The 'mixed results' statement in the article refers to other companies, not to Invivo research. Both of the referenced companies failed in reaching their goals of bringing new drugs to market to repair damaged nerves or prevent further damage to nerves after injury. Invivo's initial market entrance will be with the scaffolding device. So far - they have not had mixed results. This article, written in Dec 2008 - talks about the new primate study for 2009, which Invivo successfully completed.
Reynolds certainly did underestimate the proving time required to go from successful primate to human studies though. But as a long term speculative biotech investor I am both used to and unsurprised by this. I postulate with some surety that most seasoned investors in this unpredictable sector are also unsurprised and unruffled by the expected delays - especially since the company has made such steady progress and consistently communicates well with its shareholders.
And the FDA is presently working with Invivo on their application - they provided the guidance for Humanitarian device exemption submission on this first in kind product. That is not a refusal of approval. It looks quite hopeful actually.
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