Redefining Drug Development: How the FDA’s New Voucher Program Could Accelerate Provectus’s Affordable Cancer Immunotherapy Mission
The Food and Drug Administration (FDA) introduced a new regulatory tool that could reshape the future of drug development. Provectus may be uniquely positioned to lead in this new era.
The Commissioner’s National Priority Voucher (CNPV) program, launched in June 2025 under FDA Commissioner Dr. Marty Makary, represents a decisive shift in how the Agency evaluates and expedites new therapies. For the first time, increasing affordability is explicitly part of what the FDA considers a national priority. Other key priorities (to Provectus) include delivering more innovative cures and onshoring drug development and manufacturing.
Dr. Makary said in a July interview with Bloomberg, “We can issue a national priority review voucher for companies that are promising to equalize the price between OECD countries and the United States…” This is comparable to Most Favored Nation (MFN) pricing. This is an easy “compromise” for Provectus because we don’t buy into pharmaceutical and biotechnology industry rationalizations for higher U.S. drug prices.
The Company can go beyond MFN. Provectus will price RBS-medicines well below branded standards of care cancer immunotherapies. From a pricing perspective, compare IL PV-10 to the 2015 FDA approval of Amgen’s intratumoral oncolytic virus Imlygic (talimogene laherparepvec) for injectable solid tumor cancers. At the time, Amgen anticipated the average cost of Imlygic therapy for the approved Stage IV melanoma indication to be ~$65k, compared to systemically administered Keytruda’s cost of ~$150k per year. We think a first drug approval for IL PV-10 can be priced well below these.
The CNPV program does more than offer expedited review, down to 1–2 months. It appears to reorient the regulatory process toward value, not just innovation (or what some might call innovation). This program opens a path for companies like Provectus to show that delivering truly innovative therapies and prioritizing patient access are not mutually exclusive goals, they're inseparable.
Caveats and Caution
Our oncology regulatory strategy and affairs firm is aware of the CPNV program and will help us consider if and how it fits into our clinical development programs, starting with penile squamous cell carcinoma. According to them, everyone, of course, is interested in jumping in. The FDA is currently seeking statements of interest.
What is the CNPV Program?
The CNPV is a pilot initiative that rewards sponsors of drug candidates targeting urgent national needs, such as domestic manufacturing, unmet public health demands, and now, pricing commitments. Unlike traditional priority review vouchers, these are non-transferable and designed to speed up review timelines from a standard of 10 to 12 months to as little as 30 to 60 days.
Dr. Makary has gone even further in public statements, suggesting that companies pledging to align U.S. prices with peer nations could be prioritized under this scheme. This introduces a novel concept in FDA policy: that pricing strategy is a form of public health responsibility.
How This Could Apply to Provectus’s IL PV‑10 Programs
Provectus is developing intralesional (IL) PV‑10, our lead formulation of Rose Bengal Sodium (RBS), in clinical programs such as:
Penile Squamous Cell Carcinoma: a rare, neglected, and disfiguring disease with minimal innovation, and
Pancreatic Ductal Adenocarcinoma metastatic to the liver, post-FOLFIRINOX failure: one of the highest unmet-need cancers.
These programs aim to deliver targeted, tumor-destructive, tissue-preserving, cancer immunotherapy with potentially favorable safety, no systemic toxicity, and systems-wide benefit. Critically, we’re doing so in a way that prioritizes innovative cures, affordable manufacturing, clinical efficiency, and global accessibility.
We believe our development of IL PV-10 aligns directly with the intent of the CNPV program:
Unmet needs and Cures: Our clinical programs are deliberately focused on diseases where few treatment options exist, with a core principle of trying to cure the patient, not just treat them.
Domestic manufacturing: Our proprietary, GMP-compliant RBS and PV-10 manufacturing processes are based in the U.S.
Affordability: We’re building a business model around cost-effective, reproducible medicines, not exclusive price premiums.
A Shared Vision: Affordability as a Guiding Principle
At Provectus, our mission is clear:
To develop safe, effective, accessible, and affordable immunotherapy medicines for patients worldwide, regardless of socioeconomic status or geography.
We didn’t adopt this mission because it was fashionable.
We adopted it because we believe that the current trajectory of drug pricing is unsustainable and, ultimately, unethical. Yes, we wrote that.
Commissioner Makary’s CNPV framework is a rare alignment between policy and principle. It affirms something we’ve long believed: You can’t talk seriously about public health innovation without talking about drug affordability and access.
Pharma/Biotech vs. Provectus: A Divergence in Strategy and Ethics
It’s important to distinguish the pharmaceutical and biotechnology industries from Provectus, especially as we interpret the implications of the CNPV program.
Big Pharma often works backward from pricing models and insurance reimbursements, calibrating access as a secondary step.
Biotechs often work backward from the outcome of M&A, seeking a dataset, clinical or non-clinical, to sell themselves to Big Pharma.
Provectus, a mission-driven company, builds forward from the foundational belief that drugs must be affordable by design.
We believe that the time has come for a deeper, authentic conversation in biotech boardrooms (because it isn’t going to happen with Big Pharma boards where it’s “go along, get along”): How are we building affordability into the architecture of our drug itself?
If you’re not discussing this while you’re developing your drug, you are part of the problem, not the solution.
Looking Ahead: Opportunity and Responsibility
As the FDA begins awarding its first CNPVs, Provectus will continue to try to deliver innovation that’s not just scientifically sound, but economically humane. We are ready and willing to operate within frameworks like the CNPV that reward companies for treating patients like people, not price points.
We don’t see affordability as a constraint. We see it as a competitive advantage.
And in a healthcare system strained by cost and complexity, we believe the companies that succeed will be the ones that deliver healing, clarity, compassion, and access, from bench to bedside.
Forward-Looking Statements
The information provided in this Provectus Substack Post may include forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Such statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of Provectus’s drug agents and/or their uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this Provectus Substack Post are made as of the date hereof or as of the date specifically specified herein, and the Company undertakes no obligation to update or revise any forward-looking statements, whether because of new information, future events, or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including those described in Item 1A of Provectus’s Annual Report on Form 10-K for the period ended December 31, 2024 and the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2025.