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Mooi instap moment Dendreon

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  1. [verwijderd] 26 januari 2007 20:24

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    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 30857 by read_this_n0w

    Re: Will the pre panel meeting briefs be puclicly available as well?
    read_this_n0w:

    1. See: FDA Advisory Committee.com secure.iian.ibeam.com/events/fdcr003/...

    2. This service now charges $140 for a video webcast of FDA Advisory Committees. It was $120 at the time of the Xinlay in AIPC ODAC meeting in 9/05.

    3. The two day FDA/NCI Therapuetic Cancer Vaccine Workshop on 2/8/07 and 2/9/07 is a bargain in comparison and will be available free at: videocast.nih.gov/FutureEvents.asp#22007

    Good luck to you and to all DNDN longs.



  2. [verwijderd] 27 januari 2007 23:12

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    Denk toch dat het tot mei,ups en dows maakt, rond de 1.27,dus,buy on the lows,met het vertrouwen dat het goed zit met FDA,pakken we toch een markt erbij,een hele grote,waardoor het aandeel makkellijk boven de 2 euro gaat komen.

    RB
  3. [verwijderd] 29 januari 2007 14:44

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    DNDN skepticism

    My skepticism of the BLA is based on, but not limited to, the following:

    1. 9901 by itself cannot possibly be sufficient for approval. It if were, DNDN would have filed a BLA when the 9901 data were mature.

    2. Thus, the key question is whether 9902a is sufficiently supportive of 9901 to warrant approval based on one successful study and one supportive study. My contention is that 9902a is not supportive because the raw p-value for overall survival was 0.33 and the Cox analysis that lowered the p-value to 0.02 was not fully pre-specified.

    3. As further evidence that the Cox analysis of 9902a is data mining, I note that: a) DNDN has never completely clarified for investors exactly how the Cox analysis was conducted; and b) DNDN did not begin to talk about Cox at all until around the time when the 9902a survival data matured.

    4. Changing the 9902b protocol to make Cox the primary endpoint supports the contention in item #3 above and makes 9902b the real pivotal study, in my view. (I.e., DNDN learned ex post facto that Cox gave a good result in 9902a and hence they are testing this Cox endpoint prospectively in 9902b. This is how things are supposed to be done.)

    5. The slowness of the BLA submission—16 months from the time that the final 9902a were reported until the last BLA module was filed—suggests to me that DNDN was in no hurry to get the BLA done because they themselves do not expect approval on the first review cycle.

    6. DNDN slashed the capacity of the manufacturing output by 75%, giving further credence to the view that management itself is somewhat bearish about approval on the first review cycle.

    7. The argument that DNDN could not expedite the BLA because manufacturing buildout was the rate-limiting step does not ring true because the slowness of the manufacturing buildout was a policy decision by DNDN itself.

    8. Last but not least, DNDN’s senior management behaved during 2005 and 2006 as though this is a company to run away from. At least 75% of senior management has turned over during this period, including not just one but two CFOs. I consider CFOs the “canaries in the mine” because they, among all senior executives, have the most to lose by sticking with a loser.

    >What are the chances on a 0 to 100% scale of Provenge being approved?<

    On the first review cycle (the current BLA), I think the probabilities are as follows:

    1. Approval (including an approvable letter with minor issues such as labeling): 21%

    2. Approvable letter that defers an FDA ruling until completion of the 9902b trial: 77%

    3. Non-approvable letter: 2%.

    In case #2 above, I think the probability of a favorable outcome in 9902b and a consequent FDA approval in 2009-2010 is 45%. Based on this, the probability of a deferred approval pending 9902b is .77x.45 = 35%, and the cumulative probability of approval at some point is .21+.35 = 56%.

  4. [verwijderd] 29 januari 2007 15:26

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    Waarde Omy, als 20% van de aandelen short zou staan (zoals bij DNDN), zou ik ook met zo'n pseudo-wetenschappelijke berekening komen, die de rol en functie van de FDA volledig overbodig maakt.

