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Here is What I Hear. Nothing major-- seems to be the same as what others are reporting.
Approximately 4-6 IST trials will have started by mid summer. Patient populations will range from 10 to 40. Investigators are eager to make a name for themselves and their clinic so we can expect to see a race for who is first to release interim data. Expect interim data to start coming out in Dec 2010 and continue actively throughout 2011.
All appearances are that Bavi performs as well as or better than Avastin.
On HIV work, the Company’s collaborators are getting very close to having a “viable delivery modality.” Lots of progress has been made with both microbicide and aerosol delivery. I.V. infusion of drugs is standard practice in the cancer community, but in the anti-viral arena I.V. delivery is not desirable. Given the huge progress made in past year on aerosol and microbicide delivery technologies for large molecules, preparations have started with collaborators for first Bavi HIV clinical trials. [No indication given on start date for HIV trials.]
Dr. Garnick is actively working on an Animal Rule application to FDA. “Rob is excited to be working on this -- an Animal Rule NDA is probably the only type of application to FDA Rob has never done before.”
TMTI work is going very well. In active discussions with government to enlarge scope of work.
Regarding Avid BioSimilars, big P.R. is “coming soon” that will layout parameters of whole program, including for example info. on how much of the BioSimilars program will be dedicated to making the Company’s own proprietary products versus how much of program will be dedicated to manufacturing BioSimilars for third parties. Passage of Health Care Bill definitely helped to accelerate this program.
"It certainly would make good sense if they could pull off the financing."
I agree U2000. This is the key question and I am also hoping to hear more on this point in Dec. CC.
By way of speculation, my personal opinion is that many on this Board underestimate how quickly this stock could be trading in the $4-$5 range if Wall Street IBs decided all the stars were in alignment for PPHM to move up.
What would that take? Certainly the r/s was precondition no. 1. Condition No. 2 is also now in place, namely, the endorsements of a major league clinical scientist (Chabner) and a major league BP player (Garnick).
Now add to that mix three more factors:
3. SK goes public with blow-your-socks-off Ph II cancer data;
4. SK and Haynes/Duke go public with blow-your-socks-off efficacy data from 11.31 anti-viral pre-clinical studies; and
5. Avid is pumping cash already and raises a large wad of private placement capital through the sale of Avid shares to enter the Biosimilars field and this capital infusion shows up on the PPHM balance sheet without issuing more PPHM shares.
In my view, these 5 factors, plus Garnick's participation in the road show, are more than enough to cause Wall Street to jump on board. We just need to hear SK announce that this is his plan, and the pps can start to move. The big question in my mind is whether we will have to wait for ASCO before the road show can go on the road. Hopefully we will have an answer on Dec. 10.
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p.s. Regarding Nature publication, I heard many months ago that the lead scientist reserves the right to edit the adjectives used in the "Conclusion" paragraph and that Haynes would do this based on the level of confirmation or excitement he gets from seeing how 11.31 does in subsequent studies, many of which are still ongoing. But I could well be wrong on this point. Maybe the editors at Nature are the only ones who have any say about the final wording and when it's too late for further edits of the Concluding paragraph based on related ongoing research.
Here is what I hear:
THE DEC. CONF. CALL WILL BE WORTH WAITING FOR. I hear the Company will use Dec. CC to lay out its 2010 roadmap with a level of detail and clarity not seen in prior conf. calls.
With the endorsement of Bavi’s novel MOA by the likes of Drs. Chabner and Garnick, folks in the investment banking world as well as the BP world are now paying more attention to PPHM. With Garnick helping to beat the drums this winter, the Company could be ready to raise capital at much higher prices this spring as Bavi Ph II cancer data rolls in and Bavi 11.31 anti-viral moves into clinical trials with government support.
The Bavi relationship with Duke, CHAVI and Barton Haynes has deepened and expanded in important ways. Fully-human Bavi 11.31 is expected to start anti-viral clinical trials in first half of 2010.
More than half the Bavi cancer patients are still alive in each of the three Ph II trials, and that’s why we haven’t heard Overall Survival data yet. FDA is very interested in Bavi cancer data, because the data is stong on its own and also because Garnick and Chabner are now promoting the Bavi platform. Definitive Ph III U.S. lung trial will start in Q1 of 2010. FDA may give accelerated approval process if early results look to be same as in Ph II.
The guy who posted a few weeks ago about Garnick’s interest in using Avid to start a “biosimilars” manufacturing program was on to something that could translate quickly into new Avid revenues (and possibly be the basis for private placement capital raise for Avid).
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Here is my personal opinion:
A quick fix for pps in next few months is unlikely. Yes, a new round of gov’t funding for anti-viral programs could happen in next few months, and that would clearly help pps. But Cotara bidder would have to increase its price substantially to bring PPHM back to the table.
So we are left to wait on: infamous Duke publication (which is still coming but at a time of Dr. Haynes’ choosing); Bavi Ph II cancer data (which could be delayed until ASCO); and effects of Dr. Garnick being part of the road show this winter.
On balance, it seems like we lost one and won one. Failure to close Cotara deal was a big loss. But bringing on heavy-hitters like Chabner and Garnick may give the Company the credibility and major-league endorsement that institutional buyers want to see. Increased institutional interest would also help explain the recent increase in bashing volume and intensity.
I will wait to vote my shares until a few days before the meeting.
I hear (and you already know) that several major announcements will be made over the next two weeks.
If Mgmt. makes a run to burst through $1.00 without first doing a r/s, I will vote YES on the Incentive Plan, regardless of the success of their effort, because it means they did their best to protect the long-suffering retail shareholders who got the Company to this point.
On the other hand, if Mgmt takes the easy road and does the r/s first even though they have lots of major news to announce (I mean news like Duke publication in Nature’s Oct issue or big money thru a Cotara license or a major new gov’t anti-viral grant), I will vote against the Incentive Plan. Such a scenario means they favored having all the new authorized shares over going to bat for the retail holders like us. If Mgmt takes the easy road by doing an “unnecessary” r/s, then I want them to suffer the same r/s affects I suffer and not make up for lost shares by granting themselves new stock options.
The difficulty will be in deciding how to vote if the r/s is done first and is followed by only modest news. In that case, I may vote “for” the Incentive Plan. The Board’s first responsibility is to assure that the NASDAQ listing is maintained. I won’t punish them for doing that if the r/s was “necessary.”
Let’s wait and see what comes down. Either way the next two weeks will be exciting.
