Selinexor is a great example of good trial management. Yes they managed to get accelerated approval off open label Phase II data, but they were smart enough to run a phase III trial (BOSTON) while this was underway. This was what allowed the FDA to grant accelerated approval as they were able to draw on early data from the BOSTON trial - from the approval letter - “The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.”
What MSB should have done is start running a Phase III trial in adults as soon as they had an idea the paediatric trial was going well and they thought they would be going for accelerated approval. If they had done this we would be all talking about what a genius SI is rather than discussing what went wrong. Every trial failure MSB has had has been due to management decisions and that is why I want to see a clear out of 55 Collins St.
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