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SEC Comment Letter for Citius Pharmaceuticals, Inc. (CTXR) (CIK 0001506251) (CTXR) — Oct 9, 2015

Citius Pharmaceuticals, Inc. (CTXR) (CIK 0001506251)
Date: Oct. 9, 2015 · CIK: 0001506251 · Accession: 0000000000-15-049244

AI Filing Summary & Sentiment

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Confidence
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Date
October 8, 2015
Author
Not clearly detected
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UPLOAD
Company
Citius Pharmaceuticals, Inc. (CTXR) (CIK 0001506251)

Letter

Mail Stop 3561 October 8, 2015 Leonard Mazur Chief Executive Officer Citius Pharmaceuticals, Inc. 63 Great Road Maynard, MA 01754

Re: Citius Pharmaceuticals, Inc. Registration Statement on Form S -1 Filed September 11, 2015 File No. 333 -206903

Dear Mr. Mazur :

We have reviewed your registration statement 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 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 appropr iate, please tell us why in your response.

After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments.

General

1. We note you received a letter from the FDA on June 9 , 2014 regarding the omission of risk information and unsubstantiated efficacy claims related to Suprenza. Please disclose your plan for addressing the violations listed in the letter and the risks associated with such viol ations. Alternatively, please tell us why you believe such disclosure is not necessary.

Prospectus Cover Page

2. We note that yo u are registering the resale of common stock issuable upon the e xercise of the Placement Agent w arrants which are issuable upon the exercise of the Placement

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 2

Agent Unit Warrants. Please tell us whether the Placement Agent Unit Warrants have been exercised. To the extent that they have not, please provide your analysis as to why you believe it is appropria te to register the resale of shares o f common stock that underlie the Placement Agent warrants, which underlie Placement Agent Unit Warrants that remained outstanding at the time the registration statement was filed.

Prospectus Summary, page 1

3. Please revise your prospectus summary section to provide a n overview of your current business and the key aspects of the offering, including :

 a brief summary of the products you develop and your business goals,  the amount of capital necessary to reach such business goals,  your accum ulated deficit and capital working deficit and the fact that your auditors have issued a going concern audit opinion ,  the number of employees you have,  the material terms of your agreements with Prenzamax, LLC and Alpex Pharma S.A., and  a brief description of the potential conflict of interest your sole officer and director may have due to your agreement with Prenzamax.

4. Please expand to disclose that you have not received any revenues or other payments to date under your agreements with P renzamax or Alpex , notwithstanding that beginning in May 2012 Prenzamax generated revenues from sales of Suprenza, your first commercial product . Please disclose the conditions that must be met before you receive any revenues or payments under these agree ments.

5. We note your statement on page 37 that “We have been unable to obtain sufficient funding to conduct additional development activities on Suprenza. Because of our limited resources we have decided to focus on the development of the hemorrhoid produc t first.” Please disclose this information in the Overview section , as well as in the risk factor on page 7 where you state that “we may not be able to commercialize the next generation of Suprenza products .”

Risk Factors, page 6

Our auditors have issu ed a “going concern” audit opinion, page 6

6. We note your statement on page 31 that you expect that you will have sufficient funds to continue your operations for the next six months. Please clarify here and in the Liquidity and Capital Resources section whether you will have sufficient funds to continue your operations for the next twelve months.

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 3

Risks Related to Our Common Stock, Liquidity Risks and Reverse Acquisition, page 19

We are subject to extensive and costly government regulation, page 14

7. We note your disclosure that you may be required to conduct costly, post -marketing surveillance and/or be required to conduct ongoing post -marketing studies. Please clarify that you have committed to post -marketing studies of Suprenza.

Compliance with the r eporting requirements, page 19

8. We note your disclosure on page 19 that “The Company is not subject to the filing requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934 but files certain reports with the Securities and Exchange Commissi on on a voluntary basis .” Please note that you will be subject to filing obligations pursuant to Section 15(d) of the Exchan ge Act following the effective date of this registration statement, and revise your disclosure accordingly .

You may experience dilution of your ownership interests, page 20

9. We note your disclosure on page 20 that you r common stock is currently quoted on the OTC Markets and the OTCQB. Please clarify that the OTC Market s and OTCQB are not two separate quotation systems , and that t he OTCQB is one of the marketplace categories within the OTC Markets .