    Psycho
  6. [verwijderd] 1 februari 2007 17:31

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    Clincal Trail Paradigm for Cancer Vaccines
    1.The entire 15 page Review Article is now available free at:http://www.sabin.org/PDF/JImmuno-CVCTWG.Clinical.Development.Paradigm.pdf

    2. It was a collaborative effort of the FDA, NCI and the Cancer Vaccine Consortium and will be further discussed at next week's FDA/NCI Workshop.

    Good luck to all DNDN longs.

  7. [verwijderd] 2 februari 2007 06:28

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    By: rancherho Send PM Profile Ignore Recommend Add To Favorites
    Clincal Trail Paradigm for Cancer Vaccines
    1.The entire 15 page Review Article is now available free at: www.sabin.org/PDF/JImmuno-CVCTWG.Clin... >

    Indeed a good read. For those interested, many of the presentations providing info in the above paper including one by Hershberg on Provenge can be reached from various links in the below page:

    www.isbtc.org/meetings/am05/workshop_...

  8. [verwijderd] 3 februari 2007 11:52

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    ZEER INTERESSANT!

    Miller on DNDN today in Minyanville
    "Bottom line, Dendreon’s valuation has more to do with tactical considerations than fundamental ones, and I hope to take advantage of that." Me too.

    This entire tactical trading article is interesting, but the Dendreon story is very well laid out...too bad Minyanville isn't Forbes.com

    www.minyanville.com/articles/index.ph...

    Here's the Dendreon part:

    “Real Time” Example

    I gave several past examples of how we used tactical research and analysis, so I want to provide a “real time” analysis you can follow along with. With “the answer” to this particular situation coming towards the end of March, my firm should know whether our analysis is right relatively soon.

    Getting the tactical situation right depends on the ability to screen out bad information. When my firm was trying to figure out what was going on with Dendreon (DNDN) recently, for example, the fund contacts were really of little help. The stock has become such a battleground that everyone is busily talking their book (trying to fool us by masking their real intentions) or simply had no desire to talk about their positions at all. We at BSR were able to at least gather some bread crumbs, though, between all the spin.

    My firm's brokerage and options friends really helped us out when we started sharing those bread crumbs. They helped us separate spin from fact so we were able to determine that most of the traffic in the options was call selling with the brokerages taking the other side. The puzzling jump in short interest was generated by the brokerages hedging the long call positions. The short interest jump had been puzzling since there was no new fundamental information available that would cause a negative reaction.

    Subsequently, my firm talked to a few funds that are long the stock and can’t resist the cheap prices of the call options. Some are bleeding off (selling) shares so their long positions do not get too large – a simple risk management strategy. Others had no previous position in the stock, so they are duplicating what the brokerages are doing by going long calls and hedging on a ratio by shorting common shares.

    The result is a stock stuck around $300 mln in market cap despite a fundamental situation clearly supportive of a higher valuation. As I’ve said repeatedly, Dendreon’s prostate cancer drug Provenge clearly works and should easily sell over a billion dollars a year. There are valid questions about whether the second Phase III trial is supportive as that term is technically defined by the FDA, so there are some fundamental pressures on the valuation. Whereas these “process” questions make me merely cautious, others see the fundamental situation as hopeless for the company and are aggressively, aggressively short common and calls.

    This aggressive short position has kept the price down, causing me to get the question more times than I can count, “Well if the drug is that good, why is the stock price so low.” The same folks also point to the huge short interest as an indication something is wrong fundamentally.

    Because my firm has done our fundamental homework, we can make better use of the tactical information we’ve gathered on the players and where the short interest is coming from. Despite BSR's own caution concerning the chance we get an unreasonable panel that focuses more on process than patients, we have the stock at overweight in our model portfolio. Our fundamental caution is expressed via about 2/3 put coverage on that position. My firm would never be that aggressive on the common side without a good understanding of the tactical situation. Going against what the collective intelligence of the market is telling you can be dangerous.

