I really hope that things may happen faster with GNBT, because they have already turned in their Pre-IND package in fall of last year. So this entire story is not new to the FDA, but - according to GNBT's management team - it was ferry well and positively received and reviewed.
So all GNBT needs to do is to provide evidence for the claims they already made in that Pre-IND application, and so I really hope that FDA's approval does not take another 30 days or even longer!?