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Updated FDA Calendar of Decision Dates DSCO

76%

-26.79%
in 9 days

Updated FDA Calendar of Decision Dates

The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a s

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By Mike Havrilla (-6.40% risk: moderate) 11/13/08

1 comment

A Backlog of Decisions is Building at the FDA DSCO

76%

-37.78%
in 6 days
(closed on 11/13/08)

A Backlog of Decisions is Building at the FDA

The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.

Disco

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By Mike Havrilla (-6.40% risk: moderate) 11/07/08

Comment

Teva is on Target to Acquire Barr DSCO

76%

-8.16%
in 9 days
(closed on 11/07/08)

Teva is on Target to Acquire Barr

The accompanying table [click to enlarge image] presents an updated calendar of expected FDA decision dates, including a new NDA filing by Johnson & Johnson (JNJ) for Comfyde and recent approval for Barr Pharma's (BRL) low-dose birth control pill Lo-Seasonique. Teva Pharma (TEVA) has closed a deal with Barr's unsecured credit holders in an effort to close its proposed $7.5B acquisition by year-end, which will expand Teva's generic drug business and also add to its line-up of brand name medications through Barr's strong presenc

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By Mike Havrilla (-6.40% risk: moderate) 10/29/08

Comment

Six Healthcare Stocks on Sale DSCO

76%

+20.10%
in 5 days
(closed on 10/29/08)

Six Healthcare Stocks on Sale

Despite the notion of investing in the healthcare sector as a safe haven, the following six companies (APPY, CMED, CYPB, DSCO, MYL, PFE) are all down sharply over the past year despite solid underlying fundamentals, which are largely unaffected by global economic conditions.

Diagnostics

China Medical (CMED) is trading near its IPO levels of August 2005 despite excellent growth prospects and a PEG ratio of 0.3X, a forward PE of 8X, and a dividend yield of 1.8%. For some perspective on the velocity of the downturn in CMED, the stock

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By Mike Havrilla (-6.40% risk: moderate) 10/24/08

Comment

FDA Action Heats Up Before Year-End DSCO

76%

-5.66%
in 3 days
(closed on 10/24/08)

FDA Action Heats Up Before Year-End

The accompanying table presents an updated calendar of expected FDA decision dates and advisory committee [FDAC] meetings expected to impact the price of underlying biotech and pharma stocks. Genzyme (GENZ) faces a FDAC tomorrow (10/21) for its pending BLA for Myozyme manufactured at the 2,000L bioreactor scale. Also, Discovery Labs (DSCO) submitted its complete response to the FDA last Friday to address an approvable ruling for Surfaxin back in May and insiders continue to buy the stock. DSCO expects the FDA to rule on Surfaxin

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By Mike Havrilla (-6.40% risk: moderate) 10/21/08

Comment

Discover a small fortune. DSCO

67%

-53.41%
in 35 days

This stock has been a bit iffy to say the least. I'm seeing an upward trend that could sustain itself if the NAYsAYers would keep their damn mouths shut and let people calm their pocket pinchen.

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By gomes2gold (-10.19% risk: conservative) 10/18/08

Comment

FDA Calendar: Near-Term Movers DSCO

76%

+30.08%
in 11 days
(closed on 10/21/08)

FDA Calendar of Decision Dates: Some Likely Near-Term Movers

Some likely near-term movers on the FDA's decision date calendar for 70 different items (click to enlarge, left) include Cypress Bioscience ( CYPB ) + partner Forest Labs ( FRX ) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end.

Also, Discovery Labs ( DSCO ) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvab

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By Mike Havrilla (-6.40% risk: moderate) 10/10/08

Comment

Discovery Labs: The Next Biotech Winner? DSCO

76%

-21.76%
in 4 days
(closed on 10/10/08)

Discovery Labs: The Next Biotech Winner?

I think the recent decline in Discovery Labs (DSCO) since the Company announced a minor delay in submitting a complete response to the FDA for an approvable ruling on Surfaxin represents a buying opportunity and bought some shares on Friday at $1.74 per share. Insider buying over the past two months (including a 75,000 share buy from the CEO at $1.87) demonstrates management's confidence in already meeting the FDA's requirements and the plan to submit a complete response to FDA for Surfaxin, which should now occur by about the third

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By Mike Havrilla (-6.40% risk: moderate) 10/06/08

Comment

Insider Buying + Surfaxin Approval Expected in 2008 = BUY DSCO

76%

+0.00%
in 3 days
(closed on 10/06/08)

INSIDER TRANSACTIONS REPORTED - LAST TWO YEARS

Date	Insider	Shares	Type	Transaction	Value*
1-Oct-08	KATZER CHARLES F

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By Mike Havrilla (-6.40% risk: moderate) 10/03/08

Comment

FDA Decision Date Calendar Through January 2009 DSCO

76%

-18.66%
in 12 days
(closed on 10/03/08)

FDA Decision Date Calendar Through January 2009

The accompanying table includes a calendar of expected FDA decision dates through the end of January 2009, including nine decisions due by the end of September. Some likely near-term movers on the calendar include Cypress Bioscience (CYPB) + partner Forest Labs (FRX) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end. Also, Discovery Labs (DSCO) is not listed on the calendar, b

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By Mike Havrilla (-6.40% risk: moderate) 09/21/08

Comment

Discovery Labs: Poised for Eventful End of Year DSCO

76%

+3.98%
in 3 days
(closed on 09/21/08)

Discovery Labs: Poised for Eventful End of Year

Discovery Labs (DSCO) is set for an active end to the year with a planned complete response to the May 1, 2008, FDA approvable letter for Surfaxin, which management has guided for submission by the end of September. The Company will provide impurity data and biological activity tests to the agency and expects the NDA re-submission to be classified as a Class I review with a 60-day decision deadline compared to the more lengthy Class II resubmission process of six months. At mid-year, Discovery Labs had cash and equiv

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By Mike Havrilla (-6.40% risk: moderate) 09/18/08

Comment

Discovery Labs Looking for Surfaxin Approval by EOY DSCO

76%

+0.00%
in 1 hour
(closed on 09/18/08)

Since meeting with the FDA in mid-June, the Company has trended lower on investor disappointment that the Company would delay its response to the most recent approvable ruling for Surfaxin until September. However, the Company still expects a Class I review (60 days), which could result in approval for Surfaxin by late November or early December without the need for additional time-consuming and expensive clinical trials as the outstanding issues appear to be minor with the FDA. Summer is typically a slow time for biotech trading and provides a good time to accumulate shares ahead of potent...

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