Closetinvestor, Thanks for the reminder of the
Post# of 148187
Thanks for the reminder of the validity of clinical markers as surrogates or intermediate markers of expected PFS.
I am struggling to find guidance on FDA expectations for BTD. Do you know what these are or can you print me in the right direction?
I imagine, though may be incorrect, that these expectations may be proportional to the mortality of the disease for which the BTD is requested.
Thanks.