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Boy I can second that Krakonos! I've attended and presented at many scientific conferences over the years and they are exhausting.
He needn't bother. I biked by the WWII and the Vietnam memorials yesterday and the barricades were breeched and nary a park ranger in sight. The Lincoln memorial was a different matter. The plaza in front was breached but the ranger were securing the monument itself from the frenzied on-slot of little children, their parents and bus loads of Japanese tourists.
The Washington monument has been off limits for some time due to earthquake repairs.
Go PPHM ! (So it is on topic.)
And one more Nature article regarding recent developments ....
http://www.nature.com/news/nih-shutdown-effects-multiply-1.13872
Those *$(@^%'ing idiots in the big white building down the street from me!
A several papers that should be of interest here appearing in Nature...
1) Concerning FDA's breakthrough designation:
http://www.nature.com/news/pharma-scrambles-to-fast-track-drugs-1.13870?WT.ec_id=NATURE-20131003
2) A cautionary tale:
http://www.nature.com/news/uncertainty-on-trial-1.13868?WT.ec_id=NATURE-20131003
3) Also another method of inducing cancer cell death:
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature12692.html?WT.ec_id=NATURE-20131003
Thanks Hookula for going the extra mile. If you have a chance could you give us a more complete picture of your impressions of the Peregrine both and staffers and the other booths and participants at the conference? Did you hear any interesting talks or see any posters with relevance to immuno-theropy?
Thanks again.
Fred
It would probably be easier to take the train (ICE) from Frankfurt airport to Amsterdam. Takes 4 hours.
Yes. It would be good if CP or someone could get his, ummm..., boots on the ground.
Why do you guys think there will be a big public announcement regarding the exhibitor booth in Amsterdam?
They aren't presenting.
I would assume that the booth will have nice posters explaining the currently publicly disclosed results along with reprints of papers, etc. The booth will be manned by people to explain these results to interested parties. A principal target population will be physicians who will be or prospectively will be involved with the Phase III testing sites. Also physicians who will be encouraged to direct patients to the Phase III sites.
Discussions with potential suitors will be held in private and will not be disclosed until they are ready for a big announcement.
I don't expect a great stock surge from this meeting. It will or will not come in time.
Quote:
.. because "SOME" at the FDA "KNOW" that Bavituximab and the anti-PS platform works well.
Some employees of the FDA may believe or strongly suspect that the anti-PS platform works well and that Peregrine was screwed. The FDA is not its employees. The FDA requires clinical proof or as close to proof as the squishy sciences allow. The FDA cannot permit favoritism or the appearance of favoritism. (Ok, there have been abuses in the past.) But if you think that the FDA will show special consideration to PPHM because of the Fargo screwup I believe you are being delusional.
I just pray that they do not fall to any dirty tricks in Phase III. A BP big brother/protector would be reassuring at this point.
There is simply no correspondence between Cohen and any criminal actions of his hedge fund managers and the FDA and the Fargo imbroglio.
I have a substantial stake riding on the performance of Peregrine and want them to succeed.
I'm annoyed with the management bonuses but not that distressed. I've heard all the complaints about management many times investing in other early stage bio-tecks and tech companies. Some ] went bk, some the management sold out cheap followed by law suites, and some did the hockey stick thing. The latest SRPT and CLDX.
(Sorry for the late response; I biked from my home on Capitol Hill to Mt. Vernon and back then helped a friend set up his wireless network.)
All this in my opinion.
Why on earth should the FDA feel remorse about Peregrine's misfortune. Hopefully, maybe a few people there might want to give them a break but the actions of the FDA are tightly constrained by law. They were in no way responsible for the rogue behavior of a single CSM employee acting on her own or in collusion with others.
I'm surprised to say this, but thanks DD for your comment.
Fred
In discussing their "Sunrise" trial they stated that dosing would have six 21-day cycles of docetaxel at 75 milligrams per meter squared. mg/m^2 ???? I would understand mg/kg or even mg/m^3 but mg/m^2 ? Sounds like they would be swabbing it on the skin or something. Which can't be right.
One would expect mg per unit mass or volume.
Any answer from those in the field.
