<SEC-DOCUMENT>0001387131-17-000408.txt : 20170307
<SEC-HEADER>0001387131-17-000408.hdr.sgml : 20170307
<ACCEPTANCE-DATETIME>20170131105229
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001387131-17-000408
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20170131

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			TherapeuticsMD, Inc.
		CENTRAL INDEX KEY:			0000025743
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				870233535
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		6800 BROKEN SOUND PARKWAY NW
		STREET 2:		THIRD FLOOR
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487
		BUSINESS PHONE:		561-961-1911

	MAIL ADDRESS:	
		STREET 1:		6800 BROKEN SOUND PARKWAY NW
		STREET 2:		THIRD FLOOR
		CITY:			BOCA RATON
		STATE:			FL
		ZIP:			33487

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AMHN, Inc.
		DATE OF NAME CHANGE:	20090930

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF ENTERPRISES INC
		DATE OF NAME CHANGE:	19970915

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CROFF OIL CO
		DATE OF NAME CHANGE:	19920703
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<!-- Field: Rule-Page --><DIV ALIGN="LEFT" STYLE="margin: 0"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid; width: 100%">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

<P STYLE="font: 12pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>TherapeuticsMD, Inc.</B></P>

<P STYLE="font: 12pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>6800 Broken Sound Parkway NW, Third Floor</B></P>

<P STYLE="font: 12pt Times New Roman, Times, Serif; margin: 0; text-align: center"><B>Boca Raton, Florida 33487</B></P>

