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Short interest on 08.31 is down. Looks like some traders are giving up on the r/s theory. Just too much good news in the air to make it a safe bet.
http://www.nasdaq.com/aspxcontent/shortinterests.aspx?mode=&kind=shortint&symbol=pphm&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&FormType=&mkttype=&pathname=&page=short&selected=PPHM
NH-- I agree completely.
A big part of the judgment call they make in late Sept / early Oct will be the Stock Incentive Plan. They know most shareholders will vote against it same as last year unless the pps starts to move up significantly in the period Oct 5-19.
Thus if it's a close judgment call on Oct 2 -- like 6 one way, half a dozen the other -- they may lean in favor of putting out their best PRs in Oct in order to get the Incentive Plan approved.
Personally, I don't believe PPHM management is out to screw retail shareholders by doing a r/s unless they absolutely have to. Doing a r/s that could have been avoided would only jeopardize management's own stock ownership and stock option positions. But I do think they have a really hard judgment call to make in late Sept / early Oct. because, if a r/s turns out to be necessary, I sure would like to see a lot of great news come out right after the r/s when institutions are trying to decide if they should buy the stock or short it !
Hopefully, what might otherwise be a tough judgment call can be avoided because by early Oct we see: (1) new gov't funding, (2) Cotara license and/or (3) Nature publication.
Good refinement. Perhaps a better way to thinks about it is 2 scenarios:
In Scenario A they believe they have a good shot at establishing 10 trading days over $1.00 before Oct 22 annual meeting. Those 10 days have to finish before Oct 22 so they have to start putting out the big PRs in the week of Oct 5.
Scenario B is where they make the opposite judgment in late Sept., i.e. they do not feel sure they have enough big news to keep pps over $1.00 for 10 days prior to Oct 22. If this is their belief in late Sept / early Oct, then you are correct that they could wait until a few days before the annual meeting to trigger the R/S.
What forces them to make this judgment call in late Sept / early Oct. is the fact that, if they are going to be forced to do a r/s, then everyone says the only way for a r/s to be successful is if it happens concurrently with lots of really solid Company news. So they will save their Phase II clinical updates and other news like Nov. Nature publication and do them all together after the r/s if they are in Scenario B.
IMO
CW-- have you considered the possibility that PPHM might have way more than enough PR ammo to get the price over $1.00 for 10 days?
Why don't you start paying attention to the facts. For starters, try reflecting for just one minute on why Dr. Chabner, America's most prestigious cancer clinical trial opinion leader, has put his name and reputation behind Peregrine's Bavi program.
BKT-- You are thinking correctly. That is precisely why I said in post 41476 that the PPHM Board will decide on or about Friday Oct 2nd whether or not to put out all their best news during the two-week period Oct 5 -19 ...
or instead save their best clinical data PRs until after the R/S has been triggered so as to support the pps in the post-split period.
A lot will depend on whether the Nature article is published in the Oct issue (i.e. on or before Oct 7) and also whether they have a Cotara license and/or a new gov't anti-viral funding program ready to announce in early Oct.
I would think Haynes (and therefore SK) would have a pretty good idea by Oct 2 whether his article is being published before the Oct. AIDS conference in Paris or not.
Volgoat-- Do you agree that another DTRA-style gov't funding deal (which is likely to be announced at the start of the U.S. gov't's new fiscal year on Oct 1) would be enough to avoid r/s when combined with good Bavi clinical data?
Personally, I believe this is their ace-in-the-hole, with or without Nature publication and with or without Cotara license. All indications are that both military (DTRA) and civil (NIH) sides of gov't have been funded to expand their anti-viral programs. Bavi and 11.31 are clearly in the sweet-spot to receive this funding.
Yes, my opinion from Slide 42 is that the Company intends to load all the news into calendar Q4, which I hope means early October to make a race for getting pps over $1.00 before the Oct 22 annual meeting deadline for triggering the R/S.
My guess is that they have active negotiations pending for both a new Government funding (expansion of the anti-viral program) and a pending transaction for a Cotara license.
