BOSTON, Mass. (
) -- The Biotech Stock Mailbag is open for business. Let's kick things off with an email about
"What is your opinion on Genta's Genasense phase III results in the fourth quarter," asks Joan. "Do you believe their biomarker approach on low-normal LDH will achieve the holy grail p-value of 0.05 that [FDA] is looking for to approve the drug?"
Genta is such a blast from the past. I haven't given the company much thought or coverage since 2004 when Genasense's phase III melanoma study was
by the FDA's cancer drug advisory committee meeting.
I used to eat, drink and breathe Genta back in the day, so it was with a sense of nostalgia that I sat in on CEO Ray Warrell's presentation Wednesday at the Rodman & Renshaw investor conference.
Warrell is a man on a mission to get Genasense approved for melanoma and prove the cynics and the FDA wrong. It's been a long, bumpy road that has seen Genta rejected multiple times at the FDA, its stock de-listed and cast off to the bulletin boards for penny-stock status. Genta has been forced to issue billions (yes, billions) of shares of stock just to remain solvent. A more recent reverse stock split and capital restructuring has put the company on more solid financial footing (although it still has 500 million fully diluted shares outstanding and a stock that trades for 40 cents.)
Let me say at the top here that I don't know if this next phase III study of Genasense in melanoma is going to work or not. I'm not going to make a prediction. The old Genasense data in melanoma weren't strong, and the FDA rightly rejected the drug.