Here is what I hear:
1. The best report is on lung cancer data. Apparently it’s over the top – so much so that serious work has started on preparing a Ph II/III clinical study that will be filed and announced in Nov. or Dec. Cost of trial will be about $30 million but only a fraction of that amount is needed upfront. It really seems we have a winner here. Company believes PRs in September on the Ph II lung and breast interim data will do a lot to help the pps.
2. Big Duke/Haynes publication is definitely coming. Some thought it would be in August issue of Nature Med and now expect it in Sept. issue. I hear exactly the same as what was said in CC, namely, the collaboration between Haynes and PPHM is growing by leaps and bounds and has moved way beyond the data from Capetown AIDS conference that will be the subject of first Nature Med. Article.
3. Government anti-viral work is expanding. All the recent new hires are paid for with DTRA funds. New projects and more funding are coming but no time line given. Avid expansion is being driven by the rapid growth in government contract work. Multiple r&d centers are involved around the country.
4. No update available on Cotara license. Lips are sealed. Can’t tell if this means deal has fallen off tracks or is close to closing.
I have not heard anything recently that was not also said or implied in the last CC. No one knows how the pps will respond to the PRs in coming weeks on the above topics. Management seems more confident than ever about their clinical cancer data and pre-clinical anti-viral data, but less sure of how market will react to the PRs to be released in September.
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My personal hope is that the Duke PR department will save the day for us. I have heard they will be “active” when the Nature Med article comes out, but who knows what that means.
I would describe the mood in Gotham as "very confident" rather than "overly confident" because management's optimism is supported by very positive developments.
You won't have to wait long now to understand why. :)
Here is what I hear:
Company is very pleased with cancer data in all three Ph II trials. More updates coming over next few weeks.
BP interest at ASCO was high. BPs are impressed by Bavi’s safety profile. Unlike us, BPs are seeing overall survival data “WHICH IS HEADING IN THE RIGHT DIRECTION.” Number of patients showing long-term survival is still too small to announce in PR, but BPs like what they see.
One BP deal is ahead of the others, is now on front burner and MAY close before CC in mid July.
Russell qualification was not on the Company’s radar screen last week. More important issues are seizing Mgmt’s attention.
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My personal opinion is:
My private guess, based on the current high optimism and confidence levels of Mgmt., is that no shares have yet been sold from the pending shelf registration. The pending BP deal and pending Duke/Haynes publication give the Company confidence that it is not necessary to sell stock as these low prices, or maybe at all if BP deal closes. IMO
The sun will shine brightly on PPHM longs during June and July. Keep your finger off the trigger, lots of good things are happening on both cancer, viral and Avid fronts that we do not see. IMO
Plans for further expansion of Avid are already in motion.
Mary Boyd is far along in closing some sort of licensing deal. If it does close, then it will not be necessary to sell $7.5 million of stock plus $5 million loan to supplement Avid revenues.
"If so, what really excites me about PPHM is that there is so many indications for the same drug. We could see PHII?III for multiple cancer indications, Bavi fast tracked for DTRA Hem Fever, DUKE with a early use as microbicide all at once."
From what I hear, this statement is very close to the mark, except that:
1. The Phase 2-3 trial for 300-400 patients that is filed with the FDA this summer will be for either lung or breast cancer, not both;
2. This Phase 2-3 trial will cost around $30 million spread out over two years and will be funded mostly/entirely with revenues from gov't stockpiling of Bavi for military use (hemorraghic fever?);
3. Two mini-trials of around 20 patients each will also start this summer/fall to see how Bavi does against hard-to-treat patients, i.e. breast cancer patients where all are HER2+ and lung patients where all are squamous cell.
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IMHO, the Company would not have told all the analysts at Cowen conference that "high profile Duke paper" will be published before June 30 unless this had been confirmed first with Haynes.
IMHO, the "market" will pay attention to this stock starting in April,May and June due to the combined impact of AACR India clinical updates, Duke/Haynes pulbication, two ASCO abstracts with concurrent clinical updates from all three Ph II trials, and filing with FDA in June/July for Ph 2-3 trial for 300-400 lung or breast patients.
IMHO, the key difference between us and other biotechs who negotiate BP licenses at the end of Ph II is that Avid will be generating enough revenue in 2009 and 2010 from gov't and other contracts to pay for most/all of the Ph 2-3 trial. The ability to fund a Ph 2-3 trial ourselves gives us huge negotiating leverage with BP. My personal guess is that we will file the FDA applications ourselves and start down the path of running the Ph 2-3 ourselves, but after jacking up the price tag we will let BP run the show. In fact the ideal time to close the BP license/partnership might be in the three month period after the FDA application is filed and before it gets approved to allow the BP to put its stamp on the final clinical protocol.
See p.p.s. at bottom of post 33513.
JMO
The likelihood of a R/S or another PIPE are inversely related to (1) the strength of Ph II cancer TTP and survival data and (2) the strength of the Duke/Haynes publication and related Duke PR effort.
The likelihood of a near-term licensing or partnership deal are directly related to the same things. It’s as simple as that.
My vision is clouded by owning so many shares, but I am encouraged by what SK likes to call: “Two shots on goal.” If EITHER 11.31 comes through strong in the monkey trials, OR we get good TTP and survival data in the Ph II cancer trials, we are off to the races and the words R/S and PIPE will quickly become distant memories.
p.s. If you add in Cotara, it might even be 2 and 1/2 shots on goal.
p.p.s. I am also encouraged by hearing that a major expansion of AVID is underway. Let's hope SK is willing to confirm this publicly in the March CC. In my view, there are just not enough biotechs these days needing small clinical trial runs to justify the doubling or tripling of AVID capacity that I have heard. My hope/guess is that this increase in capacity is a sign that the Company is already talking with the military or NIH about stockpiling for hemorrhagic or HIV testing purposes.
IMHO
Comparing what I heard in Jan vs. Feb:
JAN 10: "1. Our prayers for SIV challenged monkeys –-- at least the ones who received the modified Bavi (i.e. Mab 11.31, aka PGN632) presented at Capetown AIDS conference --- are being answered as we speak. All is going well." NOW: Exactly the same, except it seems two of the four tests may have been completed now vs just one in early Jan.
JAN 10: "2. A major increase in Avid capacity is being planned. We’re talking several times current capacity. This is probably the best indication of just how well the monkey trials are going." NOW: Exactly the same, except that in Jan I could only say major capacity increase was being "planned" whereas now it seems design phase is done and work may be in progress.
