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     185  0 Kommentare Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant - Seite 4

    These forward-looking statements are based on Radius management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic, including the delay of reviews and approvals by the FDA and other regulatory authorities, delays in the supply of drug product, risks related to Radius' collaboration with Menarini, including its ability to scale its sales and marketing operations if elacestrant is approved for marketing; Menarini's ability to obtain favorable pricing and reimbursement for elacestrant, if approved; the risk that the potential market for elacestrant is not as anticipated; the risk of adverse side effects related to elacestrant are identified; risks related to manufacturing, supply and distribution of elacestrant; and the risk of litigation or other challenges regarding Radius' intellectual property rights. These and other important risks and uncertainties discussed in Radius' filings with the Securities and Exchange Commission (SEC), including under the caption "Risk Factors" in Radius' Annual Report on Form 10-K for the year ending December 31, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent Radius' management's estimates as of the date of this press release. While Radius may elect to update such forward-looking statements at some point in the future, Radius disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Radius' views as of any date subsequent to the date of this press release.

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    Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant - Seite 4 Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patientsPriority Review requested; if accepted, anticipate an 8-month FDA reviewPositive EMERALD study data previously announced on October 20, 2021First, and …