I Want It All (all of the melanoma market, that is)

You could think about the addressable market for PV-10 in two ways.

The first way is based on the label or claim under which Provectus is seeking approval for PV-10: Stage 3 and early Stage 4 metastatic melanoma, local-regional application.

The second way is based on where PV-10's value proposition exceeds the value proposition of other treatments and therapies, including surgery. I contend the real addressable market is the entire melanoma market.

Some background (sources: here and here, where I have directly used or copied text):

• Stage I melanoma is characterized by tumor thickness, presence and number of mitoses, and ulceration status. There is no evidence of regional lymph node or distant metastasis. Stage I is treated by surgery to remove the melanoma as well as a margin of normal skin.

• Stage II melanoma is also characterized by tumor thickness and ulceration status. There is no evidence of regional lymph node or distant metastasis. Wide excision is the standard treatment for stage II. Because the melanoma may have spread to lymph nodes near the melanoma, many doctors recommend a sentinel lymph node biopsy as well. If it is done and the sentinel node contains cancer, then all the lymph nodes in that area are surgically removed. In certain cases, some doctors may advise adjuvant therapy (additional treatment) after surgery.

• Stage III melanoma is characterized by the level of lymph node metastasis. There is no evidence of distant metastasis. Surgical treatment for stage III usually requires lymph node dissection, along with wide excision of the primary tumor as in stage II. Adjuvant therapy may help some patients fight off recurrence longer.

• Stage IV melanoma is characterized by the location of distant metastases. Skin tumors or lymph node metastases causing symptoms can often be removed by surgery. Metastases in internal organs are sometimes removed, depending on how many are present, where they are located, and how likely they are to cause symptoms. Metastases that cause symptoms but cannot be removed surgically may be treated with additional therapies.

Summarizing simply:

Recall PV-10's clinical value proposition has been repeated and reproduced by management, principal investigators ("PIs") and Moffitt in murine models, animals and people for multiple cancers: very efficacious, very safe, and both local regional and systemic benefits. The drug's business value proposition: easily administered (PV-10 is injected into target lesions by interventional oncologists in outpatient setting by a physcian or appropriately trained nurse practitioner or nurse; injections into tumors on organs inside the body require an imaging assist).

PI Dr. Merrick Ross, a surgical oncologist, believes PV-10 should be a first-line treatment after surgery has failed, while PI Dr. Sanjiv Agarwala, a medical oncologist (a hemonc), believes PV-10 should be used even before surgery is considered.

Given PV-10's safety profile, the drug could (should) be used as the first tool out of the oncologist's tool kit, even before surgery is contemplated or employed. If success is not achieved, surgery and/or combination therapies that include PV-10 could be utilized.

The implication is that the entire melanoma market is in play for PV-10, with maybe the exception of very late stage melanoma, a small percentage of market; however, this portion might (and probably will) be addressed by combination therapies (e.g., PV-10 + radiotherapy, PV-10 + Yervoy, etc.).

Of course, the immediate label for which PV-10 would be used does not support my contention above. The label applies to a smaller portion of the market.

But, as more and more information is available to oncologists (i.e., trial data, immunology data from Moffitt), the addressable market for PV-10 becomes the entire market for melanoma.

I think that makes (has made) for interesting conversations with Big Pharma.