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ragsto

10/09/07 10:23 AM

#814 RE: jshaffer85 #813

I for one sure hope so. If not anything else it will be setting up the FDA to have more egg on their face if they do NOT approve the drug. If they don't many will wonder just what is the real function of the FDA? Even now many wonder that.
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io_io

10/09/07 11:50 AM

#815 RE: jshaffer85 #813

<<<"This is a very declarative statement and the first one from Dor">>>


I agree, and it's actually from Dr. Mc Donald, who was very reluctant at the ODAC Panel to make any opportunistic claims in order to put pressure on the FDA (comapre that with IDMI, who were very pompous). Am a little surprised !
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NoBuddyNoz

10/10/07 3:46 PM

#839 RE: jshaffer85 #813

===== "This is a very declarative statement and the first one from Dor in a PR that highlights the data with a guarantee period."

I don't think that statement came from Dor. It came from the Expert Opinions report and was written by George B. McDonald.

A few interesting facts:

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The publication "Oral Beclomethasone Dipropionate, a Topically-Active Corticosteroid for Treatment of Gastrointestinal Graft-vs.-Host-Disease Following Allogeneic Hematopoietic Cell Transplantation," is authored by George B. McDonald, MD, inventor of orBec® and Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, located in Seattle, Washington.
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msg #812

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The second trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Research Center. ===========================================================
msg #812

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G McDonald is a consultant to DOR BioPharma, Inc. and has an equity position with the company.
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From the full text

Now let me get this straight.
1) George McDonald is the inventor of orBec
2) George McDonald is the Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center
3) The PII study was conducted in its entirety at the Fred Hutchinson Cancer Research Center
4) George McDonald is a consultant to DOR BioPharma, Inc.
5) George McDonald has an equity position in DOR

After considering the above, I find it truly SHOCKING that he would believe that the orBec data/case is conclusive.

And some posters complain about Conflicts of Interest at the FDA. Priceless! :)

NoBuddy