JAN 10: "3. The big Duke/Haynes publication will come out in Feb and will include results from the current monkey trials." NOW: This accurately reflects what I heard but clearly odds are increasing that my source may be wrong as to timing.
JAN 10: "4. Ph II cancer update will be in late January. Detailed data from both India and GA will be presented at ASCO in May." NOW: Two of three Ph II cancer updates occurred in early Feb rather than late Jan, so that estimate was off by two weeks. The last statement contained an error on my part. I should have said India and GA data have been "submitted for presentation at ASCO." No one can guarantee what status ASCO will give to our Ph II preliminary data.
Flglf4—Thanks for your words of caution.
I am not an insider, I do not work for the Company, but I’ve been around a very long time and do occasionally hear things from good sources that I repeat. Often those sources are expressing their own hopes or expectations, which have often been correct in terms of direction but have often been wrong in terms of timing.
The other thing I do from time to time is express my own personal views and hunches, which I try to indicate with “IMHO” or “JMO.” A good example of my personal hunch was my post 32511, but I admit the IMHO added to that post should have been part of the main statement, not a throw-away at the end.
Truth is that no one, not even SK, knows for sure when Haynes will feel he has enough monkey data to go “meet the press” and explain to them the implications of all the Duke discoveries and pre-clinical and primate data collected on Bavi and 11.31 these past three years. The reason I guessed at Feb 23 is because that’s the date every month when Nature’s electronic edition is published and I wanted to tweak Jessme a bit for his occasional pretense at being something other than a basher. Who knows, Feb 23 may still turn out to be a good guess.
Here is what I hear:
1. There are at least 4 different monkey experiments that Haynes et al. have designed to test the efficacy of 11.31. In different test designs the monkeys get 11.31 (1) just before being challenged with SIV, (2) within a day or two after being challenged, or (3) several weeks after being challenged when the immune system has been fully compromised. The fact that Haynes is now working on the second (?) or third (?) of these monkey trials is a sign that the first and second (?) of these trials went well. Haynes would only continue if the data were good. No news is good news.
When the long-awaited Duke publication finally comes out, the world will be on Haynes doorstep clamoring for his interpretation of the new data. Will he say this is a “very dramatic breakthrough” in the fight against all viral disease or will he describe it as a “promising development.” Duke/Chavi/NIH can’t afford to create another round of false hopes in the HIV community. Haynes has to get it right. Hence he keeps doing more monkey tests.
2. Very large expansions of AVID are being considered or are already in progress. I am hoping/guessing this will be discussed in March CC. JMO
3. GA Ph II breast data is likely to be updated prior to March CC.
Thanks Jess--
The conference you mention will start just two days after Nature puts out the digital version of its big Duke/Haynes publication on Feb 23.
Good timing.
IMHO
GREAT POST Wildhorses
You get the prize for the most insightful, value-added post on I-Hub since JBM left us.
Thank you. BOT
Hayward, I agree with your analysis.
Here is what I hear:
1. Our prayers for SIV challenged monkeys –-- at least the ones who received the modified Bavi (i.e. Mab 11.31, aka PGN632) presented at Capetown AIDS conference --- are being answered as we speak. All is going well.
2. A major increase in Avid capacity is being planned. We’re talking several times current capacity. This is probably the best indication of just how well the monkey trials are going.
3. The big Duke/Haynes publication will come out in Feb and will include results from the current monkey trials.
4. Ph II cancer update will be in late January. Detailed data from both India and GA will be presented at ASCO in May.
Relax -- It's happening.
The fact that a prestigious journal chooses to republish old data from 2005 underscores the NEW IMPORTANCE of that data.
This Nature Med. article is like the warm-up act before Duke / Haynes step on to the big stage with their blockbuster sequel on the work they've done with the Bavi MOA from 2005 - 2008.
Before Duke / Haynes / Chavi reveal the new global frontiers for anti-viral therapy soon to be launched by their work with PGN632 and other Bavi derivatives, Nature is paying due respect to Dr. Thorpe's lab where it all started.
I'm guessing the warm-up act will last about two weeks before Haynes takes center stage.
The really interesting r/s question
concerns Rodman & Renshaw. They have been holding back on recommending PPHM stock in the expectation/hope a r/s would happen first.
Now that the NASDAQ angels have given the Company through the end of March (and maybe later if another extension is granted) to trigger the r/s --- which is enough time to get out some breakthrough news on the HIV and cancer fronts --- I think R&R may be forced to recommend the stock right after the Duke/Haynes publications are released in late Nov.?, Dec.?, or early Jan?.
Pray for the monkeys. If the "in vivo" tests go well, R&R will be forced to make a move.
I don’t “hear” anything about the r/s.
My guess is they won’t do it unless they have to, which means waiting until late March to see if pps gets over $1.00 on its own. Or perhaps a latter cut-off date if NASDAQ gives all companies another three-month reprieve.
This guess is based on (1) Mgmt. knows the great majority of beneficial stockholders voted against the r/s and they don’t want to trigger a legal challenge to their “routine matter” decision and (2) Mgmt. is in the same economic position as the rest of us since their stock incentive plan was voted down and they will not be able to make up shares lost in a r/s through new grants under that plan.
“Why the wait until July?”
Good question. The only reason I said late June/July is because that is the 12 month mark and the Avastin survival chart Mojo found has hash marks at 6 and 12 months making it easier to read at those points.
In fact I expect SK to give GA survival data updates at several points between now and mid summer, for example: the Dec 15 CC, the March 15 CC, AACR annual meeting on April 18 and ASCO on May 29. If the continuous dosing of Bavi (after chemo stops) is indeed yielding survival rates in the 90% to 100% range, SK won’t hide this fact. Believe it or not, SK and Mary Boyd are already working towards a Bavi BP deal and will beat the drums louder and louder as the Ph II data comes in during the first half of 2009.
By the way, Jazz’s post 26997 shows only PFS data. I think you may be confusing Progression-Free Survival with Overall Survival. Overall Survival is the sum of Progression-Free Survival plus Progression-Happened Survival. A tumor which was initially shrunk by Bavi from 100% to 30%, but then grows back to 50% of its original size, no longer counts as a PFS patient, even though the patient is stable and lives for another two years thanks to continuing weekly doses of Bavi.
