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SEC Company Response from Pathogenics, Inc. (CIK 0001320731) — Aug 29, 2005

Pathogenics, Inc. (CIK 0001320731)
Date: Aug. 29, 2005 · CIK: 0001320731 · Accession: 0001332277-05-000064

AI Filing Summary & Sentiment

File numbers found in text: 333-123431

Referenced dates: July 25, 2005

Date
August 29, 2005
Author
Not clearly detected
Form
CORRESP
Company
Pathogenics, Inc. (CIK 0001320731)

Letter

DAVID M. LOEV, ATTORNEY AT LAW 2777 ALLEN PARKWAY, SUITE 1000 HOUSTON, TX 77019 TELEPHONE (713) 524-4110 FACSIMILE (713) 524-4122 August 29, 2005 Ms. Mary K. Fraser, Esq. Division of Corporate Finance United States Securities and Exchange Commission 450 Fifth Street, N.W. Washington, D.C. 20549

RE: Pathogenics, Inc. Form SB-2 Registration Statement File No. 333-123431

Dear Ms. Fraser:

We have enclosed three red-lined copies of the amended registration statement for your review. In response to your letter dated July 25, 2005, Pathogenics, Inc. (the "Company") has the following responses:

Comments applicable to the entire filing ---------------------------------------------

1. We have revised the wording of the Registration Statement to address the use of capitalization, the excessive use of parenthetical phrases, improper use of acronyms, excessively long sentences, legalistic and over complex explanations, highly technical business terminology and have attempted to limit our use of defined terms.

2. We have revised the prospectus as you have requested and eliminated the following technical terms from the forefront and the body of the prospectus:

Active Halogen Compounds Main long-lived oxidant produced by human granulocytes and monocytes Cytotoxicity Endogenous Endogenous Antiseptic Endothelial Cells Formulation Development Program Genotoxicity Screening Innate Immunity Novel Endogenous anti-infective Oxidizing Mechanism of Action Rhinosinusitis

<PAGE>

We have also followed your suggestion to explain the following remaining technical terms the first time they appear in the Registration Statement and have eliminated the glossary from the Registration Statement altogether:

Crural Ulcer Amino Acid Derivatives Otitis Externa ("Swimmers ear") Clinical Trials Conjunctivitis ("Pink eye")

3. We have revised the information presented on the cover page of the prospectus to include only the information specified by Item 501(a) of Regulation S-B.

4. We have removed the information from our cover page regarding responsibility for misstatements, and included only the information specified by Item 501(a) of Regulation S-B.

Prospectus Summary -------------------

5. We have either sent you the supporting documentation listed below (marked as necessary to show the location of each fact or statistic we are relying on for the claims made in the prospectus) for the factual and statistical claims we have made in the Prospectus or deleted those claims entirely. We have also deleted these citations in the prospectus.

Claim #1: In pre-clinical studies conducted by the researchers, N-chlorotaurine demonstrated the ability to kill bacteria, viruses, parasitic intestinal worms, and destroy or inhibit the growth of fungi. (Description of Business - N-chlorotaurine)

Support for Claim #1:

(a) Nagl, M and Gottardi, W. In vitro experiments on the bactericidal action of N-chlorotaurine. Hyg.Med. 17:431-439, 1992.

(b) Nagl, M and Gottardi, W. Enhancement of the bacterial efficacy of N chlorotaurine by inflammation samples and selected N-H compound. Hyg.Med. 21:597-605, 1996.

(c) Nagl, M, Larcher, C and Gottardi, W. Activity of N-chlorotaurine against Herepes simplex and Adenoviruses. Antiviral. Res. 38(1): 25-30, 1998).

<PAGE>

Claim #2: Additional pre-clinical studies conducted by the researchers showed that when N-chlorotaurine was applied in the presence of human nasal mucus, its ability to destroy microorganisms was increased. (Description of Business - N-chlorotaurine)

Support for Claim #2:

Nagl M, Lass-Floerl C, Neher A, Gunkel AR, Gottardi W. Enhanced fungicidal activity of N-chlorotaurine in nasal secretion. J Antimicrob Chemother 2001; 47: 871-4.

