exwannabe and JerryCampbell,
Not comparing overall trial results as those results mean nothing to this trial. What is usable is matched SOC/placebo data from historical trials as a base line since there has been no known meaningful improvement in patient outcomes from treatment. Your arguments against are being stomped on by FDA guidance changes whether you like it or not because, well, patients that have crossed over to a treatment that works and live longer because of it deserve to have other patients and doctors know this too. Salvage therapy repotentiation by DC therapy has been documented in prior studies from years ago. Regulators know this and are taking this into consideration while you, on the other hand, after all the discussion on the board over the years are better informed than letting on which begs the question about why you would deny what regulators are proposing in their guidance and have already approved in some cases. Justice is making a list, checking it twice, gonna find out who’s ... ; ). Best wishes.
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