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Posted On: 06/25/2020 1:36:32 AM
Post# of 153992
Closest imminent catalyst: Priority Review decision by Monday?
While we wait for the 74-day letter in HIV, including the PDUFA date and list of issues, don't forget that if the FA has bad news (refuse to file) or good news (priority review) they are supposed to convey that by day 60 - which is Saturday.
So give them until Monday close of business. Per procedure, no response is a negative response.
While we wait for the 74-day letter in HIV, including the PDUFA date and list of issues, don't forget that if the FA has bad news (refuse to file) or good news (priority review) they are supposed to convey that by day 60 - which is Saturday.
So give them until Monday close of business. Per procedure, no response is a negative response.
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