Player Avatar zzlangerhans (99.85) Submitted: 5/17/2011 2:25:50 PM : Underperform Start Price: $58.80 VCEL Score: +12.17

Lately, Aastrom has suffered from over-promising and under-delivering on the advanced clinical trials of their tissue repair cells. Did I say Aastrom suffered? I mean their shareholders suffered. Aastrom reverse split and raised more cash.

Once again delivery time approaches. Final results from IMPACT-DCM will be reported in Q3. I reviewed the interim data that was presented in January via Zacks' Napodano, a raging Aastrom bull (Aas-slave?). They claim an improvement in NYHA class of CHF that appears impressive, but no effect on exercise tolerance or structural heart measurements. Also, it is unclear whether these findings apply to ischemic DCM only or the entire study population. Regardless, the numbers are very small and insufficient to establish any statistical significance.

I expect the final data to be similar to the interim data, and I'd be surprised to see more impressive data from an interim analysis of the Catheter-DCM trial. The company will need to raise a lot more money to conduct phase III trials in CLI as well as in DCM and are unlikely to find it anywhere except the capital markets.

Just as a side note, I went onto Aastrom's website to see a picture of an overweight, red-faced guy squinting at me with the caption "IMPACT-DCM patient". I guess it's a change-up from the usual stock photos of happy people in a park or models with pipets but still, WTF? Is it supposed to be proof that their trials are actually in process? Or a reminder that their technology will benefit real people like you and me? I just found it creepy.

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