Yeah, it is sad, and it's your classic Aussie biotech taking short $ cuts with trial design. PXS is another example, the FDA advisory panel basically admitted they would of been granted a labelled approved had they run a sub study or used a different trial design.
ACL took all the short cuts they could in trial design, and went through the 505(b)(2) NDA route to save time & money. So I doubt they agreed on terms for a SPA, they would of be pulling that line out all the time if they had.
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