Also look at what the Chairman has said with regards to Phase IIb/III trials in a recent interview:
Let’s focus on the US: That is a Phase IIb/III trial that is aimed at patients who are severely ill because of the consequences of Covid-19. Assuming we have positive, statistically significant data, we would be in a position to go to the FDA and ask for approval. There is also a potential way to get approval sooner: This is by presenting the FDA clear evidence that the drug is therapeutically meaningful effective in a so-called compassionate access program. Having been granted the permission by the FDA to conduct such a compassionate access program, we are currently in this program. The study we are running has registrational quality. If it would be successful it could be the basis for a FDA approval.