Claims #3 - #6: The clinical trials conducted by the researchers to date have proved N-chlorotaurine's tolerability on the skin and mucous membranes and have demonstrated initial signs of efficacy in:

(a) outer ear infections, (b) Infected leg ulcers, (c) eye infections, and (d) inflammation of the sinuses caused by infections. (Description of Business - N-chlorotaurine)

Support for Claims #3 - #6:

(a) outer ear infections, Laryngoscope, "Acute Otitis Externa: Efficacy and Tolerability of N-chlorotaurine, a Novel Endogenous Antiseptic Agent," 2004; 114: 850-4

(b) Infected leg ulcers, Br J Dermatol, "Tolerability and efficacy of N-chlorotaurine compared to chloramine T for treatment of chronic leg ulcers with purulent coating," 2003; 149: 590-7)

(c) eye infections, Ophthalmologica, "Tolerance of N-chlorotaurine, a newantimicrobial agent, in infectious conjunctivitis - a phase II pilot study," 2000, 214: 111-4)

(d) inflammation of the sinuses caused by infections of bacterial, fungal and viral origin, Auris Nasus Larynx, "Tolerability of N-chlorotaurine in Chronic Rhinosinusitis Applied via Yamik Catheter," (Submitted) 2005.

Claim #7: This field is considered the third largest in terms of annual sales, surpassed only by drugs for treating central nervous system disorders and cardiovascular disease. (Description of Business - N-chlorotaurine - Potential Market for N-chlorotaurine)

Support for Claim #7: Nature Biotechnology, Vol. 21:1256, Nov 2003.

<PAGE>

Claim #8: Anti-infectives are the third largest segment of the pharmaceutical industry, with annual sales totaling $45 billion. (Description of Business - N-chlorotaurine - Potential Market for N-chlorotaurine)

Support for Claim #8: Roehr, Bob. Anti-infective Drug Development in Decline. 43rd ICAAC. Presented Sept. 15, 2003, as reviewed by Gary D. Vogin, MD for Medscape Medical News.

Claim #9: Of the $45 billion in the anti-infectives markets, 62% is for antibacterials, 12% is for HIV, 6% is for other viral infections, 7% is for antifungals, and 13% is for vaccines and immunology. The 4-year compounded growth rate for anti-infectives is strong at 10%. The best markets for anti-infectives are the United States (48%), Europe (22%), and Japan (13%). (Description of Business - N-chlorotaurine- Potential Market for N-chlorotaurine)

Support for Claim #9: Bartlett, Bob G. 43rd ICAAC. Presented Sept. 15, 2003.

Claim #10: Broad-spectrum, multi-indication anti-infective drugs generally have potential annual sales of $1 billion within three years of market introduction. (Description of Business - N-chlorotaurine- Potential Market for N-chlorotaurine)

Support for Claim #10: "Superbugs & Superdrugs: A Strategic Guide to the Global Antimicrobials Industry, Industries and Therapies," SMi Publishing Ltd. 2000, at page 130, "Superbugs".

Claim #11 : Treatment of sinus and ear infections are the most common reason for outpatient antibiotic prescriptions (Description of Business - N-chlorotaurine - Potential Market for N-chlorotaurine)

Support for Claim #11: Consumer Reports, "Super-germ alert," January 2001, 60-61.

Claim #12: conjunctivitis (eye infections commonly referred to as "pink eye") is considered the most common reason for non-traumatic eye complaints. (Description of Business - N-chlorotaurine- Potential Market for N-chlorotaurine)

Support for Claim #12: American Family Physician, "Should We Prescribe Antibiotics for Acute Conjunctivitis," Vol. 66, No. 9, November 1, 2002.

<PAGE>

Claim #13: The Impact of N-chlorotaurine on the Candida virus. (Description of Business - N-chlorotaurine - Research and Development of N-chlorotaurine)

Support for Claim #13: Antimicrob Agents Chemother, "Impact of N-chlorotaurine on viability and production of secreted aspartyl proteinases of Candida spp." 2002; 46: 1996-9.