There is not an active liquid trading market for the Company’s common stock , page 21

10. Please disclose the trading volume of your common stock within the last six months.

Use of Proceed s, page 23

11. We note your disclosure that the warrants are exercisable at $0.60 per share and that the Placement Agent Unit Warrants are exercisable on a cash or cashless basis with respect to 680,013 warrants. Please disclose the amount of proceeds you wi ll earn upon the exercise of the warrants assuming all the warrants held by the investors and the placement agent are exercised on a cash basis, and disclose the amount of proceeds you will earn upon the exercise of all the warrants assuming that the warra nts that may be exercised on a cashless basis are exercised on such basis. In addition, in an appropriate section of your prospectus, please describe the material terms of the warrants and Placement Agent Unit Warrants.

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 4

Business, page 34

12. We note your disclosure on page 26 that you are actively seeking to raise additional capital in order to fund your research and development efforts. Please provide a brief description of such activities.

Our Marketed Product and New Product Candidates, page 36

13. We note your disclosure that your Hydrocortisone -Lidocaine Cream is “phase 2 ready.” Please describe the steps remaining to achieve FDA approval as well as the estimated cost of accomplishing such steps and the estimated timeline for accomplishing such st eps.

Terms of the license, page 37

14. We note your disclosure on page 37 that, pursuant to the Sublicense Agreement with Prenzamax, Akrimax prepares estimates of costs incurred in selling Suprenza, which costs are used to calculate the Product EBITDA , and your disclosure on page 25 that under the Sublicense Agreement you are entitled both to a percentage of the Product EBITDA and to reimbursement for certain development costs once Prenzamax has “achieved profitability.” Please expand your discussion o f the license to explain how Prenzamax determines whether it has achieved pro fitability .

15. Please disclose here the percentage of Product EBITDA you r eceive pursuant to the Sublicense A greement , the percentage of such payments you are required to pay Alpex pursu ant to the Alpex Agreement, the percentage of the development cost repayments you receive from Prenzamax that you are required to pay Alpex pursuant to the Alpex Agreement and the percentage of the Alpex Reven ue receive d from Alpex that you are required to pay to Prenzamax. In addition, please disclose here, if true, that Akrimax determines the price it charges for Suprenza.

Phentermine – Recent U.S. Prescription Data and Market Opportunity, page 39

16. We note your use of CAGRs in the first parag raph on page 39. Please provide updated information, as you include a five -year period ending in 2011. Because your market opportunity appears to rely upon projected growth in these measures in the future, please revise here to show the actual growth of such measures for the years represented.

Suprenza Brand Phentermine – Orally Disintegrating Tablets for Obesity, page 40

17. Please briefly describe the “patient -friendly features.”

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 5

Suprenza ODT Post -Marketing Studies, page 40

18. We note your disclosure on page 40 regarding the post -marketing studies of Suprenza ODT. Please disclose the cost and timing of such studies , including the drug utilization study, and how you intend to pay for such studies, including the effect of failing to conduct the studies in the required time frame or at all . In addition, please balance your disclosure regarding the advantage that such studies could yield by disclosing the potential negative effects of such studies depending on the results. In addition, please address the r isks attendant to such studies in your Risk Factors section or tell us why you believe this is not necessary.

Treatments for Hemorrhoids, page 40

19. We note your disclosure regarding OTC hemorrhoid medications and prescription strength hemorrhoid medication s. Please tell us the basis for your statement that “[n]one of these products have undergone clinical trials or have been submitted to or approved by the FDA on the basis of safety and efficacy.” In addition, please tell us the basis for statement on pag e 41 that “[t]here are almost no sales, marketing or promotions efforts on behalf of these products.”

Sources and Availability of Raw Materials and Clinical Supplies, page 43

20. We note your disclosure on page 43 th at you have a sole supplier for phentermin e hydrochloride . Please disclose the name of the supplier , discuss the risks associated with having a sole supplier in your Risk F actors section and tell us whether you are required to file any agreements with this supplier .

Suprenza Intellectual Property, page 44

21. We note your disclosure on page 44 that you have a pending patent titled ‘Solid Dosage formulations containing weight -loss drugs.” Please clarify whether any of the intellectual property discussed in this section, includin g the pending patent , is intellectual property that you license from Alpex or your own. To the extent that you develop any intellectual property with respect to Suprenza, clarify whether you or Alpex will own such intellectual property.

Clinical Trials, page 45

Section 505(b)(2) New Drug Applications, page 45

22. Please expand your description regarding the FDA’s 505(b)(2) new drug application pathway so that investors understand the steps necessary to achieve FDA approval using this process and the estimat ed amount of time and cost it takes to accomplish each step.

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 6

For example, clarify whether you must conduct Phase 1 clinical trials when using the 505(b)(2) new drug application pathway.

Additional Government Regulations, page 46

23. We note that you state t hat you are subject to foreign regulatory agencies and that your contract manufacturer is in a foreign jurisdiction. Please disclose the foreign regulations to which you are subject.

