Soligenix Inc (SNGX)

[jb_118]

"Based on these discussions, the FDA requested that DOR review its existing clinical data from both its randomized, double-blind, placebo-controlled trials and highlight pertinent additional data that could provide a more comprehensive picture of orBec®'s clinical effect in treating acute GI GVHD. This new presentation of data formed the basis for the recently filed supplemental submission to the orBec® NDA."

"We appreciate the FDA's willingness to allow us to provide supplemental data"

Not sure who's idea it was to provide the additional data, but my guess is that the DORB folks aren't all the sophisticated when it comes to regulatory affairs. That's ok, small Bios generally aren't, and it showed in the ODAC meeting.

Good luck to the longs, but I can't get a good sense for how this is going to go.