SEC Company Response from NANOVIRICIDES, INC. (NNVC) (CIK 0001379006) (NNVC) — Jan 17, 2007
NANOVIRICIDES, INC. (NNVC) (CIK 0001379006)
Date: Jan. 17, 2007 · CIK: 0001379006 · Accession: 0001140361-07-001307
AI Filing Summary & Sentiment
Referenced dates: December 11, 2006
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CORRESP
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filename1.htm
NanoViricides Corresp 01-16-2007
LEVY
& BOONSHOFT, P.C.
ATTORNEYS
AT LAW
477
MADISON AVENUE
NEW
YORK,
NEW YORK 10022
(212)
751-1414
FACSIMILE:
(212) 751-6943
January
16, 2007
Via
EDGAR and OVERNIGHT DELIVERY
Mr.
Jeffrey Riedler
Assistant
Director
Securities
and Exchange Commission
Division
of Corporate Finance
100
F
Street, N.E.
Mail
Stop
6010
Washington
DC 20549
Re:
NanoViricides,
Inc.
Form
10-SB12G Filed on November 14, 2006
File
No. 0-52318
Dear
Mr.
Riedler:
Please
be
advised that this firm is special securities counsel to NanoViricides, Inc.,
the
above-referenced issuer (the “Issuer”). This letter is in response to the
comments of the Staff of the U.S. Securities and Exchange Commission (the
“Commission”) with respect to the above-referenced filing provided in your
letter dated December 11, 2006 (the “Comment Letter”). In response to these
comments, the Issuer has caused to be filed Amendment No. 1 to the Form 10-SB,
a
redlined version of which is enclosed with the original of this letter. The
purpose of this correspondence is to illustrate these changes to the Commission
and provide explanation, where necessary. Our responses follow the text of
each
Staff comment reproduced consecutively for your convenience.
Comment
No 1:
Your
Website at www.nanoviricides.com
We
make reference to the homepage of your webpage where you state that you believe
that “[i]t is possible that some HIV patients may be ‘cured’ by drugs developed
at NanoViricides Inc.” You also state that you hope to “spearhead” the efforts
to making advancements in curing many viral diseases. In contrast we note
the
statement on page 6 of your Form 10 that you do not claim to be creating
a cure
of influenza, HIV or any other viral disease. Please explain the
inconsistencies.
These
statements have been deleted from both the Registration Statement and the
Issuer’s website.
Comment
No 2:
Additionally,
given the current stages of your potential product candidates, it is
inappropriate for you to suggest that any persons may be cured by using your
products. For example:
•“Our
long term research efforts are aimed at augmenting the nanoviricides currently
in development with additional agents that together may lead to either total
long term control of or, in many cases, even cure of many diseases.” (page 6)
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
2 of
27
•The
Company does not expect HiviCide-I and HiviCide-II to cure HIV/AIDS in most
patients.” (page 12)
•“It
is possible that since the cells that carry the virus genome with their genetic
material usually die in a normal cycle, known as apoptosis; an eventual cure
in
some patients may be possible with our HiviCide drugs.” (page
12)
Please
delete these statements.
The
Registration Statement has been revised to delete these statements
accordingly.
Comment
No 3:
We
make reference to your NanoBiotech News (Volume 4, No. 10) which was issued
on
March 8, 2006. In that newsletter, there is a statement indicating that your
Chief Regulatory Officer, Krishna Menon proposes that preliminary data conducted
in December 2005 related to the H2Nl (common influenza) strain “is sufficient to
file an investigational new drug application with the U.S. Food and Drug
Administration.” Your President, Anil Diwan is then quoted as saying that “I
don’t have the actual data yet. . . but we’re seeing magnitudes of efficacy
improvements over the ligand.” Please provide us with more details on the
results of these studies, including whether the results of these studies
were
completely analyzed and whether you intend to submit an IND in the near future
with the FDA or if you win need to conduct additional tests prior to submitting
an IND. Please note that we also note the disclosure you have in your
registration statement under the section entitled “Background: Preclinical
Safety and Efficacy Studies’; on page 7 and it does not appear you provide any
disclosure regarding the filing of an IND in the near future. Please explain
accordingly. We may have additional questions after reviewing your
response.
