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Re: Amatuer17 post# 121016

Monday, 09/07/2015 11:48:01 PM

Monday, September 07, 2015 11:48:01 PM

Post# of 405212
You are correct that the blinding of the study technically only refers to the study participants and the study site physicians. In some cases, the sponsor/company may have a clinical development team that is keeping tabs on the study, but usually this will be restricted to overall & per site enrollment numbers, serious adverse events, and possibly some general observations from the physicians at each study site (though these observations are very limited in a blinded study).

In the case of CTIX, the company is contracting with a CRO that is overseeing most, if not all aspects of the B-OM study. I seriously doubt Leo or Menon will see much of anything going on with the study until data is officially available after the data is locked and analyzed. This is actually a good thing!

In the case of Kevetrin Ph1 at Dana Farber, the study is open-label and there is no placebo, so everyone knows that anything that happens with the patients in that study (good or bad) could possibly be drug-related. The observations are probably shared with the company on a regular basis.

For B-OM, the company will be in the dark because every patient enrolled receives a patient ID number, all drug & placebo is barcoded by a third party, so nobody will know who is receiving live drug. CTIX will unlikely receive any substantial updates until after the CRO collects all data, closes out each study site, and prepares a final study report for CTIX management. It will be at this point that Leo an Menon will have an idea about how well B performed and they can then decide how to inform shareholders. In rare cases there may be a mid-protocol data evaluation....usually for compassionate use purposes.

Of course, I don't know the exact study design, or how data is being collected, but it is probably some form of self-reported symptoms from the patient with regular office visits so the clinical team can perform a physical exam and collect patient diaries (among other study required data). If everyone is showing signs of OM with similar severity, then that could be a bad indication. If everyone is showing very little or no OM, then that could also be a bad sign that the inclusion criteria was not appropriate, or there is a huge placebo effect. Ideally, about 50% of the study participants would exhibit a pretty severe case of OM with the other half showing mild or no symptoms of OM. However, because no single study site will no what % of patients are enrolled on live drug, they will not be able to make any interpretations on patient observations alone.

As always, this is all IMHO based on my limited clinical study experience. Personally, I have a high degree of confidence that Brilacidin will be a game changer, both as an anti-infective and as an anti-inflammatory. I am eager for results like everyone else, but I am patient to let the studies run their course.

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