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<Loewen, Ondaatje, McCutcheon analyst Nigel deGruyther said that because of the agreement, Tekmira now has a deal with Roche that could see it potentially reap milestone payments of $52 million from four products developed, with between $5 million to $15 million expected over the next few years. But deGruyther, who has a 12-month target of C$4.20 on the stock, said Tekmira's work with Hana Biosciences (HNAB) to develop Marqibo, an anti-cancer drug, was also adding "more legs" to the shares.>
interesting. i thought Hana had dropped Marquibo in March after discontinuing their previous SPA, but now see they are pusuring it for leukemia under a different protocol using randomized trials, as well as for non-hodgkins lymphoma.
thanks for posting that.
I would be interested in hearing any comments on Tekmira Pharmaceuticals TSX:TKM (formerly Inex) trading at $1.76 Cdn (after today's 64% gain) as a Biotech Value based on over $1/share in cash with about 25M shares o/s and the following...
January 9, 2007 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Inex Pharmaceuticals Corporation (TSX: IEX) announced today that Alnylam has taken a worldwide exclusive license to Inex’s liposomal delivery formulation technology for the discovery, development, and commercialization of RNAi therapeutics, and that the companies have expanded their technology research and manufacturing alliance on lipid-based delivery technology. In addition, Inex will receive three InterfeRx™ license options, subject to Alnylam review and third-party obligations, to develop its own RNAi therapeutic products. Inex will also receive exclusive access to Alnylam’s intellectual property to develop oligonucleotide drugs that act through an immune stimulation mechanism, outside the RNAi pathway.
“This new, exclusive license further enhances Alnylam’s delivery capabilities and intellectual property estate, and continues to strengthen our leadership position in RNAi therapeutics,” said Barry Greene, Chief Operating Officer of Alnylam. “We view Inex as having important intellectual property and capabilities in the area of lipid-based drug delivery systems, and believe that access to this technology is important as we advance systemic RNAi therapeutics and continue to build a leading biopharmaceutical company.”
Under the terms of the agreement, Inex will receive an upfront payment of $8.0 million in newly issued shares of Alnylam common stock and/or cash, at Alnylam’s option. In addition, Inex will receive $4.0 million in R&D funding over the next two years to continue to identify and develop lipid-based delivery systems for Alnylam. Inex will provide contract manufacturing services on an exclusive basis for Alnylam proprietary products in the collaboration and Alnylam will make available a $5.0 million loan for capital equipment expenditures related to manufacturing capabilities. Inex is also eligible to receive $13.0 million in potential milestone payments for each product utilizing Inex technology, of which $9.5 million are due upon regulatory approval and successful commercialization with over $500 million in cumulative product sales, plus royalties on product sales. All figures quoted are in U.S. dollars.
http://www.tekmirapharm.com/Investor_Relations/News_Releases/inex01090701.asp
and the following link to a Powerpoint presentation at recent AGM Jun 20
http://www.tekmirapharm.com/files/Tekmira_AGM_Presentation_June_20_2007.ppt
thanks in advance
>>The DNDN non-disclosure problem is compounded by the fact that in the 10K issued in March and signed by every Director escept Susan Bayh, they not only fail to list the preapproval inspection and its outcome in the Section describing Ongoing Regulatory Activity, but describe the requirement for the inspection as something that hadn't occurred yet. Both the CEO and the CFO certified the 10K per Sarbanes Oxley as being materially accurate.
Out of curiosity, so you know why Susan Bayh did not sign it? Was this typical for her or unusual? (Or was she just not there at the time.)<<
this is perhaps unrelated, fwiw, but i sent an email (via dendreon's ir) to Susan Bayh's specific attention, in her capacity as an independent DNDN Director & Corporate Governance Committee member (and wife of a US Senator with possible political influence), on Mar 26 regarding Dendreon’s appearance on the Reg SHO list and asking her specifically as an independent Director what if any response the company was planning to combat the increased dilutive impact their Reg SHO appearance might have on their then recent $148M shelf filing.
I followed up that unacknowledged email on April 13, again without receiving an acknowledgement. I sent a 2nd follow-up (3rd email) on May 6 and on May 8th (the eve of Black Wednesday) I received a reply from Monique Greer advising my enquiry had been passed on to their legal department and I have yet to hear anything further (& since sold all of my shares).
Needless to say, after the events of May 9th, I found it rather ironic that I would receive a reply (which was closer to an acknowledgement) to my 3rd email the day prior (at 3:34 pm pacific time to be exact) – coincidence or did they then know that they would be needing to refer a lot of emails to their legal department? Now learning that Bayh didn’t sign the 10K filed in March makes me wonder whether as an outside director who is also a member of DNDN’s corporate Governance committee, her apparent “missing in action” status is by design?
as for the lawsuit, fwiw, I called for Gold to resign back in Dec 2005 after the poorly priced secondary & his actions since then (accepting a bonus for the 2005 discounted secondary, not supporting the stock at its lows in April/May 2006 with market purchases using his own funds, another discounted financing in Nov/06, forgoing partnership & thereby delaying 9902B enrolment & European/asian approval, insider selling immediately after the AC panel vote followed by the announcement of the 483 non-disclosure lawsuit, etc.) have done little but support my initial call imo. If this lawsuit is able to unseat him as CEO, I think that would be a positive development for DNDN and its shareholders.