Claim #14: Explanation of the chemical properties of N-chlorotaurine and how it is a key compound in the human defense system to infections. (Description of Business - N-chlorotaurine - Research and Development of N-chlorotaurine)

Support for Claim #14: Arch Pharm (Weinheim), "Chemical properties of N-chlorotaurine sodium, a key compound in the human defence system," 2002; 335: 411-21.

Claim #15: Comparison of N-chlorotaurine with another treatment - chloramine T - for the treatment of infected leg ulcers. (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #15: Br J Dermatol, "Tolerability and efficacy of N-chlorotaurine compared to chloramine T for treatment of chronic leg ulcers with purulent coating," 2003; 149: 590-7.

Claim #16: Study of influence of N-chlorotaurine on nasal mucous. (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #16: Am J Rhinol, "In vitro study on the influence of N-chlorotaurine on the ciliary beat frequency of nasal mucosa," 2003; 17: 149-52.

Claim #17: Application of N-chlorotaurine to sinusitis complicated by immune suppression. (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #17: ORL J Otorhinolaryngol Relat Spec, "Refractory rhinosinusitis complicating immunosuppression: application of N-chlorotaurine, a novel endogenous antiseptic agent," 2003; 65: 303-5.

Claim #18: Down-regulatory effect of N-chlorotaurine. (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #18: Immunol Lett, "Down-regulatory effect of N-chlorotaurine on tryptophan degradation and neopterin production in human PBMC," 2004; 93: 143-9.

<PAGE>

Claim #19: Tolerability of N-chlorotaurine shown in the middle ear of a guinea pig. (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #19: Ann Otol Rhinol Laryngol, "Tolerability of N-chlorotaurine in the guinea pig middle ear - a pilot study using an improved application system," 2004; 113: 76-81.

Claim #20: Efficacy and tolerability of N-chlorotaurine in treating Otitis Externa ("swimmers ear"). (Description of Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

Support for Claim #20: Laryngoscope, "Acute Otitis Externa: Efficacy and Tolerability of N- Chlorotaurine, a Novel Endogenous Antiseptic Agent," 2004; 114: 850-4.

Claim #21: Non-motor symptoms, such as dementia occurs in at least 50% of the patients; depression is also very common. (Description of Business - Choloroquine Diphosphate).

Support for Claim #21: "The Columbia Electronic Encyclopedia, Sixth Edition," Copyright 2003, Columbia University Press. Licensed from Columbia University Press. All rights reserved.

Claim #22: The Parkinson's Disease market will undergo a relatively consistant growth pattern over the next several years, growing from $1.9 billion in 2001 to over $2.4 billion in 2007. (Description of Business - Choloroquine Diphosphate - Potential Market for Chloroquine).

Support for Claim #22: Marketresearch.com: The CNS Outlook to 2007.

6. We have revised the summary section of the Prospectus to include the general nature of the studies completed on both N-chlorotaurine and Chloroquine Diphosphate as you requested and that section now states:

"All of the research and development which has been completed on N-chlorotaurine has been completed by the researchers in Austria. The researchers have completed studies on the impact of N-chlorotaurine on the Candida virus; studies on the chemical properties of N-chlorotaurine and how it is a key compound in the human defense system to infections; research on N-chlorotaurine for the treatment of infected leg ulcers; a study of the influence of N-chlorotaurine on nasal mucous; the application of N-chlorotaurine to combat sinus infections complicated by immune suppression; the tolerability of N-chlorotaurine in the middle ear of a guinea pig; and efficacy and tolerability of N-chlorotaurine in treating swimmers ear.

<PAGE>

All of the research and development on Chloroquine Diphosphate has been conducted by Alpha Research Group, LLC. Alpha Research Group, LLC has conducted a ten (10) patient clinical study using less than one half of the conventional malarial treatment dose of commercially available Chloroquine Diphosphate in a time-released formula with a brain targeting agent. Data from this study showed that Alpha Research Group, LLC's novel Chloroquine Diphosphate formulation alleviated both Parkinson's Disease motor symptoms in patients diagnosed with Parkinson's Disease, as well as the manifestation of involuntary jerky motions in patients and was generally well tolerated even after several months of continual use."

