Re: $OMER in Discussions With EMA and FDA Over Full and Conditional/Accelerated Approval for OMS721 in HSCT-Associated TMA
No, because they cannot give explicit guidance about the outcome, ulingt.
The Regulators would not like it and the company has no real basis to do so.
Read up on the Accelerated Approval (AA) program and you will find there is no fixed application, process, or processing time.
It is on a case by case basis, especially IMO when it is a drug that has not done a Phase III. It is extraordinary for OMS721 to be in the running for AA, but OMS721 for HSCT-TMA tends to be fatal, so given how safe OMS721 has been over multiple trials, there is minimal risk in approving the drug asap, giving patients a chance to survive... and it being less costly for the health system may be a consideration.
The logic behind an approval+a post-marketing trial, is inescapable and is consistent with the modern FDA goal of faster and more flexible approvals.