<The 75-million bond subscribers however are fully aware of there is problem with CMC. So why would the lawsuit have any effect on the current financing?>
well, if you had $75M and just agreed to loan that to someone based on information they provided that suggested the CMC issues in the CR were not serious and posed no problems re: approvability, and then right after you agree to pricing of said convertible financing, someone else files a lawsuit based on material undisclosed CMC issues, i suspect you, as lender, would probably want at least some clarification, if not ironclad assurances from the management written right into a modified agreement, essentially guaranteeing that there are no material undisclosed CMC issues that imperil approvability of Provenge as well as providing satisfactory security to the lender(s) (if not already included) for repayment of financing if the lawsuit is successful.
i'm not an expert by any means, but is it unreasonable to think that such potential rewording/reworking of the agreement perhaps could delay the closing of the deal beyond Monday?...which could, imo, trigger panic selling caused by people associating any delay with the lawsuit, suggesting that there may be some merit to it. that could provide the 40M shorts with an opportunity to cover at a lower price...
<Nevertheless, the 483 thing explains why the company did not do a secondary prior to 5/9, can you imagine the outcry if that had been done?>
well, if the CMC issue raised in 483 (& subsequent CR) was not serious and not a deciding factor in terms of approval as suggested by management's statements, then i don't see why it necessarily would (or should) have held up a financing before 5/9 - after all, the 483 was not considered serious enough to prevent Gold & other insiders from selling...
the more i think about this lawsuit, the more peculiar the apparent "coincidental" timing of it, coming just after the pricing of the convertible and just before it is due to close - it certainly seems like the hedgies are trying to directly interfere with DNDN's access to cash while attempting to drive the share price lower now.
why go to all this trouble and why the apparent urgency to intervene now, when approval is at least 2 years away, which should imo, cause the stock to drift lower as time passes? perhaps they sense the vulnerability of their apparent huge exposure, and having apparently been caught off guard once already by the change in the efficacy question and positive panel recommendation, they are wary of the potential for mounting political pressure to expose the basis for the FDA's indefensible decision that could conceivably implicate them?
i don't currently own any shares, but it is difficult not to follow what is going on with this story.
looking at this from a different perspective, if there is no merit to this lawsuit, the timing of its announcement, coming on the heels of the pricing of the financing, seems rather fortuitous for the shorts to try to derail/delay the closing of the convertible issue and really throw things into a panic.
not closing the convertible deal as scheduled not only adds perceived credibility to the lawsuit, but has the potential double whammy of increasing the dilution associated with the convertible or possibly altogether denying the $75M cash the company was to receive, which in turn would likely negatively impact the current share price, making negotiation of revised/new financing terms more difficult/dilutive.
in any case, Gold has a lot of splainin to do, imo.
<Well, we now know why DNDN had no interest in an appeal.>
yes, the pieces seem to fit together, though there still are a lot of questions that need answering. (I imagine Gold is rather occupied this weekend trying to reassure the would-be financiers that he has things under control)
it will be interesting to see if the convertible closes on Monday as planned - if it doesn't, we might have the answer to just how significant the issues raised by the 483 really are, and whether Gold has a future with DNDN or as a CEO with any public company.
if the financing doesn't close as scheduled, things could get very ugly very soon, but that might turn out to be a net positive longer term.
never a dull moment with this company/stock
OT: anyone think after watching that video that Gold not only looks a bit like the grown up version of Theodore Cleaver, but sounds a bit like him too?
anyone seen eddie haskell lately?
<DNDN in its current form will probably not survive until the 9902b interim look>
to me, that would actually be a positive, as i think Gold as CEO has at times been reckless and if this latest allegation is proven in court, he would be finished, imo, which then may pave the way for a partnership sooner rather than later.
the problem with this scenario imo is that, watching Gold from afar, it is doubtful he will simply roll over and go away quietly, so this lawsuit (assuming it has merit) has the makings of a long drawn out affair, until at least 9902B interim is ready, with Gold trying to hang on for the results to "save" him.
the only way this lawsuit has any impact imo is if the BoD directly intervenes (either on its own or with outside pressure from long, activist, hedge funds) - judging by the BoD's actions to date, (i.e., enduring the hedge funds' attack on the stock for over 2 years) imo, it is very doubtful they on their own force Gold out.
jmo.
<I concur with the author that DNDN timed its announcement of an FDA “breakthrough” in order to trick unsophisticated investors into pushing up the share price, and this helped get better terms in the convertible offering.>
while i won't dispute that Gold & Schiffman failed small shareholders by misreading the FDA and not raising cash after the panel at $15 or $20, (and thereby as it would have turned out, left institutional investors holding the bag after the CR), I see the timing of their FDA interim PR as their attempt to fire a shot across the bow of the shorts and get some of them to cover & drive up the price for better financing terms. after all, 113M shares were traded on May 31 - my guess is 99% of that volume (& associated price) was driven by instittutions - and the terms they got - conversion price of $10 is a much better price/less dilution than the previous two financings, which benefits the small shareholder.
i'm not a big fan of Gold & Schiffman - i think they should have announced an appeal of the FDA decision, which imo, would have provided greater visibility & support for the patient advocacy groups' efforts, while causing the 40M shorts to cover & drive up the price at least as much as the "interim result" announcement did. in that sense, i think criticism of their pr timing can be justified, but i don't think they were trying to "trick unsophisticated investors" to push up the price - imo, their primary target was clearly the institutional shorts and to a degree, it worked.
no doubt they need cash, and the note offering (terms still to be negotiated) is a way for management to avoid up-front dilution, but the rest of their pipeline besides Provenge is so far away from potential commercialization that any positive developments in that regard will have a muted effect on price, imo.
unless i'm missing something, with no prospect for appeal, little prospect for partnership, i'm afraid the opportunity cost of holding for the next couple of years until 9902B results come in(with current management at the helm at least) will be high.
good luck to those who decide to hold on...i'm going to unstuck myself.
