Aspenbio Pharma Inc (NASDAQ:APPY)

maniacdog10 (40.13) Submitted: 12/29/2010 8:37:15 AM : Start Price: $3.50 APPY Score: -87.10

A wild guess.

cgraymsa (< 20) Submitted: 7/1/2010 4:10:53 PM : Start Price: $5.60 APPY Score: -109.78

stock has been unjustly reduced because of delayed trial report. the product works.

bulletlora (< 20) Submitted: 6/11/2010 10:08:55 AM : Start Price: $6.80 APPY Score: -111.96

p and down but will recover with market.

SoMch2Knw (85.33) Submitted: 5/21/2010 2:58:23 PM : Start Price: $15.35 APPY Score: -118.17

Q: Why will this stock outperform the S&P 500?
http://stockcharts.com/charts/gallery.html?APPY
A: Rumors, manipulation and volatility.

pursueliving (< 20) Submitted: 4/26/2010 11:12:32 PM : Start Price: $24.25 APPY Score: -106.93

This little company just chugs along...and I believe it is going to be purchased by somebody, as the other bloggers have suggested. I've always believed that - purchased at $2 something, got scared and sold, repurchased today at $4.23 and hopefully won't look back. Thought - Abbott Labs recently finished a purchase - maybe another on deck?

moreofthesame (< 20) Submitted: 4/26/2010 3:51:00 PM : Start Price: $23.05 APPY Score: -106.14

Their appendicitis test is a novel concept and will help change medicine. They have already conducted 4 clinical trials and received essentially the same result. This last trial that is being analyzed had a modification to allow them to link the results to White Blood Cell Counts. This was not in their original stated goals with the last clinical study and they pulled the 510(k) filing. I anticipate that they will have their resubmission ready when they release the new trial. They will also be upgraded by at least one major financial rating company to "Strong Buy" following this and their share price will increase by $2-4 per share. They will probably also be bought out by either Merck or Novartis who they have already had partnerships with. The new CEO has experience with buyouts of this nature and I anticipate the share price will reach between $12 and 15 once again.

CTEsquire30 (< 20) Submitted: 4/23/2010 7:48:33 PM : Start Price: $20.25 APPY Score: -105.35

Upcoming FDA clinical trial approval expected!

ETFinnovators (< 20) Submitted: 12/25/2008 7:30:46 PM : Start Price: $29.75 APPY Score: -151.39

A New Emerging Diagnostics Index

The table at the web link below includes 39 companies in the ETF Innovators [ETFI] Emerging Diagnostics Index of U.S.-listed stocks with market caps of $10-$200M. The index includes diabetes care device makers such as DexCom (DXCM), personalized medicine lab service providers such as Clarient (CLRT), clinical diagnostic test developers such as OraSure (OSUR), diagnostic imaging service providers such as Virtual Radiologic (VRAD), diagnostic equipment makers such as Vision Sciences (VSCI), and genetic analysis + molecular diagnostic companies such as Affymetrix (AFFX).

http://www.etfinnovators.com/2008/12/new-emerging-diagnostics-index.html

AFFX is a stock I wrote about in late July as a value trap to avoid at over 7 bucks due to a string of poor results and lowered guidance. While the results are still poor and Illumina (ILMN) continues to dominate its now much smaller rival; the price for AFFX is now under 3 bucks and is getting so low that it could be acquired or will rebound sharply at any sign of improved results. However, with the current bear market for research spending by academic institutions + big pharma, a lack of near-term catalysts, and a $73M cash-funded acquisition of Panomics to expand its cellular + genetic analysis capabilities; I plan to keep AFFX on my watch list for a possible buy as a turnaround play.

Since I first wrote about Home Diagnostics (HDIX) 10 days ago as a value, turnaround play in the Healthcare Cost Containment Index, the shares have increased about 10%, but are still trading well below the 52-week high of just under 11 bucks reached in early September. HDIX makes blood glucose monitoring systems and testing supplies under the TRUE and Prestige brands, in addition to partnering with major drug chains and wholesalers for private label and store brand alternatives to more expensive name brands such as Abbott Lab's (ABT) Freestyle or Johnson & Johnson's (JNJ) One Touch.

Key factors to watch will be a return to sales growth in the low teens (13%-15%) and gross profit margins improving into the low sixties (62%-63%) as the Company ramps up its manufacturing capacity for the two new products and phases out the promotional activities. Once these favorable trends become apparent in the quarterly results, HDIX should find its way back to double digits around consensus analyst price targets of 10 bucks per share.

Earlier this month, AspenBio Pharma (APPY) completed enrollment in its pivotal Phase 3 clinical trial for AppyScore, which represents the first blood-based diagnostic screening test for appendicitis. On December 10, APPY guided for a time frame of 4-6 weeks for announcing the trial results with plans for an early 2009 submission for FDA approval in the form of a 510(k), which means results could be released within the next 2-4 weeks and provide an upside catalyst if the results support approval by the agency – with the added bonus of no safety concerns since the test is non-invasive.

EXACT Sciences (EXAS) has experienced a string of good news in the past 10 days, indicating wider acceptance of its non-invasive stool-based DNA [sDNA] colorectal cancer screening test by a trio of states and a major insurance company. While EXAS is up nearly 50% in the past month, the Company has lost over three-quarters of its market value in the past year. New Jersey and Maryland added sDNA testing to their colorectal cancer screening mandates while Cigna (CI) included the sDNA test as a covered benefit on a national basis.