I think the Board will make a judgment call last week of Sept / first week of Oct whether the combination of possible PRs on (1) new gov't funding, (2) Cotara license and/or (3) Nature publication are enough to keep the pps over $1.00 for 10 days in Oct when combined with all the Q4 Bavi Phase II cancer results mentioned in Slide 42.
If in early October it looks like only one (or none) of these three big announcements (i.e. new gov't funding, Cotara, or Nature Med.) will happen in Oct., then they may decide to pull the trigger on the R/S and save their Bavi clinical data to support the stock in the post-split environment (e.g. in November when Nature article is published).
On the other hand, if in early October it looks like two of the three big pending announcements will happen in October, they will probably front load all the news into October and try to avoid an R/S.
In any event, I think they will keep their powder dry during the balance of September. I don't expect to see much news in the next 2-3 weeks. If they are serious about avoiding a R/S, wouldn't it make the most sense to aggregate all their fire power into the first 3 weeks of Oct -- i.e. just before the annual meeting -- and see if they can pull it off. Slide 42 seems to support this approach.
IMO
No need to assume. Top right corner of Slide 42 says "Cal. Qtr." This tells us Nature publication and viral expansion news is expected in early Oct, OR in Nov or Dec. Let's hope for early Oct. for R/S reasons.
I was impressed by Slide 13 and the clear layout of Bavi Lung Overall Response Rate (52%) compared to three Avastin trials (35%, 28% and 32%). It makes sense that the upcoming Bavi Phase III trial Joe Shan mentioned in the last CC would be for Lung cancer.
Can anyone find out if the ORR rates reported in Slide 13 for Avastin include stable disease (i.e. 1% - 30% remission) or exclude those results. I believe SK said the 52% result reported for Bavi includes only patients with objective responses greater than 30% (i.e. stable disease patients were excluded).
The three take-aways for me:
1. They said another "government" contract (not DTRA necessarily) may be coming near term.
2. In Joe Shan's last remarks regarding Cotara he said that, in addition to working with Dr. Chabner on new trial design, the Company is "working with industry leaders" to design next set of Cotara trials, which seems to be a further indication that a BP /Cotara partnership or license may be imminent. We know they can barely afford to take Bavi into Phase III, so all this talk about designing next trial for Cotara suggests that a BP is looking very closely at partnering Phase III with us based on the emerging new data.
3. SK's reply to second question seemed to indicate that "cloak of secrecy" about non-DTRA anti-viral collaborations will be removed in "coming months," but I would have to read the transcript to confirm this. Hopefully "coming months" refers to September and first three weeks of October, i.e. before AGM which is deadline for triggering R/S.
My guess is they scheduled the CC a week earlier than usual to get the important but boring financial report out of the way before major Phase II clinical updates from GA and India start arriving next week after Labor Day. Having the CC today helped to fill the gap.
My guess is we see another small PR tomorrow that provides SEC "cover" for those controlling the pps to paint it up to $0.90 or $0.92 at the close tomorrow so when the new gap is created with a big clinical PR on Tuesday morning the pps will have to come back down to $0.90 or $0.92 to fill the gap.
Wash, rinse and repeat this cycle a few more times and the pps will be over $1.00 by mid-September with a solid base underneath it and no more gaps to be filled.
"Dr. Chabner joins a group of advisors that have been assisting Peregrine in planning for the next stage of clinical trials for its bavituximab and Cotara(R) cancer programs."
Note that Cotara is mentioned twice in the PR side by side with Bavi. Cotara would not be going into "the next stage of clinical trials" if it had not already found a BP sponsor. PPHM simply doesn't have the money to take both Bavi and Cotara into the next stage.
The fact that funding has been identified for Cotara's next round of trials is quite revealing !!!
Did SK just announce that the Cotara licensing transaction is imminent ?
Nuke-- I agree volume next week will be "telling," but my guess is that volume will go up on news rather than on no-news. A few PRs on Mon, Tues. and Wed. with updates on PH II data from GA and India would provide SEC cover for the buying that you refer to from media possession of the Duke article a week in advance.