<Dendreon to Offer $75M in Notes>
so much for an appeal, so much for a near term partnership to squeeze the 40M reported shorts, this is playing right into the hands of those same shorts & hedges funds, while exposing the company to further imo unecessary risks and undercutting PC cancer patients & shareholders, leaving them to fend for themselves.
as much as i hail & applaud the efforts and aims of the chicago & washington rally organizers & participants, i'm afraid management, (in particular Gold & now Schiffman), has proven they aren't worthy of such efforts & support.
fwiw, i'll continue to support the efforts of ProvengeNOW and the patient advocacy groups to get the FDA to provide full disclosure of the basis for their unprecedented decision to go against their own advisory committee that unanimously said Provenge was safe and showed substantial evidence of efficacy in a terminal disease, but I'm selling the rest of my shares today - might buy back in a year or two or before then if management changes.
ps - it is unfortunate that there are a few that would put DNDN shareholders, in particular those who organized and participated in the Chicago rally in a bad light by making threats to Scher, etc., however, it is a greater shame that the media focuses on those few, rather than provide a balanced reporting that devotes proportional time to the imo greater misdeeds of the other side of this debate...
I thought i would throw out some thoughts on what i increasingly see as the only two options DNDN has to realistically ensure it survives longer term. hopefully this will generate some discussion from some of our more knowledgeable posters.
the most important current aspect to ensuring the long term viability of the company, imo, is to secure adequate cash to fund ongoing R&D so that if for some reason Provenge fails, their other products in development will be much further along (than their current ph I/pre-clinical status) to support the viability of the company.
in terms of raising cash this time, i think management (in particular Gold & Schiffman) need to demonstrate much more business savvy and go on the offensive, especially since they now look extremely foolish & amateurish for not doing a financing after the panel. (if they simply do another dilution at 10% or 15% discount to market, they will do nothing for their image or reputation as managers except confirming their incompetence, imo, and merely invite the shorts/hedges to continue to manipulate & short the stock to the detriment of existing shareholders).
one plausible approach imo could be to file an appeal with the FDA primarily to raise public awareness and attention to the FDA's decision. I would hire Gottlieb, Small & Petrylak as consultants...call a press conference with all 3 present to make their case for Provenge in a very public forum (contrary to their unsuccessful, silent approach after the panel vote which allowed Scher, Hussain & Fleming to essentially have the public domain to themselves and dominate the discussion).
the FDA might still deny the appeal (perhaps just to spite DNDN for not accepting their decision quietly), but surely the FDA is going to get a lot of (deserved imo) unwanted public attention & scrutiny, particulary if the company can secure the support of 3 "heavyweights" in Gottlieb, Small & Petrylak, who imo can't & won't be easily dismissed by the press.
even if the appeal is dismissed, the public attention and focus on Provenge's saftey and "substantial evidence of efficacy" as determined by the FDA's own panel of experts and on the FDA's inexplicable decision should throw a major scare into the FDA and those 40M shorts.
and if 9902B comes back stat sig (and an appeal certainly isn't going to impact the results), the FDA has to approve per the SPA.
i see an appeal as a no lose proposition, and very possibly a way to squeeze the shorts to raise $200M cash under their shelf registrations with a lot less dilution than the previous two financings...
and if that doesn't work... then the Plan B takes shape to seize on the vulnerability of the shorts -
reported short position is 41M or approximately half the total shares outstanding - the number of naked shorts, though unkown, could be siginficant. institutional holdings as of Mar 31/07 was reported as 26.5M shares, which is probably down since the May 9th CR.
based on my read of Gold, i don't anticipate a partnership near term, though it makes more sense now than ever from the perspective of (re-)establishing credibility of management especially if they aren't going to appeal the FDA's decision. (Gold & Schiffman in particular, need their credibility restored in the market, imo)
Partnering with a major reputable pharma/biotech would allow them to save face by boosting the share price (perhaps dramatically given the apparent vulnerability of the shorts), and enable access to cash that would allow the company to continue development of its pipeline while it waits for 9902B results to mature. i don't think conserving cash and letting their clinical & pre-clinical programs sit while they wait is a wise option - if 9902B interim & final results somehow don't hit stat sig - the company is finished.
i think self-preservation dictates they make a deal, even if it is much less than what they were targeting before the CR - if they can structure it so that a short squeeze results, they can probably alleviate a lot of their current cash concerns, resume their R&D and sustain the longer term viability of the company if 9902B for some reason fails.
and if they can pull off a deal with an equity component that establishes a floor for the share price (say in the $15 or $20 range), they could potentially create a massive squeeze that could resolve their cash concerns for a long time (and make a lot of shareholders happy).
heck, i've almost talked myself into buying back some shares i sold...
comments?
<You don't consider 600,000 or so shares and options a big personal stake? I would say he has the incentive to fight. I don't think he will, but not for that reason.>
i think if those 600K shares would have been purchased in the market with his own after-tax dollars instead of having been granted for free or acquired by exercising low-priced options, his incentive to "fight" might be greater.
on the other hand, by fighting he may perceive that he is potentially & unecessarily putting his "career" (& his salary, bonus, cheap options, etc.) at risk and he can reasonably argue that quietly accepting the additional hurdle is a reasonable approach...
imo, he is looking out for his own interests, which he would argue happen to coincide with the company's interests...though there are times when they clearly haven't.
<mitch does not want to fight. Hes content to wait. He could have others fight the battle for him but with no big personal financial stake, he has no pressure to do so.>
hard to disagree with this observation, though i'm not sure his apparent refusal to partner back in 2004 supports that he wants to be a "member of the establishment" (or at least that he knows how to make friends & influence key people)
I suspect Bogdan has been advising DNDN management re: the FDA approval process for the past couple of years and the decision to file the BLA on 9901/9902A was based in part on the presumed fact that CBER (& not CDER) would be responsible for the review/recommendation if not approval decision.