Also, Massachusetts added the screening test to its Care Coordination Program for low-income individuals over age 40. Finally, University Hospitals Case Medical Center of Cleveland recently announced a pilot program for sDNA screening at two sites which will feature the test as the preferred option for those who are unwilling or unable to obtain a colonoscopy.

While EXAS represents my biggest loss for the year and has been a train wreck since I first wrote about the Company in October 2007; recently appointed Board member and healthcare dealmaker, Michael Singer, summarizes the remaining value drivers as follows:

1.) a portfolio of intellectual property in non-invasive prenatal diagnostics, non-invasive colorectal, and aero-digestive cancer screening

2.) the recent American Cancer Society endorsement of sDNA testing

3.) the commercial launch of ColoSure by LabCorp (LH)

4.) EXACT's long-standing relationships with scientific pioneers at Johns Hopkins University, Case Western Reserve University, and other leading medical institutions

bragac (< 20) Submitted: 11/4/2008 6:18:12 PM : Start Price: $23.75 APPY Score: -133.98

FDA approval Q109 then buy-out. Expect $20ish

noptov52 (27.08) Submitted: 11/4/2008 9:23:20 AM : Start Price: $24.50 APPY Score: -134.55

The results look positive, but you never know with the FDA.

thomasrn (71.64) Submitted: 10/22/2008 3:59:01 PM : Start Price: $26.60 APPY Score: -148.13

Assuming positive results as noted in ealier trials and FDA approval, this stock should rocket upwards given that there are no other blood tests available for one of the top emergency room visit complaints ie abdomen pain... appendicitis.

stockblog (33.09) Submitted: 9/28/2008 5:16:43 PM : Start Price: $32.10 APPY Score: -111.79

AspenBio Pharma Executes On Its Plan for FDA Clearance of AppyScore
AspenBio Pharma (Nasdaq: APPY) 1-Year Chart

AspenBio Pharma (APPY) is a small-cap diagnostic and animal health company whose main product in clinical development is AppyScore – a diagnostic screening test that detects blood markers that indicate both the presence and the severity (AppyGrade classifies results as normal through Grade 4) of appendicitis in patients who present with acute, severe abdominal pain of unknown origin. Key benefits of AppyScore include its low cost ($200 versus $1,500 to $3,000 for a CT scan), very low risk of false positive/negative results (99% combined specificity and 98% sensitivity), fast results (45 minutes versus a few hours for CT scans), and a proven ability to decrease both the number of unnecessary surgeries and CT scans.

The Company is also developing AppyScreen as a rapid screening test for appendicitis to be used by primary care physicians to help determine if further testing (e.g. AppyScore) and follow-up in an urgent care setting is required. AspenBio has modeled for AppyScore to achieve market share of 20% to 40% among 6 million patients presenting to the ER each year with abdominal pain, which equates to 1.2 to 2.4 million tests sold or $240 to $480 million in revenues. The Company estimates initial revenue from AppyScore/Screen in the US alone of $100 to $200 million, compared to a current market cap of under $200 million.

The Company also has an animal health segment, which faces fewer competitors and requires less investment of time and money in order to receive FDA approval, as compared to the market for their human counterparts. The worldwide market for animal health (including drugs and diagnostics) is expected to grow to just under $20 billion in 2008, representing 26% growth from just under $15 billion in 2003. The Company’s unique, recombinant technology for the production of hormones offers a variety of advantages over traditional, animal-derived hormones, including increased stability, no risk of disease transmission, a lower manufacturing cost, and a long duration of patent protection.

In late June, the Company initiated a clinical trial to support a 510(k) FDA application for its AppyScore appendicitis blood-based diagnostic test. Key study endpoints in the trial will be sensitivity, specificity, negative predictive value, positive predictive value, and appendicitis prevalence. Enrollment of the clinical trial was increased to about 800 patients in order to provide higher statistical power for the test. AspenBio is also in the final stages of completing the non-clinical section for the 510(k) submission package and expects the clinical trial to be completed in about four to six months with FDA clearance expected in early 2009. The Company also hopes to sign a worldwide licensing partnership or transaction prior to FDA clearance for AppyScore. AspenBio currently trades around $6 per share at a market cap of $188 million with about $24 million in cash, $3.6 million in debt, and a trailing 12-month loss of $7 million. The Company also announced a $5 million stock buyback plan in late April, and I believe the current price marks a good entry point for speculative biotech investors due to a high probability of successful results for AppyScore, which will support both FDA clearance and licensing discussions.

thewhipco (< 20) Submitted: 6/3/2008 12:52:58 PM : Start Price: $24.75 APPY Score: -96.01

The stock is a micro-cap that is very lightly followed. They have several products in their pipeline for both animal and human diagnostics. Their most promising product is a diagnostic blood test for appendicitis - a condition that is often mis-diagnosed at high cost to insurers, hospitals and patients. Initial trials have shown a very high specificity for the test. Because it is only a blood test, FDA approval should be relatively fast assuming that trial data remains positive.

ld5 (< 20) Submitted: 5/17/2008 9:37:32 AM : Start Price: $28.90 APPY Score: -93.78

Appyscore (appendicitis test that is 98% accurate) should receive first approval from FDA in next few months. Product will save lives, reduce insurance payments and eliminate unnecessary operations. Much faster than CAT scan, and much cheaper.

megainstincts (< 20) Submitted: 11/27/2007 2:00:58 PM : Start Price: $59.45 APPY Score: -96.37

First and only test available for diagnosing appendiciitis- will save many unnecessary surgeries, in the process make a bundle of money

fakemustash (21.43) Submitted: 10/18/2007 11:41:30 AM : Start Price: $66.10 APPY Score: -89.22

The stock is hot and increasingly noticed