Approval22 Jan 2021 12:47
Approval or not to start phase 3? We already know we are going to do another phase 3. That's a dead certainty. After initial inconclusive phase 3 results IMM had meetings with the FDA and another phase 3 was needed. Thats why Avion signed a licencing deal with IMM. They signed it knowing phase 3 already given. You don't sign a multimillion pound deal hoping it will be given or rejected( in this case Lupuzor in the trash bin). Right now my guess is they are still ironing out the protocol, endpoints, etc. The real news is the conditional approval. It really simple, whether they get it or they don't. They probably already been given the verdict. They are waiting for everything to be rubber stamped before the RNS.