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The role of anti-PD-1 therapy in non-small cell lung cancer (NSCLC) has now reached first-line status, as the FDA has now approved pembrolizumab (Keytruda) as an option for initial therapy in selected patients, according to manufacturer Merck.
Thank you, Krak.
How does this differ from what we have known for about ten years at PPHM? Does our patent portfolio include use as antiviral?
Forbes article on immunotherapy in general and Opdivo-Yervoy (both have gotten final approval) combination in particular.
Re-engineered polio virus vs. Glioblastoma. Note the temporary apparent enlargement of the tumor wasn't real:
New class of antibiotics, mode of action similar to B in that it targets the cell wall and may not generate resistance?
MPDL3280A, anti-PDL1 immune checkpoint therapy, with a discussion of the usefulness of genetic markers, and a little about how RECIST criteria may not take into account long term responses to immunotherapy. (May require log-in)
http://www.medpagetoday.com/HematologyOncology/OtherCancers/48990
When they say 'airborne,' they are referring to the conveyance of droplets of bodily fluids containing the virus thru the air, such as by sneezing or coughing. They are not saying, AFAICT, that the virus particle itself can travel thru the air, like influenza virus can. IMO if the transmission were truly airborne, the death toll in W. Africa would be gigantically higher than what we have seen.
CDC guidelines have recognized this:
I'm not sure insurance covers an intentional act, if that's what ends up being shown.
Forbes article on Novartis and CART:
http://www.forbes.com/sites/matthewherper/2014/05/07/is-this-how-well-cure-cancer/
Today's Bavi+irradiation PR noted:
Germany approves DCVax-L for GBM while in the middle of Phase III trial.
"DCVax-L is among an emerging new crop of drugs that coax the body's immune system to track down and kill cancer cells. More specifically, it harnesses dendritic cells, or master cells of the immune system that give marching orders to its soldiers, including t-cells and b-cells, which make antibodies."
http://www.reuters.com/article/2014/03/10/us-northwestbiotherapeutics-cancer-idUSBREA290KA20140310
Co. website: http://nwbio.com/about-dcvax/
Another immunotherapy compatible with Bavi?
Colonel, my thoughts are with you.
Just a possibility, but from time to time people forget which screen name they're posting under.
Let's hope not, that'll put us more years away.
Interesting if not relevant to PPHM:
http://www.sciencedaily.com/releases/2013/10/131010142754.htm
At the conclusion of the article this appears:
"This work was supported by a sponsored research agreement with Peregrine Pharmaceuticals, Inc., Department of Defense grants PC05031 (to P.E. Thorpe) and PC080475 (to Y. Yin), an NIH-supported Small Animal Imaging Research Program at University of Texas Southwestern (U24CA126608), and the Gillson Longenbaugh Foundation."
I haven't read whether or not 'breakthrough' approval carries with it the same rights to use a drug off-label that ordinary approval does. I somehow doubt that it does.
But once we have regular approval for any indication, it seems to me that the oncology community may not care what BP does, or thinks, about Bavi. Assuming the safety profile holds up and a reasonable price, we may see Bavi used as an adjunct or even solo therapy all over the place.
Sort of like the way the alternative energy industry is exploding under our feet.
Behavior like AF's most recent raises in my mind questions (1) of substance abuse, or (2) given the timing, of collusive stock manipulation, or (3) both.
Such plain recklessness in a professional might also draw the attention of a registration board.
Perhaps he is soon to make a non-financial, non-stock-scam headline.
Maybe he is being congratulated (or patting himself on the back) for the paltry uptick so far, but Cotara is not on everyone's radar, and for them, seeing its potential will take a while.
The referenced poster says, in the box labelled 'Background and Objectives:'
Stock spikes, "good study," Realist takes eleven days off after missing hardly a day of posting in the preceding weeks.
Study screwup discovered, Realist is back, again hardly missing a day.
Long ago I said that when the share price increased, Realist would be gone. So I hope that if there is good Ph II pancreatic, Realist will take at least two weeks off.
I know we can't be done with him until at least $10 now, probably another year or two.
What amazes me is how much work Realist does for what could be no more than one cheeseburger per day.
If the results of the re-look, to the extent it is possible, are to be given credit, why won't it be a new CRO or other unbiased third party that has to do it, rather than PPHM?
Well, we can assume that the big buyers of the past 2 days knew the loan would be recalled.
I am only assuming there might be some condition like a "barring retractions of a much-ballyhooed trial within 30 days of loan closing date" clause. I can't dismiss the possibility.
