Friday, June 04, 2021 3:59:12 PM
It’s a window of opportunity trial and they are looking for bio markers of response. It is not to compete with dcvax. It’s the same process and same product. So if anything it’s building on top of promising results (people seen living longer - not the much awaited phase 3 unblinded results)
Why do they need to find biomakers - well FDA bigwigs demand that for approval. So no bio marker no easy approval. Hence all the recent push at talks from LL.
Now let’s stop the debate of whether dcvax is efficacious or not. I only concede to debate around how to get this past RAs w/o bio markers. Maybe dr Bala and others can help me understand better.
Thx.
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