Replies to post #124204 on Biotech Values

[DewDiligence]

Teva’s Laquinimod PR has a modicum of doublespeak:

http://finance.yahoo.com/news/Results-of-Phase-III-BRAVO-bw-1849141841.html?x=0&.v=1

…the BRAVO study did not achieve its primary endpoint of reducing the annualized relapse rate (p=0.075).

The randomization process for BRAVO was adequately performed; however, placebo and treatment study groups showed dissimilarity in two baseline magnetic resonance imaging (MRI) characteristics. According to a standard and pre-specified sensitivity analysis included within the original statistical analysis plan, when this imbalance was corrected, laquinimod demonstrated a significant reduction in the annualized relapse rate (21.3%, p=0.026), in the risk of disability progression as measured by Expanded Disability Status Scale (EDSS) (33.5%, p=0.044) and in brain volume loss (27.5%, p<0.0001).

Huh? If the randomization was “properly performed” and baseline MRI status was a pre-specified variable of interest, why weren’t the trial arms stratified with respect to this variable?

CC today at 8:30am ET.

[masterlongevity]

the drug will not get approved without new ph 3 trials