I predict we see Ph II cancer updates before the CC. It only makes sense that King would want to have this data out in time to talk about it in the CC. This helps him have a good CC and sets the stage nicely for all the anti-viral attention from the Nature pub.
In July 14 CC, Jesup & Lamont asked: "Can you give us a little color or guidance of when we would expect to see data from the multitude of Phase II trials?"
SK answered: "... we do anticipate over the next few months to be able to give an update."
July 14 to Sept 3 is just over 7 weeks -- pretty close to "a few months."
Nuke-- Your #2 is just what I was thinking. It makes so much more sense to repeat the positive Avid cash flow story and 10Q results BEFORE rather than after the Duke Haynes publication. After the Nature Med article lots of new people all over the world will be considering an investment in PPHM, and the Company's solvency will be part of their decision.
Plus the full CC transcript and voice recording talking about the Ph II cancer trials will also be available to new investors when the Nature article is published. People will go to the CC recording to learn about a new anti-viral company and discover they have landed on a state-of-the-art cancer company as well.
Everyone likes to hear a recent update from the management team before they buy, especially if you are a first time buyer.
Azure and BKT
I agree with the points you both make. This is why I suggested in Post 40278 that there is a simple way to assure a win-win where key technical employees are motivated to stay with the Company but Senior Mgmt, i.e. the Board plus the Senior Executives, cannot benefit from granting themselves more options at a low price following a R/S.
The idea is to ADD A PROVISION TO THE INCENTIVE PLAN, OR ALTERNATIVELY ADOPT A BOARD RESOLUTION, THAT DECLARES THAT IT IS THE POLICY OF THE COMPANY THAT NO MEMBER Of SENIOR MGMT. SHALL BE AWARDED ANY OPTION FROM THE NEW PLAN UNLESS AND UNTIL THE PPS IS OVER $3.00 [OR $5.00 ?] PER SHARE.
The next CC will occur on or near Sept 14. What we need to do as retail shareholders is to agree among ourselves on this i-hub board to all write and email Mgmt stating that we will vote "NO" on the Incentive Plan unless SK confirms in that CC that Senior Mgmt will not be awarded any options in the new Plan until the price is over $3.00 [or $5.00].
All that SK has to do to assure that his Incentive Plan gets passed is to tell us in the CC that such a resolution has been adopted and therefore we can all vote "YES" on the new Plan because we know the new Plan can only be used to motivate Thorpe and lower level employees and will not be used to line the pockets of Senior Mgmt and allow them to escape the economic consequences of their failure to get pps over $1.00.
Additionally, such a Board Resolution announced publicly in the Sept. CC would have a beneficial impact on the pps all by itself because it would send a signal to the markets that Senior Mgmt. is confident the PPS will soon go over $3.00 [or $5.00] per share.
I don't believe we have to start writing these letters today. Let's give them another two weeks to pull a rabbit out of the hat. But if there has been no major pps move by Sept 4, I propose that we should all be ready to send the message to Senior Mgmt. that we will only vote "Yes" on the Incentive Plan if they confirm publicly in the CC that the new Plan won't be used by Senior Mgmt to protect themselves from the R/S consequences all of us will suffer.
All we are asking is that Senior Mgmt should put themselves in the same "economic boat" as us. If they decide to do a R/S instead of big BP licensing deal to preserve the NASDAQ listing, well that's just fine-- it's their right to make that judgment call. But if they go that route they should be in the same economic boat, and suffer the same economic consequences, as us.
