Introgen’s attempt to seek approval for its gene therapy cancer treatment, Advexin, has been slapped back by the FDA at the first hurdle, with the regulator saying its BLA was not sufficiently complete to warrant review. The move is a damaging blow that raises serious concerns about the group’s future.
The US biotech has been struggling for some months to convince the market that its trials were robust and that the product works; the regulator clearly does not feel it has sufficient evidence to answer those questions. With only $11m in cash, enough to last to the end of March next year, and the stock at a record low of 57 cents, Introgen is running out of time and options.
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