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Cellectar Granted SME Status by the European Medicines Agency
Designation Comes with Financial and Scientific Incentives FLORHAM PARK, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Designation Comes with Financial and Scientific Incentives\nFLORHAM PARK, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-sized Enterprise (SME) office.\n The newly granted SME status allows Cellectar to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective EMA pre and post-authorization regulatory filings, including orphan drug and PRIME designations. Cellectar is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process. “The receipt of our SME status is timely as we prepare to engage the EMA for discussions to harmonize CLR 131’s pivotal study,” stated James Caruso, president and chief executive officer. “SME status from the EMA, will allow Cellectar to pursue EU marketing authorization in a more efficient and cost-effective manner and will greatly benefit our company as we advance CLR 131 to commercialization.” The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies like Cellectar to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options like CLR 131. Detailed information on SME status can be found here. About Cellectar Biosciences, Inc.Cellectar Biosciences is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) deli...