7. We understand that our previous comment letter was not confidential and we have revised our disclosures regarding the status of the studies we have conducted as described in question 6, above.

8. We have revised the Summary of the prospectus as you have requested, and have eliminated references to "Phase 2b" or "Phase 2a" "pilot studies" throughout the Prospectus so as not to be related to the official characterizations used by the FDA. Additionally, the adjective "pilot" in reference to clinical studies has been replaced throughout the prospectus with the adjective "small-scale."

9. We have revised the last paragraph on page 5 of the prospectus as you have requested, and stated that "To date, neither product candidate has completed the pre-clinical d

Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

                         DAVID M. LOEV, ATTORNEY AT LAW
                         2777 ALLEN PARKWAY, SUITE 1000
                                HOUSTON, TX 77019
                            TELEPHONE (713) 524-4110
                            FACSIMILE (713) 524-4122

                                August 29, 2005

Ms. Mary K. Fraser, Esq.
Division of Corporate Finance
United States Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549

RE:  Pathogenics, Inc.
     Form SB-2 Registration Statement
     File No. 333-123431

Dear Ms. Fraser:

We  have  enclosed  three red-lined copies of the amended registration statement
for  your  review.  In response to your letter dated July 25, 2005, Pathogenics,
Inc.  (the  "Company")  has  the  following  responses:

Comments  applicable  to  the  entire  filing
---------------------------------------------

1.   We  have  revised  the  wording  of  the  Registration Statement to address
     the  use  of  capitalization,  the  excessive use of parenthetical phrases,
     improper  use  of acronyms, excessively long sentences, legalistic and over
     complex  explanations,  highly  technical  business  terminology  and  have
     attempted to limit our use of defined terms.

2.   We  have  revised  the  prospectus  as  you  have  requested and eliminated
     the  following  technical  terms  from  the  forefront  and the body of the
     prospectus:

          Active Halogen Compounds
          Main  long-lived  oxidant  produced  by  human  granulocytes  and
          monocytes
          Cytotoxicity
          Endogenous
          Endogenous Antiseptic
          Endothelial  Cells
          Formulation  Development  Program
          Genotoxicity  Screening
          Innate  Immunity
          Novel  Endogenous  anti-infective
          Oxidizing  Mechanism  of  Action
          Rhinosinusitis

<PAGE>

     We  have  also  followed  your  suggestion  to  explain  the  following
     remaining  technical  terms  the first time they appear in the Registration
     Statement  and have eliminated the glossary from the Registration Statement
     altogether:

          Crural  Ulcer
          Amino  Acid
          Derivatives
          Otitis  Externa  ("Swimmers  ear")
          Clinical  Trials
          Conjunctivitis  ("Pink  eye")

3.   We  have  revised  the  information  presented  on  the  cover  page of the
     prospectus  to  include  only  the  information specified by Item 501(a) of
     Regulation S-B.

4.   We  have  removed  the  information  from  our  cover  page  regarding
     responsibility  for  misstatements,  and  included  only  the  information
     specified by Item 501(a) of Regulation S-B.

Prospectus  Summary
-------------------

5.   We  have  either  sent  you  the  supporting  documentation  listed  below
     (marked  as necessary to show the location of each fact or statistic we are
     relying  on  for  the  claims  made  in the prospectus) for the factual and
     statistical  claims  we have made in the Prospectus or deleted those claims
     entirely. We have also deleted these citations in the prospectus.

     Claim  #1:  In  pre-clinical  studies  conducted  by  the  researchers,
     N-chlorotaurine  demonstrated  the  ability  to  kill  bacteria,  viruses,
     parasitic  intestinal  worms,  and  destroy or inhibit the growth of fungi.
     (Description of Business - N-chlorotaurine)

          Support for Claim #1:

          (a)  Nagl,  M  and  Gottardi,  W.  In  vitro  experiments  on  the
               bactericidal  action  of  N-chlorotaurine.  Hyg.Med.  17:431-439,
               1992.

