CASI Pharmaceuticals Provides Update On EVOMELA®
The Advisory Committee Meeting is a closed meeting. No additional information on the EVOMELA® application has been requested by the CDE in advance of the Advisory Committee Meeting, however, CASI will submit a Clinical Data Briefing Package which will summarize the various components contained in the previously submitted application.
EVOMELA® was accepted under CFDA's new guidelines for priority review and the review by the Advisory Committee was expected as part of the recently implemented CFDA reforms. CASI anticipates that after the Advisory Committee Meeting, the Advisory Committee will make a recommendation to CDE, followed by CDE recommendation to CFDA, and CFDA notification of review status to CASI.
As reported previously, the
- EVOMELA® is indicated for the treatment of multiple myeloma, which is classified as a rare disease in
China ; - There is no melphalan in any formulation available in
China to address this unmet medical need; - EVOMELA® has clear therapeutic advantage to currently available therapeutics.
About
CASI is a
Forward Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in
EVOMELA®, MARQIBO®, and ZEVALIN® are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates.
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617 221 9005 |
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