I also don't doubt that the signals sent by CBER to DNDN re: 9901/9902A were likely very encouraging and assuming that to be the case, it seems reasonable that DNDN's strategy would be to try to not make any unecessary waves that could be perceived as antogonistic to anyone at the FDA, particularly CDER. in other words, leave the BLA in the supposedly capable hands of CBER, trusting them to help get it approved.
i think that is the most plausible explanation for DNDN's seeming hands-off approach throughout this process and after the panel meeting and i can't say that it was necessarily unreasonable. with the change to the efficacy question & re-vote, etc., i suspect Gold (like many longs) thought this was a done deal and that their strategy had worked. Consequently, DNDN decided it would wait to raise cash until after the formal FDA approval anouncement and meanwhile Gold would take the opportunity to cash in some shares at a price that would be seen to be very "conservative" after approval and likely well below any future financing/partnering price...
the fact that CBER didn't come through as expected obviously caught the company completely off-guard, though i wonder if management was listening to what Bogdan was saying in word or in deed after the panel meeting (when he sold the majority of his shares shortly afterwards).
the CR letter sent management into full blown crisis mode and i suspect that Gold was purposefully vague on the May 10th cc about what additional efficacy data the FDA was looking for, probably because he was still in disbelief and denial and was hoping that management could somehow address any FDA concerns via another alternative other than to have to wait for the slow enrolling 9902B interim results sometime in 2008.
I suspect that the informal discussions the company has had with the FDA since May 9th re: additional data has exhausted all alternatives and confirmed (as evidenced by yesterday's pr) that 9902B is indeed required for approval, which essentially also eliminated the prospect for any appeal, at least in management's eyes.
that said, i don't see how DNDN formally appealing the decision could possibly further erode or endanger any so-called relationship they have with the FDA - CBER & von Eschenbach have proven themselves unreliable partners so who cares what they think of an appeal and CDER's ongoing opposition to Provenge won't be lessened by DNDN remaining silent.
in fact, a pr stating the company plans to formally appeal the FDA decision imo, would at least offer the prospect of much needed greater public scrutiny of the FDA's decision & more generally the propriety of same, while also supporting the efforts of the patient advocacy groups...they could make the case that changes to the COI guidelines implemented since the Mar 29th panel would have prevented Scher from casting a vote, (while drawing attention to his questionable conflicts). greater scrutiny likely resulting from an appeal could also draw attention to the public leaking of not one but two apparent confidential letters to the FDA by panel members to the Cancer Letter, the naked shorting & unusual trading in the stock & options, the apparent public leak of the FDA's CR decision more than a week before May 9th where a new york based financial type apparently had foreknowledge, etc.)
I think such a provacative pr would certainly get the market's attention...including the 40M reported shorts, whose only fear i suspect, is greater scrutiny...getting them to cover their shares would provide the basis for a much better financing while supporting existing long-suffering shareholders...and i don't see how, with the added public scrutiny, it could hurt their chances for approval even if the appeal fails & they wait for 9902B...
I think management has "calculated" that formally appealing the decision would not be in their own benefit or best interests. understandable to a certain degree perhaps, but imo, it leaves PC patients & DNDN shareholders in the cold to fend for themselves.
I wonder what Bogdan's opinion is about an appeal & if it is any different than management's?
Thanks Dew eom.
Dew, thanks for the response.
another naive question if i may...what then is the purpose of having a secondary endpoint, if not to provide another shot should the primary endpoint fail?
Dew, do you have any comments with regard to a question i posed earlier?
thanks in advance.
http://www.investorshub.com/boards/read_msg.asp?message_id=20057119
"D9902B is a randomized, multi-center, double-blind, placebo-controlled trial that's very similar in design to Studies 1 and 2 that have been described today. The eligibility criteria are men with asymptomatic or minimally symptomatic metastatic androgen-independent prostate cancer. It's a similar 2 to 1 randomization. The primary endpoint is overall survival. The secondary endpoint is time-to-disease-progression. It's an event driven analysis for 360 death events. It's powered at 90 percent for a hazard ratio of 1.45." (Dr. Frohlich, Mar 29/07 at the advisory committee)
http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4291T1.pdf
forgive the naive question, but can meeting the secondary ttp endpoint (which was a bare miss as the primary endpoint in 9901) be (or help form) the basis for interim approval, if overall survival doesn't cut it at interim? if so, anyone venture to handicap the odds? if not, what purpose does a secondary endpoint serve?
thanks in advance
Re: DNDN <Dr. Gold’s large personal sale made the filing of a lawsuit a fait accompli.>
I don't think much of Gold (and haven't long before his recent insider sales), and i'm not a lawyer but imo this lawsuit is baseless - in relative terms, Gold's sale represented a sizeable, but by no means majority part of his holdings - more telling to me was DNDN's FDA consultant Bogdan's sale of the majority stake of his shares (that he, unlike Gold, previously bought in the market).
as a DNDN shareholder, i do agree that Gold's sale effectively pre-empted the company from doing a financing after the favorable panel rec, but it is fairly obvious DNDN never seriously considered going to the market for funds until after an expected (aka taken for granted) FDA approval.
that in some ways is (or at least should be) more disturbing...as it has become blatantly obvious that management was completely unprepared for the worst case CR letter, even though it was incumbent upon them to be prepared for such a possible continency/disaster, even if considered unlikely.
this latest example of lack of stewardship again speaks to how this company is being managed, and i think it raises legitimate questions about company prospects going forward under Gold.
the conclusions i've drawn, fwiw, are
1. Gold has not been reluctant to dilute existing shareholders at a discount to market in the past and imo, he will continue to dilute (at a discount if necessary) in the future...because it serves his/management's purpose(s).
2. I don't expect Gold to partner now that his leverage is reduced, even though it would likely benefit shareholders - he wasn't willing to partner before, wanting to extract the optimum...and he doesn't seem to me to be the type to eat humble pie...he is young, he's cashed some of his shares in so he's set personally for a couple of years of waiting for final results (and judging by his support on these MBs, he can apparently afford to wait with no serious challenge to his leadership), he can issue more low-priced options or free stock grants to himself to make-up for any dilutive impact of discounted secondaries...why partner now when his leverage is perhaps at its lowest?
