Medivir AB (STO: MVIR), a research-based pharmaceutical company with a focus on oncology, announced on Monday the decision by its board of directors to continue discussions with the US Food and Drug Administration (FDA) to agree on the design of the planned pivotal phase III clinical study of remetinostat for the treatment of early-stage cutaneous T -cell lymphoma (CTCL).

Reportedly, the aim of the continued dialogue with the FDA is to agree upon the design for a phase III study that could, if successfully completed, lead to the approval of the company's most advanced candidate drug within oncology.

According to the company, the start of this study will not be possible earlier than 2019 and not in 2018 as previously communicated.

Medivir firmly believes that remetinostat has an important role in the treatment of various cancers, including early-stage cutaneous T-cell lymphoma, where there is a great unmet medical need. Also, Medivir's commitment to develop remetinostat is based on its significant commercial potential and therefore it is of utmost importance that it designs a phase III study that meets the expectations of the regulatory agencies.

Further discussions with the FDA are needed to ensure that the company can initiate a pivotal study that will allow Medivir to bring this drug through approval and to patients, the company added.

Also, details of the phase III study design will be published at a future date when finalised.