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)
                                 December 3, 2007

                           HEMISPHERX BIOPHARMA, INC.
             (Exact name of registrant as specified in its charter)

                           Delaware 0-27072 52-0845822
               (state or other juris- (Commission (I.R.S. Employer
           diction of incorporation) File Number) (Identification No.)

              1617 JFK Boulevard, Philadelphia, Pennsylvania 19103
               (Address of principal executive offices) (Zip Code)

       Registrant's telephone number, including area code: (215) 988-0080


          (Former name or former address, if changed since last report)


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))








Section 8 - Other Events

Item 8.01 Other Events.

On  December  3,  2007  we  received   notice  from  the  U.S.   Food  and  Drug
Administration  (FDA) that our NDA submission for Ampligen(R) in Chronic Fatigue
Syndrome  (CFS) had been  determined to be  insufficiently  complete to permit a
substantive review under 21 CFR 314.101 (d).  Specifically  eleven  deficiencies
were noted in the Clinical  Section and three in the  Pre-Clinical  Section.  No
deficiencies  were cited in the Chemistry,  Manufacturing  and Controls  Section
(CMC).

We believe that several  factors may influence the pace of the regulatory  path:
(1) Ampligen(R)  (Poly I : Poly C12U) has a relatively  long regulatory  history
(approximately  twenty  years) and  regulatory  guidelines  suggest  that longer
clinical development  histories may require more review; (2) Ampligen(R) is also
the  first  drug of its class to apply for NDA  review  status;  and (3) in some
circumstances, clinical data reporting guidelines have changed since the initial
studies on Ampligen(R),  an experimental therapeutic,  were executed in the late
1980s and early 1990s.

The Company will respond  promptly in writing to all of the filing issues raised
by the FDA and will request a guidance meeting to clarify any items outstanding.


For more  information,  please see the December 7, 2007 press  release  attached
hereto as exhibit 99.1

Section 9 - Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits.

(d)      Exhibits

The following Exhibit is filed as part of this report:

Exhibit No.                Description

Exhibit 99.1               Press Release dated December 7, 2007.


                                         SIGNATURES


         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.


                                   HEMISPHERX BIOPHARMA, INC.


December 7, 2007               By:  /s/ William A. Carter
                                   --------------------------
                                   William A. Carter M.D.,
                                   Chief Executive Officer







                                                               Exhibit 99.1

Company/Investor Contact:
Dianne Will                                       Sean Collins, Sr. Partner
Hemispherx Biopharma, Inc.                        CCG Investor Relations
518-398-6222                                      310-477-9800
ir@hemispherx.net

                     HEMISPHERX BIOPHARMA RECEIVES NOTICE OF
                      INCOMPLETE NEW DRUG APPLICATION (NDA)

            Company Expects to Respond Promptly while Moving Forward
                        on Planned Filings outside the US


Philadelphia,  PA, December 7,  2007---Hemispherx  Biopharma,  Inc. (AMEX,  HEB)
announced that it has received notice from the U.S. Food and Drug Administration
(FDA) that its NDA submission for Ampligen(R) in Chronic Fatigue Syndrome (CFS),
after preliminary  review, had been determined to be insufficiently  complete to
permit a  substantive  review  under 21 CFR  314.101  (d).  Specifically  eleven
deficiencies  were noted in the Clinical  Section and three in the  Pre-Clinical
Section. No deficiencies were cited in the Chemistry, Manufacturing and Controls
Section (CMC).

Hemispherx  believes  several  factors may influence the pace of the  regulatory
path:  (1)  Ampligen(R)  (Poly I : Poly C12U) has a relatively  long  regulatory
history  (approximately  twenty years) and  regulatory  guidelines  suggest that
longer clinical  development  histories may require more review; (2) Ampligen(R)
is also the first drug of its class to apply for NDA review  status;  and (3) in
some  circumstances,  clinical data reporting  guidelines have changed since the
initial studies on Ampligen(R),  an experimental  therapeutic,  were executed in
the late 1980s and early 1990s.

The Company will respond  promptly in writing to all of the filing issues raised
by the FDA and will request a guidance meeting to clarify any items outstanding.

In October,  2007,  the Company's New Brunswick  facility  passed a biannual FDA
inspection  relating to its fully  commercialized  interferon product (Alferon N
Injection) with no infractions or citations.

The Company will  continue to move  forward,  as  originally  planned,  with its
regulatory  filings in  various  countries  outside  the  United  States,  while
continuing  its  efforts to meet all the FDA  requirements.  The NDA filing rate
does not affect  ongoing  vaccine  enhancement  programs  with  Ampligen(R),  an
experimental TLR3 agonist, or ongoing Treatment IND programs for CFS in the U.S.

About Hemispherx  Biopharma  Hemispherx  Biopharma,  Inc. is a biopharmaceutical
company engaged in the manufacture and clinical development of new drug entities
for  treatment  of  seriously  debilitating  disorders.   Hemispherx's  flagship
products  include  Alferon  N  Injection(R)  and the  experimental  therapeutics
Ampligen(R),  Alferon LDO and Oragens(R). Alferon N Injection(R) is approved for
a category of STD infection,  and Ampligen(R)  and Oragens(R)  represent a large
portfolio  of  experimental  RNA nucleic  acids  being  developed  for  globally
important  viral  diseases,   severely  debilitating  disorders  and  biodefense
applications.  Hemispherx's  platform  technology includes large and small agent
components for potential  treatment of various  severely  debilitating  and life
threatening  diseases.  Hemispherx has in excess of 90 issued patents comprising
its core intellectual property estate, a fully commercialized product (Alferon N
Injection(R))  and a GMP certified  manufacturing  facility for its novel pharma
products.   The  Company  is  actively  engaged  in  further  expansion  of  its
intellectual  property on a world wide basis to reflect the global  distribution
of the various  disorders  which its  platform  technology  addresses.  For more
information please visit www.hemispherx.net.

Information  contained in this news release other than  historical  information,
should be considered  forward-looking and is subject to various risk factors and
uncertainties. For instance, the strategies and operations of Hemispherx involve
risk of competition,  changing market conditions, change in laws and regulations
affecting these industries and numerous other factors  discussed in this release
and in the Company's  filings with the Securities and Exchange  Commission.  Any
specifically referenced investigational drugs and associated technologies of the
Company  (including  Ampligen(R),  Alferon LDO and Oragens) are  experimental in
nature  and as such  are not  designated  safe  and  effective  by a  regulatory
authority for general use and are legally available only through clinical trials
with the referenced  disorders.  The  forward-looking  statements  represent the
Company's  judgment  as of the  date of this  release.  The  Company  disclaims,
however,  any intent or obligation to update these  forward-looking  statements.
Clinical trials for other potential indications of the approved biologic Alferon
N Injection(R) do not imply that the product will ever be specifically  approved
commercially for these other treatment indications.