Biotech Stock Mailbag: Genta Takes Another Stab
"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 voted down 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.
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