Putting aside all the criticism for a bit, they have done many things right lately . I believe it started with hiring a CSO with FDA filing and BLA experience. Dr Kelly working on a partner for helping fund trial(s) is also a very good move as is the filings of the EUA and its equivalents in other countries. Part of the failure is , the shareholders who either haven’t had exposure to Biotech in the past, or have but we’re expecting accelerated timeframes because of a Pandemic ..I believe even though the FDA has tweaked a few things, there hasn’t been innovative thought on how to look at the drug review process during an exceptional period in history.I think the early approval and failure of Remdisivir have caused them to pull back a bit .
But I will give credit to Cytodyn for pulling all the levers now and hoping this year we get at least one EUA and a PDUFA for HIV ...