Replies to post #846 on Soligenix Inc (SNGX)

[jshaffer85]

McDonald v. ODAC

McDonald is biased alright, he's biased towards providing patients with the greatest chance to survive the horrors of GVHD without bombarding them with systemic steroids and immunosuppressives which cripple their immune system. ODAC, on the other hand, is biased towards their own regulatory processes, precedent and perceived intellectual prowess.

Good thing ODAC doesn't make the decision here. It would be a shame if something McDonald has spent over a decade working on would be so quickly dismissed by bureaucrats who are given an hour or less to give their informed opinion on the drug.

The data summarized in McDonald's abstract is Total Treatment Failures at day 50 and 80 for prednisone responders and is not part of Dor's ODAC brief. Given the fact that McDonald was likely involved with any data compilation work after the June 13 meeting it may be indicative of where the focus lies.

[tryn2getrich]

Regarding your last point
"HOWEVER, Dor provided additional data to the FDA. Is the final package (two studies plus new data) enough for approval? Perhaps, but McDonald was implying that the two studies was enough ... the FDA disagrees."

I think the new data DOR provided is from the two completed trials, that was probably not provided before, for whatever reason. Were you implying that DOR got the data from some other unnamed trial? IF the data proves to be satisfactory then obviously the two studies are enough.