SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Comment Letter for Propanc Biopharma, Inc. (PPCB) (CIK 0001517681) (PPCB) — Oct 13, 2011

Propanc Biopharma, Inc. (PPCB) (CIK 0001517681)
Date: Oct. 13, 2011 · CIK: 0001517681 · Accession: 0000000000-11-060362

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

File numbers found in text: 333-175092

Date
October 13, 2011
Author
Not clearly detected
Form
UPLOAD
Company
Propanc Biopharma, Inc. (PPCB) (CIK 0001517681)

Letter

October 13, 2011 Via E-mail Mr. James Nathanielsz Chief Executive Officer Propanc Health Group Corporation 576 Swan Street Richmond, VIC, 3121, Australia Re: Propanc Health Group Corporation Registration Statement on Form S-1 Amendment no. 2 filed September 30, 2011 File No. 333-175092

Dear Mr. Nathanielsz:

We have reviewed your amendment filed September 30, 2011 and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please note that references to our prior comments pertain to our correspondence dated July19, 2011. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your re gistration statement and the information you provide in response to these comments, we may have additional comments. Form S-1

General

1. Please confirm that the secondary offering is limited to a 90 day period beginning upon effectiveness of the registration statement. Cover Page

2. Please expand the discussion to describe the existence a nd terms of the concurrent secondary offering.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 2

Prospectus Summary, page 2

3. Please expand the summary to include a brief description of the pl an of distribution.

4. Since the primary offering is a self-underwri tten offering conducted by your officers and directors who are also selling sh areholders in the secondary o ffering, please explain in the summary how potential investors will know wh ether the proceeds of their purchases will be directed to the company or a selling shareholder.

5. We note your response to comment 5 and reissue the comment in part. Please state in the summary whether there are any minimum purchase requirements, e.g. 100 shares.

6. Please file the escrow agreement as an exhi bit. In addition, the plan of distribution discussion in the summary should include the following information:  Whether shareholders will receive interest if their funds are re turned because the minimum is not reached;  How soon they would receive those f unds following the termination of the offering; and  With whom the funds for the shares would be escrowed. Risk Factors

General

7. The first risk factor on page 5 and the sec ond risk factor on page 6 are overlapping and duplicative. Please combine these risk f actors under one risk factor subheading.

8. Please include a separate and appropriately title d risk factor explaini ng that shareholders who purchase shares in the secondary offeri ng will not be assured that any additional proceeds will be received by the company from the primary offering as the offerings are occurring simultaneously and the minimum leve l of sales to break escrow in the public offering might not be reached. “Because pre-clinical and clini cal trials required for our product candidates…,” page 7

9. We note your response to comment 14 and th e reference to pre-clinical studies you conducted. Please expand the discussion to st ate when you conducted these pre-clinical studies and how these studies may differ from the “formal preclini cal studies” required for regulatory approval. Use of Proceeds, page 13

10. We note your response to comment 17 and your current financial condition. We also note the disclosure under “Use of Proceeds” on page 2. Please expand the discussion to

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 3

indicate the approximate amount of net proceeds from the minimum offering. In addition, with respect to each level of monies raised, please indicat e the dollar amount of proceeds you intend to allocate to clinical trials, research and development, expansion of business, and general working capital, respectively. In this regard, we also note the presentation in Table 2 and the $1.8 million allocated to “overhead.”

11. Please explain what you mean by the term “e xpansion of business.” If you have an agreement or understanding for a particular tr ansaction, please describe the terms of such agreement. 12. Please expand the discussion to clarify, if applicable, the extent to which offering proceeds may be used to repay existing liabilities. Market for Common Stock, page 12

13. We note your response to comment 20 and re issue the comment. Please expand the discussion to describe the criter ia that must be satisfied fo r acceptance of an application for quotation on the OTC Bulletin Board. Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page

14. We note your response to comment 23 and reis sue the comment in part. Please provide an analysis as to why an order placed by the Dove Clinic, of which Dr. Kenyon was the Medical Director, to an enti ty apparently formed by Dr. Kenyon to fulfill the order, is considered to be a bona fide unsolicited orde r. Please expand the discussion and consider the inclusion of an additional ri sk factor to address the signi ficance, if any, of your supply of unlicensed medicine to treat patients at the Dove Clinic, including potential legal and liability ramifications, if any, in the event the transaction is not considered to be in compliance with the provisions of Sche dule I of the Medicines for Human Use Regulations.

