Brief: Cytrx says FDA agreement on regulatory pathway for Aldoxorubicin

LadRx

19/04/2017 12:00

April 19 (Reuters) - Cytrx Corp  CYTR.O : 
    * Cytrx announces FDA agreement on regulatory pathway to 
approval for Aldoxorubicin in soft tissue sarcomas 
    * Development program can support approval, no new studies 
requested 
    * Cytrx is under confidentiality agreements with a number of 
companies for a commercial partnership for marketing of 
Aldoxorubicin 
    * NDA submission by Cytrx being prepared 
    * Goal is to submit a rolling NDA to FDA for soft tissue 
sarcomas in last quarter of 2017 
    * Proposed product label would include treatment of soft 
tissue sarcomas 
    * Is under confidentiality agreements with a number of 
companies for a commercial partnership for marketing of 
Aldoxorubicin 
    * Also plans to discuss with European Medicines Agency a 
path to filing a marketing authorization application 
    * Commercial launch of Aldoxorubicin is still projected for 
2018 in United States 
 
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