Replies to post #232473 on BOUNCE (BOING)

[dav1234]

that one shouldnt move much

[dav1234]

Theravance reports outcome of the FDA Advisory Committee meeting on VIBATIV (telavancin) for the treatment of nosocomial pneumonia (stock halted) (THRX) 21.40 +0.00 : Co announced the outcome of the Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA meeting on VIBATIV (telavancin) for the treatment of nosocomial pneumonia (NP) due to susceptible isolates of Gram-positive microorganisms. The committee was asked to consider the totality of data presented including analyses of clinical cure and 28-day all-cause mortality. The committee voted 6 (yes) and 9 (no) that the results provide substantial evidence of the safety and effectiveness of VIBATIV for the requested indication of the treatment of NP, including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (both methicillin-susceptible and -resistant) and Streptococcus pneumoniae. The committee voted 13 (yes) and 2 (no) that the results provide substantial evidence of the safety and effectiveness of VIBATIV for the treatment of NP when other alternatives are not suitable.