There are also some other ways to show FDA, and other RAs that DCVax-L does work by providing substantial evidence according to FDA's requirement. For example, if all the patients or most the patients who have lived long such as three years, four years and above have had t-cell infiltration to and around the site of initial operation, or to the site of metastasis, compared to patients who lived less and have not had t-cell infiltration or have had much less t-cell infiltration.
The new SAP should accommodate for such analysis. And if the above is true, then we will have statistically significant evidence showing the vaccine works.
I also believe Linda Liau and Prins do have something else to show immunogenicity of DCVax-L in treating GBM from their decades of research.
The new SAP should accommodate any new findings as well.
The tennet for FDA approval has always been "substantial evidence of efficacy" on the basis of the drug/vaccine is safe, or the risk and beneficial ratio is obviously in favor of approval.
I recalled one example: when the Wall Street discounted ARNA's drug, but in favor of VVUS' and even OREX's drug, because ARNA's drug was least effective of the three. My reasoning had always been FDA must approve ARNA's drug simply because it is the safest of the three, and it did provide substantial evidence of efficacy despite being the least effective. Although the three drugs were all approved, they provided opportunity of going long ARNA when its share price was very cheap and going short VVUS when its share price was on the roof due to the Wall Street stupidity.
SO if the company can supply "substantial evidence" of efficacy, DCVax-L should be approved because it is safe. It may sound simple but it will be or has been very complicated to accomodate all into the SAP.
And I believe there should be multiple ways to do just that.
