Replies to post #752 on Soligenix Inc (SNGX)

[croumagnon]

"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."

I agree. However, what makes some of us slightly optimistic in this case is that OrBec is not a threat, and is even synergistic, with chemotherapy, which happens to be the darling of Padzur, Hussein, and all the rest of the sham ODAC team. If this had been DNDN's provenge, I would be pessimistic because the masters of ODAC, the big pharma, would give them the order to shoot it down. However, with OrBec and DORB it is a totally different story and Padzur's ODAC may want to show that they have a heart and a humane nature after all by approving it and silencing those that say they do not care about the patients...

[io_io]

<<<<<"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 ">>>>


I think that's a bad analogy.

1. I loooked it up, and AVNR's drug was for something called "involuntary emotional expression disorder", not exactly a life-and-death scenaio.

2. It's not even a disease, just a symptom.

3. However it did have Priority Review (- it was not an Oncology Division drug, but was an Orphan), so the FDA originally only had 6 months, not 10 months. Even after the extension, they had 9 months total - but orBec has now gone almost 13 months.

4. Safety was the big issue, and just before PDUFA date they submitted 2 such studies, including a "thorough QT study to determine the electrocardiogram changes....."

5. I don't think safety is an issue with orBec - nothing emerged clinically.

[ragsto]

jb_118, I must disagree with what you say on AVNR which on Oct 31, 2006 received an approvable letter. Then on Jan 30th, 2007 they received another approvable letter in reference to the CMC section of filing. Then on May 31st 2007 the FDA GRANTED the CMC motion and approved the change.

So what are you trying to say?