Soligenix Inc (SNGX)

[jb_118]

"The ODAC panel agreed that it would be unethical to run another trial in acute GVHD"

I didn't get that from listening to the panel discussion. The PI from the trial and the inventor or Orbec made that assertion, but I don't think anybody on the panel either agreed or disagreed with him directly.

In the panel's mind, there was doubt as to the efficacy of Orbec, which uncertainty would allow the trial to be ethically run. The presenter said he thought the published data were sufficiently strong that he didn't think his IRB would allow a randomized trial.

I suspect the FDA will ask for another randomized trial in acute GVHD. If the company refuses to run one, they may just run the prevention trial they have planed, and seek that as an indication. We'll soon know.