Avid Bioservices Inc (CDMO)

[Protector]

EXOSOMES, largely under estimated!

I myself deeply under estimated the exosome pipeline, i mean its commercial potential and the fact that it would not only be partnered in H1/2017 but that it is ready to start manufacturing and sales after partnering with an FDA certified manufacturer, for this kind of tests, is signed.

REFERENCE MATERIAL

#1: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center

#2: The exosome related patent

#3: cjgaddy's relevant quotes from the patent

#4: Peer-Reviewed publication on PPHM's Exosome Proof of concept. Received: January 04, 2017

#5: Recent Publication Highlights Proof-of-Concept Data Supporting the Diagnostic Potential of Phosphatidylserine-Positive Exosomes in Ovarian Cancer

#6: Liquid biopsies: The next frontier in cancer? (from jbainseky's post)
In German (from Hutschi)

#7: Applicable FDA regulation. (from Bungler's post)

#8: 12 properties of PPHM's Exosome Blood Test (from my post)

#9: Biodesix, needs 72 Hours for blood test result processing. Uses centrifuges.

#10: Illumina CEO Jay Flatley statement (from jbainseky's post)

Former Illumina CEO Jay Flatley has estimated the total addressable market for a test capable of detecting Stage 2 cancer to be between $20 billion and $40 billion. If a test can detect Stage 1 cancer in addition to the tissue of origin, Flatley said in Jan. 2016 presentation the market could be worth a staggering $100 billion to $200 billion.

In #8 the properties of PPHM's Exosome based blood test are listed and qualify as a full solution being able to tap in the 100-200 Bil$ market mentioned in #10. #3 is important in that it specifically mentions the possibility to identify the type of cancer (see table that will be growing over time).

From #7 we can see that PPHM doesn't need to go through clinical trials but also that they are currently not certified (that we know) to sell the exosome test. They need, and they said they would in H1 2017, partner with one of the companies that have such FDA certification to manufacture and commercialise such tests.

#4 and #5 show that PPHM is READY with a proof of concept with 100% accuracy (no false positives) and statistical significant (p<0.0001/2) and therefor actually has the product ready for starting the commercial cycle with a partner NOW if needed.

#1 and #2 show that Peregrine is in a strong negotiation position because they do not only have the proof-of-concept, they also hold the unencumbered rights to the underlying IP.

#6 and #9 give an idea of what problems the competition has and why a comparable test for all solid cancers, FAST, SIMPLE and CHEAP wasn't yet available, emphasising the break-through of PPHM test.

#10 show the potential market for this PPHM exosome blood test. Currently biopsy's, probing, digital imaging, etc are used techniques. They are expensive, often unpleasant, take lot's of time or human intervention, etc. With the PPHM test one comes in in the morning and gets out with results.


WHY DID I UNDER-ESTIMATE the EXOSOMES PIPE-LINE POTENTIAL
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A) I didn't know that the market for proactive, diagnostic and follow-up cancer detection was this big (100-200 BILLION $)

B) I was NOT AWARE that apparently PPHM is the only party that has a 100% accurate (no false positives) and COMPLETE solution, stat. sig. at p<0.0001/2, which is the requirement for the 100-200Bil$ market equivalent)

C) I was under the FALSE impression that PPHM would need to run clinical trials to commercialise this with FDA approval. The fact they do NOT makes this exosome pipeline FINAL STAGE GRADE with proof of concept successful and peer-reviewed publication in support.

D) I initially thought about this test as a binary (have-have not) cancer test with a nice bonus of telling you benign or not and evolution stage. I never saw this as a multiple test per person thing, which now changes the complete picture.

E) I insufficiently, in the beginning, appreciated the fact that no centrifugal work needs to be done, not even micro-centrifugal, for this test. Hence no bottlenecks and hospitals can do large amounts of test intra-day so patients can come in and leave with the results. Biodesix needs 72 hours, mainly cause by centrifugal activity, for their test.

F) I focused to much on patient comfort (no more biopsies, no more probes, no more scanners, no more result doubt (false results), etc) and on the fact that PPHM emphasised this is a CHEAP test (while the above alternative are most more expensive).

G) I now see this differently and can understand that EVERY SINGLE COMPANY that is involved in this type of market will want to talk to PPHM to partner this pipeline because it is a GOLD MINE READY FOR COMMERCIALISATION NOW!


CONCLUSION
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I think it is possible that the market also needed time to figure all this out and hence as time progressed as of the Exosome PR of about 12 days ago, the PPS started to climb (speculation).