15. We note your response to comment 24 and reis sue the comment in part. Please provide the dates corresponding to the information provide d in your response. In this regard, we note the Australian predecessor to your co mpany was incorporated in October 2007 and the discussion on page 31 indicates Dr. Kenyon was the founder of the Australian predecessor. 16. We note your response to comment 24 states th e company did not sell directly to the Dove Clinic because the company was not fo rmed until after supply of the medicine was undertaken by the Dove Clinic. Please te ll us when and how, specifically, the Dove Clinic acquired a supply of the medicine prior to the formation of the company. In view of the Limited Distributor Deed, it appears ENP Limited acquired the medicine from the company. Please file the Limited Distributor Deed as an exhibit.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 4

Liquidity and Capital Resources, page 17

17. Please file the August 3, 2010 and September 16, 2010 agreements with Churchill & Associates as exhibits. In addition, please file the June 6, 2011 termination agreement as an exhibit. Related Party Transactions, page 18

18. Please identify by name the individuals to w hom you are referring in this discussion. Business

Overview, page 19

19. We note your response to comment 27 and re issue the comment. As previously requested, the overview presentation should temper your positive conclusions with the fact that substantial additional testing w ill be required. The discussion should be expanded to disclose the types of additional tests you will need to conduct and that early results obtained may not be replicated in late r and larger trials. In addition, your positive conclusions should be modified by either expressing them as a hope that additional testing will confirm any of th e positive results you describe or, alternatively, delete the conclusions.

20. We note your reference to the unpublished re trospective study and review, and the absence of significant data for most of the pa tients receiving treatment . In view of the limitations of the study, please eliminate re ferences to the study and its purported statistical results throughout the prospectus. Instead, pleas e revise the discussion to provide disclosure to the effect that a version of the proposed drug was previously administered to 46 patients and the data for the results of such treatment is incomplete or unavailable for most of the part icipants. In addition, if true, the disclosure may state that although the 2007 review of patient outcomes ha s limited, if any, recognized scientific value because it was not a controlled scien tific study, management believes that since some of the participants lived marginally longer than antici pated by attending clinicians, further research should be conducted to dete rmine whether the perceived increase in life expectancy or survival can be at tributed to the proposed product.

21. Please expand the discussion to state the dates you applied for and subsequently received approval from the UK and Australian author ities to treat pati ents with the novel suppository formulation of proenzymes and the form in which such approval was provided, e.g. written approval subs equent to a written request.

22. Please expand the discussion to state when th e special suppository was manufactured and by whom. In addition, please state when the suppository formulation was developed by Drs. Kenyon and Mitchell.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 5

23. We note the discussion of milestones on pa ge 20. Please expand the discussion to describe the pharmacological data that was pr esented to the MHRA in 2008. In addition, please discuss the 28 day multiple ascending dose study and the results of this study. Propanc’s Technology, page 20

24. We note the reference to laboratory research at the Universities of Bath and Granada. Please clarify whether this university research supports each of the bulleted points at the top of page 21concerning PRP. We may have additional comments. PRP-DCM, page 21

25. We note the reference to the international pate nt application filed in late 2010. Please state whether you have the sole beneficial interest in this patent application.

26. We note your comparison with Nexavar and “encouraging results” from your animal research. Please expand the discussion to also describe how your proposed product differs from Nexavar, the negative results of your animal testing, the amount of time required for regulatory approval of Nexavar, ma terial differences in your current ability to obtain regulatory approval and that of the developers of Nexavar at the time of approval of Nexavar, and appropriate warni ng language that there is no assurance your proposed product will receive re gulatory approval. In the al ternative, please delete the paragraph favorably comparing your research and proposed product to that of Nexavar and other researchers. 27. Please file the University of Granada and vivoPharm agreements as exhibits or provide an analysis as to why these agreements ar e not required to be f iled pursuant to Item 601(b)(10) of Regulation S-K. POPI, page 21

28. Please file the University of Granada agreement as an exhibit or provide an analysis as to why this agreement is not requ ired to be filed pursuant to Item 601(b)(10) of Regulation S-K. The PRP Formulation, page 22

29. Please clarify whether the oral enzymes you de scribe have received regulatory approval for administration to humans. In additi on, please provide the brand name of these approve products.

