Doing this off the top of my head ( scrawled notes) paraphrasing but the exact numbers are in the phone link up and that announcement that gives me a lump in the throat. Please correct me anyone who has better notes or time to read / listen again.
From all recent previous studies
The control previously published studies had a average of 4.7 months median PFS.
The control preciously publishes studies had a average of 12.6 months median Overall Survival (OS)
In our study ,for a yet to be explained reason, our standard treatment control came in at median PFS 5.5 months (17% increase ie 24 days ) and a median OS 14 months (11% increase - 42 days ) .
To have a positive trial we were wanting 6 weeks (42 days) or more increase in PFS. It came in at zero against our control.
If you took ( which we can't) the other trials average PFS for the control at 4.7 months and added 6 weeks ( 42 days 1.4 months ) that 6.1 months should have approximately been our hurdle. We only got 5.5 months so still 18 days short.
I don't know enough about the FDA and the chat ACL will be having with them once or if they discover what has caused the anomaly assuming science is Ok.
I don't know if the below article is still in date but it does describe a possible direction, if our data supported it, but it isn't cheap or quick but a concession from FDA on a further trial can happen it seems. Overnight it could put value back into the HyAct platform if the anomaly can be found and isolated in this or other treatments.. As of right now I'm holding waiting for the next few months to see if the science from the lab was any good and it was just a trial problem. Since the platform is valued at pretty much zero there isn't a lot of downside compared to what we just experienced . It will be a lot of number crunching so unless something in trial data or whatever stands out like dogs balls it won't come quickly .The odds are now very very long and depend on reason of failure but if you believe in the lab and SCLC will report at some point.
http://www.law.uchicago.edu/files/file/488-281-am-fda.pdf
PS Hi Neo . Could be so many reasons but I have assumed the call was loaded and most had already been in contact just because of the tone. Not sure if other callers had been blocked from asking but a very short call.
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