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Sunday, July 26, 2020 6:21:14 PM
I never suggested Direct approval would be easy or fast. In fact I gave a reason why it might be quite hard in practice. I did say that I believed Direct active trials should just follow on, if L is approved. Because I believe that L approval is all the affirmation they will need for the financing avenues to open up, and the runway to be clear.
But fast? Fast is relative.
Fast compared to L? Most definitely.
'Totally different programs'?
I would call them related programs or even closely related programs.
On what L will help I'm sticking with Liau, Prins and others at UCLA that it helps mesenchymal genetic group and not much for others
I predict there will be nothing in topline and nothing in full data presentation about mesenchymal. Nor will there be anything in a BLA about mesenchymal. Nor, in my opinion have any of the trial subject's samples been through genomic analysis, so imo they don't even know which patients are mesenchymal. Or were mesenchymal at some point, or were pro-neural but later became mesenchymal. Or classical. Or classical then later mesenchymal. Or had a tumor with bits of pro-neural and bits of mesenchymal. Or bits of classical and bits of mesenchymal.
I'll stop there.
But each to his own opinion.
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