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Pphmtoolong / Financing
What I “hear” is that the secured bank loan, i.e. the one that has been in the works for months now and repeatedly referenced by Mgmt., is still alive and has not been killed by the credit crisis. I also hear there is little to no anxiety within PPHM as to how the Company will stay funded.
What I guess, and this is speculation, is that their confidence comes from the AC and AV data they are seeing. IMO, they believe they can afford to wait another month or two to close the bank loan because (1) the credit markets will have returned to normal by January (or at least more so than today) and (2) Duke/Haynes data and India AC data will then be on the table and they expect to be in a much stronger negotiating position with a higher pps and a Duke/Gates/Chavi endorsement to back up their story.
Survival Data is the Key for Bavi Cancer.
Great find Mojo. Thanks so much for the link to Avastin’s survival chart. The conclusion of this Abstract is also worth repeating:
“Conclusions: Initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone.” http://content.nejm.org/cgi/content/full/357/26/2666
IMO, Mgmt. will wait to do a Bavi BP license until enough time has passed to show that the survival line for GA and India Bavi patients is trending above the Avastin survival line shown in the chart Mojo posted yesterday.
Comparing the PFS trend lines for Bavi vs. Avastin may be intriguing, but the big money lies in proving that Bavi’s second MOA (i.e. stimulating an immune response to the tumor) results in longer survival times.
The rationale for insurance reimbursement of a drug like Avastin that only improves PFS but does not improve overall survival rates is already in serious question. Bavi’s big commercial bang will come from improving survival times as compared with Avastin, not from improving PFS times as compared with Avastin.
While I love the earlier PFS charts you have made, Mojo, and while it would temporarily appease my curiosity if Mgmt. would give us more of the Georgia PFS data that we know they have, having this PFS data could be quite misleading since the really big and certain indicator of Bavi’s potential to broadly replace Avastin in the marketplace will come only from long-term survival data.
In post 30156 I said that “Georgia Bavi results with Docetaxel are good (MAYBE as good as Avastin).” Realist interprets this as a negative remark. All I meant to say is that we won’t know whether Bavi is “commercially” superior to Avastin until the survival data starts to draw a trend line above the line in the Avastin chart Mojo posted yesterday.
As of the PR on July 2, 2008, 14 of 15 GA breast tumor patients had completed the 8 week protocol. As of late January and late June 2009, six-month and 12-month survival data will be available for these patients.
Thus, in first-half of 2009 we will see whether Bavi’s dual MOA results in superior survival times as compared to Avastin. Take another look at Mojo’s chart. If 100% of our 14 evaluable patients are still alive in January (the 6-month mark), and if 90% of these patients are still alive in late June (the 12-month mark), Bavi is on the way to becoming the new SOC for cancer.
This need to wait for 6-month and 12-month survival data is, IMO, the reason why S.K. said in his presentation this week, in Slide 34, that GA breast cancer results will be updated in 1H’09. Nothing else really matters.
Keep your eye on "Science" and "Nature."
Both are weekly publications. That's where it will be.
The rules are different for Dr. Haynes.
Assuming that an article has alreeady gone through peer review, my understanding is that when Barton Haynes says the article should be published now, it gets published in the next week or two, and someone else's article that was in the queue gets bumped.
When you are one of America's opinion leaders and you sit on the editorial boards of the nation's most prestigious scientific journals and make the decisions as to which articles get published and which get rejected, you get to jump the normal six-month queue.
I am hearing that:
1. The series of Duke / Haynes publications -- documenting the last three years of pre-clinical work with PPHM antibodies -- have all completed peer review and are ready to roll. Only thing holding up these publications are the in vivo SIV primate studies to confirm that the dramatic neutralizing of HIV infection that happened in vitro also happens in vivo. All the safety and PK studies in monkeys with PPHM’s CL1 MAb are complete. Haynes wants to be sure it works in vivo before turning the HIV community upside down with this huge breakthrough. It’s not certain how many CL1-immunized monkeys Haynes will want to challenge with SIV injections, but these in vivo studies have started and results should be known in 4-6 weeks.
See Haynes’ Sept 22, 2008 statement that “…and a prototype of non-pathogenic anti-lipid antibodies will be studied in vivo for the ability to protect against R5 SHIV infection.” http://www.cavd.org/grantees/pages/progressAbstracts_Haynes.aspx
2. If Haynes says that CL1 neutralizes SIV in vivo the same as it did in vitro, Gates and CHAVI will fund a very large and aggressive program to develop a vaginal cream (microbicide) based on CL1 (or another PPHM MAb) as the active ingredient.
3. Georgia Bavi results with Docetaxel are good (maybe as good as Avastin), but early results in India with Carboplatin/Paclitaxel are even better.
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Connecting the dots at PPHM has never been easier. Just print Slide 20 from yesterday’s presentation and draw dots between top and bottom bullet points on this page. Bingo! That is your reason to hold on to your shares for another two months.
Obviously the Company is not going to launch an HIV PR campaign until the Duke data has been published. If Haynes likes the in vivo results he sees over the next month, he will put the full weight of his reputation behind the CHAVI / PPHM microbicide program,-- and Gates will fund it!
See Jake’s and Volgoat’s posts 30128 and 30140 re Gate’s commitment to microbicides as “the next big breakthrough in the fight against AIDS.”
Pray for the monkeys. We could be off to the races before Christmas.
"COMPLETELY BIZARRE" is an understatement.
Sounds like the Wall Street firm that pays you has given you new instructions.
Care to explain why you are reversing your position on the R/S?
Moby, Thanks for your post 27496. Good information
When you say that “your shares can be voted by the broker if you do not vote yourself,” is it correct to add that this is only true for “routine” matters?
I’m still trying to figure out how a vote on a r/s can be considered “routine” when Delaware law says it requires a higher vote than most matters – i.e. an absolute majority of the votes entitled to be cast, not just a relative majority of the votes actually cast. See Section 242(b)(1) of the Del. General Corporation Law.
Doesn’t this section of Del. law in effect define a r/s vote to be a “non-routine” matter?
I read BOT the same way you do.
You put your finger on an issue where I lack information and am merely speculating, namely, “… if the shareholders vote down the R/S, NASDAQ won’t rescind their grant of the 180 day grace period.”
The NASDAQ FAQ says that the Hearing Panel will “issue a written decision approximately 30 days after the hearing, but the company could receive a written decision sooner.” With a Sept 4 Hearing date, this means we should have a PR announcing the decision by Oct 4, which still leaves plenty of time to cast your vote for the Oct 21 AGM.
