SPEX - Sector: Healthcare --- Industry: Medical Laboratories & Research

[setravis]

Did this come across anyone's radar ?

[setravis]

Hmmm................
News and Insider,
Just won a law suit over a government contract.Levin Gilbert CEO bought 3000 recently from 3 to 3.15,  momentum starting on a slow day.



Press Release Source: Spherix Incorporated


FDA Activates Spherix's Diabetes Drug Investigation
Tuesday December 6, 10:54 am ET 
Naturlose(TM) to Enter Phase 3 Clinical Trial


BELTSVILLE, Md., Dec. 6 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX - News) today announced that yesterday it received confirmation from the U.S. Food and Drug Administration (FDA) that it has cleared the way for the Company to conduct a Phase 3 clinical trial of Naturlose(TM) to treat Type 2 diabetes. A successful Phase 3 trial would permit the Company to file a New Drug Application (NDA), the final step before marketing its patented product.


In a November 4 meeting with Spherix scientists and consultants, the FDA said that its Center for Drug Evaluation and Research had reviewed pharmacological, toxicological, and efficacy data from Spherix's completed Phase 1 and 2 clinical trials, and found Naturlose to be qualified for the Phase 3 trial. At the meeting, FDA officials also reviewed the Phase 3 trial protocol recently submitted to the Agency by the Company, and made helpful suggestions.

"The World Health Organization (WHO) estimates that at least 171 million people worldwide have diabetes, a number the WHO expects to double by 2030," said Dr. Gilbert V. Levin, Executive Officer for Science and Director of the Company's BioSpherix Division. He added, "according to the Centers for Disease Control and Prevention, 20.8 million Americans have diabetes, nearly one-third of whom have not yet been diagnosed. By any measure, this is a huge and growing healthcare problem. Having an active Investigational New Drug for diabetes treatment is a major step for Spherix. We are now selecting a contract research organization to start the critical Phase 3 trial. Should all go well with the trial, we will file an NDA to enter Naturlose into the diabetes drug market to help combat this global health threat."

Two Spherix-sponsored clinical trials led by Dr. Thomas Donner, Medical Director of the University of Maryland's Joslin Center for diabetes, showed Naturlose to be a promising treatment for Type 2 diabetes. The studies were conducted at the University of Maryland School of Medicine.

Naturlose is also being developed for other medical and health uses. Last week Spherix began funding a second year of its research at the Albert Einstein College of Medicine (AECOM) to develop the use of Naturlose to preserve hemoglobin and other blood components, including platelets and various medicinal proteins. AECOM is one of the world's leading blood research institutions. Spherix and AECOM recently (Spherix News Release, 11/3/05) entered into an agreement for the commercial development and sales of the anticipated products of their joint research.

Under its motto, "A World of Solutions," Spherix's mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in information technology, knowledge management, and biotechnology. Spherix's Internet address is http://www.spherix.com.

Certain statements contained herein are "forward looking" statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on March 3, 1999.




--------------------------------------------------------------------------------
Source: Spherix Incorporated

[setravis]

I will be watching this real close like...


UPDATE 1-Spherix gets FDA approval for trial, shares soar
Tue Dec 6, 2005 03:58 PM ET
(Adds details, updates share price)
NEW YORK, Dec 6 (Reuters) - Spherix Inc. (SPEX.O: Quote, Profile, Research) on Tuesday said the U.S. Food and Drug Administration has agreed to allow the company to conduct a late-stage trial of its experimental diabetes drug, and its shares more than doubled.

The company said the planned Phase III trial of Naturlose to treat Type 2 diabetes, if it proves successful, would allow Spherix to seek U.S. marketing approval for the drug.

Type 2 diabetes is the most common form of diabetes. It typically develops in adulthood and is closely linked to obesity.

Spherix shares soared and were up $2.48, or 195 percent, at $3.75 in late afternoon trade on the Nasdaq.

The company, which is based in Beltsville, Maryland, said the drug had favorable results in earlier mid-stage trials conducted at the University of Maryland School of Medicine. (Additional reporting by Ransdell Pierson in New York) (Reporting by Saumyadeb Chakrabarty in Bangalore)

[setravis]

Health Stocks in Motion

By Mark Martinez
TheStreet.com Staff Reporter
12/6/2005 2:56 PM EST 


Shares of Spherix (SPEX:Nasdaq - were among the best-performing health-related stocks Tuesday, more than doubling after the company said the Food and Drug Administration cleared the way for it to conduct a late-stage clinical trial of Naturlose, the company's type-2 diabetes treatment.

