January 15, 2014

Waiting for the FDA... (updated)

Earlier today Provectus issued an 8-K regarding the company's ongoing interaction with the FDA following the December 16th meeting with the Agency: "Reference is made to...a Type C meeting with the FDA Division of Oncology Products 2 on December 16, 2013 to discuss the Company’s oncology drug, PV-10. Subsequently, the Company took the opportunity to provide input into the documentation of meeting minute notes. It is the opinion of the Company that this may have delayed the process of receiving the final meeting minute notes. Therefore, the Company will communicate further guidance from the FDA once the meeting minute notes have been received, which is expected shortly. It is also the Company's opinion that the delay has no bearing on the FDA's decision regarding the efficacy of PV-10 but is rather a matter of observing governmental processes. This delay also has no bearing on the Company's discussions and negotiations with parties outside the FDA's jurisdiction."

I don't think there is any bad news here. There is, however, no official good news, yet. For now, maybe just this message: "The final meeting minutes didn't arrive within a reasonable period of time following the close of trading on January 15th (you know, the date by which we promised to get back to you) for us to confirm our planned PR before issuing it." Management gave itself no wiggle room by including a capitalized byline in its December 18th press release Provectus Type C Meeting With FDA Oncology Division Held December 16, 2013: OFFICIAL MINUTES EXPECTED BY JANUARY 15, 2014. The FDA set a performance goal (government fiscal year 2008-2012) of returning minutes within 30 days of a meeting 90% of the time (see here, a link found by/courtesy of a shareholder and blog reader). From the prior link, as of September 30, 2008, the Agency was not achieving performance goals for meeting management, providing minutes within 30 days 61% of the time. Even though meeting management performance may have improved since then, it's not unreasonable to still expect potential delays. Based on Provectus' 8-K today, this appears to be the case.

My investment thesis remains the same.

Bullish as the December 18th PR likely was intended to be by the inclusion of the January 15th date, I believe management's intent (temporarily unsuccessful by virtue of delay) was to have wanted to simply communicate what clearly has to be groundbreaking recognition by the FDA that local therapy PV-10 can treat systemic disease. Once PV-10 presumably had been acknowledged as a viable and needed treatment for cancer (melanoma), an important ideological decision for the Agency to embrace and make, I would imagine the FDA and Provectus subsequently worked together on outlining agreements, disagreements, issues for further discussion, and action items (coming out of the December 16th meeting) to pave a mutually acceptable approval pathway for the drug. For example, recognizing local agent PV-10 can treat cancer, a systemic disease, undoubtedly would require more relevant and appropriate endpoints. To arrive at agreement, it's quite possible the time taken between the December 16th meeting and now would have comprised, among other things, collaboration between the parties on data and statistical analysis in support of the right endpoint(s). Based on my reading of readily available administrative and correspondence documents of previously approved drugs (and the interactions of their sponsors and the FDA), all of this would be documented in some form or fashion in final meeting minutes. I'm sure such documentation, and its receipt by Provectus, would be necessary for this management to feel comfortable issuing a milestone press release.

Until then, we patiently wait some more.

Updated (1/15/14): As I noted above, I previously read about actual experiences and interactions of sponsors (whose drugs ultimately were approved) with the FDA in the kind of meeting Provectus had with the Agency on December 16th. In them, the FDA and sponsor reached a consensus during the meeting. The sponsor subsequently waited until the Agency had codified the consensus reached (i.e., memorialized and sent final meeting minutes) before the sponsor communicated the outcome to the public. Provectus appears to be in the same situation.

Provectus presumably reached a consensus with the FDA on December 16th, and clearly is waiting to receive codification of the consensus from the Agency (i.e., return of the final meeting minutes) before issuing a press release describing it. I believe this consensus will provide clarity for PV-10's approval pathway. I further believe the pathway may either be a one- or two-step process, both providing discernible timelines from the drug's commercialization.

It seems to me the company is discussing an accelerated path to market for PV-10 with the FDA when recalling the changes management recently made to Provectus' website presentation (see Paying Attention (January 15, 2014) under the blog's News tab).
Click to enlarge the figure.
Regardless, we await management to speak substantively about clarity and this potentially groundbreaking outcome. I remain very bullish about Provectus' prospects.

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