This Day On The Street
Continue to site
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

Generex Creates Own Regulatory Reality

In the first video, Gluskin presents the Generex story to attendees of the conference; the other video shows Gluskin being interviewed about Generex and Oral-lyn by conference organizers.

Gluskin, in the first video, explains to investors the Treatment IND for Oral-lyn:

"What that is, is a permission by FDA to distribute and treat patients with our product and to be able to charge for it. So it's like a mini-approval, the only difference between full-label approval and what we have here is that you can't under this IND sell product in the drugstore, but you can distribute it through doctor's offices, hospitals, dispensaries and directly to patients," says Gluskin.

Gluskin's explanation about the handling of expanded access drugs inaccurately characterizes the Treatment IND program as described in FDA rules and in comments about the Treatment IND law from the FDA published in the Federal Register on Aug. 13, 2009.

"FDA wishes to emphasize that the evidentiary standards for a treatment IND are not the functional equivalent of the amount and type of data needed for marketing approval. The standards provide a degree of flexibility that enables FDA to authorize a treatment IND on the basis of data often well short of that needed to obtain marketing approval," according to FDA comments published in the Federal Register.

In the second video, Gluskin explains Oral-Lyn's Treatment IND status by saying: "It is basically an approval that confirms that this format of delivery, particularly of large molecules such as insulin, is safe and efficacious, so we can treat the patients that refuse to take needles and we can also get paid for the drug."

Further FDA regulations pertaining to Treatment INDs state that "a sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug."

FDA spokeswoman Riley declined to comment on the Web videos in which Gluskin asserts that FDA granted Oral-lyn a "mini approval" and that Generex is making plans to commercialize and market the product. Riley said FDA has a policy of not publicly discussing unapproved drugs.
2 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
GNBT $0.01 1.85%
AAPL $94.27 -0.76%
FB $101.00 1.47%
GOOG $684.12 0.89%
TSLA $143.67 -3.09%


Chart of I:DJI
DOW 15,914.74 -99.64 -0.62%
S&P 500 1,851.86 -0.35 -0.02%
NASDAQ 4,283.5920 +14.8290 0.35%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs