Avid Bioservices Inc (CDMO)

[Protector]

Wildhorses, all credits to cjgaddy, he looked into the PPHM patent and posted this part of it.

I did nothing but comment on how I read it and concluded that the PPHM Exosome blood test apparently can tell you WHAT cancers are detected (at least for those in the table 1 that is in the patent) while in doubt about that until cj's post.

I add to that that they can do it without centrifugal work and I am trying to get an interpretation from Bungler who understand regulation better that most of us whether we need to go through an FDA approval or not in order to have a better idea of the time-to-market expectations.

THAT WOULD THEN BECOME

A) HAS CANCER (BINARY YES or NO, incl. pro-active use)
B) STAGING
C) CLASSIFYING THE TYPE OF CANCER
D) ASSESSING CANCER PROGRESSION or REGRESSION
E) ASSESSING THE EFFICACY OF CANCER THERAPY
F) BASED ON SIMPLE BLOOD TEST (No Tissue needed, no biopsy, probes, etc)
G) NO CENTRIFUGAL WORK NEEDED
H) FAST RESULT (Come-in, go out with results)
I) 100% ACCURACY (no false positives stat. sig. p < 0.0001(2))
J) CHEAP (PPHM's claim, but will of course be relative)
K) NO FDA APPROVAL NEEDED (to be confirmed on ASR regulation)
L) With Avid, PPHM has the most sophisticated cGMP award winning facility that can manufacture all this in large quantities. Remember the statement that they can produce GRAMS were others produce milligrams.

And that looks as an even more impressive set of cards to sit at a table with a BP because if the FDA part above is confirmed then we are not talking about the traditional BP vs David negotiations as PPHM with the proof of concept results that scored 100% accuracy and statistical significant (p<0.0001(2)) is all that is needed. And then being profitable within about 15 months from now, as CEO King announced, would start to look as if exosomes are going to contribute to that on top of the Avid income of manufacturing Bio-similars.

AS FOR YOUR QUESTIONS

So let me see if I can sum it up. Am I correct in assuming that PPHM may, I repeat may, have a simple blood test that I can take on a routine basis that can detect if I have cancer? And, if I have cancer, the test can identify the type and the stage of the disease - which hopefully should be early stage since I'll routinely take a test of this nature.

Then, if cancer is detected, I can take something else from PPHM which will make the appropriate immuno-oncology drug treatment more effective. Then, to see if my treatment is having an effect, I can once again do a blood test. So, if the treatment is not having a positive effect, I can then change to a different treatment. And then again get tested for effectiveness. Hmmmmmm. Pretty big.

One final question. Is it possible that an exosome test as described in PPHM's paper and patent could be an extremely important tool to help accelerate and assess the effectiveness of proposed anti-caner drugs? Seems like this would be a major step forward vs. today's programs which are massively time consuming without any way of assessing the outcomes until data collection at the end of a costly and extensive trials.

The answer seems to be YES, YES, and YES but you forgot one step, the biomarkers. They will tell you UP-FRONT if the suggested treatment will work for you or not. If you are among those for whom it works then the PPHM exosome test can indeed be used to do the follow up.

And in case of doubt we have PNG650 for digital imaging.