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Biotech Stock Mailbag: Generex

Correction: In an earlier version of this article, the name of Generex' Oral-lyn was misspelled. It has been corrected. We'd also like to note that Oral-lyn has been discussed in medical journals and presented at medical association meetings over the last ten years. regrets the error.

BOSTON ( TheStreet) -- Do diabetics hate insulin injections so much that a more convenient alternative to needle sticks could be commercially lucrative?

Pfizer (PFE) found the answer to be a resounding "No" when the launch of its Exubera inhaled insulin device crashed and burned soon after hitting the market in 2006. Diabetes patients found the insulin dosing required for Exubera to be confusing, concerns about lung problems lingered, and the design of the Exubera device was embarrassingly bad. It looked exactly like a medium-sized bong -- not exactly something diabetics wanted to carry around with them.

MannKind (MNKD) is also developing an inhaled insulin device called Afrezza that is much smaller, easier (and less embarrassing?) to use than Exubera, the company claims. Whether the U.S. Food and Drug Administration agrees and approves Afrezza, however, is a matter of significant debate that got murkier this week after Mannkind's conference call Tuesday.

If the utility of inhaled insulin is still in doubt, what about an orally-delivered insulin? Why can't diabetics simply pop an insulin pill or spray some insulin in their mouth?

Oral insulin technology was on the mind of Randall P, who writes, "I just finished reading your article on FDA's decision on Mannkind's inhaled insulin. Do you happen to follow Generex Biotechnology (GNBT) and its oral insulin product called Oral-lyn? If so, do you have any idea if the FDA will ask Generex for similar data? I would like to see what you think of Generex in a article for"

Also referring to Generex, Nader S. emails, "I came across this company as it's been quite frequent with news of late and there has been much buzz. What are your thoughts?"

I think Generex is a total bust. Here's why:

Generex's Oral-lyn is an insulin mist that patients spray into their mouths. The insulin is supposed to be absorbed buccally (through the lining of the mouth) and into the bloodstream.

Nifty technology, except none of the Oral-lyn data collected by Generex has been peer-reviewed in credible medical journals, nor has it been presented at the top-flight diabetes meetings.
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