New HIV Paper on JBM's Anti-PS Blog:
"What's New
Adding to the growing body of data illustrating the potential of anti-lipid antibodies to block HIV infection, a new paper has appeared online on the website of the Journal of Lipid Research. Andrea Balogh and colleagues report HIV-inhibiting data from experiments using anti-lipid MAbs that specifically target cholesterol. The cholesterol is located on tiny patches known as "lipid rafts" found on the surface of the cells that HIV targets for infection. Lipid rafts contain a number of different lipid species as well as co-receptor molecules that HIV has been shown to exploit to enter cells. Unlike Pfizer's FDA-approved maraviroc (Selzentry) and others in the new class of small molecule CCR5-blocking ("entry inhibitor") drugs in development by several pharmaceutical companies, the anti-cholesterol HIV MAb infection blockade does not appear to be the result of direct physical blocking of the co-receptors used by HIV to gain entry into cells. While the anti-cholesterol mabs find their target on lipid rafts, which is where some of the co-receptors essential to HIV entry congregate on a cell's surface, the MAbs seem to alter the co-receptors' relative (and apparently necessary) positions on the lipid rafts that accommodate HIV infection. The MAb binding to the cholesterol on lipid rafts apparently causes a shifting of lipid rafts and their components, moving things around so that the co-receptors are no longer ideally situated for HIV to utilize for cell entry."
http://anti-ps.blogspot.com/
Management would be on very thin ice, and would expose themselves to serious legal challenge, if the shareholders voted against an express proposal to approve a new stock option plan, but Management went ahead anyway and awarded themselves stock options on the theory that the R/S did not decrease the authorized shares so they now can do indirectly what the the shareholders expressly voted against.
An increase in Management's ability to award themselves stock options needs to be approved expressly by shareholders. Management cannot accomplish by technical slight of hand something that requires express shareholder approval pursuant to SEC rules ... unless of course they love the idea of being sued for breach of fiduciary duty.
I suppose one way they could do what you suggest is with FULL DISCLOSURE. They might be able to accomplish approval of more shares for stock option awards via an R/S if they expressly and clearly disclosed in the Proxy Statement that a vote in favor of new R/S authority constitutes and will be taken as a vote in favor of a new stock option plan.
Correct. If a company officer has been granted 100,000 shares of stock options, and the company does a 2-for-1 forward split, imagine how upset that officer would be if every other shareholder who used to own 100,000 shares before the split suddenly had 200,000 shares, but his options were still only worth 100,000 shares.
Stock options granted to officers, whether exercised or not, always increase proportionately on a forward split and decrease proportionately on a reverse split.
This is why we can be comfortable that PPMH Management won't quickly enter into a R/S split unless they are sure its going to work to at least maintain the economic value of their shareholder position, i.e. their outstanding shares plus their unexercised shares.
So Management is in the same "economic boat" as us retail shareholders regarding the effects of a R/S, with ONE VERY BIG EXCEPTION. If we approve a large new stock option plan for Mgmt. at the October AGM, then they are no longer in the same economic boat as us because they can do the R/S without lots of concurrent big-ticket PR announcements, the pps drops, and they issue themselves a boat load of new stock options at a low price to make up for the shares they lost from doing the R/S.
This is why it's important to vote NO on the new stock option plan unless the NASDAQ delisting issue has been removed by the time you vote. See post 39836 for further discussion of this issue.
Assuming the stock has not been over $1.00 by the time we have to vote, here is a simple step Mgmt could take to get my vote to authorize a new stock option plan: SIMPLY ADD A PROVISION TO THE TERMS OF THE PLAN THAT SAYS NO OPTIONS WILL BE GRANTED TO CURRENT OFFICERS AND DIRECTORS UNLESS THE STOCK PRICE IS OVER $5.00 PER SHARE.
Such a provision would be a win-win for everyone. The Company would get to use the new stock option plan to attract and motivate high performing new employees as it grows (which is important), but old management would not be rewarded for their failure this past year to do a deal that gets the price over $1.00.
From the new patent:
"Although the foregoing methods have advanced the art of tumor treatment, the development of additional or alternative vascular targeting therapies is still sought. The identification of new markers of tumor vasculature is needed to expand the number of therapeutic options. The development of new naked antibodies with anti-cancer properties would be a particularly important advance, as this permits the same targeting moiety to be used both as a single-agent therapeutic and as a vascular targeting agent for the delivery of other drugs. Therapeutic agents that have both anti-angiogenic and anti-vascular, i.e., tumor destructive, properties within the same molecule would be of great value. An even more important advance would be the identification of a class of therapeutic agents with anti-cancer properties and therapeutic effects in other systems. The development of agents capable of treating both cancer and viral infections, two of the most significant medical challenges of this era, would be a remarkable and important breakthrough."