Please
note that the Issuer neither wrote nor had the opportunity to edit the
NanoBiotech News. However, all references to the article have been removed
from
the Issuer’s updated website. The section of the Registration Statement
“Background: Preclinical Safety and Efficacy Studies” was revised to include the
Issuer’s intentions with reference to filing an IND as follows:
The
discussions in this section and throughout this Form 10-SB registration
statement describe the tests that have been conducted which have yielded
these
results. These results do not provide enough evidence regarding efficacy
or
safety to support an application with the FDA. Additional tests will need
to be
conducted. It must be noted that subsequent results often do not corroborate
earlier results.
Comment
No 4:
Also
in the newsletter under the caption “Potential pharma partners line up,” there
is language indicating that “[i]n conjunction with an expected IND filing, you
are also positioned to begin licensing FluCide to major pharmaceutical partners
and further that potential licensees have begun making inquiries. Please
tell us
if you have or intend to being marketing your FluCide drug candidate in the
near
future as we understand based on the disclosure in your Form 10-SB that this
drug candidate is still in the early development phase. We may have additional
questions after reviewing your response.
The
Issuer has deleted all references to the article in its new website.
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
3 of
27
Comment
No 5:
General
Where
comments on one section also relate to disclosure in another section, please
make parallel changes to all affected disclosures. This will eliminate the
need
for us to repeat similar comments.
The
Registration Statement has been revised accordingly.
Comment
No 6:
Pursuant
to section 12(g)(l) of the Exchange Act, your registration statement will
become
effective by operation of law on January 16, 2007 at which time you will
be
required to begin filing all of the reports mandated by Section 12(g) of
the
Securities Exchange Act of 1934. If the review process has not been completed
before that date you should consider withdrawing the registration statement
prior to January 16, 2007 to prevent it from becoming effective and refiling
it
at such time as you are able to respond to any remaining issues or
comments.
The
Issuer believes its first amendment to the Registration Statement has
sufficiently responded to the Commission’s comments.
Comment
No 7:
Please
revise your filing to include updated financial statements and related
disclosures through September 30, 2006 as required by Item 310(g) of Regulation
S-B.
The
Registration Statement has been revised to provide the updated financial
statement material.
Comment
No 8:
As
a
general matter, it is inappropriate to speak about the merits of the company
without qualifying your statements in a manner that make clear to the reader
that the company is in the developmental stage and has commenced minimal
operations. Unless you have demonstrable proof of statement concerning what
the
company or its product candidates can do or are capable of, you should not
make
such statements. You may state your objectives and/or goals but you cannot
state
your beliefs or expectations unless you have a supportable basis for such
beliefs or expectations. For example, we note the following, which we note
is
not meant to be exhaustive, but rather is provided for illustrative
purposes.
•“The
Company believes that our drugs may become the major weapons in the fight
against certain viral diseases, possibly even after the other therapies have
failed.” (page 6)
•“The
Company also plans to seek regulatory approvals in several international
markets. . . and anticipates partnering with medium and large pharmaceutical
companies at various opportunities in order to advance the various drugs
into
commercialization. (page 6)
•“It
appears very likely that using the nanoviricides technology, the efficacy
of
such a drug may be enhanced by orders of magnitude.” (page 8)
•“We
anticipate that much of our work in the tropical and neglected diseases as
well
as in the areas of interest to bio-defense and emergency preparedness aspects
will be conducted in collaborations with renowned institutions” (page
9)
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
4 of
27
•We
believe that it is possible, in war-like scenario, to develop a response
to the
biological weapons attack in a manner of days or weeks. Similarly we believe
that when a new virus outbreak occurs. . . this building block technology
may
enable us to develop a new drug to fight the new threat in a minimal amount
of
time.” (page 10)
“The
Company believes that it can help contain epidemics before they can occur
in
what the company terms the ‘War-like’ scenario of response to a bio-threat,
whether due to bio-terrorism or natural events.” (page 10)
“The
Company believes that it will be able to rapidly create new drugs against
escape
mutants, should they arise, due to our building block approach.” (page
12)
•“We
believe that we have developed technologies that may significantly alter
the
field of medicine in many ways.” (page 15)
•“Our
first two HIV drugs. . . together are expected to be capable of attacking
and
neutralizing most of the existing HN strains, clades (or subtypes), and types.
