, I could not find it on the company website.

Thanks!
WID

Thanks a lot Dew. I was a little sloppy when I typed the message.

Thanks!
WID

OT: RPC is soaring today with upgrade from Goldman. Does anyone follow this company? According to GS, it seems that RPC may have a blockbuster drug.

BALTIMORE, May 13, 2010 (GLOBE NEWSWIRE) -- Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, has initiated research coverage of Radient Pharmaceuticals Corporation (NYSE AMEX:RPC), a leading early stage cancer/oncology in-vitro diagnostic test kits provider.
Radient has won FDA approval for its lead product as a post-surgery colorectal cancer monitoring test and is the only approved product abroad for lung cancer detection and monitoring and as a general cancer screen. By year-end, Radient will submit an application for approval as a general cancer screen with the FDA, which would markedly expand its current billion dollar market opportunity. As part of its diagnostics focus, Radient is in the midst of monetizing non-core assets and business lines through divestitures and out-licensing.
In the Goldman Opportunity Research report on the Company, analyst Rob Goldman outlines milestone events that he believes will serve as catalysts for the Company's shares.
"We view Radient as a stock that offers great value and potential for its existing operations, hidden but soon-to-be monetized value in its non-core assets, and home run potential with its next-gen product, should it be awarded FDA approval. A steady stream of news and events prior to FDA submission should serve as catalysts for the stock."

Thanks a lot for the link!

I loaded more MNTA and IDIX this morning instead.

OT: VVUS is soaring today. Does anyone know what happen to Qnexa® (once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate)?

Thanks a lot!

Disclosure: I am still holding MNTA and IDIX... and I just bought more shares of MNTA on the latest pullback.

In a securities filing today, Bank of America (NYSE:BAC) talked about the cost of the British tax on bank bonuses and what it would cost them, along with their exposure to the Greece sovereign debt crisis.

Concerning the British tax on banking bonuses, Bank of America said they estimate it may cost them close to $465 million in the second quarter, which would have a significant impact on their earnings.

For the quarter ending June 30, the company said they plan on recording a compensation expense as a result of the tax, which is a one-time 50 percent tax on bonuses paid from December 9, 2009 to April 5, 2010.

For their exposure to the Greek sovereign debt crisis, BofA said they have about $193 million a risk in government-backed debt in the country. Even so, that could be limited because of credit default protection of $205 million.

As far as debt in Greece which isn’t connected to the government, their exposure is much more, with an extra $1.1 billion in loans to corporations and individuals.

Taking the entirety of the five countries under financial stress in Europe – Portugal, Ireland, Italy, Greece and Spain – their total exposure is $3.1 billion to government debt, with an equal amount of credit default protection to back them up.

Their major concern is Italy, where exposure is $2.3 billion to government-backed debt, and private debt is a gigantic $7.3 billion, according to the filing.

Bank of America said through a spokesman that they believe the debt is very “manageable.”

http://www.americanbankingnews.com/2010/05/07/bank-of-america-nysebac-on-british-tax-and-exposure-to-greece/

No doubt about pps of $20... it will go much higher in the coming days, weeks, and months.

Hi all,

Please share with me if anyone in here know something about these companies:

CPRX and XOMA.

By the way, I want to take this opportunity to thank you Dew for doing research on IDIX and MNTA...

I am very grateful for his kindness and hard works he has done and shared with us in here.

To know you must be a great honor in my life!

I wish you and others all the best!

WID

DEW: Thanks a lot for your detailed answer.

Keep up all the great works!

All the best!

WID

OT: SCLN and SLXP

Have anyone followed SCLN and SLXP. Why SCLN just does business in China, Russia, and few countries in EU. Why doesn't the company file with FDA for NDA for ZADAXIN®?

Please advice!

TIA

AMLN: It looks to me that BYDUREON will be on the market soon. It is just the label issue for the time being.

Any guess of how high AMLN and ALKS will go when BYDUREON's approval?

TIA

Biomaven0: Thanks a lot for the info. I will do more research about this firm and will post questions in here if I have any.

Thanks a lot!
WID

Lenders may be 'shocked' by size of Nama discounts

Not Good News for AIB. See Link and texts below:

http://www.irishtimes.com/newspaper/finance/2010/0313/1224266197713.html

THE FIVE participating financial institutions are likely to be “shocked” at the size of the discount demanded by the National Asset Management Agency (Nama) for taking over the first tranche of problem loans, according to an informed source.