WOW ! From skimming through the depth of detail and breadth of scope in this patent, it is staggering to realize it was filed 6 years ago-- on Aug 15, 2003. It seems PPHM has been taking a low PR profile in part to hide its light from the competition while its patent portfolio matured.
Link to the Patent: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7572448.PN.&OS=PN/7572448&RS=PN/7572448
if Haynes work with Bavi / 11.31 were unworthy of publication, it's hard to imagine why a man of his stature and importance would be charging ahead with a PPHM collaboration that SK described in the last CC as "expanding .. looking at many different areas ... a really fruitful long-term relationship."
Sojo-- I agree management has done a good job, even an excellent job, the past few years. I am especially impressed at how they have used OPM (Other People's Money) to "mobilize government, university and foundation resources... both dollars and scientists" (quote from Dia's post 39726) to build what now looks to be a successful anti-viral company on top of a cancer company.
The reason I will vote "no" absent NASDAQ compliance is because Mgmt has it within its power to close a deal -- i.e. Cotara, regional Bavi license etc, -- that removes the risk of an R/S. If they chose not to close such a deal because they could do it at a much higher price a year from now, that is fine, but if they make that decision I want them to be in the same economic boat as all of us retail shareholders, namely, if you do a R/S you get screwed the same way I get screwed. You don't get to eliminate 3/4 of my shares in a 1-for-3 R/S and then re-load your pockets with free stock option shares while my investment has been decimated.
I am voting "NO" on the stock incentive plan as a way to keep Management honest about not doing the R/S manipulation that the Wall Street funds are urging them to do. It's a classic game that is played over and over again on the street. The retail shareholders bear the pain for years and years. Then, when the company is finally ready to launch, the investment bankers whisper in management's ears that they will send the pps to the moon if only Mgmt would first do a R/S so they can get in cheap ... and don't worry about all the personal shares you lose from the R/S because you can make them up by awarding yourself big bunches of cheap options from the new stock incentive plan.
If you don't think Wall Street bankers are promoting exactly such a plan to Management right now, you don't know how the Street works. Voting "no" on the stock incentive plan is the best way to keep Management's interests aligned with ours during this high-risk period when a R/S is still on the table.
So a more correct statement of my position is this: I will vote "Yes" on the stock incentive plan only if two conditions are met: (1) NASDAQ compliance has been achieved before I vote, and (2) there is no proposal on the ballot to re-new for another year Mgmt's authority to do a R/S.
I will vote "NO" on any new stock incentive plan for management unless the stock has traded above $1.00 for 10 days before I cast my vote, in which case I would vote "YES."
From PL's confidence at the Cowen Healthcare Conference on 3.18.09, it appears likely that the Duke article was submitted to Nature in Feb or early March, 2009. This would mean that 5 months, and maybe 6 months, will have lapsed between the time the Duke article was submitted and publication of the August issue of Nature Medicine day after tomorrow.
PL said on 3.18.09: "We also have learned that there are nearer-term commercial applications that could include post-exposure treatment and topical microbicides. We are expecting a high-profile publication, which is currently in process thru Duke Univ., to be presented within the 1st half of 2009.”
See C.J.'s post on March 18, 2009 reporting on P.L.'s comments at Cowen Health Conference: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=36375783
Thanks Volgoat, CJ, Sunstar. The start of an in-house virology department is great news.
I remember SK saying in one of the CCs a year or two ago that the Company did not have the resources to proactively pursue HCV, HIV and other anti-viral applications of Bavi because the best use of limited funds was to advance the cancer programs. Maybe someone can locate the quote.
It would seem that the Bavi/Duke/NIH collaboration has been so successful that SK has changed his mind and now believes the Company needs to develop an in-house capability to pursue the anti-viral programs and products that are flowing out of the Duke collaboration.
