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Dynavax Technologies Corporation Message Board

erniewerner 33 posts  |  Last Activity: 1 hour 24 minutes ago Member since: Jan 18, 2000
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  • erniewerner erniewerner 1 hour 24 minutes ago Flag

    "They then raise some money and unveil the bad results."

    I think the prospectus that accompanies an offering would be a problem for this scenario. It would mean the CEO and CFO exposing themselves to potential litigation and penalty with too many potential witnesses aware of the infraction. All the members of the DSMB will know when the results are given to EXEL.

  • Reply to

    Comet-1 results: the longer the better

    by scrotum_harden 2 hours 5 minutes ago
    erniewerner erniewerner 1 hour 46 minutes ago Flag

    "If comet-1 takes more time than expected isn't it good news?"

    The rationale for this expectation is that the performance of the control arm is reasonably fixed and the performance of the treatment arm is the primary variable. In this case, I don't know how valid that expectation is. I think the phase 2 experience showing a 10.8 month OS for Cabo treated patients in a less refractory indication puts a cap on what to anticipate from Comet, while the performance of the placebo arm is less well characterized. The delay can have a number of potential causes. The trial enrolment may have been very back-ended, either or both arms may be doing better than expected, the DSMB may be slow, EXEL may be dragging its feet. I don't think you can read too much into the delay in terms of it being a positive or a negative. I think they would like this resolved by the time they do the CC this week.

  • erniewerner erniewerner 2 hours 49 minutes ago Flag

    "EXAM OS is way overdue. What are the chances they're sitting on non-statsig results to protect share price in light of investor jitters about COMET-1?"

    Wouldn't surprise me at all. I think statsig is unlikely with too few events remaining from the last interim.

    "It doesn't seem like they ought to sit on good COMET-1 results since it would let them raise money almost right away if they are good."

    I don't think they will sit on the Comet data, good or bad. It's just too important and I don't see anything to be gained by delaying the inevitable. The longer they wait, the more temptation there is for insider trading and leakage.

  • erniewerner erniewerner 3 hours ago Flag

    "I've long felt there was a very tricky juggling act attached to the Comet-1 trial design. Cabo's quick and robust initial 6 - 12 week response coupled with a 6 month DOR, introduced into a treatment population limited both by treatment options and life expectancy is a considerable coin toss...even by casino standards."

    Let's talk about this a bit more. Cabo seems to have activity in two different patient groups--those affected by the RET inhibition (MTC, DTC, RET-NSCLC) and those affected by the VEGF/MET axis of activity. The RET indications seem to enjoy a longer period of activity and probably benefit somewhat from the other TK's inhibited. One of the attributes of the drug in the VEGF/MET indications is it seems to have its period of activity irrespective of numerous lines of prior treatment. So the drug is active in a high percentage of heavily pre-treated patients, but for a limited period (especially in CRPC). The drug is also somewhat toxic. All these characteristics really indicate to me the reasoning behind targeting refractory indications in CRPC, RCC and HCC. Even a relatively small improvement will show up as an approvable HR. If the drug exceeds expectations, then EXEL can consider moving further up the treatment food chain, especially in RCC and HCC and challenging other approved VEGF TKI's. There is so much riding on the Comet 1 data. Not only will it determine approvability in the PC space, but it will set the expectations for Meteor and Celestial.

  • erniewerner erniewerner 4 hours ago Flag

    "can all the fanfare for bone met resolution be for naught in extending survival 2-3 months???"

    I would be happy with 1.5 months as long as it is statsig. I would be delighted with 2 months and I would be ecstatic with a 3 month improvement. The bone met resolution phenomenon is pronounced but of limited duration.

  • erniewerner erniewerner 5 hours ago Flag

    "whats your guesstimate of the prob of success for comet 1.."

    The operative word is "guess." Mine is 65/35. The best comparison is the sunitinib experience. They terminated a trial for futility with an HR of .90. It was a 1.3 month survival advantage. It was a less pre-treated population and Cabo appears to have more activity than Sutent, but without a head to head comparison, that again is more guess work.

  • Reply to

    How was COMET1 powered?

    by drfil1987 5 hours ago
    erniewerner erniewerner 5 hours ago Flag

    "ClinicalTrials.gov states March 2014 as expected final data collection, which clearly did not happen."

    The date listed at clinicaltrials was an anticipated date for data cutoff, ie the time frame they anticipated for the triggering event. That it hasn't been announced does not mean that it has not occurred.

    "Anyone know how the trial was powered, and the expected OS in each arm?"

    It's in the company's website press archives.

    "And in the case of the population recruited, I cannot see the control arm lasting a significantly longer time than expected."

    That logic cuts both ways. I don't see the treatment arm doing much better than the ph 2 data point of 10.8 months as the ph 3 population has more prespecified lines of treatment.

  • erniewerner erniewerner 6 hours ago Flag

    "I expect Comet-1 to provide some information that helps to differentiate and define Cabo responders from non-responders."

    Here's the thing. Cabo is active in a very large majority of CRPC patients. Roughly 2/3 with bone mets have a response and 80-90% experience some sort of tumor regression or reduction in the area of measured bone mets by bone scan. Trolling for markers would be more aimed at determining the means of acquired resistance than trying to enrich the initial treatment population with responders.

