Avid Bioservices Inc (CDMO)

[Protector]

n3m3sis, a couple of remarks.

You are correct about the delay. I thought PPHM had started multiple proof of concept test besides just ovarian and then we read that they didn't and that they PLAN on starting others for solid cancers. Not only was that a surprise but when I first posted about that PPHM statement it was mainly because they keep the lid on good news or play it down but do not miss out on ANY occasion to emphasise news that is perceived less good. And TIME expectations are important for this stock. Many long long are waiting since long and PPHM tells them "starting", secondly the markets think in terms of profit per PERIOD and don't want to hold to long. Finally it is kind of in contradiction with their "ready to partner" in H1/2017 UNLESS a partner is fine with ovarian and will include milestones for the other tests.

However on the rest of your post I cannot agree. Peregrines test is NOT a GENETIC test. It is a MOLECULAR test or fluid biopsy test so to speak. In stead of taking a biopsy and analysing an amount of solid substance originating from a place of interest (not always easy to reach), one looks for molecules or groups of molecules (micro-vesicles) floating in the blood stream. When cells are damages DNA can ALSO end up floating in the blood stream or be attached to something else floating in the blood stream.

The FDA regulation you are mentioning seem to apply to GENETIC tests. From what I read this is not what PPHM needs. However, I think it was by Bungler, a regulation relating to diagnostic tests has been posted. I think that regulation applies to PPHM Exosome blood test.

From that regulation I understood that PPHM NEEDS "NO" FDA approval AT ALL as long as they partner with a party that holds the FDA certification that authorises them to bring certain categories of diagnostic tests to the market.

Does that mean PPHM must wait for a partnership in all scenario's? Well no. PPHM/Avid have shown the ability to not only get FDA approvals for a large PIII clinical trials but also for manufacturing (e.g. cGMP) and even by improving and 7 award winning facilities. I figure they must be able to file for certification similar as those that diagnostic companies have. They will probably need a full production line (including post production labeling, packaging, storing, etc).

Having that doesn't exclude a PARTNER but it will keep pressure on partner negotiations because while PPHM has declared they will not go it alone the potential partners will know they COULD go it alone and that no partnership doesn't mean PPHM would be 100% blocked. PPHM could start selling and continue negotiating with diagnostic companies that only would see the price go up as PPHM's sales increases. That means negotiating pressure is reversed and is on BP, certainly if they are in competition with each other.

Finally I would like to attract the attention to something massH emphasised (I'll write ot in my words). It is much more easy to get just blood samples to run additional proof of concept test then to run full clinical trials.

The only thing PPHM is looking for in the first place is a blood sample from BEFORE the diagnosis and the result of the diagnosis with whatever current standard it has been established. Remember that PPHM's exosome test makes NO CLAIMS ABOUT THE TREATMENT!!! That is VERY IMPORTANT for the availability of potential patients. It doesn't matter if the patients will be treated with product A,B or C.

PPHM might need other blood samples of a same patient if other claimed aspects in the patent are tested. For progress of treatment testing one needs samples from AFTER the treatment.

But it would already be a BIG advantage if PPHM would come up with a:

BINARY ALL SOLID CANCERS CHEAP, FAST, SIMPLE and 100% ACCURATE BLOOD TEST

That one would allow yearly or bi-yearly screening for all solid cancers IMMEDIATELY and positive patients would then GET a second test to find the other things out such as: BENIGN or NOT, STAGE, TYPE (Lung, Liver..). This can initially still be done with the current going tests and gradually, as proof of concepts come in, be replaced by PPHM's test for specific cancers.

Then they can also start working on the progression/regression tests because they use the same technology as above.

So PPHM needs a MODULAR partnership with :

- Pre-payment (depending geographic - World-wide or partial)

- Pre-payment (depending on target cancers (all solid or or partial)

- Pre-payment for Exclusive on the above or not.

- Milestones for proof-of-concepts for cancers that THAT/THOSE partner(s) has/have pre-paid for.

- Licensing and/or participation in the profits.

Simple, straight forward, risk spreading, modular in build-up and extension, etc.

AIMO