Does this new in-house anti-viral position (which is probably the first step in building an anti-viral team) reflect that the Company has just fallen into a new source or funds, or that the Duke research is so compelling we can't afford not to have our own in-house team. Either explanation is a good one.
Sunstar, I like your thought:
"Wouldn’t it be an elegant irony if Roche sub-licenses r84 and the fees flow through to Peregrine as we move bavi through phase 3 trials?"
I understand you are pointing to the irony that comes from having Roche finance, through R84, a drug called Bavi that ends up surpassing both Avastin and R84?
Nice thought :)
Sunstar -- Thanks for the Affitech article. Nice find:
"The company now aims to broaden its base to include biotechnology investors in Scandinavia, the UK and continental Europe. "That will be my major focus over the next two to three months, to go out and raise more funds. That is clearly essential," Kaufhold said."
Makes me think that the upfront fee Affitech owes PPHM could be $X in July when deal was signed and an additional $2X or $3X more in September when they close their private placement.
If I were a Scandinavia VC or biotech fund, I would be delighted to get in on the ground floor of the 2C3 challenge to Avastin through a local company I trusted.
If I were SK I would be willing to take the chance that Affitech could raise the money easily once they had a lock on the 2C3 development rights. I bet we see in the fall that Affitech gets some nice funding and PPHM gets a good piece of it.
"The world needs a broad spectrum antiviral where you don't even need to know what virus you are going after...
Once the viral side is confirmed, things should change quickly... "
I agree, Volgoat, antiviral is the wild card that could accelerate everyone's forecast of how quickly PPHM gets to the finish line.
I disagree when you say "there was absolutely no hint to this deal on the recent conference call."
In my view there was a fair hint that this deal and other medium size deals are coming to fruition when SK said in reply to 4th Q&A:
"SK: Partnering is an ongoing process, so we have many different programs which are available for licensing. That includes what we consider the big program, our Bavituximab cancer program, obviously Cotara, and then there are all of our preclinical dev. programs as well as our antiviral programs. So we take each one of these independently, and EACH ONE is in ACTIVE discussions currently with potential partners."
Clearly Affitech was one of the deals in "active discussions" when SK made this statement on July 14.
So now we know what SK meant by the phrase "active discussions." Which of the other deals he referred to as being in an "active" stage are also about to close?
Well said Geo,
In addition, it is a fact that when your pps and cash reserves have been so low for so long, the first deal you strike is the hardest and least likely to give you good terms (because they know how bad you want it) so if you are smart that should be a relatively small deal.
The medium size deals (e.g. Cotara) should be done next when the Company has more negotiating leverage.
The really big deal, Bavi, should be done last when the Company is so strong it can credibly tell BP to take a hike.
My guess is that we will see one or two other medium size deals, including a government transaction, announced between now and the time the Affitech upfront fee is disclosed in the 10Q on Sept 15, and by then the relatively small size of this deal won't matter.
For now, a bit of mystery and ambiguity was the best approach.
One mitigating factor is that this Affitech deal closed before July 31, which means the upfront fee paid will have to be reported in the 10Q for Q1 that will be filed and discussed in the CC on or about September 15.
Another hidden nugget in CC
In response to the second Q&A, SK clearly hinted that PFS for Bavi plus Docetaxel will turn out to be higher for the full trial of 46 patients than the 7.4 months median PFS time reported for first 14 patients?
If you listen closely to the actual voice recording of the CC, you will hear that the Seeking Alpha transcript wrongly reported the words in brackets, i.e. [to overseeing], which should have read “WE’RE HAPPY WITH WHAT WE’RE SEEING IN THE SECOND PART.” Here is the corrected transcript:
“As we get these other meaningful endpoints, like progression-free survival, we’ll try to continue to report on those and again our goal will be to report on for instance for the Docetaxel study, the entire 46-patient trial, not to so much focus on the initial cohort of patients. We’re happy [to overseeing] WITH WHAT WE’RE SEEING in the second part. We think that the data will all be supportive, but it is one cohesive trial at the end of the day that we’re excited to report on.”
