Sunday, July 11, 2010

VVUS's Qnexa advisory committee

Qnexa has an advisory committee review July 15, but the FDA's documents will be available July 13. I have many reservations on Qnexa's approvability, including censorship of titration drop out data, the high discontinuation rates, adverse side effect profile, among others. But this one could also be discomforting to VVUS investors:
VVUS's latest 10-Q :
"The number of patients on the low-dose in OB-302 or the mid-dose in the OB-303 study may not be sufficient for approval."

With drugs facing increasing scrutiny regarding safety from the FDA, Qnexa faces some head winds in the regulatory process, in my opinion. We'll find out soon enough later this week.

See disclaimers on the side bar.

Disclosure: no position in VVUS.

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