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Monday, January 04, 2021 10:57:33 AM
Quote:
1) "CRO supervises ALL aspects of trials...from strategy, to regulatory compliance"
No. the responsibility for every aspect of the study rests with the Sponsor of the study, in this case IPIX
The Answer is YES: The CRO is responsible to Company to "Supervise" but the Company is Responsible to the FDA for the study (work product of CRO).
They are not mutually exclusive. The above statement does not state that the Sponsor is not ultimately responsible. It clearly states that the CRO SUPERVISES ...CRO is responsible to the Company, and Company is responsible for CRO's work product.
So what is your point?
FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals - Brilacidin for Treating
COVID-19
Brilacidin in a human lung cell line infected by SARS-CoV-2, achieved a high Selectivity Index rating of 426.
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