RE:RE:RE:RE:Question for the brainiacs.....
99942Apophis wrote: I thought the only ones removed from the first 12 were the 5 with no response leaving 7 and within that group had mostly partially response and I think 1 with complete response on the first treatment after that I also got confused and age has nothing to do with it. The confusion was because we didn't have Dr. Vera Madzarevic to present everything in a clear picture package, not funny but even our medical knowledgeable amongst us seemed to have a challenge. Again I believe it was only the 5 with no response that were removed. Can anyone confirm correct?
I can't see how a patient, not treated according to the protocol of the Phase II clinical trial (two instillations at the Therapeutic Dose 180 days apart), can be included in the formal results of that clinical trial.
Can they be included as additional information re safety and efficacy, similar to that regarding the Phase I patients? Certainly, just not as part of the formal Phase II results ... in which case, I can't see them being counted among the results for the 20-25 patients treated according to the Phase II protocol needed to submit for BTD.
Also, the secondary endpoint we're seeking is CR of 360 days or more for durable response (determined "approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment"). Thus to me, the results at 90 days, at 180 days, at 270 days, and at 360 days are just data points along the way to the 450-day determination.