Management, page 48

Directors and Executive Officers of the Registrant, page 48

24. We note your disclosure on page 48 that “[i]t is anticipated that an additional individual, designated by the Placement Agents, will serve on [your] Board of Directors. Please disclose the agreement you have with such Placement Agent s, describe the material terms of the agreement, identify the Placement Agents and file the agreement with the next amendment of your registration statement.

25. Please disclose here and in your prospectus summary section the conflict of interest Mr. Mazur may have with your company due to his position at Akrimax. In addition, please tell us the basis for your statement that Triax is one of the top ten dermatological pharmaceutical companies in the U.S.

Transactions with Related Persons, Promoters and Certa in Control Persons, page 52

26. We note your disclosure that Citius’ headquarters are located in the office space of Ischemix, LLC, a company majority -owned by Dr. Geoffrey Clark and Dr. Reinier Beeuwkes. Given that Drs. Clark and Beeuwkes have resigned as both officers and directors effective September 12, 2014, please clarify whether you have an arrangement to continue to have your h eadquarters located in the office space of Ischemix, LLC.

27. We note your disclosure on page F -29 that for the nine months ended June 30, 2015 you paid $36,000 to a consultant who is a stockholder of the Company. Please provide us with an analysis as to whether this arrangement is required to be disclosed in this section and whether any related agreements are required to be filed as exhibits.

Selling Shareholders, page 56

28. Please disclose the natural persons that have voting and investment power of the securities held by The Entrust Group Inc. on page 56.

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 7

Exhibits, page II -4

29. Please file your agreements with Alpex , Prenzamax and IGI Laboratories, Inc .

Signatures, page II -7

30. Please have Mr. Mazur sign as your principal financial officer in his capacity as such in the second part of your signature page and have your controller or principal accounting officer or persons performing similar functions sign in their capacities as such.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement, please provid e a written statement from the company acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date o f the registration statement.

Leonard Mazur Citius Pharmaceuticals, Inc. October 8, 2015 Page 8

You may contact Amy Geddes at (202) 551 -3304 or Melissa Raminpour at (202) 551 - 3379 if you have questions regarding comments on the financial statements and related matters. Please contact Sonia Bednarowski at (202) 551 -

Show Raw Text
Mail Stop 3561
October 8, 2015

Leonard Mazur
Chief Executive Officer
Citius Pharmaceuticals, Inc.
63 Great Road
Maynard, MA 01754

Re: Citius Pharmaceuticals, Inc.
Registration Statement on Form S -1
Filed September 11, 2015
  File No. 333 -206903

Dear Mr. Mazur :

We have reviewed your registration statement 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 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 appropr iate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.

General

1. We note you received  a letter from the FDA on June 9 , 2014 regarding the omission of
risk information and unsubstantiated efficacy claims related to Suprenza.  Please disclose
your plan for addressing the violations listed in the letter and the risks associated with
such viol ations.  Alternatively, please tell us why you believe such disclosure is not
necessary.

Prospectus Cover Page

2. We note that yo u are registering the resale  of common stock issuable upon the e xercise of
the Placement Agent w arrants which are issuable upon the exercise of the Placement

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 2

 Agent Unit Warrants.  Please tell us whether the Placement Agent Unit Warrants have
been exercised.  To the extent that they have not, please provide your analysis as to why
you believe it is appropria te to register the resale  of shares o f common stock that underlie
the Placement  Agent warrants, which underlie  Placement Agent Unit Warrants that
remained  outstanding at the time the registration statement was filed.

Prospectus Summary, page 1

3. Please revise your prospectus summary section to provide a n overview of your current
business and the key aspects of the offering, including :

 a brief summary of the products you develop and your business goals,
 the amount of capital necessary to reach such business goals,
 your accum ulated deficit and capital working deficit and the fact that your
auditors have issued a going concern audit opinion ,
 the number of employees you have,
 the material terms of your agreements with Prenzamax, LLC and Alpex Pharma
S.A., and
 a brief description of the potential conflict of interest your sole officer and
director  may have due to your agreement with Prenzamax.

4. Please expand to disclose that you have not received any revenues or other payments to
date under your agreements with P renzamax or Alpex , notwithstanding that beginning in
May 2012 Prenzamax generated revenues from sales of Suprenza, your first commercial
product .  Please disclose the conditions that must be met before you receive any revenues
or payments under these agree ments.

