<SEC-DOCUMENT>0001213900-17-009911.txt : 20180629
<SEC-HEADER>0001213900-17-009911.hdr.sgml : 20180629
<ACCEPTANCE-DATETIME>20170922141701
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001213900-17-009911
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20170922

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			American BriVision (Holding) Corp
		CENTRAL INDEX KEY:			0001173313
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				260014658
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		11 SAWYERS PEAK DRIVE
		CITY:			GOSHEN
		STATE:			NY
		ZIP:			10924
		BUSINESS PHONE:		845-551-8728

	MAIL ADDRESS:	
		STREET 1:		11 SAWYERS PEAK DRIVE
		CITY:			GOSHEN
		STATE:			NY
		ZIP:			10924

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	METU BRANDS, INC.
		DATE OF NAME CHANGE:	20150908

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ECOLOGY COATINGS, INC.
		DATE OF NAME CHANGE:	20080821

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Ecology Coatings, Inc.
		DATE OF NAME CHANGE:	20070711
</SEC-HEADER>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center"><IMG SRC="image_003.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: center; color: Red"><B></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 20pt 0 0; text-align: right">September 22, 2017</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><U>VIA EMAIL AND MAIL</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Suzanne Hayes</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Assistant Director</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Office of Healthcare and Insurance</P>

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

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    <TD STYLE="width: 5%"><B>Re:&#9;</B></TD>
    <TD STYLE="width: 95%"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left"><B>American Brivision (Holding) Corporation</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left"><B>Amendment No. 4 to Registration Statement
on Form S-1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left"><B>Filed July 17, 2017</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left"><B>File No. 333-213618</B></P>

