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TheStreet Open House

Generex Creates Own Regulatory Reality

Stocks in this article: GNBTNOVLLYSNYHEBCTIC

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.

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