Replies to post #243174 on Avid Bioservices Inc (CDMO)

[exwannabe]

ex, you are not going to give no chance for complete responses ? More patients in the Bavi arm will certainly have better ECOG status and that factor.... just may be enough to allow for some complete responses.

Time will tell.

I would certainly hope to see a higher CR rate in the bavi arm.

But people will event regardless of having a CR. OS is "overall" survival.

If I look at the survival data in 2100 do you expect anybody to still be alive?

As every year goes by the number will approach 290:290. Not a very meaningful number at all, my point was to make clear that a 2:1 ratio can not hold over time.

[Protector]

biopharm, I have been thinking that too.

ex, you are not going to give no chance for complete responses ? More patients in the Bavi arm will certainly have better ECOG status and that factor.... just may be enough to allow for some complete responses.

Didn't write it because we cannot prove it. But there is some theoretical support for that. We just have to ask ourselves :

What is a healthier patients in these terms?

We cannot think in ECOG terms based on patients abilities (can work, can do light work, needs help for...etc) but must translate it to the underlying biologics that CAUSE that.

Depending on the type and location of the SOLID cancer and metastasis or not, it will be the tumour size (and hindering, pushing on organs, causing malfunction, etc), the massive disabling of the immune-system due to the LARGE amounts of exposed PS and micro-vesicles exporting the PS exposing all over the blood stream so that it is no longer a locally contained problem. With macrophages and possibly more importantly MDSC's affected, inflammations (internal) will start to exist all over the body and will slowly drive the patient to continuously lie down. The body (immune system) will consume a large amount of energy to try to fight all those infections without ever being able to win, unless external help (some drug). Hence almost continuous temperature, headache, tremors, etc

So we could define a healthier patients in terms of:
- still smaller tumour (and total surface) then sicker patients
- less proliferation of exposed PS in blood stream (no localized)
- less infections, hence less threatening condition

There may be others but lets stick to the above. If we dose 3mg/Kg bodyweight for Bavituximab then that represents a finite number of molecules. Each Bavituximab molecule is so said USED up when it binds to PS and it also has a LIMITED time to do that, because it leaves the body after some time if not bound and disappears. So in that time window we want Bavituximab to bind as much PS as possible.

With healthier patients there is LESS exposed PS (smaller tumour surface, less micro vesicles, etc) and hence a better chance for bavituximab to contain the situation by binding a larger % amount of the PS allowing the immune system to be activated faster and to better work at a complete response so also allowing the Bavi dosage to remain sufficient to maintain this control and superiority over PS.

If this leads to a point where PS never gets the overhand and can stop or slow down the immune system then a CR becomes a possibility.

AIMO.

PS: bio, your question on median, the median is the middle element of a MOS table. PII had 3 MOS tables. One for Ctrl, Bavi 1mg and Bavi 3mg.