          (b)  Nagl,  M  and  Gottardi,  W.  Enhancement  of  the  bacterial
               efficacy  of N chlorotaurine by inflammation samples and selected
               N-H compound. Hyg.Med. 21:597-605, 1996.

          (c)  Nagl,  M,  Larcher,  C  and  Gottardi,  W.  Activity  of
               N-chlorotaurine  against  Herepes  simplex  and  Adenoviruses.
               Antiviral. Res. 38(1): 25-30, 1998).

<PAGE>

     Claim  #2:  Additional  pre-clinical  studies  conducted by the researchers
     showed that when N-chlorotaurine was applied in the presence of human nasal
     mucus, its ability to destroy microorganisms was increased. (Description of
     Business - N-chlorotaurine)

          Support for Claim #2:

          Nagl  M,  Lass-Floerl  C,  Neher  A,  Gunkel  AR, Gottardi W. Enhanced
          fungicidal  activity  of  N-chlorotaurine  in  nasal  secretion.  J
          Antimicrob Chemother 2001; 47: 871-4.

     Claims  #3  -  #6:  The  clinical  trials  conducted  by the researchers to
     date  have  proved  N-chlorotaurine's  tolerability  on the skin and mucous
     membranes and have demonstrated initial signs of efficacy in:

          (a) outer ear infections,
          (b) Infected leg ulcers,
          (c) eye infections, and
          (d) inflammation  of  the  sinuses  caused  by  infections.
              (Description of Business - N-chlorotaurine)

          Support for Claims #3 - #6:

          (a)  outer  ear  infections,  Laryngoscope,  "Acute  Otitis  Externa:
               Efficacy  and Tolerability of N-chlorotaurine, a Novel Endogenous
               Antiseptic Agent," 2004; 114: 850-4

          (b)  Infected  leg  ulcers,  Br  J  Dermatol,  "Tolerability  and
               efficacy  of  N-chlorotaurine  compared  to  chloramine  T  for
               treatment  of  chronic  leg  ulcers with purulent coating," 2003;
               149: 590-7)

          (c)  eye  infections,  Ophthalmologica,  "Tolerance  of
               N-chlorotaurine,  a  newantimicrobial  agent,  in  infectious
               conjunctivitis - a phase II pilot study," 2000, 214: 111-4)

          (d)  inflammation  of  the  sinuses  caused  by  infections  of
               bacterial,  fungal  and  viral  origin,  Auris  Nasus  Larynx,
               "Tolerability  of  N-chlorotaurine  in  Chronic  Rhinosinusitis
               Applied via Yamik Catheter," (Submitted) 2005.

     Claim  #7:  This  field  is  considered  the  third  largest  in  terms  of
     annual  sales,  surpassed only by drugs for treating central nervous system
     disorders  and  cardiovascular  disease.  (Description  of  Business  -
     N-chlorotaurine - Potential Market for N-chlorotaurine)

          Support  for  Claim  #7:  Nature  Biotechnology,  Vol.  21:1256,  Nov
          2003.

<PAGE>

     Claim  #8:  Anti-infectives  are  the  third  largest  segment  of  the
     pharmaceutical  industry,  with  annual  sales  totaling  $45  billion.
     (Description  of  Business  -  N-chlorotaurine  -  Potential  Market  for
     N-chlorotaurine)

          Support  for  Claim  #8:  Roehr,  Bob. Anti-infective Drug Development
          in  Decline. 43rd ICAAC. Presented Sept. 15, 2003, as reviewed by Gary
          D. Vogin, MD for Medscape Medical News.

     Claim  #9:  Of  the  $45  billion  in  the  anti-infectives markets, 62% is
     for antibacterials, 12% is for HIV, 6% is for other viral infections, 7% is
     for  antifungals,  and  13%  is  for  vaccines  and  immunology. The 4-year
     compounded  growth  rate  for  anti-infectives  is  strong at 10%. The best
     markets  for anti-infectives are the United States (48%), Europe (22%), and
     Japan  (13%).  (Description of Business - N-chlorotaurine- Potential Market
     for N-chlorotaurine)

          Support  for  Claim  #9:  Bartlett,  Bob  G.  43rd  ICAAC.  Presented
          Sept. 15, 2003.

