Except with the FDA, you literally are supposed to assume yes if they don't respond.
That is only true for an IND change being considered safe and ethical for patients. Big surprise that a change to the stat analysis after all treatment was over could not harm patients.
The FDA does not formally say if a change will be acceptable for the basis of an approval. They will, if asked, render an opinion. Either they were not asked or LP did inform LL of the reply.
NWBO could always say what the FDA has said in any post P3 meetings. They stay quiet.
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