Nama plans to tell three of the five participating financial institutions next week how much it will pay for the loans of the top 10 developers which are to be transferred by the end of this month, The Irish Times has learned.

Bank of Ireland, Irish Nationwide Building Society and EBS building society will be the first to learn of the scale of the discount when Nama issues so-called acquisition schedules outlining the first loans it will buy and the discounted price it will pay for them.

Allied Irish Banks (AIB) and State-owned Anglo Irish Bank will receive their schedules soon afterwards in sufficient time for the first 1,000 loans totalling €17 billion to be transferred from the five lenders by the end of the month.

The acquisition schedules for AIB and Anglo will be sent later than the others as they are transferring the largest loans overall to Nama, and because they provided valuations and legal due diligence on the loans and underlying properties later than the others.

Anglo is transferring a total of about €36 billion in loans to Nama, while AIB is moving €23 billion. A total of €81-€82 billion will move to Nama from the five participating lenders.

It is understood Bank of Ireland is transferring a total of €12 billion in loans to Nama, while Irish Nationwide is moving about €9 billion and EBS about €800 million.

If Nama’s plan goes according to schedule, the first transfers will be completed just before the end of the month, allowing the State’s two largest banks, AIB and Bank of Ireland – the only two publicly quoted participants in Nama – to notify the stock market on the expected writedowns on the first loans to be transferred.

This will allow the institutions as well as financial analysts and market commentators to assess the overall losses to be incurred by the banks and the expected capital deficits in their books to be filled.

This will in turn help to determine the full cost of the bank recapitalisation plan, and clarify whether the banks need additional capital from the Government and whether the State will take greater ownership of the banking system.

The valuations of the first €17 billion in loans to be transferred and the underlying properties backing them are expected to be lower than originally anticipated. This means the expected discount or so-called “haircut” facing the banks on the first loans will be higher than the average 30 per cent discount originally estimated by the Minister for Finance Brian Lenihan last September. This in turn implies the Government may have to take larger stakes than currently projected.

It’s understood the information sought by Nama has shown loan documents held by some lenders to be inadequate and poorly managed, with lenders not having sought sufficient paperwork and legal checks in some cases before making original loans.

Once the first loans are transferred, Nama plans to write to the top 10 borrowers giving them a month to prepare business plans outlining their proposals for development projects, investment properties and their wider businesses.

Many of the borrowers have begun drafting comprehensive plans, which will be assessed by Nama over the summer months.

It’s understood that some €12 billion in loans will be moved in the second tranche and €9 billion to €10 billion in the third, bringing the total loans moved in the first three waves to €39 billion, covering up to 100 borrowers.

Nama plans to manage these borrowers directly. The remaining 1,400 borrowers to be moved – who account for the remaining 50 per cent of loans – will be managed by the lenders, with staff seconded from Nama overseeing them.

The agency still plans to take transfers of all 1,500 developers and 17,000 to 18,000 loans by the end of this year, despite the vast amount of paperwork and information required from the banks.

OT - BIOD: VIAject

I want to know if anyone in here has followed BIOD? The company has been working on two pivotal phase 3 trials for insulin.

Excerpt from the company website:

"It is a proprietary form of regular human insulin which was developed to enable more effective blood-glucose control than currently marketed insulin products. Biodel has submitted a New Drug Application to the FDA for approval to market VIAject® as a treatment for Type 1 and Type 2 diabetes, based upon results from pharmacokinetic, pharmacodynamic and standardized meal studies, two pivotal 6-month Phase 3 clinical trials of VIAject® in patients with Type 1 and Type 2 diabetes, as well as interim results from the long-term, 18-month safety extension trials for patients who completed the pivotal Phase 3 clinical trials."

Thanks a lot for your help.

Shorter Period of Protection for Brand-name Drugs

The drug industry is threatening to end its support for President Barack Obama's health overhaul effort because of a rift over protecting brand-name biotech drugs from low-cost generic competitors.

The Associated Press has obtained an e-mail to board members of the Pharmaceutical Research and Manufacturers of America from the trade group's president saying "we could not support the bill" if the industry gets less than 12 years of competitive protection for the expensive products.

The pharmaceutical industry has been a major supporter of Obama's health effort. It has spent many tens of millions of dollars on advertising and lobbying.

Obama, along with generic producers and consumer groups, want a shorter period of protection.

http://moneynews.com/Economy/US-Health-Overhaul-Biotech/2010/01/15/id/346536

OT: SNTA - Does anyone follow SNTA. The company announced that preclinical results presented at the AACR-IASLC (American Academy of Cancer Research.