"Originally I was waiting for the partner announcement that I was sure to come, before taking some profits. "
Me too, with the emphasis on "some." I don't know about the wording of the PR, the degree to which the FDA was involved in the selection of the 3rd party (probably not- my guess is that they merely license or qualify them along with similar organizations, but they may have approved our chosen 3P as part of approving our study design), and I have to assume that the $15MM is in jeopardy, which is why I think, now 'they' may have us by the balls, that the buyout price if any just got a lot lower.
OTOH, I don't believe the basic tech has been impugned, the share price is doing IMO remarkably (if possibly fishily) well, and we shall just have to see what we see.
Do we have any antiviral trials going? We need an antiviral partner.
What I would like to see pronto is some clear confirmation of Bavi's broad-spectrum anti-virus capability. Anticancer drugs are a dime a dozen, and without a good appreciation of Bavi's adaptive-immune-system-stimulating MOA, we're just another anti-cancer drug in the public eye today.
Good news on the antiviral front would help confirm Bavi's MOA in unleashing the immune system to create innate immunity to both cancers and viruses and highlight its multi-use potential.
Too bad the only thing we have going is (maybe) an IST. The Colonel's intro does not show any actual antiviral studies ongoing.
Because someone's buying.
I didn't mean to suggest you (or I) doubt Bavi's MOA. We both think Bavi works, but eleven months vs. 8 months won't advance the ball. Instead of "doubles" it's "increases by a little more than a third." If that's the outcome, we will need to rely on other studies, 2-4 years from now. The time is overripe IMO for some antiviral news.
The lawsuits are coming, note the self-important PR out this AM, looking for clients or encouraging existing ones. Too bad I didn't trade in the past many months, I would like to see one of the suits up close, if only as a Spaniard in the works. IMO the plaintiffs' lawyers in these cases generally are as bad as the worst stock frauds, and in fact the most prominent of them recently suffered a major judgment against him or a criminal conviction, I can't recall which.
And we need to balance the private-equity/hedge-fund operators on the BOD with more people with qualifications or at least a demonstrated interest in science or in public affairs, and with some good institutional (not Wall Street) affiliations or some other elements of a public reputation.
Unless the holes in this study are magically patched up, the best we can expect from all this at this stage IMO, on the public facts, is 2-4 more years of delay while BP continues to rip the public off with its narrow-spectrum, poorly-functioning drugs.
The worst? Lack of access to capital forces buyout at $5-7.
OK, but wasn't the survival of the control arm within historical norms? And thus not likely to have been inflated by the error you mention?
They can't lose, even if, in the worst-case scenario, we get bought out for $5-7. Certainly the prospect of a buyout gets larger, and the time for one gets nearer, with crap like this going on.
And failing a buyout, well, the technology is still good, they got in cheap, and their time holding PPHM just began, unlike ours.
This reminds me of the first Hubble photo and the consternation it caused.
Good post.
Well, the error could always be in our favor, lol, but failing that I think we have set the clock back 2-4 years.
Well, I have always couched my thoughts on value for investors in terms of the known info. And I guess my gut valuations on BP partnership or buyout are mostly that also, possibly with some incremental stuff potential partners are privy to that we are not.
To expect these boxcar multiples that are being suggested is to assume not just that the "full moon" exists, and not just that we are making progress toward it, but that we already have it in our pocket.
It may prove to be the case, and I will certainly still be around for it (in part, at least) unless we get bought out, but right now I'm not willing to base my expectations on it.
This is my 15th post today, I am now gagged until tamra.
You got the video, not just the summary? Well, I really wanna hear Rucker, so let me go back and try yet again.
My calculations are: quintupled over the price a year ago, made in a post comparing change over a year, NOT THREE MONTHS.
My statements here have repeatedly been 10x over three months.
"In May 2011, the Food and Drug Administration (FDA) approved the drug telaprevir (Incivek), an oral treatment for hepatitis C marketed by Vertex."
"January 31, 2012, Vertex gained FDA approval[4] of the first drug, ivacaftor,[5] to treat the underlying cause of cystic fibrosis rather than the symptoms, in patients over age 6 who have the G551D gene mutation. In the US, 30,000 people have cystic fibrosis. About 4% of those, or 1,200, have the G551D gene mutation. Vertex is marketing the drug at $294,000 a year per patient."
From Wikipedia.
I think I've made enough valuation posts.
"pphm may break the mold"
Our informed hope, yes.