A lot of news is going to come out between now and Oct 4. If the pps is not already near or over $1.00 by Oct 4, and if the Hearing Panel conditions their 180-day extension on s/h approval of the R/S (which I am guessing will not be the case), then I would have to reassess my position on the R/S at that time.
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Separately, my remark about the POSSIBLE pricing of a full-value Cotara deal (assuming excellent Ph II data) comes directly from remarks made by management almost a year ago. It is purely my speculation that a deal closed before all the Ph II data is on the table would fetch about half of a full-value deal.
Nudging mgmt. to monetize assets now.
Another benefit of voting “NO” on the R/S is that it will nudge mgmt. to act a.s.a.p. to close a Cotara license agreement and/or 2C3 license agreement and/or VEA license agreement and/or monetize Avid--- in order to get the stock over $1.00 for 10 days.
By contrast, voting “yes” on the R/S will take the pressure off mgmt to close a non-dilutive funding this fall.
Just to be clear, I am not bashing mgmt. and I continue to support them. I think they’ve done a superb job of avoiding premature deals and building huge pipeline value with very limited resources. I will vote in favor of electing all the same directors for another year.
It’s just that we are now at a crossroad. The combination of NASDAQ listing rules and shorting ploys have forced us to make a choice between monetizing non-core assets prematurely or suffering the effects of a R/S. My vote goes for using the early sale of a few non-core assets to keep our listing.
I see no grounds for accusing mgmt of negligence or bad faith conduct. It’s simply business. Wall Street is on Tustin’s doorstep pushing mgmt. to ask us to approve a R/S for up to 1-for-10 shares, with full disclosure that (a) mgmt. will be protected from adverse effects of the R/S through its new Stock Option Plan and (b) we will be exposed to more dilution and will have less price leverage.
I reject the security and certainty of Wall Street’s R/S game plan because I know from what I hear that Barton Haynes is truly excited about our anti-PS results in SIV monkeys and mgmt. is truly excited about the July and August cancer data coming out of GA.
Bavi really is as good as Avastin or better. If the Company were in a dire state, the Wall Street game plan would be a reasonable solution. But the contrary is true. Bavi is working, more government funding is coming (probably for malaria), Avid revenues are exploding, and the R/S is unnecessary (except as a formality to satisfy old policies of the NASDAQ Hearing Panel).
From what I hear, if we vote “no,” mgmt will be just fine with that vote and will solve the delisting issue by closing the Cotara deal prematurely, perhaps at $300 or $400 million instead of $600 million. On the other hand, if we vote “yes”, that will work just fine for mgmt as well. They are giving us control of the outcome.
We have no one to blame but ourselves if we vote to leave our wallet on the car seat with the door open and Wall Street picks it up. Management is neutral. The choice is ours.
How does price leverage work?
In a perfectly rational world where everyone had a computer-like mind, price leverage would not matter. Before buying or selling, everyone would calculate the entire value of PPHM’s pipeline and AVID revenue potential against the pipeline and revenue potential of comparable biotechs and then compare our market cap to their market cap and then decide if we were overvalued or undervalued and then buy or sell. In such a world a R/S wouldn’t matter because after the R/S you would still own the same percent of the outstanding market cap and the pps of your post split shares would go up and stay up to the same extent as the number of your shares went down.
The reality however is people buy shares on a gut, emotional feeling. When the Duke PRs hit the papers and nightly news programs and people realize little PPHM owns the patents on the anti-PS paradigm shift in viral medicine, they are going to say: “Wholly Moses, what a deal, I can still buy this stock for $1, I’m so lucky to get it before it goes up.”
The notion being argued now to PPHM mgmt. by Wall Street firms, i.e. that our PPS can only go up 10 times from $0.50 to $5.00 if we first do a R/S so that Wall Street is induced to buy, is utter hogwash.
Let’s assume a 1-for-5 R/S and every 100 shares you own becomes 20 shares.
Without the R/S you will get a 10 fold increase on your full 100 shares as the pps moves from $0.50 to $5.00. By contrast, the day after the R/S your adjusted post-split 20 shares will automatically move from $0.50 to $2.50, but then as the price climbs from $2.50 to $5.00 on all the good news, you will only double your money, not multiply it 10 fold.
Emotionally, it’s a lot easier for small investors to buy a stock at $1 and believe it will go to $5, then to buy a $5 stock and believe it will go to $25.
If PPHM owns the rights on a major breakthrough for both viral disease and cancer, I am confident retail gut excitement around the globe will move this stock 10 fold from $0.50 to $5.00 with or without the support of big Wall Street firms.
What is MUCH MUCH LESS SURE is that after a 1-for-5 R/S and the stock opens at $2.50, that it will then move 10 fold from $2.50 to $25.00. Logically it shouldn’t make a difference, but emotionally people think a $2 stock is a lot cheaper than a $10 stock. Both blocks of stock represent the same percent of the company’s market cap., but one seems relatively cheap and the other seems relatively expensive.
It’s called price leverage, and Wall Street is hoping you don’t understand it. Wall Street knows how hard it’s going to be for you to persuade your wife not to finally let go of your 20 shares when the pps gets to $5.00 (which is actually just $1.00 on a pre R/S basis).
Price leverage (not fear of further dilution from more PIPEs) is the big reason why I’m voting against the R/S. I can’t afford to wait 2 years to see the post R/S price get to $25.
Let’s take a look at a quick 5 banger. After all the news comes out this fall, which scenario do you think is more likely to happen quickly: (A) that the pps moves from $0.50 to $2.50 without a R/S, or (b) that after a 1-for-5 R/S the pps moves from a post R/S price of $2.50 to $12.50, which is where it has to go for you to realize the same profit?
Not that I can see.
Nothing in the 14A would indicate a separate vote is planned to reduce the authorized capital.
I don't know if Tustin mis-spoke or EZ mis-heard, but I think Tustin was trying to say that the 15M new Stock Option Shares would be reduced in the same ratio as the outstanding shares are reduced.
Someone should be able to clarify this with IR or Tustin.
Maybe the legal advice I received was wrong. My friend is not a Delaware specialist, but what he said sort of makes sense from what I can see in the statute language.
Why I am voting “NO” on Items 3 and 4
As of today I am strongly leaning towards a “NO” vote on both the R/S and the Stock Option Plan. If management did not have the ability to award themselves low-priced options to make up for the shares they lose in the R/S, I would be more willing to trust they will do the right thing for ALL shareholders.