The question was about long-term Overall Survival (OS) time and how it compares to Avastin. The essence of the Answer was that OS is not yet available, but PFS is a meaningful indicator of OS and “we’re excited to report on” PFS for the entire 46 patients because “we’re happy with what we’re seeing in the second part” of the trial.
It seems pretty clear that SK is hinting that when you look at the entire trial population of 46 patients as opposed to just the first 14 patients, the PFS number is going to be better than 7.4 months. Why else would he be “happy” and “excited to report on” the full trial results.
Remember how we were all a little discouraged when it was reported that median PFS for Bavi + Docetaxel was only 7.4 months as compared to 7.5 months for Avastin.
But now it looks like Bavi is going to beat Avastin on all 3 counts:
(1) better safety, (2) better ORR and (3) better PFS.
Note: In response to the very first question, SK said we would be getting this update on the full Bavi + Docetaxel study “over the next few months.”
Thank you WH. Great find.
Here is another significant excerpt:
"I also wanted to clarify my understanding of Bavituximab and its treatment implications and to better determine if the EXCITEMENT THAT SURROUNDS BAVITUXIMAB is justified."
Clearly there is far more excitement about Bavi in the science and medical communities than the investment community has yet come to realize.
Dia76-- Love your list, but it's the first time I've seen it said that the Duke/Haynes article has been "accepted" for publication. Can you back that up or are you just guessing?
On the other hand, I have heard from someone who heard from someone that Haynes remains very excited about Bavi, so it would be my guess as well that the article has been "accepted"-- but that is not official yet.
Please advise if you have better info.
As long as it's brief, I rather enjoy trenchant satire that casts a true light on our Gadflies.
We need some levity now and then to balance the moronic commentary of our bashers.
Bravo! BigWorld puts it all in a nutshell. Very astute. Thank you.
As you may know from my prior posts, I especially appreciate your heads up to "remember, most of the Bavi studies are being done on patients with advanced disease....imagine the effectiveness profile if we were treating chemo naive patients with early onset disease? I think we'd see a huge impoprvement over current therapies."
Your statement is more true for Bavi than for other experimental drugs that treat very sick patients because a major Bavi MOA is to stimulate the immune system, and this MOA has to work much better in patients who begin the treatment with a healthier immune system. For other drugs that don't use the immune system as a principal MOA, the strength of the patient's immune system at the start of the trial would not make nearly so much difference in the outcome.
___________________________
"When a company is desperate they tend to issue press release after press release, all worded to sound very promising, etc. Contrast that with what PPHM has been putting out for over a year now. Downplaying results in their PR's....just confidently and methodically moving "the ball" forward, inch by inch. I agree with you in regard to a deal being in the works. One deal is all it will take to secure the company financially, raise the stock price to remove delisting as any possible issue, and ultimatley get it over the $5.00 a share threshold that would allow most mutual funds to aquire it. With sufficient funding they could move forward so much quicker with Bavi, multiple indications, multiple sites. The naysayers can do what they always do, that's their perogative. But I'm very comfortable being long on this stock and I have the patience to see it through at least until the poison pill price of $11 a share. I think we're going to be rewarded eventually. The results of the various studies have been very good when you take into consideration the benign side effect profile so far encountered. And remember, most of the Bavi studies are being done on patients with advanced disease....imagine the effectiveness profile if we were treating chemo naive patients with early onset disease? I think we'd see a huge impoprvement over current therapies."
I agree this is "knock your socks off" data, but not because 65 patients met or exceeded the 6 month survival mark. The number 65 is all patients in the "current and previous clinical studies." It was only 100% of the patients in this dosimetry study that met or exceeded six months.
Does anyone know how many patients were in the "first two cohorts" of this dosimetry study?
For me, what makes it such amazing data is that these were all patients with RECURRENT GBM. If it does this well in "recurrent" patients who are on death row, imagine how much better it will do in newly diagnosed patients.
Note the "About Cotara" paragraph: "In this study, 25% of 28 RECURRENT patients survived for more than a year." That means one-quarter of these death-row patients survived MORE THAN TWICE AS LONG as these very sick patients usually survive.
