Quote:
Originally Posted by freedogger
Tell us why please.
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You mentioned they'd get approval in 2012. The head and neck phase III isn't close to finished, meaning that they won't have the data in hand early enough to package it into the BLA for approval this year. The BLA alone is a minimum 6 month wait for appraisal by the FDA. And given this is the first reovirus, you're also looking at an ODAC panel meeting to serve as an additional hurdle. In other words, just based on time alone your prediction is not possible.
Second, and most important: their efficacy data in head and neck to date is very weak and from relatively small patient populations (groups of less than 20). That makes it a very, very weak proposition to have confidence in the phase III trial being a success.
I follow many of these biotechs as it's practically the only thing I invest in. The ONCY story is the typical of companies with weak drugs. There are many, many better ones to invest in. As a clinical prospect, it's way better than the dca scam run by the U of A guy... but that's faint praise.