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oc631

04/20/12 2:11 PM

#140547 RE: oc631 #140545

Maybe I should make this a multiple choice quiz.



Why did BMY withdraw the late-stage, head-to-head study between Peg-lambda and Peg-Alfa?



A- They were unable to enroll patients. Nobody wants to use that shit.

B- The cost of running the late-stage study couldn't be justified since BMY realises the market is going oral.

C- BMY was worried Lambda would show inferior efficacy and/or safety in the head-to-head late-stage trial.

D- All the above.
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iwfal

04/20/12 2:38 PM

#140549 RE: oc631 #140545

Ifn-lambda

Any idea why they canceled this study?




clinicaltrials.gov/ct2/show/NCT01447394



Probably because they will already have the data from the previous large randomized ph ii (interim results here #msg-61755220) - but they want to pursue a different path to approval than as a single agent in a traditional treatment regimen (e.g. perhaps they want to get it approved as part of a BMY regimen).
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ciotera

04/20/12 3:18 PM

#140555 RE: oc631 #140545

Any idea why they [BMY] canceled this [lambda] study?



No idea.. difficulty recruiting for a non-DAA study?
They are however still testing it against alpha with their own DAAs.