Soligenix Inc (SNGX)

[jb_118]

"We then take into account that the data given in June deemed important enough to take further consideration leads me to believe that the chances are very high for approval."

The fact that the FDA delayed the decision shouldn't be interpreted as either positive or negative. If applicant submits substantial additional information, the FDA delays a decision by 60 days. Substantial is not meant to imply whether the data are good or not, just whether they will take additional time to assimilate for analysis.

Off the top of my head, AVNR made a similar addition to their data package, got a 60 day extension, and was bludgeoned when the agency finally issued an approvable letter questioning the entire data package and demanding more trials. It wasn't even close.