The Company believes that our HiviCide drugs will enable a long-term nearly
virus-free lifestyle for most HIV/AIDS patients, beyond what is feasible
today
with HAART therapy.” (page 17).
•“[T]o
the best of our knowledge it is possible that we have the world’s most
efficacious drug to treat these viruses [human influenza and bird flu]” (page
43)
Given
the preliminary nature of the development of your product candidates, these
statements are inappropriate and should be deleted from your
document.
These
statements have been deleted from the Registration Statement.
Comment
No 9:
Please
provide us with third party documentation supporting the following statements
you make in this section:
“We
believe NanoViricides is the first company to bring this proven feature to
the
anti -viral therapy platform:’ (page 5)
Nanomedicines
against anticancer are an established goal of the NCI/NIH nanotechnology
initiative.
“Non-H5N1
HP AI strains are expected to become the next pandemic threats on the
horizon.”
(page 5)
NIH
has
funded Sanofi to develop a vaccine against H7N1. This is a non H5N1 highly
pathogenic influenza A strain.
http://www.sanofipasteur.com/sanofi-pasteur/ImageServlet?siteCode=AVPI_US&imageCode=17693&codeSite=AVPI_US.
“There
is now acceptance in the industry, the scientific community and the public
health community that injectable drugs should be developed and deployed when
they provide high efficacies,” (page 8)
“BioCryst
life threatening influenza injection fast tracked”
18th
January 2006
By
Staff
Writer
The
FDA
has granted fast track designation to BioCryst Pharmaceuticals peramivir
injection for the treatment of influenza infections, including highly virulent,
life-threatening strains of influenza such as avian flu.
LEVY
& BOONSHOFT, P.C.
Securities
and Exchange Commission
Page
5 of
27
Peramivir
is an influenza neuraminidase inhibitor that, in preclinical studies, has
shown
potent, broad spectrum activity against multiple strains of flu, including
the
H5N1 virus.
On
December 22, 2005, BioCryst announced that the FDA had given the company
approval to begin human clinical trials using injectable peramivir.
In
correspondence with BioCryst, the FDA said that it agrees that the use of
peramivir in the proposed indication meets the criterion of treating a serious
life-threatening condition. Based on this conclusion, the FDA designated
peramivir injection for influenza infection as a fast track product, meaning
that the drug will be the subject of a faster regulatory process.
"The
FDA's decision supports our belief in the potential of peramivir as an effective
therapy for the treatment of influenza, including highly virulent,
life-threatening strains like those associated with avian influenza," said
Dr
Charles Bugg, chairman and CEO of BioCryst.
“While
the HIV-l type is prevalent in North America, Europe, and a majority of the
World, a distinct HIV type called HIV-2 with a marked prevalence in West
Africa,
has recently been spreading worldwide.” (page 12)
Please
see the chapter on Human Retroviruses. Longo, DL and Fauci, AS “The Human
Retroviruses” in Harrison’s Principles of Internal Medicine, 16th
ed.
McGraw Hill. pp. 1071- 1076. Also, AS Fauci and H Clifford-Lane, “”HIV Disease:
AIDS and Related Disorders”, pp. 1076-1139, ibid.
“According
to the US Centers for Disease Control and Prevention (‘CDC’), an estimated 5% to
20% of the American population suffers from influenza annually, more than
200,000 people are hospitalized from flu complications, and approximately
36,000
people die from the flu in the US. The worldwide death