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Find FDA Investigational New Drug (IND) Submissions for Musculoskeletal in UNITED STATES

A collaboration with SCORR Marketing

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            Lead Product(s): Diclofenac Hydroxyethylpyrrolidine

            Therapeutic Area: Musculoskeletal

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 19, 2020

            Details:

            FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm™, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug.

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            Lead Product(s): OK100 stem cell

            Therapeutic Area: Musculoskeletal

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 16, 2020

            Details:

            Celavet is submitting the study protocol to the CVM for Investigational New Animal Drug (INAD) status.

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            Lead Product(s): Cad-1883

            Therapeutic Area: Musculoskeletal

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 23, 2020

            Details:

            The Phase 2 trial is a multicenter, randomized, placebo-controlled study that will evaluate the safety and efficacy of CAD-1883. Efficacy outcome measures.