While we wait for the 74-day letter in HIV, includ

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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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For BLA, 60 days is only notification for refusal to file, so no response would mean that they haven't refused it, which is a positive. The 74 days is the timeline for the FDA to ask for additional information or modification before they accept and set a PDUFA. There seems to be no information asked since March so if there is no response by Monday then expect a PDUFA on July 10th.

For priority review notice would be at 60 days. Leronlimab being the only HIV drug that doesn't develop resistance and effectiveness and unmet medical need being standards for priority review, priority review should be a given.