BMSN Why it is running explained.
On May 30, 2012 Regen entered into a Letter of Intent (“LOI”) with Clinartis LLC (“Clinartis”), a contract research organization, whereby Clinartis will provide services to Regen which will include the following:
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Assessment of the probability of clinical and regulatory success, and commercial potential of intellectual property;
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Due diligence on published data and data supporting patent claims;
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Development of the regulatory strategy for development of novel therapies;
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Design and development of clinical development program for novel therapies;
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Support for solicitation of FDA and other regulatory agencies feedback on the regulatory strategy and clinical development of novel therapies;
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Preparation and submission of INDs, BLAs, NDAs to FDA and similar regulatory submissions in foreign jurisdictions;
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Feasibility assessment for conducting clinical trial for novel therapies;
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Setup, management and monitoring of clinical trials on a global basis;
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Analysis of clinical data, preparation of study reports.
The LOI contemplates Regen and Clinartis entering into a Master Services Agreement which shall outline the general terms for providing services by Clinartis.
