Great News! I’m glad to see we are re-submitted and on the 30 day clock with FDA, but I especially liked Dr. Sylvia Holden’s quoted comment about Kevetrin having unparalleled magnitude of potential….Fantastic!
Gotta love this line: As a stand-alone or combination front-line therapy, the magnitude of the potential of Kevetrin™ is simply unparalleled by anything that I have ever seen in the laboratory before.
From the PR and I also believe in the 10Q from Friday:
'Primary endpoints for the study will be safety and tolerable dosing levels for a future Phase 2 clinical trial.'
What about efficacy in Phase I as they've previously stated before? Does anyone have any thoughts in this area as to whether phase I is just exclusively safety and tolerable dosing levels? It would be nice if this is a potential break-thru drug that it could be fast-track through all phases of development.