Bavi and the research going into its understanding is the product of DoD and NIH funding. Funding for basic studies are largely derived from the US Federal research grants. Sequester is poisoning the well and severely impacting basic research in all the sciences. The center of medical as well as physical science research will shift elsewhere and the next Dr. Thrope may well stay put in Europe.
I've overheard grumblings from acquaintances who are employees or for mer employees of the FDA about industry hacks occupying executive positions in the FDA.
BioCenturyTV.com this week has Dr. Brawley of the American Cancer Society commenting on cancer drug development and care availability. Comments in this segment should be of interest to the PPHM investor.
http://www.biocenturytv.com/player/2625187568001/2625203211001
Should pre clinical combination of Bavi and dow stream immune-theropy prove promising, one wonders if BP will allow the combination to proceed to the clinic.
Did anyone else notice that I believe Steve mentioned that the "rear" end of bavi plays an important part in activating the immune response. the "front" part being responsible for attaching to ps and blocking the immuneo-surpressive action of ps exposure. This seems to be a new insight into bavi's mode of action.
(I was just wondering if Beta Bodies with their truncated design do not have this back end effect. They of course directly attach to ps with that immune-stimulative action. Could it be that BB's are not as effective as plain bavi and be the reason they were not highlighted in this presentation?)
Seeing that bavi requires substantial ps exposure to attach and be effective I was wondering how the addition of bavi would contribute to the bavi/PD-1, etc combinations that may exclude chemo agents. I guess this is all TBD in new ongoing trials. (Sometimes I wonder if Steve is just throwing red meat to the wolves.)
(Ok, I'll take off my reviewer hat now.)
And then there's the Queen, Soros, the Freemasons and the gay lobby in the Vatican... When will it ever end! LOL
I think this report is relevant to anyone investing in biotech. (It's just much easier to reproduce published results in physics and EE.)
A disturbing report in todays Nature News Highlights concerning reproducibility of published results in the squishy sciences:
http://www.nature.com/news/nih-mulls-rules-for-validating-key-results-1.13469?WT.ec_id=NEWS-20130806
Thanks for the video.
Humm.... Sequestration strikes again.... Maybe expedited review will not be so expeditious after all.
And congress goes on summer recess...
I hope you are right and that here is an ongoing diligent investigation of the apparent irregularities in Peregrine's trials aimed at hedge funds or other entities. You seem to assume that "the government" or "the Feds" have infinite resources and that the FBI/SEC/FDA seamlessly cooperate in pursuit of the baddies. Neither of those assumptions are creditable to me. All government agencies have limited resources especially these days and inter-service rivalries are all too common. Investigative agencies need to be selective in application of those resources. If the Peregrine irregularities are part of a much larger investigation we may have a chance in getting this resolved. But there are many baddies out there and only a few are selected for intense pursuit beyond a cursory investigation at any one time. Peregrine is a tiny bio-tech its problems can be brushed off as human error. Any hedge fund or other experienced player will have thoroughly covered their tracks. Lets hope that this is resolved but I wouldn't expect it to happen tomorrow.
Fund Peregrine Pharmaceutical to Test Bavi for Herpes
The complete jackasses in the big white building several blocks down the street from me won't fund anything. A better chance would be to crowd-sourcing it.
(Ok, I'm still pissed about being furloughed for 11 days this fiscal year and possibly longer in FY14. I can handle the 20% pay cut but my younger PhD colleagues with families and mortgages are hurting.)
Cancer, Viruses... How about parasites?
Phosphatidylserine exposure on the surface of Leishmania amazonensis amastigotes modulates in vivo infection and dendritic cell function. (2013)., Parasite Immunol. JL Wanderley, PE Thorpe, MA Barcinski, and L L Soong
Thorpe's last publication ?
Probably not a big potential money maker though. Brazil has its problems.
All this speculation about 6 meetings at ASCO. You seem to focus on business meetings. Maybe that was the case but I sure hope that the presenters had at least 6 meetings with scientific colleagues. Scientific meetings are all about presenting your work and coming up to speed with the work of others and seeking collaborations with others. (Ok, and meeting old friends.) 3 presentations should generate at least 6 serious lunch/off line discussions with other leaders in the field and potential collaborators.
Been there / done that many times.
Fred
Thanks for your comment FTM. I realize that PD-1 may be used with chemo agents in the near term but the vector of investigation is away from their continued use without being sent special delivery on a MAB themselves.