See link..

http://finance.yahoo.com/news/Synta-Presents-Results-at-bw-3114970089.html?x=0&.v=1

Besides the news on the preclinical result, there is evidence of insiders buying as well. See link below:

http://www.secform4.com/insider-trading/1157601.htm

Please advise!

Best regards,

WID

IDIX to report Phase II trial of IDX184, designed for the treatment of hepatitis C virus (HCV) infection.

(Some of you may already see this)

In February – March 2010, we expect Idenix Pharmaceuticals, Inc. (IDIX), to release the data from the Phase II trial of IDX184, designed for the treatment of hepatitis C virus (HCV) infection.

The ongoing, Phase II trial is comparing the efficacy and safety of oral IDX184 in combination with pegylated-interferon alpha/peg-IFN alpha and ribavirin/RBV (the current standard of care for HCV infection) to placebo plus peg-IFN alpha and RBV in approximately 80 treatment-naïve HCV genotype 1 patients, who did not receive any prior therapy. The trial is divided into four dosage groups (50mg, 100mg, 150mg and 200mg once-daily), with each group comprising of 20 patients, of which 16 are receiving IDX184 in combination with peg- IFN alpha and RBV and 4 are being treated with placebo plus peg-IFN alpha and RBV for 14 days. The data from this Phase II combination trial will be released sometime in February - March 2010.


Hepatitis C infection is caused by a virus called HCV. There are various types of HCV that cause hepatitis C infection. These different types of HCVs are classified under six groups, called genotypes, denoted by genotype 1 to 6. Of these, genotype 1 is the most common type of HCV, which accounts for nearly 70% of all HCV infections and is regarded as the most difficult HCV to treat.

For more info, please see the attached link:

http://www.newbiomedicine.com/Revere/UploadFiles/file/IDIX%20IDX184%20Phase%20II%20December%2022,%202009.pdf

iOwnSomeBio:

It is a typo. I only own 7K.

Thanks!
WID

Thanks a lot Dew!

To be honest with you, I am a small investor who is currently holding 2K shares of BAC, 10K shares of RF, and 7K shares of MNTA.

My investment capital is very limited so I want to listen to the expert in here to help me making my decision and you are the best in here that I have been following.

Best regards,

WID

Good Morning Dew:

I just came back from vacation and am hppay to see MNTA is up much higher from last month.

I am no expert in biotech stocks and I hold 70000 shares of MNTA.

If you were me, what should you do?

Thanks a lot for your opinion.

Merry Christmas and Happy New Year to you and yours.

Best regards,

WID

California Housing Market Turns Corner

Nov. 25 (Bloomberg) -- California, one-time hub of subprime mortgage lending and the nation’s leader in home foreclosures, has turned the corner toward a housing recovery, according to the state Association of Realtors.

Single-family home prices in California rose for the eighth consecutive month in October. The median cost of an existing, detached house gained 0.3 percent from the previous month to $297,500. Prices dropped about 3.2 percent from a year earlier, compared with annual declines of 7.3 percent in September and 17 percent in August.

“California has hit and passed the bottom of this real estate cycle,” Leslie Appleton-Young, vice president and chief economist of the Los Angeles-based Realtors group, said in a statement today.

Sales of existing houses climbed 1 percent in October from a year earlier, the Realtors group said. The state is on pace to record 562,400 sales in 2009, based on the rate of transactions last month. Foreclosures represented 41 percent of sales, down from a peak of 59 percent in February, research company MDA DataQuick said on Nov. 19.

Home sales throughout the U.S. are being boosted by a drop in interest rates and a federal tax credit for homebuyers. Fixed 30-year mortgage rates dropped for a fourth consecutive week to 4.78 percent, matching a record low set in April, mortgage buyer Freddie Mac of McLean, Virginia, said today in a statement.

The median single-family house price in California is 50 percent below the peak of $594,530 reached in May 2007, the state Realtors group said.

California Unemployment

California, the most-populous state, has one of the highest jobless rates in the country. The state’s unemployment rate is 12.5 percent, compared with the national rate of 10.2 percent, according to the U.S. Department of Labor.

Dangers still facing the state housing market include joblessness and the end of the federal tax credit next year, Appleton-Young said in an interview.

“There are a lot of minefields -- a lot of uncertainty going forward -- but we were looking at eight consecutive months of increases in the statewide median, and we are seeing multiple offers” on many homes for sale, she said. “It’s going to be a slow recovery.”