<P STYLE="font: 12pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">January
31, 2017</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>VIA
EDGAR SUBMISSION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Mr.
Jim B. Rosenberg</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Senior
Assistant Chief Accountant</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Division
of Corporation Finance</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Securities
and Exchange Commission</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">100
F Street, NE</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Washington,
DC 20549</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 1in; text-indent: -0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Re:&#9;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>TherapeuticsMD,
Inc.</B><BR>
<B>Form 10-K for the Fiscal Year Ended December 31, 2015</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Filed
February 26, 2016</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Form
10-Q for Quarterly Period Ended September 30, 2016</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Filed
November 4, 2016</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>File
No. 001-00100</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dear
Mr. Rosenberg:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
behalf of TherapeuticsMD, Inc., a Nevada corporation (the &ldquo;<U>Company</U>&rdquo; or &ldquo;<U>we</U>&rdquo;), this letter
is in response to the comments of the staff (the &ldquo;<U>Staff</U>&rdquo;) of the United States Securities and Exchange Commission
(the &ldquo;<U>Commission</U>&rdquo;) contained in its letter to the Company, dated January 25, 2017, regarding the Company&rsquo;s
Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed with the Commission on February 26, 2016 (the &ldquo;<U>Form
10-K</U>&rdquo;), and the Company&rsquo;s Quarterly Report on Form 10-Q for the period ended September 30, 2016, filed with the
Commission on November 4, 2016 (the &ldquo;<U>Form 10-Q</U>&rdquo;).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
your convenience, we have set forth the text of each of the Staff&rsquo;s comments in bold, followed in each case by the Company&rsquo;s
response thereto.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Form
10-Q for the Quarter Ended September 30, 2016</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Notes
to Unaudited Consolidated Financial Statements</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Note
3: Summary of Significant Accounting Policies</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Revenue
Recognition</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I><U>Prescription
Products</U></I><U>, page 9</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.5in; text-align: justify; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>1.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>In your response to the penultimate bullet of prior comment 2, you indicate that you recognized revenue from Woodstock and Due
West when the product was dispensed at the pharmacy. Your revenue recognition policy provides no indication that you defer revenue
recognition until a prescription is dispensed. Please address the following comments:</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.5in; text-align: justify; text-indent: 0">&nbsp;&#9679;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><B>If you
defer recognition of revenue until a prescription is dispensed, tell us:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 1in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9675;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1.5in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>why you do not appear to continue to have some deferred revenue on your balance sheet after January 1, 2015, the date you were
able to estimate product returns as disclosed on page F-13 in your 2015 Form 10-K; and </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 1in; text-align: justify; text-indent: 0">&#9675;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1.5in; text-align: justify; text-indent: 0"><B>why
a reserve for product returns is necessary if revenue has not been recognized upon shipment to the wholesaler and/or pharmacy
and product cannot be returned once a prescription is dispensed as indicated in the last paragraph on page 5 of your response.</B></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify; text-indent: -0.25in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>&nbsp;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prior
to September 1, 2016, the Company sold prescription products primarily through wholesale distributors and retail pharmacy distributors.
The accounting policy related to the Company&rsquo;s revenue recognition is described below in the response to the second bullet
of the Staff&rsquo;s question number 1.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company did not record deferred revenue related to the sale of prescription products through retail pharmacy distributors. Prior
to September 1, 2016, sales of the Company&rsquo;s prescription products through its retail pharmacy distributors were recognized
as revenue when the price was fixed and determinable (when the coverage and amount were verified and quantified by insurance)
and the product was dispensed to the end customer by the retail pharmacy distributor. The window of time between the moment the
sale was made to the retail pharmacy distributor and the product was dispensed to the end customer was generally a day. The amount
related to this timing difference was reviewed each period-end and had been deemed nominal. The Company&rsquo;s return policy
states that once a customer buys a prescription product from a retail pharmacy distributor, the product may not be returned. However,
in limited circumstances, when an end customer contacted the Company and was very dissatisfied with the product, the Company provided
a refund to such customer instead of processing the refund through the retail pharmacy distributor. As such, the Company provided
a reserve based on its experience which historically has been nominal. On September 1, 2016, the Company centralized the distribution
channel for both its retail pharmacy distributors and wholesale distributors, a process managed by a third-party logistics provider,
in order to facilitate sales to a broader population of pharmacies and minimize business risk exposure to any one pharmacy. After
such date, the Company recognizes revenue based on the wholesale distributor model described below.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&rsquo;s deferred revenue balance prior to January 1, 2015 related to the recognition of revenue of prescription products
sold through wholesale distributors until the right of return no longer existed. At that time, given the limited history of prescription
products sold through wholesale distributors, the Company could not reliably estimate expected returns of the prescription products
at the time of shipment. Accordingly, the Company deferred recognition of revenue on prescription products sold through wholesale
