Why don't you tell us why you think it would not be considered? Cardio bypass blood filters are Class II devices, CTSO's cartridge is unique, and has demonstrated low risk and known benefits. Those are the requirements for the 510(k) de novo process.
Dude, look at the market. Most of the offshore drillers hit 52-week lows today. The sell-off was not SDRL-specific.
Two years ago, SPPI's share price was double ITMN's. Today, ITMN's share price is 10X SPPI's. Worse, SPPI's share price is half what it was then. SPPI shareholders have been betting on the wrong horse ... again.
Why would you think the "research" would fall short? Reduction of inflammatory biomarkers in fewer than 150 patients would be the primary endpoint, which already was demonstrated in obtaining the CE Mark.
And what's this about the process being time consuming? Its purpose is to accelerate, not delay, approval. The volume of cardio bypass procedures performed in the US would allow data capture for 150 patients in a very limited timeframe.
You may have misunderstood. CTSO is forming an audit committee. An audit committee reports to the board of directors. The chair of an audit committee is a member of the board of directors. CTSO is looking to ADD to the board a person with credentials to serve in this capacity. CTSO will not be installing a new board of directors or, as far as we know from what has been communicated to date, appointing a new chairman.
S&P 500 opened at 1031 and SPPI at $3.90 on July 1, 2010. S&P 500 since is up 194%, and SPPI is up 204%. What bull market runup did SPPI miss?
These transactions have nothing to do with retirement accounts. As Dr. Chan explained in his email reply, Kraus is selling stock acquired via option exercise in conjunction with estate planning. Option expiration dates and tax liability may vary based on whether Kraus is among the living or the dead.
mak's post is verbatim from an non-comprehensive Investopedia article and does not take into account the variations in listing criteria between the different NASDAQ markets (Global Select, Global and Capital). Google "nasdaq listing requirements 2014" and click on the "Initial Listing guide for the NASDAQ OMX" pdf link for the truth.
LNG would not be the place to be if exporting "isn't going to happen". FERC just approved another Louisiana LNG export facility. That puts all three of the projects approved so far that definitely will be built in XCO's backyard. Where do you think the gas will be produced? Why do you think well-heeled institutional investors with long term investment horizons are maintaining their interest in XCO?
Notwithstanding the fact Dr Chan has said CTSO expected to uplist every year for the past few years, "A company’s board of directors may declare a reverse stock split without shareholder approval. Although the SEC has authority over a broad range of corporate activity, state corporate law and a company’s articles of incorporation and by-laws govern reverse stock splits." Further, "If a company is required to file reports with the SEC, it may notify its shareholders of a reverse stock split on Forms 8-K, 10-Q and 10-K." (SEC*dot*gov, "Reverse Stock Splits") You may be correct that we will hear about it after the fact (and likely after we already have noticed the share price is higher and the shares we own are fewer).
That is untrue. Only one of the four NYSE MKT initial listing standards has a revenue requirement, and it states verbatim:
"Pre-tax income from continuing operations of at least $750,000 in its last fiscal year, or in two of its last three fiscal years." (NYSE MKT Company Guide, Part 1. Original Listing Requirements, Subsection 101.a.2)
(Reuters) U.S. regional refining margins fell 6.66 percent on average in the week ended Sept. 12, declining in three out of the five regions, Credit Suisse said in a weekly report on Monday.
Margins in the Gulf Coast dipped the most, down 20.25 percent, while margins in the West Coast and Midwest fell 16.33 percent and 5.68 percent, respectively.
Rockies refining margins climbed 5.07 percent, and the margins in the Northeast rose 3.88 percent, Credit Suisse said.
The 6.66 percent average fall in U.S. refinery margins was calculated by taking the average of regional margins.
The following table shows the changes in refinery margins:
Date Northeast MidWest Gulf Coast Rockies West Coast
Current week 12-Sep-14 12.57 21.60 14.57 34.81 19.47
Previous week 05-Sep-14 12.11 22.90 18.27 33.13 23.27
Change 0.47 (1.30) (3.70) 1.68 (3.80)
Percent Change 3.88 (5.68) (20.25) 5.07 (16.33)
Trailing 4-week 12-Sep-14 11.56 20.50 17.38 32.97 20.76
Previous year 13-Sep-13 9.27 16.87 11.76 23.48 13.36
Change Y-on-Y 2.28 3.64 5.62 9.49 7.40
Anything is possible, given this May 19 report:
Walgreens denies report of speeding up Boots takeover, Drug Store News says. Following a report in The Telegraph that claimed Walgreens may seek to acquire the remaining stake in Alliance Boots in as little as eight months, the company denied any plans to accelerate its purchase of Boots, reported Drug Store News. Walgreens spokesman Michael Polzin said, "The window for step two of the transaction begins in February 2015. The current agreement doesn't allow for a move prior to that," according to the industry news service.
That's not true. I'll repeat my contribution to another (since deleted) thread this morning: Google "nasdaq listing requirements 2014" and click on the "Initial Listing guide for the NASDAQ OMX" pdf link for the truth. Pay particular attention to the three different NASDAQ markets.
I wonder if Jana Partners recently lost money in oil futures, as did many, and simply is looking to recoup the loss by using headlines to goose APA's share price. May set a stop limit to protect this gain.
The relevant press releases are under the Investor Relations tab/ Press Releases link on SPPI's website, dated 12.9.2011 ("Spectrum Pharmaceuticals Affirms Strong Patent Protection for FUSILEV® (levoleucovorin) Through December 31, 2019" ) and January 17, 2013 ("Spectrum Pharmaceuticals Announces Extension of FUSILEV® (levoleucovorin) for Injection Patent Until 2022"). BTW just stopped by to see if this dog was worth playing again; appears not.
Price is too low for a merger announcement. Maybe Farris found a buyer for Wheatstone or Kitimat interests that are up for sale.
Why did ENDP discontinue a Phase III clinical trial and return to BNC.TO global rights to the drug in 2012 if it holds blockbuster potential? The trial, designed to compare the drug with another drug not FDA-approved but widely-used off-label, was not recruiting at the expected rate and FDA issues with the trial design could not be resolved. It's a tough space littered with failed clinical trials, one dominated by an existing FDA-approved SOC with 70% success rate, and for which no new drugs have been approved for thirty years. CTSO shareholders beware.