fdaextensionofpdufa.htm
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): July 18,
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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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
July
18, 2007, DOR BioPharma, Inc. (the “Company”) received notification from
the United States Food and Drug Administration (FDA) that the action date for
the FDA's review of the New Drug Application (NDA) for orBec® (oral
beclomethasone dipropionate) for the treatment of gastrointestinal
graft-versus-host disease (GI GVHD) has been extended to October 21, 2007.
The
original action date under the Prescription Drug User Fee Act (PDUFA) for the
orBec® NDA was
July 21, 2007.
The
extension is the result of DOR's July 13, 2007 provision of supplemental
information to the orBec®
NDA. This
information was requested by the FDA at a June 13, 2007
NDA review meeting. According to FDA policy, the submission of this supplemental
information was classified as a major amendment, putting the new action date
for
the orBec® NDA
at October 21, 2007.
On
July
19, 2007 the Company issued a press release discussing this
event.
Item
9.01 Financial
Statements and Exhibits
(c)
Exhibits:
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99.1
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Press
release issued by DOR BioPharma, Inc. on July 19,
2007.
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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
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Title: Chief
Executive Officer
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Date:
July 19, 2007