     Claim  #10:  Broad-spectrum,  multi-indication  anti-infective  drugs
     generally  have  potential annual sales of $1 billion within three years of
     market  introduction. (Description of Business - N-chlorotaurine- Potential
     Market for N-chlorotaurine)

          Support  for  Claim  #10:  "Superbugs  & Superdrugs: A Strategic Guide
          to  the Global Antimicrobials Industry, Industries and Therapies," SMi
          Publishing Ltd. 2000, at page 130, "Superbugs".

     Claim  #11  :  Treatment  of  sinus  and ear infections are the most common
     reason  for  outpatient antibiotic prescriptions (Description of Business -
     N-chlorotaurine - Potential Market for N-chlorotaurine)

          Support  for  Claim  #11:  Consumer  Reports,  "Super-germ  alert,"
          January 2001, 60-61.

     Claim  #12:  conjunctivitis  (eye  infections  commonly  referred  to  as
     "pink  eye")  is  considered  the  most common reason for non-traumatic eye
     complaints.  (Description  of  Business - N-chlorotaurine- Potential Market
     for N-chlorotaurine)

          Support  for  Claim  #12:  American  Family  Physician,  "Should  We
          Prescribe  Antibiotics  for  Acute  Conjunctivitis,"  Vol.  66, No. 9,
          November 1, 2002.

<PAGE>

     Claim  #13:  The  Impact  of  N-chlorotaurine  on  the  Candida  virus.
     (Description  of  Business  - N-chlorotaurine - Research and Development of
     N-chlorotaurine)

          Support  for  Claim  #13:  Antimicrob  Agents  Chemother,  "Impact  of
          N-chlorotaurine  on  viability  and  production  of  secreted aspartyl
          proteinases of Candida spp." 2002; 46: 1996-9.

     Claim  #14:  Explanation  of  the  chemical  properties  of N-chlorotaurine
     and  how  it  is  a key compound in the human defense system to infections.
     (Description  of  Business  - N-chlorotaurine - Research and Development of
     N-chlorotaurine)

          Support  for  Claim  #14:  Arch  Pharm  (Weinheim),  "Chemical
          properties  of  N-chlorotaurine  sodium,  a  key compound in the human
          defence system," 2002; 335: 411-21.

     Claim  #15:  Comparison  of  N-chlorotaurine  with  another  treatment  -
     chloramine  T  -  for the treatment of infected leg ulcers. (Description of
     Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

          Support  for  Claim  #15:  Br  J  Dermatol, "Tolerability and efficacy
          of  N-chlorotaurine  compared to chloramine T for treatment of chronic
          leg ulcers with purulent coating," 2003; 149: 590-7.

     Claim  #16:  Study  of  influence  of  N-chlorotaurine  on  nasal  mucous.
     (Description  of  Business  -  N-chlorotaurine- Research and Development of
     N-chlorotaurine)

          Support  for  Claim  #16:  Am  J  Rhinol,  "In  vitro  study  on  the
          influence  of  N-chlorotaurine  on the ciliary beat frequency of nasal
          mucosa," 2003; 17: 149-52.

     Claim  #17:  Application  of  N-chlorotaurine  to  sinusitis complicated by
     immune  suppression.  (Description  of Business - N-chlorotaurine- Research
     and Development of N-chlorotaurine)

          Support  for  Claim  #17:  ORL  J  Otorhinolaryngol  Relat  Spec,
          "Refractory rhinosinusitis complicating immunosuppression: application
          of  N-chlorotaurine,  a  novel endogenous antiseptic agent," 2003; 65:
          303-5.

     Claim  #18:  Down-regulatory  effect  of  N-chlorotaurine.  (Description of
     Business - N-chlorotaurine- Research and Development of N-chlorotaurine)

          Support  for  Claim  #18:  Immunol  Lett,  "Down-regulatory  effect of
          N-chlorotaurine  on tryptophan degradation and neopterin production in
          human PBMC," 2004; 93: 143-9.

