I don't think we are yet ready for an FDA assessment. Some time in Feb CSL will release definitive results on the real world efficacy of CSL112. These will then go off to the FDA for their authorisation for CSL to market the drug. My hope is that the reason CSL has taken so long is in order to cover all the requirements for quick approval. You only need to look at the inadequate trials done by MSB to see the FDA don't like time-wasters.
I don't think we are yet ready for an FDA assessment. Some time...
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