According to management, Provectus presumably would not fall under NCE because there is a history within the FDA with rose bengal.
UPDATE (11/3/12): NCE status is not relevant to Provectus' discussions with potential oncology partners. The company's new synthesis of rose bengal does not change its immuno-chemoablative properties, so PV-10’s “active moiety” is, in fact, not new.
A blog reader shared this link on the topic of NCE status and whether it matters for Amarin and its Vascepa drug. I found it informative.
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