Tuesday, February 23, 2016 5:45:06 PM
"ATHX: I don't really care about this company at all, but because I'm interested in the stroke space, I looked a little bit deeper at the recent 1-year results http://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/@scon/documents/downloadable/ucm_481665.pdf
I still haven't looked that deeply at the company's history. That said, I actually agree that AF's article trashing the results was poorly written. IMO his article was haphazard and unconvincing. But I agree with his overall conclusion, which is that the 1-year results are nothing to get excited about.
First, the argument about 'following the money' w/r/t the Healios deal is bogus. If finding successful biotech candidates was as easy as following moderate investments from regional players, we'd all be rich. If you really want to follow the money, how does Healios' investment compare with the loss of value the company experienced following the negative primary result from the Ph2 trial? And what of the loss of partnerships from Chugai and Pfizer?
When actually looking at the 1-year data, there are 2 things that strike me:
1) what's the proposed biologic rationale for a delayed benefit (none at 90 days, significant at 1-year)? I think AF probably misstated his point about 1-year outcomes in his article. Of course 1-year outcomes matter, but given what we know about stroke, I don't think anyone would expect a stroke treatment to have zero efficacy at 90 days and significant efficacy at 1-year. Clearly ATHX didn't expect this either, as they selected 90 days as their primary endpoint. That doesn't mean it's impossible for a treatment to have such effect, but unless there's a very strong biologic rationale, this should raise a big red flag
2) If I'm understanding slide 7 correctly, there was little/no data collection of subsequent care or how subsequent care may have differed between the two arms. This ties back into the first point -- if we don't know whether patients received comparable care after 90 days, it could further confound the 1-year results. It also ties back to my prior comment about wanting to see more detailed patient baseline characteristics to understand any other potential differences between the two arms. Particularly in such a small trial, small imbalances can have a large effect."
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