"Sure, so we haven't recognized any revenue from India, so we did send them some shipments, but those were for the clinical trials, so went to expense rather than revenue right now. So once we get through the Phase IV marketing trials, we can begin to recognize revenue."
Despite what Gluskin said on the Oct. 19, 2009 conference call, there is no record on the company's Web site or on a conference call transcript from 2007 or 2008 saying that a clinical trial in India was a "condition" for Oral-lyn's approval.
And Generex's own press release of March 25, 2008, which describes the 210,000 canisters of Oral-lyn as a "commercial order" intended for an "Indian product launch," contradicts Fellows' claim on the same conference call that the shipment of Oral-lyn was intended for use in a clinical trial.
It also seems that Generex didn't disclose the halt to Indian Oral-lyn sales in SEC documents relating to the sale of more than $32 million in company securities in four separate financing deals from May-September 2009.
None of the four prospectuses filed with the SEC outlining the sale of Generex common stock and/or warrants in these four deals disclose information about the Indian government's actions with regards to Oral-lyn.
Of course, even though Oral-lyn was pulled from the market in India, the drug could get reapproved there if subsequent trials are performed and Generex reapplies for approval.
But in the meatime, for Generex, it seems like whatever happens in India, stays in India.
-- Reported by Adam Feuerstein in Boston
Biotech Stock Mailbag: Generex
Biotech Stock Mailbag: Generex, Part II
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