3. based on the response i have received from IR, the company appears to be complacent (if not complicit) with regard to its appearing on the SEC's Reg SHO list, despite this issue directly affecting its shareholders. imo, if management were truly on the side of its loyal, small investors, the company should be drawing public attention to this issue and to the unusual trading volumes in its stock & options, particularly after the panel rec, (perhaps as a defense to lawsuits such as the one filed), however, i suspect their interests are more aligned to being in bed with the wall st. financiers and hedge funds who keep them in their positions while they both screw the small guy.
more importantly, drawing attention to this issue would help to put the spotlight on nefarious hedge funds, brokerages, analysts, media and a complicit (by their apparent inaction) SEC, and how these various parties' interests seem to have been aligned with an unprecedented FDA decision of going against its own panel of experts and not approve a safe treatment for a terminal indication to give AIPC patients an option. that combined with the efforts of the PC patient advocacy groups to expose the FDA's rationale for their inexplicable decision to deny a safe & promising treatment, imo would offer the best hope for shareholders in the near term, yet the company's efforts in this regard pale in comparison to the herculean efforts of certain individual MB participants...
i thought the science would overcome the above management shortcomings and the manipulation of the hedge funds, analysts, brokers, etc. that i knew existed before the panel & FDA decision...i'm not sure that is the case anymore going forward.
i sincerely hope the patient advocacy groups and those MB participants who have actively organized to support their efforts are successful in getting congress to revisit the FDA's Provenge decision and provide some hope to terminal PC patients, and I support their efforts as best i can, but realisticly, they are fighting long odds here and it is not something that investment decisions should be based on...whatever the outcome, however, they are the only ones involved in this story who imo, have earned any respect for their efforts.
<What many don't understand is that the "bankable" secondary, the $147 million non-stock portion of the shelf is highly problematic for a lender to consider at this point.>
sorry to be blunt, but the "many" you refer to must be idiots if they can't figure out that no one in their right mind is going to lend DNDN money when they don't have an approved product or revenues, without your long-winded & imo tangential explanation.
and btw, the $147M addition to the previous shelf could be in the form of any combination of debt and/or common equity...so they aren't limited to raising only $53M in common stock as you suggest.
<They can't use longer-term data than the specified three years for 9901/9902A because it wasn't in the protocol.>
i think i know the general gist of the answer to my question, but i'm going to pose it anyways since i'm not sure i really understand the underlying logic...
i understand that the FDA essentially ignores any data not collected as per the agreed upon trial protocol for fairly obvious reasons, (ie there are no controls over data collection not subject to a formal protocol & what may have influenced it, so its value in establishing & measuring the treatment effect is unreliable) however, in the case of a trial designed to test treatments for & on terminally ill patients, wouldn't the length of survival be an important & reasonably objective consideration, even if looked at "after the fact"?
i know this is probably a moot point from the point of view that since the FDA disregards/dismisses it out of hand (at least in terms of evaluating efficacy), but why wouldn't/shouldn't it be legitimately given some weight (depending on the extent of being able to measure & actually measuring potential contributing factors) to the efficacy question? is it just too subject to "manipulation" (ie. cherry picking) or alternatively not susceptible enough to rigorous and rigid analysis that statisticians seem to defend to the death?
<They do business before the FDA.>
maybe that is part of the answer...
not to butt in here "but"
<I recently found out that some friends of mine who work in biotech on the East Coast and who had both a corporate/financial and personal/emotional investment in wanting to see Provenge approved went to the panel meeting. The very next morning ALL of them called their brokers and told them to SHORT DNDN. My question to all of you is (and I'm really trying here to understand what happened at that panel meeting): What did they see at the panel meeting that all of you guys missed?>
wouldn't you think that answers to your question would be more insightful if you posed your question to your "biotech friends" who actually did the shorting???, unless of course you are being rhetorically rhetorical...
The reason many equity deals with pre-commercial biotech companies specify a 19.9% stake — rather than 20%+ — is not arcane. It is so the acquiring company does not have to recognize a pro rata share of the acquired company’s losses on its own income statement.
you are correct as to why companies opt to go for less than 20% equity when they invest in development stage biotech, but if you read my post, i referred to the 20% figure as arcane, (not because its inherently arbitrary status was given importance by a committee of beancounters (which i happen to be , but due to its arbitrariness by nature...eg. what makes 20% a better "choice" than 25% or 16.6% or etc.)?
this is probably pointless wishful thinking, but seems to me Sanofi would now represent the most logical partnering candidate, given petrylak's analysis of the provenge followed by taxotere subgroup in 9901/9902A.
DNDN would no doubt be negotiating from a position of weakness (before even factoring in Gold's "wild card" status into the equation), but i think a win-win deal could possibly be structured, though my personal opinion is that Gold (& his youthful inexperience & ego & major gaffs) is the major stumbling block.
assuming that there is a very good chance that 9902B interim or final results are stat sig within the next 2 to 3 years, Sanofi could essentially take a "right of first refusal" option on the company by making a 19% equity investment or about 15M shares (keeping it below 20% to avoid arcane accounting rules of presumed 'significant influence', while still scaring off any other potential suitors) for say $7.50 a share, plus a reduced royalty on worldwide Provenge sales.
the company raises $100M in cash, enough to keep their R&D development alive & hopefully progressing the next indication for active cellular immunotherapy, while waiting for 9902B results to mature...but more importantly imo, it eliminates lingering uncertainty about their intermediate future and establishes greater credibility & thereby a floor to support the share price.
that said, i suspect gold, having "endured" two discounted dilutions to get to this point, will opt to continue that route to retain control of Provenge, since he, as CEO, can virtually personally remedy any diultion he might suffer, and has already demonstrated little regard for diluting DNDN shareholders...
jmo
DNDN dilution...
