the "parameters" of Ph-3 NeuVax Clinical Trials were forged by NeuVax experts in Collaboration with the best of the FDA experts. Together, the two groups (realizing fully the magnitude and significance of the NeuVax potential) determined the subset of cancer patients who are Most Likely to benefit from NeuVax therapy. Phase III Clinicals are very serious "Human Experiments." Human "subjects" are not expected to take unwarranted nor "unsafe" risks during the course of such trials. These 'double-blind' studies are relatively simple in that there is one "group" which DOES receive the product being "tested" (NeuVax) while the approximately "other" 50% of the test group participants receive either "nothing" or a "placebo" injection. The FDA's Clinical Trial Data Monitoring Committees (Board) are, to the best of my knowledge, singularly responsible for continuously monitoring the ongoing test data. Only the FDA knows which "test subject" receives the active injection. When it comes to Breast Cancer (BC) "recurrence" rates, the HIGHEST levels of known recurrence within the "Node Positive" BC cancer victims happens to be those women whose BC's gene encoding INCLUDES the growth-promoting HER2/neu protein. Statistically, the highest rate of recurrences are within the first 2 years following initial surgery. Although the 3+ atypical cells are known to be the most "aggressive," 1+ and 2+ recurrence rates are often as "expressive" as is the 3+ grouping of BC HER2/neu diagnosis. NeuVax Clinical Trials is NOT "cherry picking" from among a "small" group of BC "types." In fact, NeuVax Ph-3 Trials focuses upon those BC patients who represent the largest grouping of BC patients: Node Pos, HER2/neu 1+ and 2+ with either Pos or Neg EG and PG (Estrogen and Progesterone) receptor sites.
Why is NeuVax likely to successfully meet its intended Phase III end-point? Because the highest levels of NeuVax testing to date (Phase I and II Clilnicals) have already clearly demonstrated a Statistically Significant reduction in the Recurrence rates of the active cancer progression in women who: are Node Pos, HER2/neu Pos, who first submitted to surgery and chemo and radiation treatments and who then received the NeuVax injections (one per month for six months FOLLOWED BY one Booster shot every six months thereafter). The VERY SAME women who are presently participating in Ph-3 NeuVax Trials!!!! These fortunate "test subjects" realized HUGE benefit from the NeuVax injections (during Ph-1 & 2 testing). Phase III of the NeuVax trials is nothing more than a FOCUS upon the BEST PROSPECTIVE CANDIDATES insofar as who may derive the greatest benefit from NeuVax Versus the same sort of patient diagnosis/prognosis who will not receive the potentially significant NeuVax injections.
It remains my great hope and strong opinion that by or around this time next year (Dec 2013) we will have received "Priliminary" NeuVax Ph-3 results that clearly demonstrate the benefits of NeuVax and which will lead to, in very short order, to the full FDA approval of NeuVax, thus ushering into recognition the most revolutionary new therapy in helping to deal with the HER2/neu, growth promoting protein associated with BC as well as with other forms of Cancer!