Replies to post #786 on Soligenix Inc (SNGX)

[tryn2getrich]

"approvable after fulfillment of additional regulatory conditions."

I'm long as well, but i don't read this as approval with conditions. I read this statement to mean a standard approvable with additional data required or an additional trial before full approval. But the release does appear to take non-approval off the table.

"Is it not best to error in favor of the patient when safety is not the issue. "

One word, provenge.

[io_io]

<<<<<"Also discussed after the AC meeting was that in the last 20 years there were 15 drugs submitted for this condition and that only 5 made to a decision process, and out of the 5 orBEC was at the front of the pack">>>>


What was actually said was that there had been only twelve TRIALS (not FDA submisions) for treatment of GVHD treatment, and the only one with a survival advantage was the orBec 875 Study. I don't know of any drug that has been submitted ever to the FDA for GVHD treatment.

There have been others for GVHD prevention. Actually I remember that somewhere between '97 and '99 there was a drug Tacrolimus submitted to the FDA for GVHD prevention, and even though it was already on the market for something else, it was denied (approvable). It seems to be widely used off-label today in GVHD prevention. Maybe it is generic, I don't know, but the transplanters believe it is the best available. Certainly I doubt they can do a further trial as it seems to be a SoC.

Maybe Pazdur will remember this mistake as he considers orBec.