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Biotech Stock Mailbag: Spectrum Pharma

Already this week, we're seeing signs that investors and analysts are growing nervous about what FDA and its panel will think about Qnexa. On Tuesday, Lazard analyst Bill Tanner downgraded Vivus to hold from buy, citing concerns about Qnexa safety ahead of the FDA panel. The downgrade caused a selloff in Vivus.

I'm not necessarily agreeing with Tanner's bearish Vivus thesis (by the way, he has a buy rating on Orexigen and a hold on Arena), but I do think he's right to be worried about the outcome of the FDA panel. Instead of trading up into this very important event, I expect Vivus shares to remain fairly flat, if not fall, until we get more clarity from the FDA and its experts on the efficacy and safety of Qnexa.


Amy P. asks, "I find it very interesting that on the bottom of the web page for Crave-NX, Generex Biotechnology (GNBT) states that Generex Oral-lyn is available for sale in India."

It's interesting but not surprising. Generex's marketing people don't appear to be entirely on the same page as the company's lawyers, who have finally updated filings with the Securities and Exchange Commission to more accurately reflect the regulatory and commercial status of Oral-lyn, Generex's oral insulin spray, in India.

"To date, we have received regulatory approval in Ecuador, India, Lebanon and Algeria for the commercial marketing and sale of Generex Oral-lyn, although as per the terms and conditions of the regulatory approval in India, a local clinical study must be conducted before the product can be offered for commercial sale in that country," Generex disclosed in its 10-Q for the fiscal third quarter ended April 30, 2010. (Emphasis mine.)

The company's previous disclosure, in its 10-Q for the quarter ended Jan. 31, 2010, did not make clear that sales in India were conditioned upon completion of a study:

"The product Oral-lyn was approved in India in January 2009, but per the requirements of the approval, a study in India with Oral Recosulin is still ongoing and we have not recognized any revenue from the Indian market to this point," according to the Generex's 10-Q for the fiscal quarter ended Jan. 31. Emphasis mine.

The new, more transparent disclosure was made after I wrote an article on April 6 revealing that Generex did not disclose that the Drugs Controller General of India, in March 2009, had revoked approval of Oral-lyn in India pending review.

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