RE: FDA Stich-Up9 Oct 2019 21:17
Bailedintime...
All trials agreed through fda must be controlled with certain objectives and effectiveness.
Single trial does not mean necessarily a comparison trial with other Antibiotics or placebo.
See the last paragraph of this copied of trial research studies:
‘ Single-arm or non-randomized trials, in which everyone enrolled in a trial receives the experimental therapy, are common in Phase 1 and 2 testing. While Phase 3 trials are frequently randomized in order to provide more precise data on safety and effectiveness outcomes, a Phase 3 trial might use a single arm if a small target population makes conducting a randomized trial impractical. In these cases, researchers must use endpoints like response rate that can demonstrate clinical impact in the absence of direct comparison data. “
Do you mean a single trial proposed by motif must be a comparable one as the one they did in phase3??
I don’t think so myself otherwise what’s the point of motif proposal to the fda !
The fda asked for more data and the unusual situation motif is left with is for them to sugges a simple single trial to confirm or refute of dili. This makes more sense than to conduct another expensive double trial which will take a long time years probably and far more expensive to conduct. The fda concerns mainly about Iclaprim potential dili..
We will have to wait for the fda minutes and actual requirements...