<PAGE>

     Claim  #19:  Tolerability  of  N-chlorotaurine  shown  in the middle ear of
     a  guinea  pig.  (Description  of  Business - N-chlorotaurine- Research and
     Development of N-chlorotaurine)

          Support  for  Claim  #19:  Ann  Otol Rhinol Laryngol, "Tolerability of
          N-chlorotaurine  in the guinea pig middle ear - a pilot study using an
          improved application system," 2004; 113: 76-81.

     Claim  #20:  Efficacy  and  tolerability  of  N-chlorotaurine  in  treating
     Otitis  Externa  ("swimmers  ear").  (Description  of  Business  -
     N-chlorotaurine- Research and Development of N-chlorotaurine)

          Support  for  Claim  #20:  Laryngoscope,  "Acute  Otitis  Externa:
          Efficacy  and  Tolerability  of  N-  Chlorotaurine, a Novel Endogenous
          Antiseptic Agent," 2004; 114: 850-4.

     Claim  #21:  Non-motor  symptoms,  such  as dementia occurs in at least 50%
     of the patients; depression is also very common. (Description of Business -
     Choloroquine Diphosphate).

          Support  for  Claim  #21:  "The  Columbia  Electronic  Encyclopedia,
          Sixth  Edition,"  Copyright  2003, Columbia University Press. Licensed
          from Columbia University Press. All rights reserved.

     Claim  #22:  The  Parkinson's  Disease  market  will  undergo  a relatively
     consistant  growth  pattern  over the next several years, growing from $1.9
     billion  in  2001  to over $2.4 billion in 2007. (Description of Business -
     Choloroquine Diphosphate - Potential Market for Chloroquine).

          Support  for  Claim  #22:  Marketresearch.com:  The  CNS  Outlook  to
          2007.

6.   We have revised the summary section of the Prospectus to include the
     general nature of the studies completed on both N-chlorotaurine and
     Chloroquine Diphosphate as you requested and that section now states:

               "All  of the research and development which has been completed on
          N-chlorotaurine  has been completed by the researchers in Austria. The
          researchers have completed studies on the impact of N-chlorotaurine on
          the  Candida  virus;  studies  on  the  chemical  properties  of
          N-chlorotaurine  and  how  it  is  a key compound in the human defense
          system to infections; research on N-chlorotaurine for the treatment of
          infected  leg  ulcers;  a study of the influence of N-chlorotaurine on
          nasal  mucous;  the  application  of  N-chlorotaurine  to combat sinus
          infections  complicated  by  immune  suppression;  the tolerability of
          N-chlorotaurine  in  the  middle ear of a guinea pig; and efficacy and
          tolerability of N-chlorotaurine in treating swimmers ear.

<PAGE>

               All  of  the  research and development on Chloroquine Diphosphate
          has been conducted by Alpha Research Group, LLC. Alpha Research Group,
          LLC  has  conducted  a ten (10) patient clinical study using less than
          one  half  of the conventional malarial treatment dose of commercially
          available  Chloroquine  Diphosphate  in a time-released formula with a
          brain targeting agent. Data from this study showed that Alpha Research
          Group, LLC's novel Chloroquine Diphosphate formulation alleviated both
          Parkinson's  Disease  motor  symptoms  in  patients  diagnosed  with
          Parkinson's Disease, as well as the manifestation of involuntary jerky
          motions  in  patients  and  was  generally  well  tolerated even after
          several months of continual use."

7.   We  understand  that  our  previous  comment  letter  was  not confidential
     and  we have revised our disclosures regarding the status of the studies we
     have conducted as described in question 6, above.

8.   We  have  revised  the  Summary  of  the  prospectus as you have requested,
     and  have eliminated references to "Phase 2b" or "Phase 2a" "pilot studies"
     throughout  the  Prospectus  so  as  not  to  be  related  to  the official
     characterizations  used  by the FDA. Additionally, the adjective "pilot" in
     reference  to  clinical studies has been replaced throughout the prospectus
     with the adjective "small-scale."

9.   We  have  revised  the  last  paragraph  on page 5 of the prospectus as you
     have  requested,  and  stated  that "To date, neither product candidate has
     completed  the  pre-clinical  d