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However, remember the letter that LP sent to

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longfellow95   Tuesday, 04/14/20 04:26:19 PM
Re: meirluc post# 277315
Post # of 312175 
Quote:
However, remember the letter that LP sent to the FDA where she emphasized that when judging a treatment, comparisons of the survival rates of the different GBM subgroups should be considered separately? For example DCVax-L may be much more effective in patients with Met+ GBM than in those with Met- GBM. I am guessing that she may have been trying to change the FDA's policy but believe that her audience also included the medical community

I am not sure but LP may also have mentioned that because of the cross over problems, results of the trial should be compared to historical results (not certain about that point).



Yes, I do remember that letter.
I've never previously offered a 'read between the lines' interpretation of it though.

FDA reader; 'Flipping hell, all they want to do is remediate their own bloomin' trial!'.

Well, my take definitely wouldn't be that extreme.
But you get my drift...

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