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flipper44

08/27/15 3:18 PM

#39493 RE: sentiment_stocks #39492

Great footwork. Then it still potentially fits this framework.

For ethical and economic reasons, the technique of sequential testing has been developed to enable the examination of data at a series of interim analyses. The aim is to stop recruitment to the study as soon as there is sufficient evidence to reach a firm conclusion. -- See post 38892



To facilitate timely enrollment in these trials, FDA officials encouraged sponsors to base initial AA applications on surrogate clinical outcomes reported in interim analyses of phase III trials rather than on final analyses that identified improvements in surrogate clinical measures for patients enrolled on phase II trials. -- See post 39317

vator

08/27/15 3:28 PM

#39494 RE: sentiment_stocks #39492

The PR was clear to me. It was designated as halted in Germany only because they have a funky system listing these things.

The straight out say that screening has halted but the trial continues. It did not say screening only in Germany halted.

Dan88

08/27/15 6:15 PM

#39503 RE: sentiment_stocks #39492

Thanks Senti. From the beginning I was convinced it might be a halt due to AA consultation with FDA and other authorities in EU if the halt is not universal or at least HE if the halt is only for Germany.

Now thanks to your guys hard work and the possibility of AA just gets stronger.

Either way or maybe it just some adjustment of the trial which I have not seen at this time. I have determined as always to see the light, the approval of DCVac platform as an effective cancer treatment!

That day may just come earlier than most have expected!