</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Dear Ms. Hayes:</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">This letter is in response to the letter
dated July 26, 2017 from the staff (the &ldquo;Staff&rdquo;) of the Securities and Exchange Commission (the &ldquo;Commission&rdquo;)
addressed to American Brivision (Holding) Corporation (the &ldquo;Company&rdquo;, &ldquo;we&rdquo; or &ldquo;our&rdquo;). For ease
of reference, we have repeated the Commission&rsquo;s comments in this response and numbered them accordingly. An amended Registration
Statement on Form S-1/A submitted accompanying this Response Letter is referred to as Amendment No. 5.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt"><B><U>Business</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt"><B><U>Our Products, page 37</U></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B>1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;We
acknowledge your revised disclosure in response to comment 3, and note that you reference in the eighth bullet a variety of secondary
endpoints for the MDS trial. You state the trial concluded that there was a statistical improvement in neutrophil count and neutrophil
function. Please also discuss the conclusions of the trial regarding the trial&rsquo;s various secondary endpoints. In addition,
please disclose and explain the p-value results in the trial, provide an explanation of the term &ldquo;statistically significant&rdquo;
and discuss how statistical significance relates to the FDA&rsquo;s evidentiary standards of efficacy.&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B></B>In response to
Staff&rsquo;s comments, the Registration Statement has been revised.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">For the discussion of the conclusions
of the trial regarding the trial&rsquo;s various secondary endpoints, please kindly refer to the revised disclosure in the last
bullet point on page 37 of Amendment No. 5. The beginning of this bullet point reads &ldquo;As stated in the report of MDS Trial,
in particular, with regard to the&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">For the disclosure and explanation of
the p-value results in the trial, please kindly refer to the revised disclosure in the last bullet point on page 37 of Amendment
No. 5. The beginning of this bullet point reads &ldquo;As stated in the report of MDS Trial, in particular, with regard to the&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">For the explanation of the term &ldquo;statistically
significant,&rdquo; please kindly refer to the revised disclosure in the second bullet point on page 38 of Amendment No. 5. The
beginning of this bullet point reads &ldquo;In statistical hypothesis testing, a result has &ldquo;statistical significance&rdquo;&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">For the discussion of how statistical
significance relates to the FDA&rsquo;s evidentiary standards of efficacy, please kindly refer to the revised disclosure in the
first bullet point on page 38 of Amendment No. 5. The beginning of this bullet point reads &ldquo;In order for statistical significance
to meet the FDA&rsquo;s evidentiary standards of efficacy, any&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B>2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;We
refer to your revised disclosure on page 38 regarding product candidate ABV-1502 in the seventh bullet, in which you describe your
primary endpoints for your proposed Phase II trial. Since both of the primary endpoints relate to safety and tolerability rather
than efficacy, please explain how the trial will be considered a Phase II trial.&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt; text-align: justify">In response to Staff&rsquo;s comments,
the Registration Statement has been revised. Please kindly refer to the revised disclosure in the seventh and eighth bullet points
on page 39 of Amendment No. 5. The beginning of these bullet points read, respectively, &ldquo;We plan to conduct phase I trial
that is especially&hellip;&rdquo; and &ldquo;Currently, we have commenced the cooperation with MDACC and another cancer&hellip;&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B>3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;We
note your revised disclosure on page 40 that the conclusions of your Phase I trial for ABV-1504 showed no &ldquo;clinically significant&rdquo;
findings in various measurements, and demonstrated that the oral administration of the product candidate was &ldquo;safe and well-tolerated&rdquo;
for certain doses. Since a safety determination is solely within the FDA&rsquo;s authority, please remove the statement that your
product candidate is safe. In addition, please explain the term &ldquo;clinically significant,&rdquo; and disclose the number of
individuals who participated in this trial, the date of the trial and its location, and dosage information (both amount and frequency).&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">In response to Staff&rsquo;s comments,
the Registration Statement has been revised. We have removed the statement that our product candidate is safe from the fifth bullet
point under &ldquo;IV. ABV-1504 Major Depressive Disorder (&ldquo;MDD&rdquo;)&rdquo; on page 41 of Amendment No. 5. The beginning
of this bullet point reads &ldquo;The primary endpoint of Phase I clinical trial was to assess the safety profile&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify">For the explanation of the term &ldquo;clinically
significant,&rdquo; please kindly refer to revised disclosure in the first bullet point on page 11 of Amendment No. 5. The beginning
of this bullet point reads &ldquo;PDC-1421 was observed to be associated with some adverse events in serum&hellip;&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt; text-align: justify">For the disclosure of the number of
individuals who participated in this trial, the date of the trial and its location, and the dosage information, please refer to
the revised disclosure in the third and fourth bullet points under &ldquo;IV. ABV-1504 Major Depressive Disorder (&ldquo;MDD&rdquo;)&rdquo;
on page 41 of Amendment No. 5. The beginning of these bullet points read, respectively, &ldquo;BioLite has completed Phase I clinical
trial. The clinical trial&hellip;&rdquo; and &ldquo;There were 9 subjects in cohort A with 7 administered PDC-1421&hellip;&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B>4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;We
refer to your revised disclosure on page 40 regarding your Phase II trial for ABV-1504. Please disclose the number of subjects
participating in this ongoing trial, when it started and when you expect the trial to end, and the location of the trial.&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt; text-align: justify">In response to Staff&rsquo;s comments,
the Registration Statement has been revised. Please kindly refer to the revised disclosure in the eighth bullet point under &ldquo;IV.
ABV-1504 Major Depressive Disorder (&ldquo;MDD&rdquo;)&rdquo; on page 41 of Amendment No. 5. The beginning of this bullet point
reads &ldquo;There are 60 subjects participating in the Phase II Part II trial...&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt; text-align: justify"><B>5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Please
further expand your disclosure regarding your planned Phase II trial for ABV-1505 on page 41 to disclose the number of subjects
who will participate in the trial.&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt; text-align: justify">In response to Staff&rsquo;s comments,
the Registration Statement has been revised. Please kindly refer to the revised disclosure in the seventh bullet point on page
42 of Amendment No. 5. The beginning of this bullet point reads &ldquo;The BioLite has obtained U.S. FDA Phase II IND approval
with the IND number: 129107&hellip;&rdquo;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt"><B><U>Selling Stockholders, page 54</U></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt"><B>6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Please revise
your disclosure so that the footnotes correctly correspond to the applicable selling stockholder.&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">In response to Staff&rsquo;s comments, the Registration Statement
has been revised. Please kindly refer to the revised disclosure from page 59  to page 62 of Amendment No. 5.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt"><B></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;&#9642;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">In responding to your comments, the Company acknowledges that:</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 29px; padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company is responsible for the adequacy and accuracy of the disclosure in the filing;</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="padding-bottom: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.</FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 8pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt">We appreciate the assistance the Staff has provided with
its comments. If you have any questions, please do not hesitate to call our counsel, Joan Wu, Esq. of Hunter Taubman Fischer &amp;
Li LLC, at (212) 732-7184.</P>

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

<TABLE BORDER="0" CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top">&nbsp;</TD>
    <TD>Sincerely,</TD></TR>
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 35%">Kira Huang</TD></TR>
<TR>
    <TD COLSPAN="2" STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left">Chief Financial Officer</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: left">American Brivision (Holding) Corporation</P>


</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">cc:&#9;Joan Wu, Esq.</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD STYLE="vertical-align: top">&nbsp;</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0pt; margin-top: 0pt; margin-bottom: 6pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; text-indent: 0pt; margin-top: 0pt; margin-bottom: 6pt"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
