<SEC-DOCUMENT>0001178913-23-002350.txt : 20230703
<SEC-HEADER>0001178913-23-002350.hdr.sgml : 20230703
<ACCEPTANCE-DATETIME>20230703070506
ACCESSION NUMBER:		0001178913-23-002350
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20230703
FILED AS OF DATE:		20230703
DATE AS OF CHANGE:		20230703

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			MediWound Ltd.
		CENTRAL INDEX KEY:			0001593984
		STANDARD INDUSTRIAL CLASSIFICATION:	MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36349
		FILM NUMBER:		231063593

	BUSINESS ADDRESS:	
		STREET 1:		42 HAYARKON STREET
		CITY:			YAVNE
		STATE:			L3
		ZIP:			8122745
		BUSINESS PHONE:		97289324010

	MAIL ADDRESS:	
		STREET 1:		42 HAYARKON STREET
		CITY:			YAVNE
		STATE:			L3
		ZIP:			8122745
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
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<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Washington, D.C.&#160; 20549<br>
      ______________________</div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">FORM 6-K</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">REPORT&#160;OF FOREIGN PRIVATE ISSUER</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16 of the<br>
      Securities Exchange Act of 1934</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">For the month of July 2023</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Commission File Number: 001-36349</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman', serif; font-size: 12pt;"><font style="font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;"><u>MediWound Ltd. </u></font><font style="font-family: 'Times New Roman',Times,serif; font-size: 10pt;"><br>
        (Translation of registrant&#8217;s name into English)</font></div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-weight: bold;">42 Hayarkon Street</div>
    <div style="text-align: center; line-height: 1.25; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-weight: bold;">Yavne, 8122745 Israel</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;(Address of principal executive offices)</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
    </div>
    <div style="text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: center; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif;">Form 20-F &#9746; &#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; Form 40-F &#9744;</font></div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):&#160;&#160; __</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):&#160;&#160; __</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">EXPLANATORY NOTE</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-align: justify; text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">On July 3, 2023, MediWound Ltd. (the &#8220;Company&#8221;) issued a press release entitled &#8220;MediWound Receives Positive Scientific Advice from
      European Medicine Agency (EMA) on EscharEx Phase III Study Design&#8221;. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management
      of the Company), is hereby incorporated by reference into the Company&#8217;s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019, February 25, 2020, May 15, 2021 and August 9,
      2022&#160;(Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-230487, 333-236635, 333-255784, and &#160;333-266697, respectively) and on Form F-3 filed with the SEC on May 25, 2022 and March 31, 2023 (Registration Nos. 333-265203 and 333-268297,
      respectively).</div>
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      <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="color: #000000; font-weight: normal; font-style: normal;">2</font></div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">SIGNATURE</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
      undersigned, thereunto duly authorized.</div>
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              <div>&#160;<font style="font-family: 'Times New Roman',Times,serif;">Date: July 3, 2023</font></div>
            </td>
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              <div>
                <div>&#160;&#160;&#160;&#160;&#160;&#160; MEDIWOUND LTD.</div>
                <div>&#160;</div>
                <div>By:&#160; <u>/s/ Hani Luxenburg</u></div>
                <div>Name:&#160; Hani Luxenburg</div>
                <div>Title:&#160; &#160; Chief Financial Officer</div>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">EXHIBIT INDEX</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">The following exhibit is filed as part of this Form 6-K:</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
    </div>
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            <td style="width: 72pt; vertical-align: top; font-family: 'Times New Roman',Times,serif;"><u>Exhibit</u></td>
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              <div><u>Description</u></div>
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          <td style="width: 72pt; vertical-align: top; font-family: 'Times New Roman',Times,serif;"><a href="exhibit_99-1.htm">99.1</a></td>
          <td style="width: auto; vertical-align: top; text-align: justify; font-family: 'Times New Roman',Times,serif;">
            <div><a href="exhibit_99-1.htm">Press release dated July 3, 2023 titled &#8220;MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on
                EscharEx Phase III Study Design&#8221;.</a></div>
          </td>
        </tr>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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      <hr align="center" style="border: none; border-bottom: 1px solid black; border-top: 4px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"><font style="font-weight: bold;"><u>Exhibit 99.1</u></font><br style="line-height: 1.25;">
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      <div style="text-align: center; line-height: 1.25; font-weight: bold; font-size: 12pt;">MediWound Receives Positive Scientific Advice from European Medicine </div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold; font-size: 12pt;">Agency (EMA) on EscharEx Phase III Study Design</div>
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt;">
      <div style="text-align: center; line-height: 1.25; font-style: italic;">
        <div style="line-height: 1.25; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-style: italic; font-variant: normal; text-transform: none;">
          <div style="line-height: 1.25;">Affirms the clear path forward for the Company&#8217;s global Phase III study of EscharEx in venous leg ulcers</div>
        </div>
      </div>
    </div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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    <div style="line-height: 1.25; font-family: 'Times New Roman', serif; font-size: 11pt;"><font style="font-family: 'Times New Roman',Times,serif; font-size: 10pt; font-weight: bold;">YAVNE, Israel, July 3, 2023</font><font style="font-family: 'Times New Roman',Times,serif; font-size: 10pt;"> (GLOBE NEWSWIRE) &#8211; MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has received positive
        scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company&#8217;s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs)
        and to the overall data required for subsequent potential marketing authorization submission and commercialization.</font></div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study
        arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients
        as the basis for approval, assuming the data are robust and similar to the company&#8217;s previous studies.</div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">"We are very pleased to receive positive Scientific Advice from EMA supporting our Phase III development plan for EscharEx. The constructive feedback we have garnered from both the U.S. Food and Drug Administration (FDA)
      and the EMA provides consensus, empowering us to conduct this pivotal Phase III study on a global scale&#8221; said Ofer Gonen, Chief Executive Officer of MediWound. &#8220;EscharEx addresses an important medical need for patients suffering from chronic wounds,
      and we look forward to bringing this next-generation therapy to market.&#8221;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;">In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective,
        randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which
        EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each.&#160; Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC).&#160; Patients who
        achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same
        active pharmaceutical ingredient (API) as the NexoBrid<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, which has been approved for debridement of thermal burns in the U.S. and Europe.</div>
    </div>
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      <div style="line-height: 1.25; font-family: 'Times New Roman', serif; font-size: 11pt;"><font style="font-family: 'Times New Roman',Times,serif; font-size: 10pt; font-weight: bold;">About MediWound Ltd.</font><font style="font-family: 'Times New Roman',Times,serif; font-size: 10pt;"><br>
          MediWound Ltd.&#160;(Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing
          standards of care. The Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.</font></div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
        <div style="line-height: 1.25;">
          <div style="line-height: 1.25; font-family: 'Times New Roman', Times, serif;">MediWound&#8217;s first drug, NexoBrid<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize
            associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&amp;D pipeline including the Company&#8217;s lead drug under development, EscharEx<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>. EscharEx is a
            Phase III biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. Additionally, MediWound has a Phase I/II biologic for basal cell carcinoma,
            MW005, with results expected in Q3 2023.</div>
        </div>
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">For more information visit&#160;<u>www.mediwound.com</u>&#160;and follow the Company on&#160;<u>LinkedIn</u>.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Cautionary Note Regarding Forward-Looking Statements</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we
        expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about
        future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by
        the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as &#8220;anticipates,&#8221; &#8220;intends,&#8221; &#8220;estimates,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;continues,&#8221; &#8220;believe,&#8221; &#8220;guidance,&#8221;
        &#8220;outlook,&#8221; &#8220;target,&#8221; &#8220;future,&#8221; &#8220;potential,&#8221; &#8220;goals&#8221; and similar words or phrases, or future or conditional verbs such as &#8220;will,&#8221; &#8220;would,&#8221; &#8220;should,&#8221; &#8220;could,&#8221; &#8220;may,&#8221; or similar expressions.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives
        anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx&#174; and NexoBrid&#174;. Among the factors that may cause results to be materially different from those stated herein are the inherent
        uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and
        future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and
        product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability
        to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional
        financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our
        products and product candidates in the future.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">These and other significant factors are discussed in greater detail in MediWound&#8217;s annual report on Form 20-F for the year ended December 31, 2022, filed with the Securities
        and Exchange Commission (&#8220;SEC&#8221;) on March 16, 2023 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound&#8217;s current views as of the date hereof and MediWound undertakes,
        and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.</div>
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      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Investor Contacts:</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
        <table cellspacing="0" cellpadding="0" border="0" id="z278ccdb905104eb4be8a40c8c7bb6b97" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: #000000; width: 100%;">

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                  <div style="text-align: left; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif;">Hani Luxenburg<br>
                    </font></div>
                  <div style="text-align: left; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif;">Chief Financial Officer<br>
                    </font></div>
                  <div style="text-align: left; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif;">MediWound, Ltd.<br>
                    </font></div>
                  <div style="text-align: left; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif; color: rgb(0, 0, 255);"><u>ir@mediwound.com</u></font><font style="font-family: 'Times New Roman',Times,serif;"><br>
                    </font></div>
                </div>
              </td>
              <td style="width: 70%;">
                <div><font style="font-family: 'Times New Roman',Times,serif;">Monique Kosse</font></div>
                <div><font style="font-family: 'Times New Roman',Times,serif;">Managing Director, LifeSci Advisors</font><br>
                  <font style="font-family: 'Times New Roman',Times,serif;">+1-212-915-3820</font><br>
                  <font style="font-family: 'Times New Roman',Times,serif;"><font style="color: rgb(0, 0, 255);"><u>monique@lifesciadvisors.com</u></font></font></div>
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