Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-262

"the FDA will likely reject the BLA resubmission as there is no new data"

The FDA hasn't completed the review but IMO it's more likely that approval will be witheld because there is no new data to be considered from the trial. That is the "rejection" that was referenced in my statement, but that's self evident to most people. I specifically said that I expected the FDA to "accept the re-submission" but "reject the application for approval".

Perhaps what should be troubling to holders is the fact that despite the 9:1 ODAC vote, the FDA issued a CRL the first time around. It perhaps suggests that some older hands at the FDA are familiar with the trials from the Osiris days and the comments from other regulators regarding the evidence from the trial and perhaps the attitude displayed to engage in better quality trials that would provide more conclusive evidence. The 9:1 vote wasn't sufficient to overcome misgivings about the quality of the evidence. So trusting in SI's approach to arguing with the FDA by providing long term data might be a mistake. What the FDA has said has been completely consistent with the comments from the Australian and Candian regulators.