Richard Hamm who was acting finance officer before Schiffman arrived on the scene, on the 3rd qtr cc on Nov 8 2006 (8 days before the Nov. 16th financing) responded to the following Charles Duncan question this way...
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Charles Duncan, JMP Securities - Analyst [10]
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"Final question is related to your balance sheet. Pretty well-managed cash in the period. As you look out to building commercial infrastructure and also building out manufacturing capacity, what do you think the guidance is going to look like for next year? And do you feel like you have enough cash to get the ball over the goal line?
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Rick Hamm, Dendreon Corporation - SVP, Corporate Development, General Counsel [11]
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We have enough cash to get through our BLA and through the FDA decision point. Clearly, if we get a positive approval from the FDA, we'll be looking to raise cash in order to enhance our commercialization and manufacturing build-out efforts."
http://www.investorshub.com/boards/read_msg.asp?message_id=14635720
this is "corporate speak" for we can't/won't discuss financings since disclosing info about them will likely directly impact the share price, and therefore the level of dilution...
by my calcs, they were running on fumes (for a development stage biotech) heading into the panel, and the fact they have laid off only 40 so far won't be enough cost-cutting if they don't partner soon...which to me translates to a financing announcement is imminent...
<Anybody with any common sense would not disscuss these items with a newspaper reporter prior to being announced in a PR!>
I'm not here to defend DNDN management, in fact, these layoffs may have been avoided (& the R&D pipeline advanced) if Schiffman had decided to dilute 10M shares @$15 a few weeks ago before the CR letter.
the fact is Gold & Schiffman misread the FDA & thought approval was in the bag, particularly after the favorable panel rec, like most longs did. their misread is understandable to the extent that the FDA decision appears to have been unprecedented and baseless, however, they also have greater access to the inner workings of the FDA than most if not all of us here. The DNDN guy with the most FDA advisory experience (& lone inside buyer of significance last year when the stock was being pounded), Bogdan sold 60% of his shares for a nice profit right after the panel rec.
not too much attention was paid to this news on the MBs, though i do seem to recall someone defiantly asking people to recommend a certain post if they weren't going to sell a single DNDN share in response to the shorts' massive selling campaign after the panel rec.
yes, the apparently leaked FDA decsision on Provenge appears to have been heavily influenced by anal retentive statisticians without adequate or proper weighing of its efficacy benefits and safety, or worse, was influenced by external financial interests.
it should be obvious to anyone that management was caught completely off guard by this decision & totally unprepared to deal with the consequences of it. not only have they had to make some quick & difficult internal decisions (ie. who & how many to layoff to preserve dwindling cash), they now also have to unexpectedly come up with a plan for the interim analysis and timeline to communicate coherently to potential partners, IBs and shareholders so DNDN can raise the cash they need soon, perhaps having to explain why enrolment has taken so long...while these interested parties wonder whether to partner, invest, sell, etc.
and by the way, it should also be obvious that any company, particularly a public company after 9/11, katrina, etc. needs a disaster recovery plan in place - it is just simply good, essential business practice. what DNDN experienced on May 9th was imo, a disaster, not necessarily avoidable, but made worse by their obvious lack of preparation for the worst case scenario. why should it seem surprising or strange that they may be sending out mixed messages when they are still in damage control mode, recovering from this shock? they are trying to put on the best face to a very difficult situation, trying to stay positive when they probably are devastated personally & perhaps professionally also.
sadly i think there are still a lot of people in denial and unable or unwilling to come to grips what has happened and more importantly the implications of same, or they still lack the essential skill of being able to read between the lines to figure things out...
perhaps you should consider changing your moniker to eager-eye?
looks like someone decided to spend more than $23K today to buy over 4,700 Nov $40 call options. (there is an OI of over 15K for the $40 Nov calls, at least 50% more than any other Nov call strike price & by far the most actively traded Nov option - call or put). most of the active option trading today was in the $5 May, June & Aug puts, as one would expect.
can't believe a small retail investor would make such a relatively large bet on something that far out of the money...looks like too much of a longshot...but am also having a hard time understanding how this could possibly be part of a hedge strategy.
strange, but perhaps strange is the new normal with this stock.
anyone have any thoughts on this?
<The decision has to be made objectively on behalf of multiple stakeholders.>
what other stakeholders are there besides individual patients?
are you referring to perhaps shareholders, competitive treatments & their owners, researchers who might have their life's work at stake by the perceived threat of a new treatment paradigm, overleveraged shorts, who thanks to a complicit SEC have sold an unknown number of counterfeit DNDN shares in addition to the huge number of apparent legally shorted shares to the point where if they are on the wrong side of the decision, the (financial) risks to a broader range of "stakeholders" is perceived greater than the benefit of a "few"?
I am not suggesting appointed committee experts forego any clinical trial evidence in their deliberations or to allow any personal bias or "choice" to interfere with their professional judgement. (and if they truly are professional, by definition their personal interest will be subserviant to the greater good of their clients and they should be able to clearly distinguish between the two.)
<not as a extension of personal choice>
a decision (vote) by its very nature requires choice, and when made by an individual selected because of his/her specific expertise in the subject matter, that decision, if made by a true professional, will be a result of an independent, objective thought process unique and personal to each individual, and not as a result of what someone else thinks or decides.
i'm admittedly a layman when it comes to the nuances of Provenge's clinical trial results, but am nevertheless a professional in another field and understand enough about the exercising of professional judgement and the decision making process to recognize that the final FDA decision on Provenge was precedent setting and leaves a lot questions in light of the expert panel's recommendation that it was undeniably safe and showed substantial evidence of efficacy.
and in my layman view of the trial results, it seems clear that 9901 was clearly statistically significant of a survival benefit and while 9902A was not significant in log rank, it did support the survival benefit based on cox regression, and subsequent studies by Petrylak and Small re: results of those who subsequently took taxotere and specific cause mortality further support the efficacy of Provenge, to the point where imo, a reasonable person would see the minimal risks due to very limited safety issues and the potential significant benefit(s).
