hopefully the added time, complete in-vivo mouse tox battery + prpf31 patent = a better quality/query free IND submission for the FDA to assess/approve.
First time an external party will inspect us under the hood, no secrets and no more flying under the radar - key elements they’ll seek are our:
1) pre-clinical safety & efficacy data points: patient derived to NHP 2) clinical trial strategy/design: granular target population - inclusion/exclusion, dosing, endpoints etc 3) drug design & manufacturer: chemical makeup/manufacturing ins and outs 4) safety monitoring plan - the latest 4c stepped through this
A huge body of evidence, and immense milestone for the team (and shareholders) which I believe will be of the highest quality
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(20min delay)