... and the others who were not so lucky to survive that long were no worse off for taking a shot at it because Cotara is SO DARN SAFE. That's the really big news today. The survival data from the older Cotara studies was already off the charts, but there remained a safety/dosimetry question-- were the other patients who didn't survive so long exposed to any serious risks by taking a one-in-four shot at doubling their survival time?
If 25% of RECURRENT patients double the normal GBM survival time, my guess is that this percent will grow to at least 50% in healthier, newly-diagnosed patients.
WE WILL SEE A BIG PHARMA COTARA LICENSE VERY SOON !!! :) :)
My understanding is that, after the original protocol is finished, continuing doses of Bavi without chemo are offered to all patients who have had an objective response (stable response also?) as part of an extension protocol.
I don't believe the Company has reported anything on how many patients accept the extension protocol.
Does anyone have more information on these points?
Long term survival data is indeed the holy grail, but BP doesn't need to wait another year for that data. A good estimate of survival times can be made from knowing the rate at which the tumor starts progressing after chemo therapy stops.
If Bavi plus chemo shrinks a tumor from 100 units in size to 50 units in size, and then the tumor grows back to 60 units after the chemo stops (i.e. a 20% increase from 50 units) then under official cancer criteria this tumor has "progressed" and can no longer be counted as a PFS (Progression Free Survival) patient.
However, unlike Avasitn where the tumor grows back with a vengance once treatment stops, many believe that the speed at which the tumor grows back will be much slower in a Bavi patient due to Bavi's ability to trigger an immune response that lasts and lasts long after chemotherapy has stopped. Unlike Avastin, Bavi's much better safety profile allows it to be administered after the chemo has stopped.
Unlike us, the BP's are seeing the data on how quickly the tumor grows back following a Bavi protocol, and from this data they can make a very intelligent guess today whether or not Bavi long-term survival data will be better than Avastin.
From today's PR:
"Bavituximab is a monoclonal antibody with a unique mechanism that allows the body's own immune system to recognize and act on the tumor and its supporting blood vessels, resulting in anti-cancer effects."
Notice how the Company's public statements over the past few months have become increasingly bold and assertive on whether Bavi's second MOA does in fact trigger an adaptive immune response. No longer do we see the old hedging: "... a unique mechanism that MAY allow the body's own immune system to recognize and act on the tumor."
Folks, if Bavi does in fact trigger an adaptive immune response against all tumor types, this MOA would enable the body's immune system to also find and destroy the small metastatic cells that break off from the primary tumors.
... and that means GAME OVER. :) :)
TYP-- I will vote all my shares against your proposal.
Love the hint in that phrasing:
"Having just completed a busy round of SUCCESSFUL data presentations and PARTNERING MEETINGS ...".
A fair reading of this phrasing is that both the data presentations and the partnering meetings were "SUCCESSFUL."
Sounds like we may be getting close to a BP partnering announcement. As a minimum it was a "BUSY" round of partnering meetings at ASCO and may also have been a "successful" round.
"ORR response rate better than avastin. TTP is about the same and side effects are less."
... and the fourth and most important factor, LONG TERM SURVIVAL, may be better as well.
I am no doctor, but from what we know about Bavi's MOA, it's quite possible that there is some progression of some tumors after 7.4 months but this progression is much slower and more manageable because Bavi has allowed the immune system to kick into the fight against the tumor.
The big deal will happen if Bavi beats Avastin on survival times. Beating Avastin only on PFS, ORR and safety would still leave the world in the same quandry: why pay big bucks for a drug that does not increase survival times.
One can guess that if 70% of Bavi patients have Objective Responses vs. roughly 50% for Avastin, than perhaps the average percent % of tumor remission is also greater and it would take longer for the tumor to get back to its original size.
A major key to Bavi's success would seem to be its safety profile, which allows for continuing treatment whereas Avastin must be stopped to prevent adverse side effects. The ability to use Bavi on a continuing basis long after the chemo has stopped bodes well for achieving much better survival data than Avastin.