Re: My guess is a second BTD is coming
in response to
by
posted on
Feb 08, 2020 10:31AM
Bear, re the CKD data...won't the FDA be privy to that information? I assume all big pharma companies have access to that vital data on eGFR through confidentiality agreements. I can't imagine the FDA will be kept in the dark about it.
Now what may be problematic, is that the FDA can't ask academic experts like yourself about the CKD data without it becoming publicly available and therefore critically commented on. If that is the case (I am purely speculating on this point), perhaps a second indication can be given AFTER the eGFR data comes out...late March (as you have suggested)? What do you say?