GNBT.OB

[GatewayStocks]

GNBT FDA Meeting This Friday For bird flu Vaccine & Canadian meeting march 1st for Oral-lyn oral insulin spray.

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Generex to Meet With FDA on Bird Flu Drug
Monday January 23, 9:07 am ET 
Generex Sets Date to Meet With FDA to Discuss Human Studies of Bird Flu Vaccine; Shares Rise


NEW YORK (AP) -- Tiny drug developer Generex Biotechnology Corp. saw its shares shoot up 25 percent in premarket electronic trading Monday after regulators set a date to discuss potential human studies of its experimental bird flu vaccine.
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The Food and Drug Administration said it will meet with Generex on Feb. 10 to discuss what it will need to apply for approval and to begin human studies. The meeting is just one of the earliest stages of a usually lengthy process of clinical trials and data analysis, but worries about a potential bird flu pandemic have caused strong investor response to even earlier-stage bird flu vaccine candidates in recent months.

Shares of the Toronto-based firm jumped 25 cents, to $1.25 in premarket trading on the INET electronic exchange. The Nasdaq-listed stock closed Friday at $1 per share.

The bird flu strain targeted by Generex's Antigen Express vaccine has killed at least 80 people and decimated bird populations throughout Asia. Scientists have warned that it could mutate, becoming easily transmittable between humans.

Generex said its vaccine could be key in fighting the vaccine because it can be manufactured synthetically, making it less expensive to produce the vaccine and speeding up the process.
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Canada;
The company will meet with Health Canada's Biologics and Genetic Therapies Directorate to discuss applying for marketing clearance for its Oral-lyn oral insulin spray.

[stocks2watch2]

Glad to see someone else on here is interested in GNBT.I think were gonna see 2.00 on this one soon. I'm holding 40,000. Theres a lot of positive things happening and upcoming events.

[stocks2watch2]

Up 10 % in pre. mkt.
Price-1.48

[stocks2watch2]

In-PharmaTechnologist insulin series

The big pharma companies may have dreamed of launching the world's first non-injectable insulin, but it has been Canadian biotech company Generex that shattered this dream, bypassing EU and US regulatory processes and launching its inhaled insulin in Ecuador last November. But do biotech companies prove a real threat?

The approval of Oral-lyn, an oral (buccal) insulin spray product, which is delivered into the mouth by the company's proprietary RapidMist system, was mainly based on the results of clinical trials in Ecuador involving only 250 Type 2 diabetics.
Oral-lyn is now available in Ecuador for Type 2 diabetics and the company hopes to soon have it approved there for Type 1 diabetes and is now conducting a six-month study in this patient population.

In addition, the firm is planning to roll Oral-lyn out in several other South American countries later this year, however, Oral-lyn's success will ultimately depend on whether it is able to receive approval and break into the more lucrative international markets.

The large-scale Phase III clinical trials required by regulators in the US, Europe, and elsewhere have not yet begun and whether Generex's product can stand up to the much tougher international standards remains to be seen.

Generex does however provide a nice case study, of a biotech company going it alone and so far achieving some success.

When asked the important question as to why, if the company is confident of the quality of their product, they chose to launch their product in South America, Fabio Chianelli, business development, Generex, told www.In-PharmaTechnologist.com:

"Regulatory approval in South America is much more relaxed than in other parts of the world. We launched here first to generate revenue from sales of the product in Ecuador, in order to finance larger costly Phase III trials."

"Other small biotechnology companies are usually partnered with large pharmaceutical companies and do not need to take this route. For us, money is sensitive," he said.

Oral-Lyn also tests the water of the potential for non-injectable insulin, as the rate of uptake in Ecuador may provide a good indication of how popular the big pharma's new products will be when they are eventually released onto the world market.

Meanwhile, nasal insulin sprays, where insulin particles are inhaled through the nose and are then absorbed by the nasal mucous membrane, is another area of budding development.

Scientists have known for years that the nasal route of administration of is highly efficient, but successful nasal insulin products have been difficult due to low delivery payload, poor reproducibility or mucosal irritation.

[GatewayStocks]

$1.50+12% Pre-market... 1.51 resistance...virtually no resistance to $2 area

FDA meeting on Friday

[setravis]

This chart looks like a Cup with Handle (continuation) Pattern
Volume: 4,699,828
Avg Vol (3m): 3,453,120

[stocks2watch2]

Just broke out to new 52 week high @ 1.53  on high volume.

[setravis]

GENEREX BIOTECH CORP (NasdaqSC:GNBT) Delayed quote data 

Pre-Market (RT-ECN): 1.60  0.06 (+3.90%) 

[D&Data]

tic taci tic tac....GNBT will rock 2day or monday wiz FDA's discution...

To watch ...

[Ovos Moles]

This is my first time in this forum, i´m Portuguese but i´m watching very closely GNBT, CBMX and NVAX, all of theme related with the bird disease. But i really like GNBT, lets wait and see for the decision, buy on the rumor sell with the news, that´s the book trend of technical analysis. I also like another penny stock AVNX.
Good trades
Ovos Moles

[boatguy]

Gnbt had news-up25% pre market

http://biz.yahoo.com/iw/060213/0109536.html

[stocks2watch2]

Up-22% in pre mkt.
Generex Biotechnology Completes Positive Pre-IND Meeting With FDA for Its Avian Flu Vaccine
Market Wire (Mon 7:15am) 
http://biz.yahoo.com/iw/060213/0109536.html

[setravis]

Headline News link:  http://finance.yahoo.com/q/h?s=GNBT

Should be a good opportunity......

Technicals
Record Price High
Most Actives

Last Price Quote is:
10.19%above 13-day EMA
34.87%above 50-day EMA
RS Rating: 84 

Fundamentals
Key Data:
Market Cap (M): $89.58 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy

[stocks2watch2]

GNBT, upcoming events. 3-01-06 meeting with Health Canada.The topic of the meeting will be Generex Oral-lyn, the Company's proprietary buccal (oral) insulin spray product (no lung deposition). The Company believes this is the first non-injectable insulin to be the subject of a Pre-NDS meeting.
Price-1.54
Holding 40,000 looking for over 2.00

Generex Biotechnology Announces Pre-NDS Meeting Scheduled for Generex Oral-lyn(TM) With Health Canada
http://biz.yahoo.com/iw/060119/0106769.html

[stocks2watch2]

Check out what this news letter is saying about  , ;. Just don't pay them to tell you what the name of the company is, I'll tell you for free~ It's GNBT .

http://www.isecureonline.com/reports/CUT/ECUTG204/?o=336559&u=11918870&l=784431.