CLINICAL Development Plan
To date a total of 13 studies, 9 in-vivo preclinical studies and 4 stability
studies, have been conducted. A comprehensive package of in vitro studies demonstrated the PK profile of ML141 is similar to that of marketed docetaxel products. All required studies for NDA submissions are completed or nearly completed.
It is the companies intention to submit ML141 in the US and in EU in the coming months via 505(b)(2) regulatory pathway.
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