Medical imaging technology company,, announced on Thursday the successful completion of patient enrollment for its phase III clinical trials.
The clinical trials, with its aim to demonstrate non-inferiority of the group’s drug-device combination, enrolled a total of 80 patients — out of these, 48 were designated to lung transplant whilst 32 were in lung resection.
The following readout process will now move to image and statistical analysis, the company explained -- this is a process to conclude the readout which is expected to take around 10 weeks.
The completion of the readout is important to form the basis for an NDA, or a Pre-New Drug Application meeting with the FDA, as emphasised by regulatory consultants of the group.
Following a pre-NDA meeting, with its considerations incorporated into a submission, the process will conclude with Polarean’s submission which the company expects to be made by the end of Q2 2020.
"The Company is pleased to have successfully completed enrolment for its Clinical Trials and looks forward to the next stage of statistical analysis ahead of readout and the proposed submission of the NDA,” said Richard Hullihen, Polarean’s Chief Executive.
Additionally, Polarean further announced the appointment of Mr. Alex Dusek as Vice-President of Commercialisation as the group ramps up preparation for commercialisation.
Having led product launches at multinational biotechnology firms like Bayer and United Therapeutics, Mr Dusek will bring with him “a wealth of direct pharmaceutical industry launch preparation" that is consistent with Polarean’s commercial targets.
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