Ann: Trading Halt, page-15

Read the FDA Advice here - https://www.fda.gov/media/136238/download

First impressions suggest that the release by the FDA is for guidance only. The Co. will need to establish whether the trial efficacy will be affected by the plethora of COVID-19 circumstances. For example; pertaining to travel, schedules, on-site monitoring requirements etc... However, the advice states....

"In general, FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that something is
suggested or recommended, but not required. "

Point 2 - Sponsors, in consultation with clinical investigators and Institutional Review Boards
(IRBs)/Independent Ethics Committees (IECs), may determine that the protection of a
participant’s safety, welfare, and rights is best served by continuing a study participant
in the trial as per the protocol or by discontinuing the administration or use of the
investigational product or even participation in the trial. Such decisions will depend on
specific circumstances, including the nature of the investigational product, the ability to
conduct appropriate safety monitoring, the potential impact on the investigational
product supply chain, and the nature of the disease under study in the trial.

I believe the team will be reviewing the circumstances of the trials over the coming days to determine whether the efficacy of the trials will be affected.

I'd hate for the team to proceed with the trials for the information/results to be discredited at the back-end, only then having to repeat the trials under more certain circumstances.