The problem is that R&R and other Wall Street heavy weights will lean on Mgmt. to do the R/S EVEN IF the stock gets over $1.00 for 10 days on its own from all the good viral and cancer news coming out this fall.
It comes down to this: either you believe there is major cancer news and major Duke / HIV / Bavi news coming this fall, or you don’t. If Bavi ant-PS really is a major breakthrough on both the viral and cancer fronts, the pps is going to roar up to a pre R/S price around $5 over the next six months on retail and small fund buying-- with or without the heavy hitters on Wall Street.
I have heard very clearly that it is R&R and their WS friends, not SK and ES, who pressured the Board to authorize the R/S EVEN IF IT IS NOT REQUIRED TO MAINTAIN OUR NASDAQ LISTING. The big WS firms are telling Management they are the only ones who can save the company from oblivion and they will only do it if the R/S comes first so they can increase their buying leverage without overpaying you and me for our shares. That’s what a R/S does: IN THE NEAR TERM THE BUYERS GET MORE FOR THEIR MONEY AND THE SELLERS GET LESS FOR THEIR SHARES. IT’S CALLED LEVERAGE. See post 27366 for an introduction to the concept.
If you can hold onto your shares for another 3-5 years, then you won’t suffer from a R/S because our PPS will eventually settle out to where it should be based on the market cap. of comparable companies. But over the next 12 months sellers in a post R/S environment will be screwed as the pps makes it inevitable climb from $2 to $5 (which is only $0.40 to $1.00 in pre R/S terms assuming a 1-for-5 R/S).
From what I hear, PPHM management strongly believes the stock will go over $1 this fall on its own from all the pending news, but they are getting so much pressure from R&R to do a R/S that they are hedging their bets in the 14A by saying “OK, if the shareholders are dumb enough to approve the R/S after all the negative disclosure in the 14A, then I guess it’s OK as long as we protect ourselves by getting more free options. If the long suffering retail shareholders are stupid enough to approve the R/S, then the blood is not on my hands.”
If I thought PPHM was close to a desperate situation and a Hail Mary R/S pass was the only way to keep the NASDAQ listing alive, then under those facts I would vote in favor of the R/S. But desperation is the opposite of where we are. During the period September – November, it will become clear to all (not just to Jazz) that anti-PS is the biggest breakthrough in medicine since antibiotics were discovered.
If we retail shareholders who have waited so long for this moment vote “NO” on the R/S, then big Wall Street players who have been waiting in the wings will immediately be forced to participate in the buying as the pps moves from pre R/S $1 to pre R/S $5. Why is that so? Because if they don’t participate in the initial buying spree when Duke PRs the anti-PS paradigm shift in viral medicine, small aggressive funds will take it from $1 to $5 and big WS funds will then have to take it from $5 to $10 in order to own a piece of the action.
By contrast, if we say “YES” to the R/S, the shorting game will start in a major league way on Oct 22, the day after the AGM, and continue all the way through the winter and spring of 2009. Wall Street will own the company, and they won’t allow the PPS to move more than a double, or maybe a triple, until 2010 when you and I are exhausted and our wives force us to sell. After most of us have thrown in the towel, WS will take it from $5 to $50 (i.e. $1 to $10 on a pre R/S basis assuming a 1-for-5 R/S), and then do a 2-for-1 or 3-for-1 forward spit to bring the outstanding shares back up again almost to the number we have today.
In Wall Street jargon this is known as “playing the accordion.” What we call “falling off the roller coaster,” they call “music.”
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For the record, I would vote in favor of the R/S if the proposal were modified so that:
1. Authority to do the R/S was granted “ONLY IF NECESSARY” to preserve our NASDAQ listing (i.e. only if pps doesn’t stay over $1.00 for 10 days prior to Jan 22, 2009).
2. The discretion of the Board started with a R/S ratio of 1-for-2, not 1-for-3; and
3. Management does not protect itself from the loss of leverage and other risks of an R/S through a new Stock Option Plan (i.e. item 4 is deleted from the 14A).
Authorized capital will stay at 325M after R/S.
Here’s what a business lawyer sent me today in reply to my question:
Start of lawyer’s email:
“Provided the Board gets the affirmative vote of a majority of all the outstanding stock (not just a majority of the shares that are voted), then Section 242(a) of the Delaware General Corporation Law allows a company to amend its Charter so as:
“… (3) To increase or decrease its authorized capital stock or to reclassify the same, by changing the number, par value, designations, preferences, or relative, participating, optional, or other special rights of the shares, or the qualifications, limitations or restrictions of such rights, or by changing shares with par value into shares without par value, or shares without par value into shares with par value either with or without increasing or decreasing the number of shares, OR
by subdividing or COMBINING the outstanding shares of any class or series of a class of shares INTO a greater or LESSER number of outstanding shares.”
Because the authority in the last line to “combine into a lesser number of outstanding shares” (i.e. a reverse split) is separated by an “OR” from the authority to “decrease its authorized capital stock” in the first line, the effect is that both actions have to be authorized separately. Shareholder approval to authorize a reverse split of the outstanding stock will not also effect a decrease in the authorized capital unless this second step is separately authorized and approved by the shareholders.”
End of lawyer’s email.
______________________________
My understanding from speaking with this lawyer is that the Item 3 of the Proxy as presently drafted would cause the 15M shares in the Stock Option Plan to be reduced to the same extent as the outstanding shares are reduced, but would not cause any reduction in the authorized number of shares.
Also, it seems to follow from the article at http://findarticles.com/p/articles/mi_pwwi/is_200211/ai_mark02048410 that Level 8 Systems would not have gone to the trouble of separately addressing the effect on authorized shares if this were not separately required by the law.
“What could UTSW and Thorpe possibly gain in exchange for giving Hayne's the public nod on all things PS?”
Moby— Confusing the issue seems to be your forte. If you’ve read the Haynes’ patents and followed today’s discussion at all, you know that what UTSW and Thorpe are giving the public nod to is “all things vaccine-design related”, which is a very small subset of the universe of “all things PS.”
Giving the nod to Haynes' vaccine enhancement / patent extension is a very small price to pay for the huge credibility and endorsement that Duke and Haynes bring to the Thorpe / UTSW table.
MOBY
You’re exposing your true colors. Your game is better than to fall back on obvious falsehoods like: “Peregrine doesn’t own their PS patents.”
