If you've followed Provectus long enough, and gotten to know the principals and their ways, you develop a better understanding of their respective processes.
Eric's process in this instance may have required him to wait for the above mentioned review period to pass, so as to examine and evaluate what (if any) significant and/or general comments the FDA might have provided to him about the protocol, before Provectus would commence or move forward on actions and activity dependent upon an agreed to, uncommented on, essentially approved, etc. protocol (e.g., Phase 3 trial commencement, filing the protocol with country-specific versions of the Agency, regional license transaction consummation, etc.).
The ClinicalTrials.gov website page for the melanoma Phase 3 trial notes the protocol was received November 4th. Assuming Eric submitted it to the Agency, say, either October 31st (Friday) or November 3rd (Monday) [leaving a day or two for it to make its way to the website], a 30 to 45-day period of time takes one anywhere from early- to mid-December (e.g., 1st, 3rd, 15th, 18th).
No comments:
Post a Comment