Dan Weiss

AspenBio: Bursting with Possibilities

My timeline is unchanged from the prior release with an expected decision somewhere around the beginning of 2010.

AspenBio: Bursting with Possibilities

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.

FDA Calendar Updates: AspenBio, CytRx, Cephalon, Pozen, Sanofi, AMAG

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.