This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Generex Creates Own Regulatory Reality

Stocks in this article: GNBTNOVLLYSNYHEBCTIC

TORONTO ( TheStreet) -- Generex Biotechnology (GNBT) CEO Anna Gluskin may have run afoul of U.S. regulations governing experimental drugs when she spoke to investors earlier this year about the prospects for the company's Oral-lyn insulin spray.

Gluskin said at a January conference that the U.S. Food and Drug Administration had essentially granted a "mini-approval" for Oral-lyn and that Generex was moving ahead with plans to commercialize and market the diabetes treatment to doctors and a wide swath of diabetes patients in the U.S.

The FDA does not have a "mini-approval" process, and Generex has not filed an application seeking full marketing approval for Oral-lyn as a treatment for diabetes, according to FDA spokeswoman Karen Riley. Generex is still only about halfway through a single phase III study of Oral-lyn, according to the company's latest corporate update.

In September 2009, FDA permitted Generex to make the still-experimental Oral-lyn available to certain diabetes patients under the regulatory agency's expanded access program, known formally as a "Treatment IND" protocol. The FDA program grants access to experimental, unapproved drugs for patients with serious or life-threatening diseases who lack other treatment options.

The standards by which the FDA reviews an experimental drug for the expanded access program are different and less thorough than if FDA were reviewing the drug for final marketing approval, according to FDA regulations confirmed by Riley.

FDA rules do permit companies to recoup costs associated with granting expanded access to unapproved drugs, but companies like Generex are prohibited from marketing or generating any profits while operating under Treatment IND approvals.

Generex's Oral-Lyn is an insulin mist that patients spray into their mouths. The insulin is designed to be absorbed buccally (through the lining of the mouth) and into the bloodstream, in contrast to standard injectable insulin like those made by Novo Nordisk (NVO), Eli Lilly (LLY) and Sanofi-Aventis (SNY)>, among others.

Generex did not comment on this story in response to a phone call and emails seeking comment.

Two videos of Gluskin making questionable statements about Oral-lyn were posted to the Web after her presentation at the OneMedForum 2010 Conference on Jan. 13 in San Francisco, a health care conference in which small biotech firms pitch themselves to investors.

1 of 5

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,827.75 +12.81 0.07%
S&P 500 2,072.83 +5.80 0.28%
NASDAQ 4,787.3170 +29.0650 0.61%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs