I was in attendance at the presentation. SI referred to the PDUFA date on two occasions. His exact words were
- first instance ‘ it’s resubmitted for BLA approval. The filing has been accepted. We have got what is called a PDUFA date ahhhh for Jan 7th we think it will be approved well, ahead of that potentially but that is the latest that the FDA will give us a decision on’
- second instance ‘ There’s a dialogue between us and the FDA that we are in the midst of and we are anticipating an approval ahead of the Jan 7 final date but we’ll see. That’s an ongoing process and will be updating the market in due course’
I was in attendance at the presentation. SI referred to the...
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