distributors until the right of return no longer existed, which occurred at the earlier of the time the prescription products
were dispensed through patient prescriptions or expiration of the right of return. The Company tracks return rates for all of
its products since inception. This includes tracking all lots through product lifecycle - from manufacture through expiration.
Based on this analysis, on January 1, 2015, the Company began estimating and reserving for returns based on historical return
rates, while recording actual product returns against this return reserve as received.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.5in; text-align: justify; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Clarify for us when you recognize prescription revenue. If you recognize some revenue for prescription products upon shipment
to wholesalers and/or pharmacies and others upon the prescription being dispensed, tell us the circumstances for recognition under
each scenario and provide us proposed revised policy disclosure to be provided in future periodic reports that clarifies this
distinction.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company recognizes revenue related to prescription products sold through retail pharmacy distributors when the product is dispensed
to the end customer, while revenue related to prescription products sold through wholesaler distributers is recognized when the
prescription products are shipped to the distributors and the control of the products passes to each distributor.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prior
to September 1, 2016, sales of the Company&rsquo;s prescription products through its retail pharmacy distributors were recognized
as revenue when the price was fixed and determinable (when the coverage and amount were verified and quantified by insurance)
and the product was dispensed to the end customer by the retail pharmacy distributor. The window of time between the moment the
sale was made to the retail pharmacy distributor and the product was dispensed to the end customer was generally a day. The amount
related to this timing difference was reviewed each period-end and had been deemed nominal. The Company&rsquo;s return policy
states that once a customer buys a prescription product from a retail pharmacy distributor, the product may not be returned. However,
in limited circumstances, when an end customer contacted the Company and was very dissatisfied with the product, the Company provided
a refund to such customer instead of processing the refund through the retail pharmacy distributor. As such, the Company provided
a reserve based on its experience which historically has been nominal. On September 1, 2016, the Company centralized the distribution
channel for both its retail pharmacy distributors and wholesale distributors, a process managed by a third-party logistics provider,
in order to facilitate sales to a broader population of pharmacies and minimize business risk exposure to any one pharmacy. After
such date, the Company recognizes revenue based on the wholesale distributor model described below.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Revenue
related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped
to the distributors and the control of the products passes to each distributor. The Company accepts returns of unsalable prescription
products from wholesale distributors within a return period of six months prior to and up to 12 months following product expiration.
The Company&rsquo;s prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to January
1, 2015, the Company deferred the recognition of revenue on prescription products until the right of return no longer existed.
Prior to that date, the Company could not reasonably estimate the amount of future returns. As of January 1, 2015, the Company
began estimating and reserving for returns based on historical return rates, while recording actual product returns against this
reserve as received.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Provided
below is the Company&rsquo;s proposed disclosure to be included in its next annual report and future filings that will include
a revised policy disclosure describing recognition of revenue related to sales of prescription products:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>&nbsp;</I></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>&ldquo;<U>Prescription
Products</U></I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
sell our name brand and generic prescription products primarily through wholesale distributors and retail pharmacy distributors.
We recognize revenue from prescription product sales, net of sales discounts, chargebacks, wholesaler fees, customer rebates and
estimated returns.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Revenue
related to prescription products sold through wholesale distributors is recognized when the prescription products are shipped
to the distributors and the control of the products passes to each distributor. We accept returns of unsalable prescription products
sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration.
Our prescription products currently have a shelf life of 24 months from the date of manufacture. Prior to January 1, 2015, we
deferred the recognition of revenue on prescription products sold through wholesale distributors until the right of return no
longer existed as, prior to that date, we could not reasonably estimate the amount of future returns. As of January 1, 2015, we
began estimating and reserving for returns based on historical return rates, while recording actual product returns against this
reserve as received.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prior
to September 1, 2016, we recognized revenue related to prescription products sold through retail pharmacy distributors when the
product was dispensed by the retail pharmacy distributor, at which point all revenue and discounts related to such product were
known or determinable and there was no right of return with respect to such product. On September 1, 2016, we centralized the
distribution channel for both our retail pharmacy distributors and wholesale distributors, in order to facilitate sales to a broader
population of retail pharmacies and mitigate exposure to any one retail pharmacy. Beginning on September 1, 2016, all of our prescription
products are distributed under the wholesale distributor model described above.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
offer various rebate programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer
loyalty. The consumer rebate program is designed to enable the end user to submit a coupon to us. If the coupon qualifies, we
send a rebate check to the end user. We estimate the allowance for consumer rebates that we have offered based on our experience
and industry averages, which is reviewed, and adjusted if necessary, on a quarterly basis.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Management&rsquo;s
Discussion and Analysis of Financial Condition and Results of Operations</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><U>Liquidity
and Capital Resources, page 30.</U></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.5in; text-align: justify; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>2.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>We acknowledge your response to prior comment 3. Notwithstanding your assertion that the impact of increased collection time
