Soligenix Inc (SNGX)

[drbio45]

What I find very positive from the press release was this

" 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."


The FDA briefing document sent to the ODAC panel expressed that the data from the phase 2 shouldn't be considered because it took place 10 years ago and didn't include non-myeloablative patients so it was a different patient population.

The ODAC panel didn't focus ont he phase 2 for this reason. The FDA is going to include this data in their review. I think this bodes very well for DOR's chances. This was so far under the radar screen very few people gave it a chance. They should rethink that position.