PPHM, it is NOW or NEVER!
RM, the 3rd NCCN trial is that PPHM IO trial...BUT...if a deal is coming and it would NOT be with Merck then that trial will, IMO, be canceled (if that NCCN procedure allows that).
REMEMBER
PS-Targeting plays on MANY fields. NCCN trials with Chemo and Radio will have NO resistance IMO. They will just bring more to the table on HOW PdtSer targeting combines with others and possibly allow to fine tune or confirm the MOA.
In the new field of Immuno Therapy and more specifically Immuno Oncology which includes the traditional phase I MONO Therapies anti-PD-1, anti-CTLA-4, CAR-T, etc PdtSer-targeting has no role to play. It is clearly a drug that you need to combine with something else.
In phase II COMBINATION therapies the war is on between BP's and the 200-300% increase you mention when PdtSer-Targeting is added is in that anti-PD-1 and anti-CTLA-4 arena. (Dr Brekken's results @ UTSW). We have a test, Yervoy (anti-CTLA-4) plus Bavituximab (19 patients of 22 treated then stopped because the SOC (Standard of Care) changed). Yet we NEVER saw those results and that is because either BMY or PPHM didn't want us to see them because it is UNTHINKABLE that they would not have processed and monitored the results of this open (not-blinded) trial.
But the above is under attack by CAR-T. As I wrote in an elaborate post on the question CAR-T is more comfort for the patient, a better technique with better results but in solid cancers sees all that be broken down to the ground because of the toxicity of immuno modulators such as OX40 that are needed in the process. CAR-T offers CURE vs anti-XYZ offer live prolongement only.
After Dr. Wolchok's finding and publication/presentations on the subject, PPHM PdtSer-Targeting is the perfect replacement for OX40 and alikes in CAR-T for all solid cancers. ex-CEO King said renewed interest and Dr/ Wolchok said a test on humans is designed and waits for the company (understand->'the green light') to start.
Novartis CEO said on CNBC that the biotechs that remain are expensive. Gilead CEO was looking for cornerstone molecules and with KITE stepped into CAR-T. And ROCHE is the other deep pocket player in the field. All will want to grow BEHIND the current limitations to non-solid cancers. The market for solid cancers is BIG, HUGE and will engulf chemo, radio and the anti-XYZ IO easily. The key is PdtSer-Targeting, Dr. Wolchok said it explicitly and hence the key is a threat for all that are invested or still purring revenue out of competing technologies for CAR-T+PS-Targeting for all solid cancers.
And then we didn't even mention Biomarkers, also PdtSer-IP based, that now that Sunrise identified them and lead to patents, will allow to speed up clinical trial tremendously. That on its own, due to time to market, is big.
And Beta-bodies, the a full human version of Bavituximab, with new patents and related protection, all in the portfolio of PPHM, unencumbered.
And while not forgetting about digital imaging, there are the Exosomes, also PdtSer based and also subject of new patents in PPHM's portfolio. The diagnostics market for liquid byopsies in solid cancer is even bigger then cancer treatment. here also, what PPHM has and tuned after the first Ovarian cancer success is huge.
The PtdSer IP portfolio of PPHM, plus all what is KNOWN today because WE sponsored clinical trials and before all the fact that a LOT OF RISK is gone (super safety profile, the knowledge that PS-targeting has efficacy if it will be compared to a normal control arm, the fact that its MOA has been fine tuned, 1000 patients treated, etc) is of BIG value for anybody taking this over with deeper pockets.
There is a BIG difference in asking the FDA for some of the fast approval paths when the drug was administered to 1000 people before and has performed well before, even if not approved because of control arm anomalies where the drug wasn't involved in).
Since a GOING IT ALONE scenario is out of the question THIS is the perfect moment to get the maximum out of PS-Targeting leaving the strategic choices to who-ever is next. Depending on WHO gets it PS-Targeting will be deployed in a certain way. For GILD, NOVARTIS or ROCHE the remaining protection for Bavituximab (some years+ max 7 years extension) is MORE THEN SUFFICIENT to be on the market with a CAR-T+PdtSer targeting combination before the others can even start testing it. And then they will be ready with Betabodies variations that should even work better because they do not need the blood to help binding as do bavituximab and they take AGAIN several years of protected advancement.
CONCLUSION
We must see that we get the LEVERAGE of our investment in PPHM because we paid for the above. We took the risk of seeing PdtSer-Targeting being toxic, or not doing anything or being squandered away in early breadcrumb deals to finance the project. All that didn't happen because WE SHAREHOLDERS SPONSORED it took the share dilution each time PPHM funded itself with more money of the market to pay for all the above.
Then NOW that investment needs to come back and PPHM BoD and CEO must be kept OFFICIALLY informed that :
- WE KNOW ABOUT THE VALUE and the market potential
- WE WANT publicity and bidding's on the technology in order to obtain FAIR prices
- WE KNOW about the tricks of letting a 3rd party company valuate it in way the real value is never reflected because no other 'KEY'parties (GILD, ROCHE, NOVARTIS, etc) are solicited to make bidding's.
So I think we MAY NOT see deal terms BEFORE the ANNUAL MEETING. Therefore I will PRO-ACTIVELY NOT VOTE the directors in (my personal strategy), because I want to avoid that AFTERWARDS they can claim that they where voted in by the large group of retail shareholders and therefore kind of had an IMPLICIT trust to make any deal since they (PPHM) said UP-FRONT at several occasions that they would monetize the R&D part of the company..
This is NO DETAIL. We all INVESTED in PS-TARGETING. If we vote the directors in EXPLICITLY (versus letting them be elected with their 1 required vote for re-election since there are only 7 candidates for 7 seats) then they could say that we APPROVED the strategy they defended in the proxy material, namely making PPHM into Avid manufacturing. Yet AGAIN, we all invested in PdtSer-Targeting R&D where the leverage is. So let's not give them the signal that taking the leverage away is OK.
So YES to certified letters directly to PPHM HQ, at the attention of BoD and CEO. Yes to NOT voting the Directors in EXPLICITLY, just let them be elected by default. And YES to stay ALERT and do EVERYTHING NEEDED to make sure we get the CORRECT VALUE for our investment, the risk we took, the waiting of 10 to 20 years for some, and the dilution we were prepared to suffer in order to get it back with big leverage when a deal was closed. Shareholders of other companies (e.g. MEDAREX) have be STOLEN BEFORE, do not let it happen to us. All together we can make the difference.
As a courtesy:
The Board of Directors BY CERTIFIED MAIL
c/o Joseph Carleone, Ph.D., Chairman
and by reference Messrs. R Hancock, G Sargen, J McComb, P Walsh, M Bamforth, R Lias
Peregrine Pharmaceuticals, Inc.
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