on overall liquidity is not material because of your sufficient existing cash resources, your write-off of $2.2 million of receivables
resulting from developments in the pharmaceutical industry that negatively affected independent pharmacies as stipulated in the
first paragraph on page 8 of your response is material. As a result, please provide us proposed disclosure to be included in Management&rsquo;s
Discussion and Analysis or elsewhere in your upcoming Form 10-K that:</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 1in; text-align: justify; text-indent: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1.5in; text-align: justify; text-indent: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Describes the developments in the pharmaceutical industry that negatively affected independent pharmacies that prompted your
strategic decision to centralize the distribution channel for both your retail pharmacies and wholesale distributors
in order to facilitate sales to a broader population of pharmacies and minimize business risk exposure to any one pharmacy as
indicated in the bullet at the top of page 4 of your response.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1.5in; text-align: justify; text-indent: 0">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.75in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company acknowledges the Staff&rsquo;s comment. Provided below is the Company&rsquo;s proposed disclosure to be included in its
next annual report and future filings that will include a disclosure describing the Company&rsquo;s decision to centralize the
distribution channel for both retail pharmacies and wholesale distributors:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: windowtext">&ldquo;As
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a result of developments in the pharmaceutical
industry that negatively affected independent pharmacies, including such pharmacies&rsquo; reliance on third party payors, in
2016, we identified that payment periods for our retail pharmacy distributors were becoming longer than in prior years. As a result,
during the third quarter of 2016, we centralized the distribution channel for both our retail pharmacy distributors and wholesale
distributors, in order to facilitate sales to a broader population of retail pharmacies and minimize business risk exposure to
any one retail pharmacy. During the third quarter of 2016, we entered into new distribution agreements with our retail pharmacy
distributors to effectuate this centralization which were effective September 1, 2016.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.5in; text-align: justify; text-indent: 0"><B>&#9679;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><B>Discloses
the factors contributing to your material receivable write-off.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company acknowledges the Staff&rsquo;s comment. Provided below is the Company&rsquo;s proposed disclosure to be included in its
next annual report and future filings that will include a disclosure describing the referenced receivable write-off:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&ldquo;During
the third quarter of 2016, we wrote-off accounts receivable balances of $2.2 million related to two retail pharmacy distributors.
Both pharmacies are relatively small owner-managed pharmacies and share a similar amount of collection risk. Among the factors
that contributed to our decision to write-off these balances were our inability to collect the outstanding balances and the lack
of a continuing communication and business relationship with these parties following the centralization of the distribution channel
for both our retail pharmacy distributors and wholesale distributors, effective September 1, 2016.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.75in; text-align: justify; text-indent: -0.25in">&#9679;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-align: justify; text-indent: 0"><B>Discloses
the existence of new distribution agreements that you signed with your distributors effective September 1, 2016.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company acknowledges the Staff&rsquo;s comment and has included the requested disclosure in response to the first bullet of the
Staff&rsquo;s question number 2.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 -11pt 0.75in; text-indent: -0.25in">&#9679;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 1in; text-indent: 0"><B>Discloses the current and anticipated
continuing impact, if any, on your accounts receivable collection cycle.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Company&rsquo;s
Response:</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Provided
below is the Company&rsquo;s proposed disclosure to be included in its next annual report and future filings, as applicable, with
respect to the current and anticipated continuing impact, if any, on the Company&rsquo;s accounts receivable collection cycle:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&ldquo;For
the fiscal year ended December 31, 2016, our&nbsp;days sales outstanding, or DSO, was ___ days compared to ___ days for the year
ended December 31, 2015. The increase in our DSO as of December 31, 2016 was primarily the result of ______. We anticipate that
our DSO will fluctuate in the future based upon a variety of factors, including longer payment terms associated with the centralization
of the distribution channel for both our retail pharmacy distributors and wholesale distributors, as compared to the terms previously
provided to our retail pharmacy distributors, changes in the healthcare industry generally and specific terms that may be extended
in connection with the launch of our hormone therapy drug candidates, if approved.&rdquo;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: center; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">*
* * * *</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
you or any other member of the Staff should have any further comments or questions regarding this response, please feel free to
contact the undersigned by phone at (561) 961-1930 or Joshua M. Samek, Esq. of Greenberg Traurig, P.A., the Company&rsquo;s outside
counsel, at (305) 579-0856.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 12pt; text-align: justify; text-indent: 0.5in"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">Sincerely, </TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 30%; border-bottom: Black 1pt solid">/s/&nbsp;Daniel A. Cartwright</TD>
    <TD STYLE="width: 20%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">Daniel
A. Cartwright</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">Chief
Financial Officer</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>cc:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Joshua M. Samek, Esq.</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: left">
    <TD>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Greenberg
Traurig, P.A.</TD>
    <TD COLSPAN="2">&nbsp;</TD></TR>
</TABLE>

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