Replies to post #763 on Soligenix Inc (SNGX)

[jshaffer85]

re ODAC comments

Read Hussain's comments too. While she basically hides behind the fatal-flaw=primary-endpoint-failure axiom she does ask why the 80 day endpoint isn't just as important. Overall she does seem to have some positive inclination but can't get beyond the headline failure.

[jb_118]

"Remember, if he likes the drug and asks for another trial it will never be approved."


This is the drug's best chance IMO. It already took a LONG time to get these trials done, and DORB doesn't have a lot of resources.

"The fred Hutchinson center supplied 47 percent of the patients. since they use the corn oil they would not be able to do a placebo trial so a new trial would never recruit patients.""

One could almost make an argument then that the corn oil should be the placebo.

What hasn't been mentioned recently, and what I think is the biggest sticking point frankly in the data package, is the huge differential in the myelo's and the non-myelos. That has yet to be even plausibly explained, and adds to the concern that the observed survival data is an artifact.

[ragsto]

drbio, Thanks for the link. It is well worth reading every word. After reading the transcript along with everything else, ie extension, Provenge, lawsuits, Von E, image, coi's, there is just so many positives on why this should be given the green light. I am very comfortable but at the same time some what nervous for nothing is a guarantee. I still stand by my odds of 80% approval of some sort after you factor everything else into the mix. Corn oil is not the answer and a patient should always be put 1st, especially when safety & survival are center stage.

[sbbumn2007]

the hutch has used corn oil for years, yet they were able to do several trials. no reason they could not do another trial now. However, you do raise a point that is seldom discussed, with such an imbalance of patients at one center it raises the question of the adequacy of this as a multicenter triaL.