Avid Bioservices Inc (CDMO)

[Protector]

cjgaddy, thanks GREAT NEWS.

I am not sure why exosomes where not brought up last Q/CC or Q&A (well in the Q&A we could say that with only one analyst asking questions what was the chance that it would have been an exosome related question) but it was CERTAINLY NOT due to the doom scenario's that have been advanced on here saying Exosomes probably had a problem ....

However, a 100% accuracy in an exosome test described as:

Blinded plasma from 34 suspect ovarian cancer patients and 10 healthy subjects were analyzed for the presence of PS-expressing vesicles.

that is a breakthrough in Cancer screening.

This study provides proof-of-concept data that supports the high diagnostic power of PS detection in the blood of women with suspect ovarian malignancies.

There are no suitable screening modalities for ovarian carcinomas (OC) and repeated imaging and CA-125 levels are often needed to triage equivocal ovarian masses. Definitive diagnosis of malignancy, however, can only be established by histologic confirmation.

PPHM probably took ovarian carcinoma because the lack of screening procedures. I hope they will next do intestinal (another cancer that profits from early detection but has a high threshold for patients given the the way the screening is performed.)

But a 100% result on 44 patients (34/10) that is not by chance, hence p-values of 0.0002 and smaller that is HARD NEGOTIATION CURRENCY!

Now that PPHM has not only the proof of concept test-kit BUT ALSO data obtained with this proof of concept test the road to partnership negotiations is fully open.

And if this needs FDA approval, these results are a highway to BTD granting because it is all ex-vivo and only needs reliability confirmation.

Furthermore there would be no problem at all to quickly have hundreds of patients samples if further clinical trails would be needed because there is no EXTRA performance on the patient, at the most the patient must agree to have the blood sample double checked and who would oppose that. The Proof of Concept test was ready in DEC as far we know and the test results are already available from BEFORE 22 Jan 2017 and this for a test conducted in ONE SINGLE Center (@UTSW).