Spherix said the FDA's Center for Drug Evaluation and Research reviewed pharmacological, toxicological and efficacy data from the company's Phase I and II trials, and found Naturlose to be qualified for a Phase III trial. The company is now in the process of selecting a contract research organization to start the new study. "Should all go well with the trial, we will file an NDA to enter Naturlose into the diabetes drug market to help combat this global health threat," the company said. Shares were trading up $2.13 to $3.40.

[Terliso]

WHOAAA...195%  .... good catch.. (applaud)

[calven]

Here is the intraday entry i just missed by .03!

My Bid of 4.80 didnt get a fill (shown by the blue line below) ... reached 4.83 and shot up to 5.20 in 5 minutes..

Would have had a 300-400$ gain in less than 10 minutes.


Trade was based on my ESM (exhausted selling model) bottom...

[setravis]

 

AP
Spherix Up on Plans for Clinical Trial
Wednesday December 7, 3:53 pm ET 
Spherix Shares Up After FDA Says Co. Qualified to Begin Late-Stage Clinical Trials for Naturlose


BELTSVILLE, Md. (AP) -- Shares of Spherix Inc. jumped Wednesday to a new 52-week high after the provider of biotech and information technology services said that the Food and Drug Administration told the company it was qualified to begin late-stage clinical trials for a sugar aimed at diabetics.


Spherix shares rose $1.40, or 37 percent, to $5.15 in afternoon trading on the Nasdaq at more than 100 times their average volume. Shares hit a new 52-week high of $5.85, surpassing the old one of $3.95 set last December, after sliding to a recent 52-week low of $1.19. Company shares are up 59 percent on the year so far.

The company said that the FDA reviewed data from its early and mid-stage clinical trials for Naturlose, the brand name for the low-calorie natural sugar tagatose. The Phase III clinical trial would study the use of Naturlose in patients with Type 2 diabetes, or adult-onset diabetes where the body does not properly use insulin and produces low levels of the hormone.

With a successful Phase III trial, the company said it would submit an application to the FDA to market the sweetener.

[setravis]

Got the  Mo...... The MoMo !
Got it big time....Plus, IMHO,The market cap does not reflect the potential of this news.
Old shorty may try to take over ....Watch it close if you are holding.
And it is only natural for profit takers, to take it off the table.

Support @ $3.05...2.14...1.99
Resistance @ $7.80...9.30

Recent CandleStick Analysis
Very Bullish
Dec-06-2005 Bullish Engulfing 
Dec-01-2005 Bearish Engulfing 

Technicals
Record Volume..
Record Price High
13-day EMA Cross Above 50-day EMA
Close Above the 50-day EMA
Close Above the 13-day EMA
Most Actives
Record Price Break Out
MACD - Bullish
Percentage Gainer

Last Price Quote is:
193.33%above 13-day EMA
216.69%above 50-day EMA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $16.33 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: N/A

[LiveLife]

Repost from swing trading MB today:

I did finalize and revised the stock trading template as I mentioned in the swing trading MB:
http://www.3stocksonfire.org/trading/index.php?topic=3635.225

I hope this tool will benefit the 3SOF members and visitors!

With recent spiking gains, I do not know if SPEX is trendable still, but I applied the template.

[ScottishTrader]

Maybe look for the bounce on the 61.8% fib just above 3.00???

[calven]

Scottish trader,

I am also following this one with the ESM (model) I use... waiting for a volume spike, break of the down trendline and a break of the 40 period ma..

Possible higher low wave forming currently...

cal

[setravis]

Took a bounce back to the up side from a
61.8% Fibonacci retracement.
Volume now @ 1,546,115 and moving    now +35.62%    Let's rock! 


Technicals
Percentage Gainer

Last Price Quote is:
28.85%above 13-day EMA
80.82%above 50-day EMA
RS Rating: 99 

[stocks2watch2]

SPEX is on fire, not sure what's going on yet. BOught 4000@ 4.3 for a quick trade.

[stocks2watch2]

I'm out @ 4.70

[setravis]

SPEX is on fire, not sure what's going on yet. BOught 4000@ 4.3 for a quick trade.

I'm out @ 4.70

Applaud the trade.....make a fast buck ........