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Also...."On June 18, 2019, we met with representatives

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ejobkar   Wednesday, 10/02/19 08:09:06 AM
Re: ejobkar post# 683
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Also....

"On June 18, 2019, we met with representatives of the U.S. Food & Drug Administration ("FDA") for a Type C Guidance Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial. We discussed our clinical development efforts with the FDA and proposed safety and efficacy endpoints for our next clinical trial. In July 2019, the FDA provided its meeting minutes for this meeting that documented general agreement with the Company's proposed randomized clinical study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints and other key aspects of our clinical trial design including appropriate quality of life measures. On October 1, 2019, the Company submitted a Phase 2b/3 randomized, controlled clinical trial protocol to the FDA incorporating these suggestions. If this trial demonstrates significant improvement on various measures of patient health status, we believe it could potentially form the basis to submit a new drug application (NDA) for the eventual marketing of BIV201 in the US. While the FDA has not provided final guidance nor do we have certainty as to what that guidance would entail, our goal remains to commence the planned Phase 2b/3 trial in the next several months in a manner consistent with what was reviewed with the FDA. We may still need to address certain risks associated with yet to be validated quality of life measures."

"In September 2019, the Company manufactured the first batch of a novel patent-pending liquid formulation of terlipressin for use in the Phase 2b/3 trial subject to FDA clearance. This new product format is intended to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the powder version."

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