Replies to post #778 on Soligenix Inc (SNGX)

[jshaffer85]

re Pazdur

It does make sense that he was swamped because while those who prepared the brief focused Question #2 on how to design a proper efficacy trial (assuming one was needed) Pazdur himself focused on whether one was feasible.

You are right DrBio that something in the presentation convinced him that the crux of the decision would come down to whether another trial is feasible. He was pointed in his discussions with the panel about trying to answer that question. He mentions treatment IND, but then asks, if one is in place would another efficacy trial be possible (NO)?

Given the consensus in the summary minutes states that a prophylactic trial is the proper trial it seems Pazdur has some flexibility for some conditional/accelerated approval arrangement even though it makes little sense.

I think he must understand that an approvable requiring another placebo-controlled efficacy trial (whether compassionate use is allowed via treatment IND or not) is the same as killing the drug with a rejection.

[ragsto]

drbio, By Padzur's comments after the vote was taken it appeared to me that he favored the data after seeing the 80 day vs the 50 day. That I believe was the revised data the FDA was looking for in their June meeting. It appears that the FDA wants to approve orBec buts wants to cover their ass by having the revised data as backup. The more I see what has transpired with what has been going on lately with not only orBec but other drugs before the FDA I am really looking for an approval for orBec.