Avid Bioservices Inc (CDMO)

[Protector]

BAVI had no chance to begin with in Pancreatic.

The randomizing was exceptionally in favour of the control arm. It had the healthiest patients in amounts that make BAVI beating the SOC by only two weeks look miraculously good.

Unfortunately for the FDA that will not be sufficient, hence the sub-set approach and temporarily in the freezer (note - I am saying that on the longer term we didn't hear the last on pancreatic but it will not be with this combo). Then again, we cannot complain about this because if BAVI would have the healthiest patients and would have beaten the SOC by 3 months it would have been equally valid and we would have said: randomizing is randomizing!

And in that scenario, yes, you would be correct that we would have seen better results because we know for sure now that there is a latency with BAVI (we know it since the results of the Gov experiment in viral). In viral that latency must be dealt with differently (pro-actively) while in Oncology you need preferably early detection or patients that are the least possible damaged by the disease and any treatments.

In that we must make the difference between past damage (from chemo/radio/immuno, etc) while BAVI wasn't there to activate the immune system and hence such damage weighs on the patient and secondly 'instant' damage that comes into existent DURING a treatment where BAVI is part of the treatment. In this later case BAVI has the opportunity to bind the PS exposed due to that damage so that the immune system can start its work.

This is the main difference with past damage that remained because BAVI wasn't there to bind PS and therefore the patients suffers from that damage already at a moment where NEW damage (new treatment) starts. While that new treatment will have BAVI binding PS and the immune system getting activated all will now depend what the damage-on-damage does to the patient and if the patient will die before the immune system could repair both sets of damage. If it can the patient is looking at serious recovery from both, the old and new, damage.

So yes, health is a factor, because infections etc all play in that scenario.

PS: As a side note I think Bavi treatment, and actually ALL ONCOLOGY, VIRAL and INFECTION/INFLAMMATION treatment should be accompanied by a diet steering at low PS intake through food.

see section dietary sources of phosphatidylserine (PS)

And Soy Lecitine is in almost EVERYTHING because it is a very good emulsifier. There are plenty of sources of lecithin (Sunflower, etc) that do not have the PS levels of Soy so we don't need it.

I did a test with low PS intake diet and if you go on a low PS diet and you get scratches from your race bike or other sports they heal MUCH faster, but not in the beginning. I am in my 9th week now and I ran into the corner of an open Aluminium window frame and had a 7cm scratch on my arm and it was gone in a few days. Would have taken a week or two before. So PS is a continuous suppressor of the immune system if it is exposed in the blood stream.

I now threw out all soy butter/margarines/spreads, soy-milk and coco-milks, puddings, etc and switch to olive (oil) based products.
They have some more calories but after looking into it they are in the end better for all the erst, certainly compared to dairy products.