Shares of NeurogesX, already badly beaten up over the past year, tanked after regulators raised questions about the efficacy of its pain patch for HIV-related pain. Its stock ($NGSX) dropped to as low as 75 cents a share and then recovered somewhat by midmorning as analysts sifted through the agency's remarks, which are intended to help shape an expert panel review coming up Thursday.
Wedbush analyst Gregory Wade tells Bloomberg that he was none too surprised to see the critical remarks. And even though he doesn't believe that the in-house regulatory review of the application will prevent a vote in its favor, any approval still wouldn't do much to improve the company's prospects.
About 1 in 3 HIV patients suffers from HIV-related neuropathy, notes NeurogesX. But one of the regulators doesn't believe that they'd be well served by Qutenza.
"It would not be in the best interest of these patients for us to approve a product for which substantial evidence of efficacy has not been demonstrated, or one for which the benefits do not clearly outweigh the risks," said Bob Rappaport, director of the agency's division of anesthesia, analgesia and addiction products, according to the Bloomberg report.
- here's the article from Bloomberg