<if you or a loved one had HRPC, would you or would you not want Provenge available as an option?<
I think these kinds of questions are detrimental to success at biotech investing.>
it is a good thing to remain objective (i.e., emotionally detached) from one's investment, just as it is a good thing for an advisory committee member to be similarly, if not moreso disposed, particularly from undue and external influences.
that said, the question that imo needs to be answered by each individual member of the Advisory Committee, at its most simple and basic level (after seeing all the evidence and due deliberation, etc.) is, if i had AIPC, does this treatment demonstrate actual, real and measurable benefit(s) that outweigh the risks?
with all dew respect, if you can't find an intellectually honest answer after framing the question in that manner, then you have become nothing but an anal retentive statistician/mathematician/bureaucrat/nerd or worse.
all jmo.
<I agree that an AA would be a perfectly equitable solution.
However, it appears we are past that. It would be hard for the FDA to go back to that now.>
this might fit in with the "FDA issued a CR to allow the shorts to cover their huge exposure to avoid a major market meltdown" theory (which imo would make the FDA appear even more farcical than they already do), but didn't ODAC/CDER essentially discredit the TTP endpoint for prostate cancer back in 2005?
if so, then it seems this back door attempt at approval would also be slammed shut by ODAC/CDER & the FDA, which more and more seems to me to be rife with conflicts of interest, curious decisions on treatments and virtually no accountability to explain their rationale nor are their public positions open to challenge.
so then it all goes back to survival and since 9901/9902A survival wasn't impressive enough, it has to come from 9902B.
i never imagined that life and death decisions made by the FDA were not based on general agreement & consensus regarding the safety & efficacy of the science. i can only conclude that a corrupted FDA is the only viable explanation what transpired on Wednesday.
Re: Honey could save diabetics from amputation.
interesting. thanks for posting.
i never heard of Manuka honey before, but found these write-ups on it from a New Zealand university.
Manuka honey is gathered in New Zealand from the manuka bush, Leptospermum scoparium, which grows uncultivated throughout the country. (More recently, as a result of systematic screening of Australian honeys, a honey with the same properties has been found to be produced from Leptospermum polygalifolium, which grows uncultivated in a few parts of Australlia.)
http://bio.waikato.ac.nz/honey/special.shtml
also this
http://healthismoney.blogspot.com/2007/01/honeys-healing-powervideojoke.html
not only does it have to be Manuka honey, but it has to be active or UMF (Unique Manuka Factor) Manuka honey (with a minimum UMF of 10) to have the beneficial antibacterial wound healing effects (which apparently has been found to work even against resistant strain "superbugs").
Honey could save diabetics from amputation
MADISON, United States (AFP) - Spreading honey on a diabetic ulcer could prevent the need to amputate an infected foot, researchers say.
A doctor at the University of Wisconsin who helped about half a dozen of her diabetic patients avoid amputation has launched a controlled trial to promote the widespread use of honey therapy.
The therapy involves squeezing a thick layer of honey onto the wound after dead skin and bacteria have been removed.
The honey kills bacteria because it is acidic and avoids the complication of bacterial resistance found with standard antibiotics, Jennifer Eddy, a professor at the University's School of Medicine and Public Health, told AFP.
"This is a tremendously important issue for world health," Eddy said.
Diabetics typically have poor circulation and decreased ability to fight infection and ulcers can be hard to treat. An amputation is performed every 30 seconds somewhere in the world, Eddy said.
"If we can prove that honey promotes healing in diabetic ulcers, we can offer new hopes for many patients, not to mention the cost benefit, and the issue of bacterial resistance. The possibilities are tremendous."
Honey therapy is already used to treat bed sores in New Zealand and as an alternative form of medicine in Europe, but has largely been relegated to history books in the United States.
Eddy first heard of it in medical school when a professor commented that of all the ancient remedies, honey actually seemed to work when he tried it out in the laboratory.
She tried honey therapy as a last resort six years ago with a 79-year-old diabetic patient who had developed foot wounds resistant to standard treatments.
"I tried it only after everything else had failed and... we had essentially sent him home to die," she said. "All antibiotics were stopped when we started honey, and his wounds rapidly healed."
Eddy hopes to have the trial completed and the results published by 2008 or 2009.
http://news.yahoo.com/s/afp/20070504/hl_afp/healthscience_070504213618
now if someone could figure out what is killing all the bees in north america, there might be an investment opportunity there...
America's bee killer could make dinner a bland meal
http://www.wilmingtonstar.com/apps/pbcs.dll/article?AID=/20070504/NEWS/705040340/-1/State
OT Sort of...
Blood Insurance
excerpts
A Monterey company is offering a different kind of health insurance — in this case, a way to fight future disease.
BioBanc USA in Ryan Ranch is storing its healthy clients' white blood cells for future use, when they are older and their immune systems are struggling.
"Usually people go to the doctor when they're sick, but this is people being proactive with their health," said Dr. Hugh Wilson, BioBanc USA's laboratory and medical director.
White blood cells are the body's defense against infection and disease, doing battle with invading or defective cells. As the body ages, the immune system grows weaker, and white blood cells are less effective.
And while red blood cell types are as easy as A, B, O, white blood cell matches occurs in about one in 10 million people. Using one's own blood for immunotherapy can make a crucial difference, said Dr. Dominique Charron, a member of BioBanc International's advisory board.
"If you have a disease, those frozen cells are re-inserted and they are more capable of fighting infection," said Charron. "You really have a better chance for the treatments to be done, and to be done more efficiently."