Surely you know that PPHM’s exlusive world wide license is commercially the same thing as ownership.
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“I find it hard to believe that they're going to let Duke have it all, lock, stock and barrel, without any of the fights and case law your friend revealed to you today.”
Apparently you need reading glasses. I said:
“It’s a common practice for the new patent filer [Duke] to agree to license the prior patent for a fair price [paid to PPHM]. In return, the owner of the prior patent [PPHM] agrees not to bring an “inherency” challenge against the new patent.”
Duke and PPHM are preparing for a commercial COLLABORATION, not a lawsuit. By the way, UTSW and Thorpe are huge beneficiaries of that collaboration.
Get it now.
Patent Law; Common Practice
1. Patent Law:“Inherency” Doctrine. I spoke with a patent lawyer today about your remark on the Haynes’ patent application – the one where you said: “Either it is completely novel, or it infringes on Peregrine’s IP.”
He thought your remark reflected ignorance of the large body of case law where parties fight over whether an “extension” of a prior patent to a different application constitutes something that is novel (and therefore patentable) or whether the new extension should be viewed as obvious and not patentable because it was “INHERENT” in the prior art.
He gave me this link to a 2005 William and Mary Law Review Article summarizing the complexities of the Inherency Doctrine: http://papers.ssrn.com:80/sol3/papers.cfm?abstract_id=861384
He said a common strategy for a patent lawyer drafting an “extension” patent is to refer indirectly and obliquely to the prior art (e.g. the use of 2aG4 in Fig 13), but not directly cite the prior patent you are most worried about because that’s the job of the company that challenges your extension patent. Your job is to get the application through the examiners at the USPTO and have it approved. Whether the new (vaccine) application was inherent in the prior patent and whether the prior patent should have been cited is all stuff you argue about in court years down the road.
2. Common Practice. He also asked me if there was any business relationship between the owners of the prior patent (PPHM/Thorpe) and the owners of the new patent that builds on the prior patent (Duke/Haynes). He said that it’s a common practice for the new patent filer to agree to license the prior patent for a fair price. In return, the owner of the prior patent agrees not to bring an “inherency” challenge against the new patent.
As I understood my conversation today, the reason for doing all this so that the new patent filer (i.e. Duke) can create a stronger patent position vis-à-vis the rest of the world. The problem is this: Thorpe’s earlier patents did not describe the vaccine potential of his anti-PS invention in the same detail that Haynes has now done, so this opens the door for a BP vaccine developer to come in and steal all the value of the Duke vaccine research these past three years. So to stop this from happening and allow Duke to get the credit, and commercial profit, from all the research they have funded, PPHM agrees that it won’t challenge the new Duke / Haynes patent.
Bottom Line: PPHM is not going to bite the hand that feeds it. IMHO, what we’re going to see more and more clearly over the next two months is a collaboration among Haynes / Thorpe / Duke / PPHM / CHAVI / NIAID and Gates vis-à-vis the rest of the world. The Haynes vaccine patents are a big part of that collaboration.
Ask yourself this: When a BP comes in and starts making an effective AIDS vaccine using Thorpe’s anti-PS mabs as a centerpiece of the vaccine design, and refuses to pay PPHM anything for this use of Thorpe’s technology, who would you rather have bring the lawsuit again the BP: PPHM or Duke? Gee, that’s a tough call.
You can bet PPHM is going to let Duke and Gates and NIAID have all the credit and fame and patents they want in exchange for collaborating with us and putting PPHM on the radar screen of every fund manager around the globe.
Haynes Patents / Cell Phone Analogy
In the battery compartment of many cell phones, there is a long list of the 20 or so patents needed to produce the phone and make it work. Big advances in technology often depend on a long series of prior patented discoveries from third parties that are brought under one roof through license agreements to produce the final commercial product.
That seems to be what is happening with Haynes patents. He is taking Thorpe’s prior discoveries and Thorpe’s monopoly on anti-PS targeting and incorporating that as a core COMPONENT of his patented new vaccine strategy.
Next to final paragraph of Haynes WIPO patent (see Jazz post 26401 for link) talks directly about anti-PS antibodies as a “COMPONENT” of a new vaccine strategy.
The purpose of the Haynes patent is to demonstrate that he had a novel and patentable idea when he thought of using anti-PS mabs against microparticles as a component of how and when a vaccine is delivered.
For me, it’s very encouraging that a scientist as busy and as important as Barton Haynes takes the initiative to have Duke’s patent lawyers file patents on a vaccine strategy whose fundamental building block is Thorpe’s anti-PS patent portfolio. It would have been easy for Haynes to just publish the results of his studies in the Journal of Virology last week and leave it at that. But no, he went to Duke’s I.P. lawyers and said “Stopping PS-exposing microparticles will be such an important part of ANY successful AIDS vaccine that we should make these studies top secret until you file patents for us on the idea that a successful AIDS vaccine needs to address PS-exposing microparticles.”
Now we know why we had to wait all spring and summer to hear the results of Duke studies that were completed last winter.
IMHO, the reason NIAID/CHAVI cancelled the large vaccine study last week (see July 18 NY Times article http://www.nytimes.com/2008/07/18/health/18vaccine.html?_r=1&sq=HIV%20Vaccine&st=cse&adxnnl=1&oref=slogin&scp=1&adxnnlx=1216916082-J8vbpFnlbShNMbAbz1401A ) is because Haynes told them, based on his new findings published last week in the Journal of Virology, that there is simply no way any vaccine will work unless it concurrently addresses the huge problem caused by PS-exposing microparticles.
In the last two paragraphs of the NY Times article, you see this ironic reference to Haynes work (now patented per today’s WIPO application) and his "UNRELATED" discoveries:
“In an unrelated [OH SURE!!] development, researchers at Duke University reported new findings Thursday showing that H.I.V. stuns the immune system earlier than scientists previously understood. The window of opportunity in stopping H.I.V. may be a matter concerning the first few days, not weeks, after the virus enters the body, a team headed by Dr. Barton Haynes reported in The Journal of Virology.”
IMHO, the reason PPHM management is so confident is that they know that the next big NIAID/CHAVI vaccine study (to replace the one cancelled last week) will be based on the recently patented Haynes discoveries about PS-exposing microparticles and will rely on PPHM’s anti-PS mabs as the vehicle for solving the microparticle problem.
Last thing I heard was the CC.
