Biotech Values

[exwannabe]

DCTH:

PS Beware the SPA - DCTH also had an SPA with a similar kind of endpoint and was stat sig, but received a refusal to file from the FDA (allegedly over manufacturing types of issues)

Per DCTH there were 3 issues, CMC was just one. The issue most talked about is that the safety records were incomplete, the FDA wanted the patients' hospital records.

The third issue, which is almost never talked about, was that the FDA wanted a statistics issue "clarified". I find this very interesting.

Given the nature of DCTH management I would put the odds at 50% that they somehow cooked the trial numbers (in the sense of the analysis was not in accordance with the SPA).

I really hope they have an AC meeting on this one next summer, could be fun.