Dan Weiss

Dan Weiss
Contributor since: 2007
Awakening- at this point its a wait and see on APPY. I dont think anyone liked the wording of that press release and I definitely have my doubts about the management team at this point. That being said the stock is now priced completely for failure on AppyScore so any positive data that they are able to get out of the trial would be a positive.
Emory- I did not write a ten predictions for 2010 so Im assuming you are talking about someone else. My last major predictions public piece was in regards to stocks to buy under the Obama administration which have greatly outperformed all of the key indices. In regards to APPY, I have lost money just like anyone else in the stock and have not ever been affiliated in any way with AspenBio.
FYI.. New targets from Jeffrey Frelick at ThinkEquity. Conservative estimate if study points to no improvement in NPV or sensitivity $6, average scenario if small improvement in NPV or sensitivity $10, bullish scenario of significant improvement in NPV and sensitivity $22. Timing still most likely in late May to first two weeks of June.
I have expanded my original timeline after speaking with the company to: May 17-June 18 to reflect the increased complexity due to testing on three different options and the fact that the company would like to have the results along with the 510k submittal closer together.
Interesting article from the University of Pennsylvania on AppyScore for those who may be interested: www.uphs.upenn.edu/new.../
I tend to be a longer term investor so Im not concerned with day to day volatility. The stock has traded with tremendous volume in the past week so a period of consolidation is not unexpected and does not change any of my longer term price targets. I would note that my $12-16 target is based upon full FDA approval of the 15 minute device and not on the clinical study results expected in the next 1-3 weeks although $8 is a reasonable target if the results prove to show strong efficacy. Note that if the results were to not show efficacy (which I consider to have very remote odds: 10% or less) the stock would substantially decline.
The specificity was actually 60% when combined with a WBC at a 15 cutoff and 70% at a 20 cutoff with an NPV of 98%. If these results are repeated, I dont think APPY will have any problems having this product at nearly every emergency room in the country (but we will wait for the results in a couple of weeks to confirm).
An additional point is that a retrospective analysis of the clinical results of the 1/09 study showed that AppyScore combined with WBC resulted in an NPV of 98%. I anticipate additional confirmation of these results in a couple of weeks but as always with any biotech they are speculative investments. This compares to the current standard of care which is a CT scan having a NPV of just 78%.
Im thinking that the author is referring to the potential market size of APPY rather than the science which is quite different between the three different companies.
Appyscore as a standalone had an 87% NPV in the study conducted in early 2009 which was the primary reason for the large decline in share price at that time. The company retroactively looked at results where Appyscore was used in combination with WBC or neutrophil and the NPV results were higher than 95%. Because the original clinical study did not specify that the Appyscore was to be used in conjunction with a WBC or neutrophil the company could not successfully present this data in an FDA filing which is the primary reason for the just recently completed clinical study. The labeling of the product will likely be, "“to be used to evaluate patients with abdominal pain suspicious for acute appendicitis” whereby it can rule out negative cases and prevent unnecessary CT scans.
Highbury acquisition has gone through by AMG.
We have been doing work on the website-- thanks. In the meantime I would be happy to share my other ideas with those who may be interested.
Im also a fan of the May 2.5 call options which are priced very inexpensive for a major pending event.
News today (2/9) is a potential net positive for the company although it does mean a slight delay in a decision. The company will be releasing results of a pivotal study with 800 patients in March (the study will be completed within 30 days from today). I am expecting strong results on at least 2 of the 3 components which if it were to occur would likely push the share price much higher from today's level. The risk is clearly that the study fails to show AppyScore works by itself and with other items such as a CBC.
My timeline is unchanged from the prior release with an expected decision somewhere around the beginning of 2010.
approval just given for bepreve after the closing bell today.
Solid growth of Cinryze sales from Viropharma just reported this morning. In terms of looking ahead, DYAX is next up on the plate for potential approval of an acute HAE indication.
I would advise extreme caution on BIEL. In the first quarter of 2009 alone (January-March) the company nearly doubled its shares outstanding from 266.9 million to 492.2 million with sales at 0.005 per share and I would not be shocked if significant additional shares were issued since then.
