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Posted On: 01/06/2021 12:01:00 PM
Post# of 149265
Re: ClosetInvestor #71465
Closetinvestor,
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.
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.
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