November 26, 2014

It's Eric's process

When Provectus issued its November 6th Provectus Biopharmaceuticals Submits PV-10 Phase 3 Melanoma Protocol to FDA press release, the action of merely submitting the protocol to the Agency felt incomplete because management noted in the PR "The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days."

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 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).

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