Whilst I hope we get the BLA approved, does not feel 100%...

Whilst I hope we get the BLA approved, does not feel 100% correct or should not have been stated in this way. "You've go enough to get approved for children - go ahead and file". This feels like a very definitive statement indicating it will be approved and BLA is really a formality.

Perhaps SI was being a bit sloppy with the wording (which is unusual as his communication always appears to be quite measured).

1. Was the actual statement more like "we (this review team) think you've got enough to get approved for children"
2. Is this the same group who will review / approve the BLA. If not, there should have been a qualification that still needs further BLA review team to get approval. 9-1 vote with CRL comes to mind. If it is the same group who will review the BLA, quote should still qualify the statement with a review is still required with formal BLA information.
3. Don't think the FDA will be very happy with quotes of conversations from the meeting. Reduced the trust of confidential discussions. Conversations in meetings often do not precisely reflect their meaning. The only accurate outputs are the agreements at the end of the meeting. As communicated in ASX announcement ... agreed sufficient to allow BLA resubmission. FDA, might turn this into a 6 month review as punishment.

Also lines MSB up for another lawsuit if BLA is rejected, for anyone that buys shares as of today on basis it will be approved.