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Monday, November 20, 2017 11:13:36 AM
Speculation about SCLC results:
In last May I did some simulations using randomly assigned progression free survival values from known survival curves, aldox and topo medians about 3.5 months, then aldox at 4 months, 4.5 , 5.0, 5.5 and 6 months. Censoring for topo 12 % (average of SCLC trials with topo), for aldox 15 % (estimates for amrubicin are below 10 %). And about 2 to 1 back loaded enrollment distribution based on dates in relevant CytRx press releases and entries at ClinicalTrials.gov.
I got results saying that even with both medians at 3.5 months there was pseudo-probability higher than 50 % that the event target would be hit after June 2017. With higher aldox medians or higher censoring rates even later.
Now, my simulation spreadsheet is a work in progress and I would not put too much weight on its results. Still, the extremes are
a. For the target event to be hit before July with Topo median at 3.5 month would required aldox median also around 3.5 month plus very low overall censoring ( << 10 %). If so, then aldox SCLC trial was an unmitigated disaster and CytRx is not keen to admit it. Possible, but I don't think so. For one thing, SCLC trial results ARE material information considering the size and financial condition of CytRx. They really don't need more fuel for lawsuits.
b. If aldox median happens to reach over 5 months (i.e. slightly better than values recorded for amrubicin) then CytRx may still be waiting the event count to hit the target.
Anyway. Ongoing SCLC trial is back in CytRx presentations, whatever that means.
Helps a lot. Doesn't it. (Irony!)
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