30. Please expand the discussion to state when the PRP product was patented and by whom.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 6

31. Please expand the discussion to identify the “r ecent scientific evidence” pertaining to rectally administered proenzyme formulati on and identify who conducted this research. Target Indications, page 22

32. We note the reference to “the larger scale clinical trials” at the top of page 23. Please expand the discussion to clarify whether you are referring to trials curr ently in progress or trials you plan to initiate. In addition, pleas e indicate when these tr ials started or when you anticipate them to begin and the estimated time required to complete these trials. 33. The aforementioned reference to “larger scal e clinical trials” may imply that you have already conducted smaller clinical trials. Please advise or revise the discussion accordingly. Development Strategy, page 23

34. We note your reference to completion of a “pr oof of concept” clinical trial. Please expand the discussion to clarify whether you are referring to the completion of Phase 1, 2, and 3 clinical trials as described under “Curre nt Operations” on page 25.

Anticipated Timelines, page 24

35. We note your development strategy is to develop the proposed product through the “proof of concept” clinical trial prior to seeking a licensee. Your timeline chart, however, does not include a proj ected timeframe for a “proof of concept” clinical trial nor is such trial described in the discussion. Please expand the discussion accordingly.

36. Please expand the discussion to correlate th e timeline chart and discussion with the expenditure information presented in Table 2. In this regard we note, for example, that $1.8 million is allocated for overhead, however no information is provided concerning the period of time for which these expenditures will be incurred. Corporate Strategy, page 25

37. Please expand your definition of what you mean by the term “virtual company” to specify what, if any, activities are actually conducted by your employ ees. For example, is your research conducted by third parties? Key Highlights, page 25

38. Please provide support for the statement that the treatment is new and that it will “uniquely target many aggressive tumor types. ” In this regard, we note the discussion under “Company History” and “The PRP Formulation.”

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 7

Multiple mechanisms of action

39. Please reconcile the statements in this bullete d point with the statements under “The PRP Mechanism of Action” that the mechanism of proenzymes is not fully known or understood. Encouraging data from patient treatment

40. Please expand the discussion elsewhere in the pr ospectus to describe the research in the past 15 years and the clinical experience in UK and Australia that “provided persuasive evidence that PRP is an effective treatment against cancer.” In addition, please tell us whether this “persuasive evidence” is suffi cient to support regulatory approval of your proposed product for public use and sale. If not, please tell us why this “evidence” is not sufficient. Unique intellectual property

41. Please provide support for the statement that your intellectual property is unique. In this regard we note that you do not have pa tents on the proposed products, the use of proenzymes does not appear to be unique, nor does the use of injection or suppositories for the administration of medical treatment appear to be unique. Limitations of Current Therapies, page 26

42. We note your response to comment 51 and the absence of support for your beliefs concerning the advantages of your proposed pr oduct. Please expand the discussion to balance the presentation to include discussion of:  Your early stage of development;  Absence of regulatory approval for your product;  Absence of clinical trial history for your product; and  The absence of a treatment study of your proposed product with significant probative value. Market Opportunity, page 26

43. We note your response to comment 53 and the deletion of informati on with respect to oncology drug sales in 2009. However, you conti nue to present aggregate drug sale data and have not provided information with re spect to the portion of the oncology market attributed to each of the specific types of products you intend to provide. If you do not intend to serve the global market and rather just service the colorectal and pancreatic solid tumor market initially, the discussion of your anticipa ted market should be revised accordingly. Since you apparently intend to eventua

Show Raw Text
October 13, 2011
Via E-mail
 Mr. James Nathanielsz Chief Executive Officer Propanc Health Group Corporation 576 Swan Street Richmond, VIC, 3121, Australia
Re: Propanc Health Group Corporation
Registration Statement on Form S-1 Amendment no. 2 filed September 30, 2011
  File No. 333-175092