Obstacles also may include homeowners who want to sell their houses and are waiting for higher prices, and an unknown number of foreclosed properties that have yet to hit the market, said Andrew LePage, an analyst with MDA DataQuick, in a Nov. 17 interview.

‘Aren’t Normal Times’

“The market’s starting to tighten up a little bit,” LePage said. “In normal times, we would technically be in a seller’s market. Of course, these aren’t normal times.”

The median time it took a median to sell a California house fell to 34.1 days in October from 45.5 days a year earlier, the Realtors group said. The association’s index of unsold inventory dropped to a four-month supply from 6.1 months a year earlier. The index shows the time needed to deplete the supply of homes on the market at the current sales rate.

The median price for a California condominium was $267,520, down 3.6 percent from a year earlier and 1 percent from September, the Realtors group said. Condominium sales rose 9.4 percent from a year earlier and 5.5 percent from September.

Fed Said to Ask Banks to Submit Plans to Repay TARP

Nov. 23 (Bloomberg) -- The Federal Reserve asked nine of the U.S. banks that were part of this year’s stress tests to submit plans for repaying the government’s capital injections, a person familiar with the situation said.

The central bank this month asked Bank of America Corp. and eight other banks to give plans including a timetable, said the person, speaking on condition of anonymity. The firms may have the option to repay the Troubled Asset Relief Program funds soon if they’ve been able to raise common equity recently and would continue to exceed capital buffers set in the stress tests, the person said.

The Fed’s request may put more pressure on banks to repay TARP funds. Banks have had leeway to work with their supervisors and decide when to approach the government with a repayment plan. Together the nine banks have received about $142 billion in TARP funds, out of the $700 billion Congress authorized in 2008 for the financial rescue.

“It would send a terrific message to the market if there was a plan and a timetable for at least the top banks in TARP to pay the money back,” said Joel Conn, president of Lakeshore Capital Inc. in Birmingham, Alabama, which owns stock in PNC Financial Services Group Inc. “It would signify they are good enough to stand on their own.”

The banks in the stress test that have yet to repay TARP are Bank of America, PNC, Citigroup Inc., Fifth Third Bancorp, GMAC Inc., KeyCorp, Regions Financial Corp., SunTrust Banks Inc. and Wells Fargo & Co.

Stress Tests

The request was reported earlier today by DealReporter.com, a news service that focuses on mergers and is part of Pearson Plc’s Financial Times Group.

The Fed released results in May from stress tests that showed how the 19 largest U.S. lenders would fare in a slower recovery with higher-than-forecast unemployment. Ten companies including Bank of America, Wells Fargo and Citigroup needed to raise additional capital.

Regions doesn’t comment on talks with regulators, spokesman Tim Deighton said. Bank of America and SunTrust declined to comment. Citigroup’s Stephen Cohen declined to comment.

Julia Tunis Bernard, a spokeswoman for Wells Fargo, Bill Murschel, a KeyCorp spokesman, and Debra Decourcy of Fifth Third didn’t return calls for comment. Fred Solomon, a PNC spokesman, and GMAC’s Gina Proia declined to comment.

To contact the reporters on this story: Scott Lanman in Washington at slanman@bloomberg.net; Craig Torres in Washington at ctorres3@bloomberg.net.

Please look at this report and see BAC will fly soon...

http://seekingalpha.com/article/165641-countrywide-bank-of-america-reos-fall-to-february-2007-levels?source=feed

I can see BAC will be in the $20's by earning date and some where in the mid $20's by the end of this year!

The shorts have the upper hands right now but not too long.

Looking for more action near the close today and early next week.

OCT 17 options looks cheap!

It will put the bottom for the pps at $10.75 since the big boys get in at $10.75 per share.

Do you agree with me?

Thanks!
WID

Tony111:

Thanks a lot for your quick response.

Thanks!
WID

Conflict of interest and resignation at drug agency

I don't have an account at nature.com and I am interested in this article. If you have an account with nature.com, would you please share with us this info.

http://www.nature.com/news/2009/090819/full/460943e.html

Thanks a lot!

WID

MNTA: Is there a relationship between MNTA share price today and the S-3 filed for 90,000 shares........

