Soligenix Inc (SNGX)

[drbio45]

"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.

After the panel voted and were asked to give the company and the FDA guidance to how to run another trial in acute GVHD, did any of them have a suggestion. Dr. Perry said prior to the vote that he didn't think they would have any difficulty running another trial but he kept it a secret. The other panel members said prophylaxis would be the way to go. That means they were on board that you couldn't run another trial in acute"

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.

There may have been doubt in the panel's mind but they don't have imput on the decision. Pazdur said the drug had a different impact in his mind irrespective of the panel vote. That means more to me because he will have input on the outcome

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.

I agree that we will no soon. You didn't say how you felt. The drug met every seconday endpoint. The drug beclomethasone is an already approved safe drug. What is the risk for the FDA to approve the drug