Avid Bioservices Inc (CDMO)

[biopharm]

What makes the two of you say that we will have indisputible trends to take to the FDA just from the blood?

Horselover45, I have been playing this scenario out over and over and I don't ever recall it being stated but I would strongly believe that there should be more "white blood cells" or "leucocytes" that reside in blood samples taken from those patients that have been given a PS targeting agent such as Bavituximab and my best educated guess is that the trial will be designed to draw blood samples at intervals where once a certain pattern develops... this would be the very first indication of "immuno-therapy" at its finest. As for overall survival? I think it will become obvious that it all begins with the blood test.

As for what exactly will be the criteria is the question: Leucocytes or any of the sub-types of Leucotypes or possibly some other newly discovered criteria....but will stick with leucocytes for us non-scientists : )

White blood cells, or leukocytes (also spelled "leucocytes"), are cells of the immune system involved in defending the body against both infectious disease and foreign materials. Five different and diverse types of leukocytes exist, but they are all produced and derived from a multipotent cell in the bone marrow known as a hematopoietic stem cell. They live for about three to four days in the average human body. Leukocytes are found throughout the body, including the blood and lymphatic system.[2]

The number of leukocytes in the blood is often an indicator of disease. There are normally approximately 7000 white blood cells per microliter of blood. They make up approximately 1% of the total blood volume in a healthy adult.[3] An increase in the number of leukocytes over the upper limits is called leukocytosis, and a decrease below the lower limit is called leukopenia. The physical properties of leukocytes, such as volume, conductivity, and granularity, may change due to activation, the presence of immature cells, or the presence of malignant leukocytes in leukemia, and may be reported as Cell Population Data.

2.2 Neutrophil
2.3 Eosinophil
2.4 Basophil
2.5 Lymphocyte
2.6 Monocyte

http://en.wikipedia.org/wiki/White_blood_cell

This is a very simple example and with the better understanding of how PS targeting affects the immune system, Scientists, researchers and certainly Dr. Robert Garnick!... clearly know the most reliable, scientific and expedited pathway that would ultimately position the FDA to allow some form of early approval based on these blood samples. The safety profile of Bavituxmab should also, I believe... weigh heavily in the FDA decision making.

So who knows if they are working with some form of "leucocytes" for a measurement basis-- but it would certainly be based on the patients original blood work pre-treatment vs the improvements made on the 2nd, 3rd, 4th.. blood samples during dosing and hopefully by the 5th measurement there is enough solid scientific evidence for that coveted FDA passage into Big Pharma Land.