Thanks a lot!

http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6477329

Barakett’s Atticus Fund Has a Large Position in BAC

Atticus, run by Timothy Barakett, bought $355 million in shares of Charlotte, North Carolina-based Bank of America Corp., a new position, according to a filing yesterday with the U.S. Securities and Exchange Commission. The fund’s holdings in U.S. stocks rose to $3.71 billion as of June 30 from $118 million on March 31.

http://www.bloomberg.com/apps/news?pid=20603037&sid=aJkV1Kupxqdc

Like a kid in a candy store ... and the candy's on sale

One option is a bank, specifically Allied Irish Banks (NYSE: AIB). While it just reported increased impaired or at-risk loans, the company is probably still the best of the Irish banks. Concern that the bank will need to raise more capital than indicated so far, as well as worry about the "bad bank" being set up by the Irish government, continue to hold the price of the stock at low levels. If it can survive the downturn in the Irish economy and get rid of the majority of its bad loans, it could turn into a fantastic investment from this point forward./

There's also the investment bankers and brokerages. Some, like Morgan Stanley (NYSE: MS), might be worth investing in. Heck, if it gets cheap enough, even I will take a closer look. (Even possibly bad companies can be good investments if you get them at the right price.)

Does anyone in here have any idea why MNTA drops today?

Thanks!
WID

Momenta Pharmaceuticals Reports Financial Results for the Second Quarter of 2009

CAMBRIDGE, Mass., Aug. 6, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA - News), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended June 30, 2009.

For the second quarter of 2009, the Company reported a net loss of $16.8 million, compared with a net loss of $15.0 million for the same period last year. At June 30, 2009, the Company had cash, cash equivalents, and marketable securities of $72.1 million, compared with $108.5 million at December 31, 2008.

"In the second quarter we made substantial progress in the novel drug development side of our business, advancing both our novel anticoagulant, M118 and our novel oncology product candidate, M402. We are very pleased that the M118 EMINENCE Phase 2a study achieved its primary endpoint," said Craig A. Wheeler, President and Chief Executive Officer. "On the generic side of the business, we and Sandoz are actively working to progress the FDA's review of the ANDAs for M-Enoxaparin and M356," he concluded.

Second Quarter 2009 Financial Results

Revenue for the second quarter of 2009 was $6.6 million, compared to the $3.6 million revenue for the same period last year. The increase in revenue was due to increased reimbursable expenditures on our collaborative programs partnered with Sandoz. Research and development expenses for the second quarter of 2009 were $17.7 million, compared to $12.9 million for the same period last year. The increase in research and development expenses principally resulted from increased manufacturing, process development and third-party research costs in support of the M356 program.

General and administrative expenses for the second quarter of 2009 totaled $5.8 million, compared with $6.3 million for the same period last year. The decrease in general and administrative expenses was primarily due to decreased professional fees.

The change in cash and marketable securities for the second quarter of 2009 totaled $15.8 million. The change in cash for the second quarter of 2009 would have been $13.3 million if adjusted for a payment of $2.5 million due in June 2009 under a collaborative agreement that was not received until July 2009.

Recent Corporate Developments

In June, the Company announced top line results from the M118 EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) trial. The Phase 2a trial of the novel anticoagulant enrolled approximately 500 patients undergoing percutaneous coronary intervention (PCI). Patients were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH).

The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction, repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group; however it should be noted that the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.

In June the Company announced the appointment of Bruce L. Downey to its Board of Directors, effective June 11, 2009. Mr. Downey is the former Chairman and Chief Executive Officer of Barr Pharmaceuticals, Inc. and a former Chairman of the Generic Pharmaceutical Association (GPhA). He succeeds Momenta co-founder Robert S. Langer, who has served on our board for over eight years. Dr. Langer continues to advise the company as a scientific consultant.

In April, the Company presented results from preclinical studies of the Company's novel oncology product candidate, M402, at the American Association of Cancer Research meeting in Denver, CO. One of the key findings was that M402, in combination with chemotherapeutic agents, inhibited spontaneous tumor metastasis in a murine metastatic breast carcinoma model.

Conference Call Information

Management will host a conference call on Thursday, August 6, 2009 at 10:00 am EDT to discuss these results and provide an update on the Company. To access the call, please dial (877) 718-5099 (domestic) or (719) 325-4838 (international) prior to the scheduled conference call time and provide the access code 1438216. A replay of the call will be available approximately two hours after the call and will be accessible through August 18, 2009. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 1438216.

A live audio webcast of the call will be available on the "Investors" section of the Company's website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through August 20, 2009.

Thanks a lot for the VPHM news!