Dear Mr. Nathanielsz:

We have reviewed your amendment filed September 30, 2011 and have the following
comments.  In some of our comments, we may ask you to provide us with information so we may better understand your disclosure.  Please note that references to our prior comments pertain
to our correspondence dated July19, 2011.
 Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe  our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your re gistration statement and the information you
provide in response to these comments, we may have additional comments.
 Form S-1

 General

1. Please confirm that the secondary offering is limited to a 90 day period beginning upon
effectiveness of the registration statement.
 Cover Page

2. Please expand the discussion to  describe the existence a nd terms of the concurrent
secondary offering.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 2

 Prospectus Summary, page 2

3. Please expand the summary to include a brief description of the pl an of distribution.

4. Since the primary offering is a self-underwri tten offering conducted by your officers and
directors who are also selling sh areholders in the secondary o ffering, please explain in the
summary how potential investors will know wh ether the proceeds of their purchases will
be directed to the company or a selling shareholder.

5. We note your response to comment 5 and reissue the comment in part.  Please state in the
summary whether there are any minimum purchase requirements, e.g. 100 shares.

6. Please file the escrow agreement as an exhi bit.  In addition, the plan of distribution
discussion in the summary should include the following information:
 Whether shareholders will receive interest if their funds are re turned because the
minimum is not reached;
 How soon they would receive those f unds following the termination of the
offering; and
 With whom the funds for the shares would be escrowed.
 Risk Factors

 General

7. The first risk factor on page 5 and the sec ond risk factor on page 6 are overlapping and
duplicative.  Please combine these risk f actors under one risk factor subheading.

8. Please include a separate and appropriately title d risk factor explaini ng that shareholders
who purchase shares in the secondary offeri ng will not be assured that any additional
proceeds will be received by the company from the primary offering as the offerings are occurring simultaneously and the minimum leve l of sales to break escrow in the public
offering might not be reached.
 “Because pre-clinical and clini cal trials required for our product candidates…,” page 7

9. We note your response to comment 14 and th e reference to pre-clinical studies you
conducted.  Please expand the discussion to st ate when you conducted these pre-clinical
studies and how these studies may differ from  the “formal preclini cal studies” required
for regulatory approval.
 Use of Proceeds, page 13

10. We note your response to comment 17 and your current financial condition.  We also
note the disclosure under “Use of Proceeds” on page 2.  Please expand the discussion to

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 3

 indicate the approximate amount of net proceeds from the minimum offering.  In
addition, with respect to each level of monies  raised, please indicat e the dollar amount of
proceeds you intend to allocate to clinical trials, research and development, expansion of
business, and general working capital, respectively.  In this  regard, we also note the
presentation in Table 2 and the $1.8 million allocated to “overhead.”

11. Please explain what you mean by the term “e xpansion of business.”  If you have an
agreement or understanding for a particular tr ansaction, please describe the terms of such
agreement.
12. Please expand the discussion to clarify, if applicable, the extent to which offering
proceeds may be used to repay existing liabilities.
 Market for Common Stock, page 12

13. We note your response to comment 20 and re issue the comment.  Please expand the
discussion to describe the criter ia that must be satisfied fo r acceptance of an application
for quotation on the OTC Bulletin Board.
 Management’s Discussion and Analysis of Financ ial Condition and Results of Operations, page
15

14. We note your response to comment 23 and reis sue the comment in part.  Please provide
an analysis as to why an order placed by the Dove Clinic, of which Dr. Kenyon was the
Medical Director, to an enti ty apparently formed by Dr. Kenyon to fulfill the order, is
considered to be a bona fide unsolicited orde r.  Please expand the discussion and consider
the inclusion of an additional ri sk factor to address the signi ficance, if any, of your supply
of unlicensed medicine to treat patients at the Dove Clinic, including potential legal and
liability ramifications, if any, in the event the transaction is  not considered to be in
compliance with the provisions of Sche dule I of the Medicines for Human Use
Regulations.

