January 18, 2012

Provectus Receives Guidance From FDA On Pathway to Approval for Phase 3 Trial of PV-10 For Metastatic Melanoma

Let's cut to the chase: Management got their SPA (for the pivotal MM Phase 3 trial). Congratulations!

Of course, the PR did not explicitly say Provectus reached an agreement with the FDA on the trial design. Such agreement will come (and subsequently be announced via another PR) when the company submits the final protocol (trial design) to the FDA for its endorsement and the agency endorse such.

Remember, words have meaning. The PR, to include the appendix (About the Special Protocol Assessment), was carefully constructed. Compare Provectus' PR today with the PRs of other companies that have agreed with the FDA on their respective SPAs. The company's PR, by inclusion of this appendix, is the same as those others.

Today's PR should suggest that management got their SPA (of course, as delineated, potentially subject to some iterations with the agency).

Great news! And another big step for the company.

From a time frame perspective, if management were to submit the final protocol this week or next (i.e., as soon as possible), and without further iterations with the FDA, I would expect Provectus to announce agreement in early- to mid-March (Q1).

A friend of the blog suggested to me today that institutional investors and hedge funds, while perhaps nibbling at the stock along the way, will jump in or get off the sidelines only when the "official" agreement PR (together with details of the trial design) is out. For those [investors] not yet looking at the company, a PR clearly stating "agreement" with the FDA on the SPA will get their attention.

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