Research has not so far demonstrated that immunotherapy is a sure-fire cure for some of the most lethal diseases, but it is showing some positive results.
In 1999, Robert Gorter, a Dutch doctor working in Germany, figured how to cultivate dendritic cells, which he developed into a treatment for 171 women with breast cancer who received chemotherapy or radiation treatments with no success in eradicating their tumors. Dendritic cells are produced by white blood cells.
Ten percent of the women went into remission as a result of the treatment, while 60 percent experienced some improvement in their quality of life, though they did not recover.
"If you can talk about time left in terms of weeks instead of days, or months instead of weeks," said Wilson, "I think it's worth it."
Wilson said he is a strong believer in the procedure's potential to improve lives, though he stops short of saying it is a cure for cancer.
"Right now it would be a stretch to say that it is a cure," said Wilson, "but there have been some patients with advanced disease who have had the progression (of the disease) halted. There have been a few who have gone into complete remission."
Immunotherapy is also being looked at as a possible treatment for Alzheimer's disease, influenza and pneumonia.
http://www.montereyherald.com/local/ci_5783296
<From their philosophical point of view and from their future interests on future organization and approvals, they do risk diminishing their clout. But apparently they view the damage of losing on this one as so large, they're willing to accept that risk.>
or they see CBER taking control of Provenge approval, most notably by interrupting the panel voting in mid-stream (when it was going the wrong way) to clarify the efficacy question, as already having diminished their clout, so that publicly challenging CBER and appealing to the FDA after the fact isn't much of a risk in their eyes either. in fact, they will look like heroes in the unlikely event that Provenge/9902B fail - they will then gain back all that lost clout & then some and it will be CBER that has the credibility issue...
that said, i think Pazdur knows that Provenge is safe and has a very good chance of significantly extending lives of AIPC patients, particularly in combo with taxotere, but it seems clear that he was the driving force behind Scher & Hussain's letter writing campaign and very likely the leaker of the letters to TCL, which tells me he values his position and the CDER/ODAC approval process he largely controls more than patients.
I further suspect Pazdur already has plans to make it up to Scher & Hussain for the credibility hit they took on his behalf if & when Provenge is approved and commercially successful, so the risk they may have perceived for going out on a limb & covering for their boss is miniminal also.
what needs to happen here is a thorough investigation of who leaked the contents of not one but two supposedly confidential letters to the FDA that potentially if not in reality influenced the public trading of a stock. Those found to have violated FDA &/or perhaps SEC policy and rules should be severely & publicly sanctioned (i.e. dismissal).
Bravo!
<<P.S. They had previously discontinued research on an analog - alcapone - that triggered violent behavior.>>
perhaps this explains such prevalent violent behaviour around Chicago in the 1920's...particularly Feb. 14, 1929 and possibly also contributing factor to dementia in later years if you manage to survive those violent outbursts?
I think, all of you would have to admit that Goodman's actions in the middle of the panel vote is unprecedented and, thus, we are a bit in unchartered waters here.
i'll have to defer to those who, unlike me, have observed a lot of panel votes, but if unusual as you suggest & i suspect, i think the message such a "clarification" during a panel vote sends is 'we (ie. CBER & the FDA) want this treatment approved'.
perhaps that is what is upsetting to the "process over patients" people like Scher & Hussain & Pazdur's ODAC, causing them to go to great lengths to stir up controversy and try to discredit the CBER panel decision if they can't overturn it (& thereby ultimately cause problems for Von E.)
this has become more about politics than process or patients.
i encourage people concerned with tactics employed to try to derail Provenge approval & availability (whether via naked shorting, or malicious analyst reports, etc.) write their representatives in Congress, particularly the Congressional Black Caucus members who co-sponsored Rep. Gregory Meeks Mar. 29, 2007 Bill entitled "Recognizing that the occurrence of prostate cancer in African-American men has reached epidemic proportions and urging Federal agencies to address that health crisis by designating additional funds for research, education, awareness outreach, and early detection." H.RES.288
http://tinyurl.com/28qhk3
If Provenge is as promising as some people think, surely there are ample sources of capital to complete the clinical program.
if Provenge is safe (and the AC experts unanimously & emphatically said it was via their 17-0 vote, even with knowledge of the CVA side effects in a small number of patients) and that 9901/9902A Provenge trials have demonstrated substantial evidence of efficacy, why should its approval and public availability be delayed? just because some anal retentive and/or conflicted hypocritic doctor wants to protect the turf they feel is being threatened?
as far as ample sources of capital, it appears that there is an equal if not greater source of counterfeit DNDN shares thanks to a corrupted marketplace and regulatory environment to suppress the price/value of the stock. are you now trying to suggest the market is being efficient regarding the valuation of DNDN???
a rather curious commentary i must say.
Any sign of a "turf war" within the FDA, especially regarding oncology, would be a bad signal to send to Congress at this point.
i think you are overestimating ODAC & Pazdur's hand when it comes to their apparent internal battle with CBER & Provenge, & how that might look to Congress.
Last time i checked, the Democrat's black caucus is pretty influential when it comes to matters that directly & disproportionately affect their constituents, and the greater incidence of prostate cancer among black men is (or should be) well known to this group.
frankly, i would welcome ODAC & Pazdur creating a turf war based on whether the FDA's decision to approve Provenge is justified, since it would draw deserved attention to ODAC's, and in particular, Scher's conflicted position and Pazdur's apparent not-so-hidden agenda.
While i suppose some in the black caucus could be bought off (as with any politician), i think Pazdur would meet his comeuppance if he really wants to push the issue of Provenge approval into a public & political debate...
in fact, close public scrutiny of this issue, imo, would help serve to clean up the FDA & ODAC in particular, something that appears to be desperately needed based on my layman's read of this situation.