UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of
Report (Date of Earliest Event Reported): May
9, 2007
Commission
File No. 000-16929
DOR
BIOPHARMA, INC.
(Exact
name of small business issuer as specified in its charter)
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DELAWARE
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41-1505029
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(State
or other jurisdiction of incorporation or organization)
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(I.R.S.
Employer Identification Number)
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| |
|
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1101
Brickell Ave., Suite 701 S
Miami,
FL
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33131
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(Address
of principal executive offices)
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(Zip
Code)
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(786)
425-3848
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(Issuer’s
telephone number, including area code)
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Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
[
]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
[
]
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act
(17 CFR 240.13e-4(c))
On
May 9, 2007, DOR BioPharma,
Inc. (the “Company”) issued
a
press release announcing that the
Oncologic Drugs Advisory Committee (“ODAC”) appointed by the U.S. Food and Drug
Administration (“FDA”) voted that the data supporting orBec®
(oral
beclomethasone dipropionate) did not show substantial evidence of efficacy
by a
margin of 7 to 2 for the treatment of gastrointestinal graft-versus-host disease
(“GI GVHD”). The FDA is not bound by ODAC’s recommendations, but it will take
the panel’s advice into consideration when reviewing the New Drug Application
(“NDA”) for orBec®.
The FDA
has said it will respond to DOR’s NDA by July 21, 2007, under Prescription Drug
User Fee Act (“PDUFA”) guidelines.
Item
9.01 Financial
Statements and Exhibits
(c)
Exhibits:
99.1 Press
release issued by DOR BioPharma, Inc. on May 9, 2007.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
DOR
BIOPHARMA, INC.
By:
/s/
Christopher J. Schaber
Name:
Christopher J. Schaber
Title:
Chief Executive Officer
Date:
May
11, 2007