I'm confident that Trius is designing and planning a "superiority" clinical trial Vs. Linezolid where initial data is to be released at the time of Tedizolid's commercial launch. Once infectious Disease specialists are confident that TED is more efficacious than Linezolid then Ted becomes the standard of care for all MRSA infections. Off-label administration rules the day with emerging pathogens. The so-called WallStreet experts are significantly underestimating the potential of this antibiotic because they really don't understand chemistry, off-label admin. and microbiology.
"Non-inferiority" is the easiest path to NDA. Ted was given once a day with very few side-effects. My point was that if Trius would design a trial to test for "superiority" vs. Linezolid I am confident it would "out-data" the soc hence becomes the drug-of-choice for all MRSA infections.
No way they will do a superiority trial. Those trials have to be very large to get to a p value that is significant.. Those trials are large, expensive, take a long time to complete and are risky. Until the FDA mandates that superiority trials are done, very few companies will take on that expense and risk
hooligan, They are expensive but statistical significance can be achieved with a population of 50. Trius will wait until an European partner is announced but this will occur. it has too because tedizolid is a more potent compound then linezolid. That is a fact.