Ann: Trading Halt, page-9

I doubt that the FDA has turned on its head and said that they would harmonise with the EU/UK endpoints, but if they did, they wouldn't need any more cash to run that US trial as the raise was originally funded for that exact plan.

I imagine it's more likely that they aren't wanting US trial centres yet and are suggesting that they are completed in the EU/UK/AU/NZ/Israel under the EMA endpoints, and once completed to have US trial centres under their desired endpoints.

Its either that, or they received a response in the early morning and haven't had the chance to construct an announcement/want to carefully go through the advice given how important it is, then inform the market. As opposed to letting the information float around and trading to continue.