I hope to hear more in mid August.
The postponement of the delisting deadline to January, combined with DTRA’s $44M, unlocks a whole new lease on life for PPHM – things are looking up.
As Jazz keeps pointing out, Barton Haynes would not have filed a patent that relies heavily on anti-PS mabs to clean up apoptotic debris unless he already had strong data on the efficacy of anti-PS mabs to do just that. Since PPHM and Chen are the only ones making anti-PS mabs, sounds like Bavi is going to be a centerpiece of the government’s new approach to HIV as well as hemorrhagic fever.
Based on what I heard in June, I expect the DTRA deal will open the doors to other government contracts with additional cash.
I expect the Duke publications will introduce a global paradigm shift in the approach to anti-viral drug development and will give PPHM a credibility endorsement as big as would have come from closing a BP mega deal. The difference, of course, is that the Duke, NIH, CHAVI, Gates Foundation endorsement moves the stock price without having to first negotiate BP license terms.
Given SK said some of the Duke publications “have been submitted,” I’m guessing we will start seeing these studies late Aug. and early Sept. I'm guessing that a few weeks after the principal Duke articles are published, perhaps in late Sept., the Company will close a non-dilutive bank financing, using the Duke endorsement, larger Avid revenues and, hopefully, a higher pps as items that will give the bank comfort in addition to whatever rights the bank may have in Cotara technology as collateral.
The transcript of the CC makes pretty clear that Mgmt would now prefer “to raise additional capital through non-dilutive structures such as a term loan or similar debt structures.” Not only did PL mention debt financing before Avid financing, he also said they were “actively” seeking debt financing --- an adverb not used later when he said monetizing Avid was still a possibility “under the right terms.”
The Avid deal was something the Company was being forced into this summer to accomplish the non-dilutive financing before the NASDAQ delisting deadline. Now that they have a six month reprieve on delisting, they can afford to let Avid revenues ripen for a while and solve their short term funding needs with a small non-dilutive bank loan. I’m guessing it will be under $10M.
IMHO, by late October it will be clear to R&R that non-dilutive bank funding is in place, Duke/NIH will have endorsed Bavi as a breakthrough AV platform, both Ph II Bavi cancer data and Ph II Cotara data will be coming in strong, and Avid revenues will be increasing dramatically. Facing these facts, I believe R&R will put out a buy recommendation this fall rather than wait for a R/S that is unlikely to happen, or if it happens is unlikely to hurt the pps. The time when a R/S destroys the value of the old guard’s position is when it is followed by a dilutive financing. A company that is well funded, doesn’t need to do a dilutive financing, and has bright business prospects, is the type of Company that doesn’t get hurt by a R/S.
The Company needed another 3 months for its business prospects to brighten through publication of the Duke studies, release of more Ph II Bavi data and a non-dilutive financing on better terms than were being negotiated in June.
By the grace of the Gods they got it -- PRAYERS OF GRATITUDE!!!
Got any ideas?
Yes. I believe if Avant could get $40 million up front for CDX 110, PPHM can get more than that for Cotara GBM. Final Indian Phase II GBM data will all be in by this fall and Mary Boyd should have the Cotara license closed by Christmas.
Having $40 million in the bank from a Cotara license is more than enough to bring Ph II Bavi data to the point where first mega license can be closed.
Note that Cotara has these four advantages over CDX 110:
1. Cotara is effective on 100% of GBM tumor types whereas CDX-110 is effective on only the 45% of GBM tumors that show the EGFRvlll marker.
2. Cotara involves a single infusion, whereas CDX-110 is only effective when combined with a 3-week continuous daily Temozolomide dosing regimen.
3. Cotara enables patients to avoid the side effects of chemotherapy.
4. Cotara can be used synergistically with CDX-110 as an additive therapy to achieve complete remissions because any therapy like CDX plus TMZ that causes necrosis creates more target for Cotara and causes Cotara to work even better.
Perhaps these are the same four reasons why Avant pps has fallen so much in last few weeks.
I agree with your observation when you say Avid:
“… must have been able to convince DSM that they weren’t going out of business. Doubt they would have made this agreement without getting some assurances.”
I would supplement your observation by what I heard and reported in my post on April 15: “Most likely structure will be to bring in a partner that funds an expansion of the facility and then PPHM will retain a dedicated portion of the enlarged facility for its exclusive use. For example, after the expansion, PPHM might control only 40% of the capacity but that could be almost as much capacity as it currently manages.”
I have not heard anything new on the Avid expansion issue beyond what I reported on April 15. My personal guess, however, is that the assurances DSM received went far beyond an assurance that Avid “won’t go out of business.” To ink this deal, I believe DSM received assurances that Avid has commitments in place to enlarge, perhaps even double, Avid’s capacity.
There is no way DSM would designate Avid as its exclusive CMO for western U.S. unless there were firm commitments in place to expand Avid capacity so that it could be sure to meet all Bavi needs, plus all Halozyme & other customer needs, plus all DSM needs.
PPHM does not have an extra $5 to $10 million lying around to fund this kind of an Avid expansion.
Bottom line: My personal view (not anything I’ve heard) is that today’s news is a very strong indicator the Company will close a non-dilutive Avid financing in the next few days rather than a non-dilutive bank financing. My guess is that today’s deal with DSM was a condition precedent to closing a BP-Avid alliance on favorable terms, and vice-versa for the DSM deal. I’m betting the terms of the BP-Avid alliance are fully negotiated and obligate the BP to close in the next 3-5 business days now that the DSM deal has closed. Just my hunch.
Maintaining NASDAQ Listing Until Oct AGM
Jake, Thanks for the very helpful FAQ link in your post: http://www.nasdaq.com/about/FAQsHearings.stm
It confirms what I heard about our listing being maintainable through the October AGM, but I had never seen the rules in writing.
Most noteworthy are these two excerpts from the FAQ.
“The plan of compliance should discuss how the company intends to remedy the deficiency within the next 30-60 days and should evidence the company’s ability to sustain compliance for the next six to twelve months.”
“If the Panel determines that the company has presented a definitive plan that will likely enable it to achieve and sustain long-term compliance, it may grant the company a conditional listing, known as an exception. Exceptions are of limited duration and often incorporate milestones measuring the company's progress in regaining compliance. A Panel has discretion to grant an exception not to exceed the earlier of 90 days from the date of the Panel decision or 180 days from the date of the Staff delisting notification.”