RE: Short study patient options13 Oct 2023 08:01
I can't see how using it as a first line treatment targeting what it actually will be targeting isn't a phase 2 study already.
From what's been observed already it seems that efficacy and the continued safety profile will be observed. Could it be enough for the FDA to grant authorisation.
The FDA are obviously heavily involved as it's only running in the US and with thier approval. Tap would very much understand the inner workings of the FDA.