I never said FDA wouldnt allow Hc. I wrote that the FDA generally ask for a new / extra trial if stat. Sig. Is not shown but that the treatment could indicate to work. and that when using historical data you run into some issues around the comparison of data from different trials as all trials have different exclusion criteria .. it is total common sense and I do not understand people get upset when I mention it and start twisting my words . and furthermore it makes it sound almost seamless and as a matter of course that the FDA gives us approval on this basis .. I write these things to create a balance between pros and cons and to hear some arguments that are not black or white and berries pre of a one-sided attitude to the state of things. I hope the FDA wakes up and understands the need to give DCVax and other similar personal treats an approval as it is indisputably the way of the future to treat cancer and other nasty diseases. and having said that, you hear from pretty much every party representing fatal and rare diseases that the FDA is having an extremely hard time changing its attitude in relation to all the new guidelines that have been made in recent years. I'm not saying it's not succeeding in getting the FDA to approve DCVax and I hope it succeeds, but it's not as straightforward as many in here make it sound.
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