5. We note your statement on page 37 that “We have been unable to obtain sufficient
funding to conduct additional development activities on Suprenza. Because of our limited
resources we have decided to focus on the development of the hemorrhoid produc t first.”
Please disclose this information in the Overview section , as well as in the risk factor on
page 7 where you state that “we may not be able to commercialize the next generation of
Suprenza products .”

Risk Factors, page 6

Our auditors have issu ed a “going concern” audit opinion, page 6

6. We note your statement on page 31 that you expect that you will have sufficient funds to
continue your operations for the next six months.  Please clarify here and in the Liquidity
and Capital Resources section whether you will have sufficient funds to continue your
operations for the next twelve months.

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 3

 Risks Related to Our Common Stock, Liquidity Risks and Reverse Acquisition, page 19

We are subject to extensive and costly government regulation, page 14

7. We note your disclosure that you may be required to conduct costly, post -marketing
surveillance and/or be required to conduct ongoing post -marketing studies.  Please clarify
that you have committed to post -marketing studies of Suprenza.

Compliance with the r eporting requirements, page 19

8. We note your disclosure on page 19 that “The Company is not subject to the filing
requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934 but files
certain reports with the Securities and Exchange Commissi on on a voluntary basis .”
Please note that you will be  subject to filing obligations pursuant to  Section 15(d) of the
Exchan ge Act following the effective date of this registration statement, and revise your
disclosure accordingly .

You may experience dilution of your ownership interests, page 20

9. We note your disclosure on page 20 that you r common stock is currently quoted on the
OTC Markets and the OTCQB.  Please clarify that the OTC Market s and OTCQB are not
two separate quotation systems , and that t he OTCQB is one of the marketplace categories
within the OTC Markets .

There is not an active liquid trading market for the Company’s common stock , page 21

10. Please disclose the trading volume of your common stock within the last six months.

Use of Proceed s, page 23

11. We note your disclosure that the warrants are exercisable at $0.60 per share and that the
Placement Agent Unit Warrants are exercisable on a cash or cashless basis with respect to
680,013 warrants.  Please disclose the amount of proceeds you wi ll earn upon the
exercise of the warrants assuming all the warrants held by the investors and the
placement agent are exercised on a cash basis, and disclose the amount of proceeds you
will earn upon the exercise of all the warrants assuming that the warra nts that may be
exercised on a cashless basis are exercised on such basis.  In addition, in an appropriate
section of your prospectus, please describe the material terms of the warrants and
Placement Agent Unit Warrants.

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 4

 Business, page 34

12. We note your disclosure on page 26 that you are actively seeking to raise additional
capital in order to fund your research and development efforts.  Please provide a brief
description of such activities.

Our Marketed Product and New Product Candidates, page 36

13. We note your disclosure that your Hydrocortisone -Lidocaine Cream is “phase 2 ready.”
Please describe the steps remaining to achieve FDA approval as well as the estimated
cost of accomplishing such steps  and the estimated timeline for accomplishing such st eps.

Terms of the license, page 37

14. We note your disclosure on page 37 that, pursuant to the Sublicense Agreement with
Prenzamax, Akrimax  prepares estimates of costs incurred in selling Suprenza, which
costs are used  to calculate the Product EBITDA , and your disclosure on page 25 that
under the Sublicense Agreement you are entitled both to a percentage of the Product
EBITDA and to reimbursement  for certain development costs once Prenzamax  has
“achieved profitability.”   Please expand your discussion o f the license to explain how
Prenzamax determines whether it  has achieved pro fitability .

15. Please disclose here the percentage of Product EBITDA you r eceive pursuant to the
Sublicense A greement , the percentage of such payments you are required to pay Alpex
pursu ant to the Alpex Agreement, the percentage of the  development cost repayments
you receive from Prenzamax that you are required to pay Alpex pursuant to the Alpex
Agreement  and the percentage of the Alpex Reven ue receive d from Alpex that you are
required to pay to Prenzamax.   In addition, please disclose here, if true, that Akrimax
determines the price it charges for Suprenza.

Phentermine – Recent U.S. Prescription Data and Market Opportunity, page 39

16. We note your use of CAGRs in the first parag raph on page 39.  Please provide updated
information, as you include a five -year period ending in 2011.  Because your market
opportunity appears to rely upon projected growth in these measures in the future, please
revise here to show the actual growth of such measures for the years represented.

Suprenza Brand Phentermine – Orally Disintegrating Tablets for Obesity, page 40

17. Please briefly describe the “patient -friendly features.”

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 5

 Suprenza ODT Post -Marketing Studies, page 40

18. We note your disclosure on page 40 regarding the post -marketing studies of Suprenza
ODT.  Please disclose the cost and timing of such studies , including the drug utilization
study, and how you intend to pay for such studies, including the effect of failing to
conduct the studies in  the required time frame or at all .  In addition, please balance your
disclosure regarding the advantage that such studies could yield by disclosing the
potential negative effects of such studies depending on the results.   In addition, please
address the r isks attendant to such studies in your Risk Factors section or tell us why you
believe this is not necessary.