Mix two novel chemicals together in a patient and what do you get ? Not necessarily an additive effect. Could be multiplicative with a multiplier <1. Could be disaster. We have to await the clinical results and not assume that everything is necessarily going to work to our advantage.
Nonetheless, I'm maintaining my 110K stock investment in PPHM.
Yes these are excellent illustrations. However they do illustrate that Bavi is dependent on chemo or radiation. (Bavi is ineffective as a mono-therapy.) The present movement in research is to move beyond the nonselective radiation and chemo agents. It is not at all obvious to me that Bavi will play well with PD-1 or other downstream immuno-stimulative agents. I do hope the current pre-clinical work pans out but success is not assured no matter how hopeful SK was yesterday. I await the results with crossed fingers. And then of course we need confirmation in the clinic.
Perhaps they will publish it in the Journal of Non-Reproducible Results considering the anomalous control MOS.
"why are they bailing on this?"
I would assume that with their limited funds they need to focus on the most promising drug combination. This combo yields mediocre results so far. If they wait long enough an extended survival may appear after 80% pass but this will not be apparent for some time. At least definitively killing it now (Garnick's axe) prevents us from hyperventilating in the dark about this drug combo while we await a final analysis.
I totally agree. Very clever of .... to set up that dose switching in Fargo.
IMHO
Hey, has anyone besides myself seen today's Biocentury This Week regarding Breakthrough Designation. It can be accessed at http://www.biocenturytv.com
It is quite informative updating FDA's present thinking on BD.
MOS is clearly resolved but there are still quite a few ticks on the KM curve for pancreatic. Too bad they never seem to revisit the data later when more of these are resolved and the extended survival data is hopefully indisputable.
I just watched BioCentury This Week on ch 9 in DC. Today's program is devoted to providing added clarity to breakthrough designation. Janet Woodcock spoke first followed by Harvey formerly of FDA and now head of regulatory affairs of Phizer. (Any thoughts on the revolving door?)
The program can be accessed by going to http://www.biocenturytv.com
Also there is discussion of compassionate use.
A friend, colleague and brilliant materials scientist died of liver cancer a year ago. Among other things he headed a project to develop new blast resistant composites to protect our soldiers from IEDs. The project died with him. We need bavi and also a reversal of sequester science cuts. NIH, NSF, & DoD funded science is being gutted and we will loose a generation of scientists. This eventually will affect all research organizations in this country including biotech.
"there is an under-current of impropriety with the stock."
This is a serious accusation.
Could you please explicate?
No, I need a 200PPS buyout.
(Though I don't think I have that many years left to live.)
Shhh... He's really Hercule Poirot. Our, oh so fastidious, PPHM sleuth.
"He had a team... And they will carry on his legacy..."
I pray that you are right. But I've been in research for over 40 years and have seen top operations fall apart after the big man retires or passes. A leader with similar interests, insight and drive must step forward to carry on or else they all drift away.
"now what? how is this gona affect the shareholders? stock? the future of this company "
I have not seen a serious discussion of Dr. Thorpe's passing on the future of PPHM. I believe that we all agree that there should be little short term (a few years) impact. I am not as sanguine about the longer term.
His day to day advice will be sorely missed to be sure. But will anyone keep his group at UT together once the idea man and rainmaker is gone? What is the status of his present research contracts and will they be renewed when the time comes? Will promising post-docs seek out his lab? Will the replacement have his or her own divergent interests and priorities. And will the beneficial relationship with PPHM persist.
I know that there are licensed patents that are secure "locking up" ps as a target. That is great. But Thorpe's lab was constantly initiating studies for new applications and improved designs. This was largely funded by government for the public's benefit with PPHM and us stockholders as incidental beneficiaries. Such basic research can not be funded or adequately pursued by a small biotech.
That's why the long term (7-20 years) is problematic for me.
This is a serious question now that the immediate shock of his passing is over.
I am not bashing.
I still maintain my 110k stock holdings in PPHM.
Yes pure speculation on my part.
If you know as a fact that only the placebo arm was tainted I'd expect a visit from the FDA. IMO
Well some people died a few weeks sooner and a few died a few weeks later but it was a crap shoot either way. Could anything be proven beyond a reasonable doubt especially with fancy bp lawyers in the court room?