Re: MD&A... Phase 3...Questions for BDZ....
in response to
by
posted on
Sep 05, 2015 12:47AM
I'm hoping you can help me out with some thoughts BDZ, or anyone....
Without going into heavy detail (I'm not a science guy as I've mentioned many times) my understanding is there will basically be 2 groups.
1- Those taking RVX-208 in combination with a statin....subdivided into 2 groups taking 2 different types of Satins.
2. A second group taking just the statin...again I'm assuming divided into 2 with roughly half taking one statin and the other half the other.
My first question is...Will there be a 3rd Placebo group? Taking a placebo in combination with a Statin? I thought this was how these things happened....one group continues their normal treatment, one group takes the drug being tested, and one group takes a sugar pill in combo with their regular treatment. Then the results for the 3 groups are measured against each other with the hope that the drug or therapy being tested significantly outperforms the group continuing their normal treatment and those with placebos.
My other question....Would it be reasonable for us to expect the company to provide something like a quarterly score card about the number of MAC events? Or is that an unrealistic expectation and outside of normal trial protocol.
TIA if you or anyone can shed some light.