They asked for type A meeting early last week. FD
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Posted On: 08/15/2020 8:40:27 AM
They asked for type A meeting early last week. FDA has 30 days to respond. 10-K said they hope to have everything submitted by end of 2020. Approval summer 2021. Could possibly also include monotherapy request since FDA already asked for all that trial safety data. But not likely. However if approved for combination therapy patients could always just skip the other drugs on their own if LL suppresses viral load all by itself. May get approval from UK for HIV combo before US?
Now we have to hope Covid gets approval quicker so we can start selling all the inventory we should have coming in. A shame about the many HIV delays when clearly it is safe and effective in combo .. trial results in early 2018 but no approval until 3 years later. Way too long to navigate the FDA bureaucracy.
Now we have to hope Covid gets approval quicker so we can start selling all the inventory we should have coming in. A shame about the many HIV delays when clearly it is safe and effective in combo .. trial results in early 2018 but no approval until 3 years later. Way too long to navigate the FDA bureaucracy.
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