The typical length is 90 days, however, APPY has a significant amount of information in the filing which will typically result in more communication between the company and the FDA resulting in a more realistic timeline being approximately 180 days (although its always possible the period could be shorter). In terms of market potential the appendicitis test has an overall market possibility of $1 billion or more on a global scale (which is not far off from the market size of HGSI with lupus considering that company's split with Glaxo). My current expectation is for likely approval of the ELISA at the end of this year with the hopeful full approval of the AppyScore test coming later next year.
I like APPY here although the full market potential will likely not be reached until the second half of 2010. The firm has developed the first test for appendicitis which will not require a CT scan and is currently pending its first 510k submission to the FDA. Ive spoken with almost a dozen physicians who say if this works it will become the standard of care in emergency rooms where anyone who has abdomen pain will be given this test. Estimates for the global market from Think equity, a respected investment research firm are around $1 billion per year, all for a company with a less then $100 million market cap. Of course, this is a highly speculative name but one where if it hits returns of 12-18x the current price or more is very possible.
Very positive briefing docs completed by FDA yesterday for panel meeting on 6/26. Bepreve showed no major side effects (minor side effect of dry mouth was found) and p values showed that Bepreve is effective with conjunctivitis and itching of the eye. Should set up for a positive vote tomorrow.
The larger item for Viropharma will be the FDA decision in August on whether generic companies can create Vancocin but the acute HAE decision is also important for VPHM.
Fantastic results from ALGT. They seem to be winning on two fronts with lower energy prices and by a trading down effect of consumers. Interesting that this company could earn $5 per share this year in a recessionary environment assuming no major spikes in oil prices. Looks interesting in the low 50s.
I actually like some education stocks on the long side but LOPE looks like a near no-brainer short at this time based on valuation. Also, APEI looks expensive at these levels. A stock like DV is actually relatively attractive at my opinion based solely on valuation.
Meadow Valley acquisition closed today with 75% premium to today's closing price of $6.41. Deal closed at $11.25, Congrats to those who own the stock.
I like your strategy but I am not a fan of COCO or CECO in the sector. DV, ESI or STRA are much stronger players in the education industry without the issues that COCO and CECO have faced in recent years. STRA is a bit expensive for my taste but DV or ESI could be nice setups.
All three names have shown material losses since the post although the decline in UA is a bit less then I would have expected. I would continue to be bearish on all three names although at $0.19 TRMP may be worth covering even with a $0 target.
In the short-term Treasuries could actually continue to rally. Economic conditions will remain poor through at least much of next year and the Federal Reserve's new policy is quantitative easing through the purchase of these bonds which would be shorted in these instruments. Keep in mind in Japan that the 10-year rates fell below 1% so anything is possible. Long term, I agree with the author 100% that Treasuries are overvalued but they can be propped up for a long time by the Government.
Bush threatened congressional republicans that he would use TARP money for the bailout if this did not pass Congress. I would expect an announcement over the weekend that a limited amount of TARP money will be used.
GM has very little secured debt so its likely the bondholders would get something back regardless but its possible in a worst case scenario they get money back at slightly lower than current levels and have to wait a significant period of time to receive it while courts negotiate it.
A couple of things to keep in mind. The mini-bonds are unsecured bonds that trade on exchanges therefore they are naturally less risky than the equity but at the same do still have risk. THat being said most are trading at about 16 cents on the dollar (they have a par value per share of $25). GM has said on multiple occassions that they plan to try to restructure this debt which would most likely result in a double or more from current levels if it is completed.
You could sell the March 3's for about 0.60 if you think they will survive until a bailout or for some the January 2010 2 1/2 or 5 could be interesting. Now ,personally I like the bonds of GM which are extremely attactive at current levels (they actually sell for less than the equity in some cases) and would likely give holders some value even if GM went bankrupt unlike the equity.
Disclosure: I have bought both GMW and RGM (these are traded on the markets but are senior unsecured debt) with yields close to 60%. Both have a $25 par value and are selling at just below $2.50 or less than 10 cents on the dollar.