I will definitely be looking to the 10-Q for info
Post# of 72440
Posted On: 05/03/2016 3:48:42 PM
Re: Loose Lips #22009
I will definitely be looking to the 10-Q for info regarding the B-OM trial. I expect the results to be good but I don't understand why the trial sites on the whole are apparently only averaging one patient each every 2 or 3 months.
Were the eligibility criteria too stringent? I know that they were trying to design a trial that eliminated any potential confounding factors like previous treatments. However, including such patients in the pool gives you not only a bigger potential patient population but also more data (and quicker) that can be used in designing the Phase 3. Is it really going to take 2 years to complete a trial with only 70 subjects?
I'm glad that we have that B-OM interim update coming within the next couple of months. Who knows, maybe it will be stopped at that point because it has already proven efficacy!
"Since news on the B-OM front has been pretty quiet as of late I have been wondering about whether or not we are going to get any sort of interim data. I am thinking that the addition of another trial site is about as good of an update as we need right now. My opinion is this is a positive, because why continue to add trial sites and spend more funds if the treatment is not benefiting patients?
That may be over simplistic though. Could it be that adding another site is driven by statistical need, either positive or negative? The positive side: larger patient population and more input to strengthen the data. The negative side: maybe they need a larger patient population because the numbers are weak and they need a larger data set to draw positive statistics from? I don't really think that is the case but I am putting my musings on the board. Anybody have opinions on it?
Either way I do not see adding another site as speeding up the trial, UNLESS the enrollment numbers at the current sites have been declining and they need a minimum number of patients to complete the trial. In that case then it will sure help keep things moving. Leo has stated in past communications that it was a challenge to find patients which met the trial specifications due to the need of not having certain previous treatments which would skew the data for Brilacidin treatment. That's one of the reasons for not performing at MD Anderson if I recall." - Loose Lips
Were the eligibility criteria too stringent? I know that they were trying to design a trial that eliminated any potential confounding factors like previous treatments. However, including such patients in the pool gives you not only a bigger potential patient population but also more data (and quicker) that can be used in designing the Phase 3. Is it really going to take 2 years to complete a trial with only 70 subjects?
I'm glad that we have that B-OM interim update coming within the next couple of months. Who knows, maybe it will be stopped at that point because it has already proven efficacy!
"Since news on the B-OM front has been pretty quiet as of late I have been wondering about whether or not we are going to get any sort of interim data. I am thinking that the addition of another trial site is about as good of an update as we need right now. My opinion is this is a positive, because why continue to add trial sites and spend more funds if the treatment is not benefiting patients?
That may be over simplistic though. Could it be that adding another site is driven by statistical need, either positive or negative? The positive side: larger patient population and more input to strengthen the data. The negative side: maybe they need a larger patient population because the numbers are weak and they need a larger data set to draw positive statistics from? I don't really think that is the case but I am putting my musings on the board. Anybody have opinions on it?
Either way I do not see adding another site as speeding up the trial, UNLESS the enrollment numbers at the current sites have been declining and they need a minimum number of patients to complete the trial. In that case then it will sure help keep things moving. Leo has stated in past communications that it was a challenge to find patients which met the trial specifications due to the need of not having certain previous treatments which would skew the data for Brilacidin treatment. That's one of the reasons for not performing at MD Anderson if I recall." - Loose Lips
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