February 9, 2015

PV-10, Phase 3, Provectus: Almost [but not quite] there

Almost there (image source)
Provectus issued press release Provectus Biopharmaceuticals Met with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study today, with the byline FDA allows Provectus to go forward on Phase 3, and filed an associated 8-K.

Previously, on December 22, 2014, the company issued press release Provectus Biopharmaceuticals to Meet with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study with Aim to Maximize Speed of Enrollment regarding its Type C meeting with the FDA.

I imagine management's talking points are:
  • Provectus met with the FDA,
  • Eric has effectively managed his/the company's interactions with the Agency,
  • The FDA allowed Provectus to move forward with the company's Phase 3 trial, and
  • There are no more changes to the trial design.
My additional takeaways include:

1. While we're continuing to see and read about the making of more sausage, Eric continues to make progress towards kicking-off the company's Phase 3 trial. This meeting result should enable Provectus to commence patient enrollment and treatment following completion of various/certain procedural trial-related items. The Phase 3 trial after all is a registration study that successful completion of which should lead to drug approval.

2. We'll need to see the final version of and thus the changes in the trial protocol posted on ClinicalTrials.gov to draw what (if any) conclusions about how much (if anything) Eric was able to positively change of the trial's operational aspects. If he did effectively manage the FDA, he should have got a lot of what he wanted.

3. I imagine the elapsed time between the dates of the meeting (January 29th) and today's press release (February 9th) primarily if not exclusively comprised waiting for the Agency to confirm in writing Eric's understanding of the meeting's results.

4. Eric was being Eric in issuing a useful but overall poorly written press release from a stock market perspective. He approves (and also may write or mostly write), I believe, all releases related to Provectus' clinical development program. His statement in the PR, among other things, that "[t]he outcome of the review does not affect the fundamental design of the study nor the patient population, but does affect certain details concerning some secondary end points and statistical analysis matters, such as the treatment of missing data" (underlined emphasis is mine) is his way of communicating, I believe, that he endeavored to cover as many of his trial bases as he could, in this case as an example discussing with the FDA a potential scenario in which data is missing from the trial, and how to handle such a situation from among other things a data reporting and analysis perspective. Eric is a process- and detail-oriented (i.e., anal retentive) individual, a character trait I value in his clinical development program role and given his responsibilities, albeit taken in the context of his inexperience entering the role and his experience set now.

5. Although Eric has repeatedly missed timelines and deadlines he has set for himself (and thus Provectus) and despite prior expectations for an earlier start to this trial that repeatedly changed — 3Q 2014 in June at ASCO, 4Q 2014 in September at ESMO, 4Q via the corporate website presentation prior to the December 22nd press release, 1Q 2015 via an updated version of the presentation in January and potentially imputed from today's press release — the 6-month delay from 3Q14 to 1Q15 on the front-end (pre-Phase 3 trial start) may save time and improve outcome on the back-end (drug approval).

6.  I find it hard to believe there were no discussions related to PV-10's label, which would be finalized or put into place should the trial be successful. Eric being Eric, however, means his press release would not discuss the topic because the label was in-process; that is, publicly discussing the label before the trial had an outcome would be premature.

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