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Jhawker

11/03/20 9:32 AM

#331408 RE: farrell90 #331402

I am sure you are right about placebo being soc. No way would it be a “sugar pill”

loanranger

11/03/20 9:51 AM

#331420 RE: farrell90 #331402

"Many question the ethics of using a placebo when studying a life threatening illness."
I understand and agree.

"Many clinical trials will use the approved treatment as an alternative to placebo when a drug in the same class is studied for serious illnesses."
I agree with that as well, but such a trial is not described as a "placebo-controlled trial", the language that the Company itself used. The FDA calls it an "active control (or positive control) trial".

A placebo is described by the FDA as an "inert treatment".

rmzport

11/03/20 9:56 AM

#331423 RE: farrell90 #331402

"Many clinical trials will use the approved treatment as an alternative to placebo when a drug in the same class is studied for serious illnesses." To your point, if memory serves, daptomycin was used in the Brilacidin trial for ABSSSI