    Bottom line, Dendreon’s valuation has more to do with tactical considerations than fundamental ones, and I hope to take advantage of that.

    With a fourth Phase III trial to report data in 2008, the chance Provenge will never be approved appears slim – it might simply be a question of 2007 or 2009. Therefore, we’re also backstopped fundamentally as long as we’re willing to be patient.


  13. [verwijderd] 8 februari 2007 16:43

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    Dit is een smg van David Miller, welke DNDN al een tijd volgt en een buy heeft
    is een analyst met een nieuwsletter,

    zeer gebalanceerd artikel en hij is altijs=d zeer conservatief.
    dit was een reply op een aanval van een lezer van hem die hem te negatief vond, hij geeft hier duidelijk aan dat hij een buy ziet, maar dat hij ook risico ziet

    een must read

    www1.investorvillage.com/smbd.asp?mb=...
  16. [verwijderd] 12 februari 2007 21:53

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    lekker..

    en nog steeds 18mln - minus (2-3mln??) shorts op een totaal aandelenpakket van zo;n 81 miljoen

    ook is er flink wat may 7,50$ calls gekocht.. 500k aandelen worth vandaag
  18. [verwijderd] 12 februari 2007 22:04

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    quote:

    psycho-pharma schreef:

    ++5,37% (++24cents)
    $4.71

    2.750.000 stuks

    P.
    en 9100 opties verhandeld, dat komt overeen met 910.000 aandelen (opties is per 100aandelen)
    voornamenlijk call opties=recht om te kopen
  19. [verwijderd] 13 februari 2007 12:04

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    meestal klopt het wat hij zegt

    By: thebigass Send PM Profile Ignore Recommend Add To Favorites
    Interesting phone conversation with Ameritrade!
    Today I got a phone call from Ameritrade. The ostensible purpose of the phone call was that emails they were sending me were getting bounced back. This is probably true, as I had recently changed hosting providers and there was a lag where some mail did not get through.

    Meanwhile, he mentioned to me that there is a "new rule" on concentrated positions for DNDN. They are going to change the threshold to, and I quote, "50 or 60 or 70%" on concentrated accounts with Dendreon. This only effected one of my accounts and is of no consequence to me since I have plenty of equity and cash reserves, I just needed to link that one account to the other accounts I have there. But I found his vagueness astounding.

    When I told him it was already at 50% he said yes, but it could go up. When I asked him why the requirement was changing, he gave a pat answer that it is a low priced, volatile stock and they need to ensure there is adequate equity. When I pressed him why they said "50 or 60 or 70%" and why they could not tell me which number was going to apply and when, he had no answer and said it depends on the value of the account. I told him it was my intention to add more shares on margin (which is true, but not yet) so I needed to know what would be the requirement in my case, and he said that it could change based on the circumstances. I told him I would like to know as much as possible and he said I should speak to someone else who would call me back -- I took that person's number but only got a voicemail so I will try again tomorrow.

    Of course, I wanted to say to him "this wouldn't have anything to do with Ameritrade having lent too many shares out to shorts and needing to get some back to cover their asses by fleecing small time traders out of their shares" but I demurred, and decided to give him that attack tomorrow. If he doesn't call me, I will certainly call him.

    Stay tuned!

    I think the heat is on... prepare for battle. Full power to deflector shields. Fire the proton torpedoes!

    This doesn't matter to me, I can back my entire portfolio with cash if they want me to, but I think they are gunning for shares and people might want to be aware of this and prepare for this. Our short friend may be shaking money around and trying to get the rules changed in the 9th inning. I know this issue has been brought to this board before, so I thought I would let you know that it appears as if it is going to start to happen. Some of you with accounts at other brokerages might want to look in on this too.

    Good luck.



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