"The additional data requested by the FDA for inclusion in the Company’s De Novo submission relates mostly to the novelty of the contrast agent and its intended application to oral tissues."
This is the problem, this is what is different from CZM's Convivo. "the contrast agent and its intended application to oral tissues". Ironically, if it didn't use the contrast agent, it would have been approved?
In fact as I look at it they probably have to do another oral cancer trial. Meantime they can continue to progress the other applications and the AI. It's even possible that the mastectomy margin application might be completed more quickly. Until then we rely on CZM and the occasional research sale, or sales in other jurisdictions.
"The additional data requested by the FDA for inclusion in the...
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| Last trade - 15.11pm 29/05/2024 (20 minute delay) ? |
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