Ann: Island receives FDA feedback on Phase 2a clinical study, page-19

I think this outcome is due to a combination of factors.

1. The FDA is incredibly conservative and risk averse.
2. ILA are using a new formulation of their drug and they haven't shown that it will reach the same level in the blood as the old formulation. It almost certainly will, but the FDA doesn't like to take any risks.

I am not surprised by this request from the FDA, what I am surprised is that ILA haven't redesigned the PEACH trial to have a lead in phase in each patient where they measure the level of ISLA101 in the blood before they expose the healthy volunteer to the virus. There may be a good reason for not using this approach, but you would think this would be the fastest way to get this trial underway.