<SEC-DOCUMENT>0001079973-12-000595.txt : 20120807
<SEC-HEADER>0001079973-12-000595.hdr.sgml : 20120807
<ACCEPTANCE-DATETIME>20120807081528
ACCESSION NUMBER:		0001079973-12-000595
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120807
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120807
DATE AS OF CHANGE:		20120807

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AspenBio Pharma, Inc.
		CENTRAL INDEX KEY:			0001167419
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				841553387
		STATE OF INCORPORATION:			CO
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33675
		FILM NUMBER:		121011357

	BUSINESS ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104
		BUSINESS PHONE:		(303) 794-2000

	MAIL ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ASPENBIO INC
		DATE OF NAME CHANGE:	20020213
</SEC-HEADER>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Press release, dated August 7, 2012 issued by AspenBio Pharma, Inc., titled &#8220;AspenBio Pharma Submits Pre-IDE Information Package to FDA for AppyScore&#8482; Appendicitis Test System.&#8221;</font></div>
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<DESCRIPTION>EXHIBIT 99.1
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<div style="TEXT-ALIGN: right">Exhibit 99.1</div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 12pt; FONT-WEIGHT: bold">AspenBio Pharma Submits Pre-IDE Information Package to FDA for</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 12pt; FONT-WEIGHT: bold">AppyScore&#8482; Appendicitis Test System</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Company scheduled to meet FDA and receive feedback prior to end of third quarter</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-WEIGHT: bold">CASTLE ROCK, Colo., August 7, 2012</font><font style="DISPLAY: inline; FONT-SIZE: 10pt"> &#8212; </font><font style="DISPLAY: inline; FONT-WEIGHT: bold">AspenBio Pharma, Inc.</font> (Nasdaq: <font style="DISPLAY: inline; TEXT-DECORATION: underline">APPY</font>), an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company, announced that it has submitted a pre-IDE (Investigational Device Exemption) information package to the U. S. Food and Drug Administration (FDA) for the use of the <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font>&#8482; test system to aid physicians in evaluating children and young adult patients at low risk for acute appendicitis, allowing for more conservative patient management.&#160;&#160;In conjunction with the pre-IDE package, AspenBio has scheduled a meeting with the FDA prior to the end of the third quarter to work cooperatively on the clinical and regulatory plan.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Steve Lundy, President and CEO of AspenBio, commented, &#8220;The pre-IDE submission with the FDA is a significant milestone on our path to advance <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font> towards commercialization.&#160;&#160;Following feedback from our upcoming meeting with the FDA, we plan to initiate the pivotal clinical trial for <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font>.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The pre-IDE documentation has been submitted to the FDA in order to obtain the agency&#8217;s guidance regarding the regulatory pathway; the proper approach to refine the clinical and statistical plan; and to ensure AspenBio is working closely and cooperatively with the FDA review team.&#160;The basis for pre-IDE submission is data from an analysis of over 500 patient samples collected in AspenBio&#8217;s 2011 pilot trial.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the FDA or the Company.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About AspenBio Pharma</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">AspenBio Pharma, Inc. is an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company focused on the clinical development and commercialization of its lead product, <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font>.&#160;&#160;<font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font> is a unique blood-based test with projected high sensitivity and negative predictive value that is designed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management.&#160;&#160;<font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font> is initially being developed for pediatric, adolescent and young adult patients with abdominal pain as this population is at the highest risk for appendicitis as well having the highest risk of the long-term health effects associated with CT imaging.&#160;&#160;For more information, visit <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.aspenbiopharma.com</font>.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Forward-Looking Statements</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This press release includes "forward-looking statements" of AspenBio Pharma, Inc. ("AspenBio") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that AspenBio believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font> required for FDA submission, obtain FDA clearance or approval, complete and obtain CE Mark, cost effectively manufacture and generate revenues from <font style="FONT-STYLE: italic; DISPLAY: inline">AppyScore</font>, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, AspenBio does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in AspenBio's recent filings with the SEC, including its Final Prospectus filed on June 20, 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">For Investors &amp; Media:</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Gregory Tiberend / Jason Rando</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Tiberend Strategic Advisors, Inc.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">(212) 827-0020</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">gtiberend@tiberend.com</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">jrando@tiberend.com</font></div>

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