Treatments for Hemorrhoids, page 40

19. We note your disclosure regarding OTC hemorrhoid medications and prescription
strength hemorrhoid medication s.  Please tell us the basis for your statement that “[n]one
of these products have undergone clinical trials or have been submitted to or approved by
the FDA on the basis of safety and efficacy.”   In addition, please tell us the basis for
statement on pag e 41 that “[t]here are almost no sales, marketing or promotions efforts on
behalf of these products.”

Sources and Availability of Raw Materials and Clinical Supplies, page 43

20. We note your disclosure on page 43 th at you have a sole supplier for phentermin e
hydrochloride .  Please disclose the name of the supplier , discuss the risks associated with
having a sole supplier in your Risk F actors section  and tell us whether you are required to
file any agreements with this supplier .

Suprenza  Intellectual Property, page 44

21. We note your disclosure on page 44 that you  have a pending patent titled ‘Solid Dosage
formulations containing weight -loss drugs.”  Please clarify whether any of the intellectual
property discussed in this section, includin g the pending patent , is intellectual property
that you license from Alpex or your own.   To the extent that you develop any intellectual
property with respect to Suprenza, clarify whether you or Alpex will own such
intellectual property.

Clinical Trials, page 45

Section 505(b)(2) New Drug Applications, page 45

22. Please expand your description regarding the FDA’s 505(b)(2) new drug application
pathway so that investors understand the steps necessary to achieve FDA approval using
this process and the estimat ed amount of time and cost it takes to accomplish each step.

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 6

 For example, clarify whether you must conduct Phase 1 clinical trials when using the
505(b)(2) new drug application pathway.

Additional Government Regulations, page 46

23. We note that you state t hat you are subject to foreign regulatory agencies and that your
contract manufacturer is in a foreign jurisdiction.  Please disclose the foreign regulations
to which you are subject.

Management, page 48

Directors and Executive Officers of the Registrant, page 48

24. We note your disclosure on page 48 that “[i]t is anticipated that an additional individual,
designated by the Placement Agents, will serve on [your] Board of Directors.  Please
disclose the agreement you have with such Placement Agent s, describe the material terms
of the agreement, identify the Placement Agents and file the agreement with the next
amendment of your registration statement.

25. Please disclose here and in your prospectus summary section the conflict of interest Mr.
Mazur may  have with your company due to his position at Akrimax.   In addition, please
tell us the basis for your statement that Triax is one of the top ten dermatological
pharmaceutical companies in the U.S.

Transactions with Related Persons, Promoters and Certa in Control Persons, page 52

26. We note your disclosure that Citius’  headquarters are located in the office space of
Ischemix, LLC, a  company majority -owned by Dr. Geoffrey Clark and Dr. Reinier
Beeuwkes.  Given that Drs. Clark and Beeuwkes have resigned as both officers and
directors effective September 12, 2014, please clarify whether you have an  arrangement
to continue to have your h eadquarters located in the office space of Ischemix, LLC.

27. We note your disclosure on page F -29 that for the nine months ended June 30, 2015 you
paid $36,000 to a consultant who is a stockholder of the Company.  Please provide us
with an analysis as to whether this arrangement is required to be disclosed in this section
and whether any related agreements are required to be filed as exhibits.

Selling Shareholders, page 56

28. Please disclose the natural persons that have voting and investment power of the
securities held by The Entrust Group Inc. on page 56.

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 7

 Exhibits, page II -4

29. Please file your agreements with Alpex , Prenzamax  and IGI Laboratories, Inc .

Signatures, page II -7

30. Please have Mr. Mazur sign as your principal financial officer in his capacity as such in
the second part of your signature page and have your controller or principal accounting
officer or persons performing similar functions sign in their capacities as such.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 1933 and
all applicable Securities Act rules require.   Since the company and its management are in
possession of all facts relating to  a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement, please provid e a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company  may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for acceleration.  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of  1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time for us to review any amendment prior to the requested effective date o f the
registration statement.

Leonard Mazur
Citius Pharmaceuticals, Inc.
October 8, 2015
Page 8

 You may contact Amy Geddes  at (202) 551 -3304  or Melissa Raminpour  at (202) 551 -
3379  if you have questions regarding comments on the financial statements and related matters.
Please contact Sonia Bednarowski  at (202) 551 -