15. We note your response to comment 24 and reis sue the comment in part.  Please provide
the dates corresponding to the information provide d in your response.  In this regard, we
note the Australian predecessor to your co mpany was incorporated in October 2007 and
the discussion on page 31 indicates Dr. Kenyon was  the founder of the Australian
predecessor.
16. We note your response to comment 24 states th e company did not sell directly to the
Dove Clinic because the company was not fo rmed until after supply of the medicine was
undertaken by the Dove Clinic.  Please te ll us when and how, specifically, the Dove
Clinic acquired a supply of the medicine prior to the formation of the company.  In view
of the Limited Distributor Deed, it appears ENP Limited acquired the medicine from the
company.  Please file the Limited Distributor Deed as an exhibit.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 4

Liquidity and Capital Resources, page 17

17. Please file the August 3, 2010 and September 16, 2010 agreements with Churchill &
Associates as exhibits.  In addition, please file the June 6, 2011 termination agreement as
an exhibit.
 Related Party Transactions, page 18

18. Please identify by name the individuals to w hom you are referring in this discussion.
 Business

Overview, page 19

19. We note your response to comment 27 and re issue the comment.  As previously
requested, the overview presentation should temper your positive conclusions with the fact that substantial additional testing w ill be required.  The discussion should be
expanded to disclose the types of additional tests you will need to conduct and that early
results obtained may not be replicated in late r and larger trials.  In addition, your positive
conclusions should be modified by either expressing them as a hope that additional
testing will confirm any of th e positive results you describe or, alternatively, delete the
conclusions.

20. We note your reference to the unpublished re trospective study and review, and the
absence of significant data for most of the pa tients receiving treatment .  In view of the
limitations of the study, please eliminate re ferences to the study and its purported
statistical results throughout the prospectus.  Instead, pleas e revise the discussion to
provide disclosure to the effect that a version of the proposed drug was previously
administered to 46 patients and the data for the results of such treatment is incomplete or unavailable for most of the part icipants.  In addition, if true, the disclosure may state that
although the 2007 review of patient outcomes ha s limited, if any, recognized scientific
value because it was not a controlled scien tific study, management believes that since
some of the participants lived  marginally longer than antici pated by attending clinicians,
further research should be conducted to dete rmine whether the perceived increase in life
expectancy or survival can be at tributed to the proposed product.

21. Please expand the discussion to state the dates you applied for and subsequently received
approval from the UK and Australian author ities to treat pati ents with the novel
suppository formulation of proenzymes and the form in which such approval was
provided, e.g. written approval subs equent to a written request.

22. Please expand the discussion to state when th e special suppository was manufactured and
by whom.  In addition, please state when the suppository formulation was developed by
Drs. Kenyon and Mitchell.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 5

 23. We note the discussion of milestones on pa ge 20.  Please expand the discussion to
describe the pharmacological data that was pr esented to the MHRA in 2008.  In addition,
please discuss the 28 day multiple ascending dose study and the results of this study.
Propanc’s Technology, page 20

24. We note the reference to laboratory research at  the Universities of Bath and Granada.
Please clarify whether this university research  supports each of the bulleted points at the
top of page 21concerning PRP.  We may have additional comments.
 PRP-DCM, page 21

25. We note the reference to the international pate nt application filed in  late 2010.  Please
state whether you have the sole beneficial  interest in this patent application.

26. We note your comparison with Nexavar and “encouraging results” from your animal
research.  Please expand the discussion to also describe how your proposed product
differs from Nexavar, the negative results of your animal testing, the amount of time
required for regulatory approval of Nexavar, ma terial differences in  your current ability
to obtain regulatory approval and that of the developers of Nexavar at the time of
approval of Nexavar, and appropriate warni ng language that there is no assurance your
proposed product will receive re gulatory approval.  In the al ternative, please delete the
paragraph favorably comparing your research  and proposed product to that of Nexavar
and other researchers.
27. Please file the University of Granada and vivoPharm agreements as exhibits or provide
an analysis as to why these agreements ar e not required to be f iled pursuant to Item
601(b)(10) of Regulation S-K.
POPI, page 21

28. Please file the University of Granada agreement as an exhibit or provide  an analysis as to
why this agreement is not requ ired to be filed pursuant to Item 601(b)(10) of Regulation
S-K.
 The PRP Formulation, page 22

29. Please clarify whether the oral enzymes you de scribe have received regulatory approval
for administration to humans.  In additi on, please provide the brand name of these
approve products.

