Thursday, December 06, 2012 11:34:04 PM
http://www.scientificamerican.com/article.cfm?id=fda-under-pressure-to-relax-drug-rules
"FDA advisers at last week’s meeting did recommend approval of telavancin (Vibativ) — a derivative of vancomycin — for the treatment of hospital-acquired pneumonia when alternative drugs are not suitable. But that vote came nearly two years after the FDA had rejected the drug for a second time because clinical data did not measure up to the agency’s guidelines.
“The agency has painted itself into a statistical corner,” says Scott Hopkins, chief medical officer of Rib-X, a drug company in New Haven, Connecticut
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The most probably cause to approve Bavi's pipeline... Median Overall Survival and Less/No Side effects from standard of care
This is the argument that Peregrine needs to sell to the FDA and we just may be the right drug company.... with the right drug pipeline.... at the right time.... and you think BP's foresee this possibility? I hope so
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