Soligenix Inc (SNGX)

[NoBuddyNoz]

===== "What is so shocking ?"

Not a darn thing; I was being sarcastic.

===== "He is not approving the drug. It's the FDA's responsibility to do that, not his."

I didn't SAY he was approving the drug, I said "After considering the above [McDonald's COIs], I find it truly SHOCKING [<-- sarcasm] that he would believe that the orBec data/case is conclusive."

Take a look.

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The Expert Opinion paper concludes that two randomized, double-blinded placebo-controlled trials have demonstrated that orBec®, formulated as gastric-release and enteric coated pills and dosed at 8 mg/day, is safe and effective in treating acute GI GVHD when used in conjunction with a 10 day induction course of prednisone.
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In other words, McDonald concluded that Dor's two studies demonstrated that orBec is safe and effective. I was attempting to bring forth what I see as McDonald's severe bias in favor of orBec, which in turn calls his 'conclusions' into doubt.

But as you say, it's not his call, it's the FDA's. I wonder what they think about the conclusiveness of the orBec data?

Here's a quick little summary (http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4301m1.pdf). It includes a bunch of junk and also findings from the IDMI meeting. To get the orBec relevant info, read the background on page 3, and the ODAC discussion on pages 6 and 7.

It would seem that the AC's opinion regarding the conclusiveness of orBec's data differs somewhat from McDonald's. A typical response would be, ~"The AC panel was biased; The AC panel had COIs; The AC panel and interests they represent, stand to lose both status and money if orBec is approved". To which I reply, McDonald is AT LEAST equally biased, conflicted, and interested; Quite likely more so.

Don't get me wrong, I'd love to see orBec approved. It would benefit patients and Dor investors directly (I'm in neither group), and it would indirectly benefit biotech/pharma investors in general (a group to which I certainly belong). But just because I'd benefit from orBec approval doesn't mean that I will blind myself to the facts of the situation. It would require a fairly serious leap of faith, and an abrupt change of guidelines, for the FDA to approve orBec based on those two studies. Nothing McDonald says will change that.

THE BIG HOWEVER ...

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.

My two cents,
NoBuddy