30. Please expand the discussion to state when the PRP product was patented and by whom.

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 6

 31. Please expand the discussion to identify the “r ecent scientific evidence” pertaining to
rectally administered proenzyme formulati on and identify who conducted this research.
 Target Indications, page 22

32. We note the reference to “the larger scale clinical trials” at the top of page 23.  Please
expand the discussion to clarify whether you are referring to trials curr ently in progress or
trials you plan to initiate.  In addition, pleas e indicate when these tr ials started or when
you anticipate them to begin and the estimated  time required to complete these trials.
 33. The aforementioned reference to “larger scal e clinical trials” may imply that you have
already conducted smaller clinical trials.  Please advise or revise the discussion
accordingly.
Development Strategy, page 23

34. We note your reference  to completion of a “pr oof of concept” clinical trial.  Please
expand the discussion to clarify whether you are referring to the completion of Phase 1,
2, and 3 clinical trials as described under “Curre nt Operations” on page 25.

Anticipated Timelines, page 24

35. We note your development strategy is to  develop the proposed product through the
“proof of concept” clinical trial prior to  seeking a licensee.  Your timeline chart,
however, does not include a proj ected timeframe for a “proof of concept” clinical trial
nor is such trial described in the discussion.  Please expand the discussion accordingly.

36. Please expand the discussion to correlate th e timeline chart and discussion with the
expenditure information presented in Table 2.  In this regard we note, for example, that
$1.8 million is allocated for overhead, however no information is provided concerning the period of time for which these expenditures will be incurred.
Corporate Strategy, page 25

37. Please expand your definition of what you mean by the term “virtual company” to specify
what, if any, activities are actually conducted by your employ ees.  For example, is your
research conducted by third parties?
 Key Highlights, page 25

 38. Please provide support for the statement that the treatment is new and that it will
“uniquely target many aggressive tumor types. ” In this regard, we note the discussion
under “Company History” and “The PRP Formulation.”

Mr. James Nathanielsz Propanc Health Group Corporation October 13, 2011 Page 7

 Multiple mechanisms of action

39. Please reconcile the statements in this bullete d point with the statements under “The PRP
Mechanism of Action” that the mechanism of proenzymes is not fully known or understood.
 Encouraging data from patient treatment

40. Please expand the discussion elsewhere in the pr ospectus to describe the research in the
past 15 years and the clinical experience in UK and Australia that “provided persuasive
evidence that PRP is an effective treatment against cancer.”  In addition, please tell us
whether this “persuasive evidence” is suffi cient to support regulatory approval of your
proposed product for public use and sale.  If not, please tell us why this “evidence” is not
sufficient.
 Unique intellectual property

41. Please provide support for the statement that your  intellectual property is unique.  In this
regard we note that you do not have pa tents on the proposed products, the use of
proenzymes does not appear to be unique, nor  does the use of injection or suppositories
for the administration of medical treatment appear to be unique.
 Limitations of Current Therapies, page 26

42. We note your response to comment 51 and the absence of support for your beliefs
concerning the advantages of your proposed pr oduct.  Please expand the discussion to
balance the presentation to include discussion of:
 Your early stage of development;
 Absence of regulatory approval for your product;
 Absence of clinical trial history for your product; and
 The absence of a treatment study of your proposed product with significant
probative value.
 Market Opportunity, page 26

43. We note your response to comment 53 and the deletion of informati on with respect to
oncology drug sales in 2009.  However, you conti nue to present aggregate drug sale data
and have not provided information with re spect to the portion of the oncology market
attributed to each of the specific types of  products you intend to provide.  If you do not
intend to serve the global market and rather just service the colorectal and pancreatic
solid tumor market initially, the discussion of your anticipa ted market should be revised
accordingly.  Since you apparently intend to eventua