Thursday, November 09, 2017 4:33:02 AM
It is so hard to draw accurate conclusions based on such a limited sample size. While patients 1-3 reoccurred they all (including patient 4) had the UUTUC complication factor and were treated at 1/2 the therapeutic dose. Plus folks totally ignored that there was no disease progression and that if they were retreated at let’s say the 90 day mark, they might not have reoccurred at all.
Further the only patient treated at the therapeutic dose was the only one with non-reoccurrence - however that patient had redness and inflammation- so they have to follow-up so that complicates the results as well. Is the redness and inflammation a result of the higher dose or just an isolated reaction? Again, it is hard to get a complete answer with just 1 patient.
It appears that the next 5 patients will give more information to assess a proper dose, which seems to be something that the PR suggests they have not totally pinned down yet (what proper dose to use for the Phase II). This makes sense since you are going from mice to humans - you may have to tweak an effective dose - hence, the purpose of the study.
The 50% sell-off, to me would have been warranted if safety and tolerability could not be achieved at 1/2 the therapeutic dose - or the disease continued to progress - because then it would be back to the drawing board. However, this is not the case - it could very well be that a higher dose is necessary or that folks with the UUTUC complication need multiple treatments at 90 day intervals - however, it is simply too early to just say it doesn’t work, and a 50% haircut basically says that.
Maybe now that some results are out there Roger will go back on the radio to give some perspective etc. and clarify some issues...
Following the charts is like driving a car forward while looking in the rear view mirror.
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