  • erniewerner erniewerner 6 hours ago Flag

    "Can there be any chance this trial has not yet achieved its data-locking final event?"
    Slim to none.

  • Reply to

    Is there a dose reduction provision in COMET-1?

    by wildbiftek Jul 23, 2014 7:10 PM
    erniewerner erniewerner Jul 25, 2014 2:14 AM Flag

    "I'm guessing that treatment will be halted upon disease progression as well as in the Abiraterone trial for instance, am I correct?"

    Correct. Treatment is withdrawn at progression. And yes, there does seem to be a bounce back on treatment withdrawal with VEGF inhibitors in general. It was first noticed with Avastin, but I'm guessing it probably happens with the TKI's also.

  • Reply to

    Is there a dose reduction provision in COMET-1?

    by wildbiftek Jul 23, 2014 7:10 PM
    erniewerner erniewerner Jul 24, 2014 12:54 AM Flag

    "Does anyone know if COMET-1 permits dosing to drop to 40 mg?"

    EXEL is very stingy with information about their trials. EXAM had nothing listed and when I directly asked EXEL if the trial had a provision for dose reduction, they wouldn't answer directly. As it turned out there was a provision for a two step reduction if needed. 80+% of EXAM Cabo arm patients had at least one reduction. 60+% of the CRPC RDT and expansion cohort patients had a dose reduction. Granted, Comet 1 is starting at a lower 60 mg per day dose, but I would bet dollars to donuts the protocol incorporates a provision for step down to 40 and perhaps even 20mg if needed. Best guess is that all the monotherapy trials have similar provisions built in.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 10:19 PM Flag

    "You called the Comet 1 Interim results dead on."

    I did, but I wasn't smart enough to trade on it. Frankly I regret that decision. After looking at all the phase 2 data, my feeling is that Cabo treatment will add about two months to OS. The 10.8 month median survival for the expansion cohort solidified that expectation for me. The results will be out very soon and we will see where we go from there.

    Looking at your valuation model, about a year ago I figured Cobi for $100m per year. That was assuming an even split in the market with the competing GSK drugs. I don't see MTC worth more than $40m per year. I think the other numbers are ballpark, but there are more VEGF TKI's in various pipelines. It also doesn't account for EXEL's management's proven ability to spend. Still, I agree with the thesis that it is very much under valued down here. I still have more confidence in Meteor and Celestial than in Comet 1. We'll see and I do have my fingers crossed.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 9:12 PM Flag

    'How are you handicapping it?'

    65/35 it makes the primary endpoint.

    "Do we all need to cross our fingers?"

    Yes you do;

    "I am assuming you wouldn't stay long if you didn't think Comet 1 would meet its endpoints."

    That is a reasonable assumption.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 9:06 PM Flag

    "No One buying a company pays the short position. Those who "loaned" the shares for shorting, recall their shares."

    Go back and reread the original thread. The concept forwarded was that a the acquirer of a company that also happens to have a large short position could somehow avoid covering that short if they eventually buy the company. I agree that a potential suitor is not responsible to cover the cost of the extra shareholder positions created by shorts. Those positions are paid off by the shorts covering when instructed to do so by their brokerages.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 8:58 PM Flag

    '"Let's say ABC has issued 1 million shares and XYZ has shorted 100K shares of ABC. There are now 1.1 million shares on the market held by "longs." Wrong! There are still only 1M shares. Its just at there 100K that have been borrowed. There is no "creation" of shares.'

    Maybe the big numbers are hard to understand. ABC biotech opens its doors and has an IPO and issues 10 shares. Here are the lucky holders after day 1. Anderson holds 3 shares, Wilderguide 3 shares, Blackjack 3 shares, and Wildebeest 1 share. On day 2, Nomad borrows Wildebeest's share and sells it to Ernie. There are now long holders of 11 shares. On day 4, Nomad buys the whole darn company through a mandatory tender. He pays Anderson, Wilderguide, Blackjack and Wildebeest for their 10 shares and in addition he is forced to cover his short of one share so that Ernie can get paid for the one share he bought on the open market.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 8:48 PM Flag

    "Ernie, the version I'm reading is "NCCN guidelines 3.2014 NSCLC" which still lists cabozantinib for mutation-specific NSCLC treatment. Have I missed something? Where do you see this deletion?'

    My mistake, thx for the correction. I looked a few months back and for some reason couldn't fine the listing. It is still the only drug recommended and it is a cat 2A listing.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 4:57 PM Flag

    NCCN is not going to contribute much to EXEL success. Cabo was listed for RET driven NSCLC in the 2013 version, only to be deleted in 2014. I thought one of the best NCCN opportunities for Cabo was in differentiated thyroid cancer, but this one didn't come through either. With Comet 1 reading out soon (in the next few weeks), I see very few of the prostate docs sticking their necks out until they see the OS result from that trial. We have a truly binary event coming and its either win or lose without any room in the middle. Making the primary endpoint will make any action by the NCCN irrelevant and if Comet 1 fails, there will not be many supporters left in the PC arena. I have my fingers crossed.

  • Reply to

    legal question

    by alsodoglover Jul 21, 2014 3:32 PM
    erniewerner erniewerner Jul 21, 2014 4:43 PM Flag

    "erniewerner.......When you say...."Even if it were a material event (which is not generally considered to be the case).......are you saying that a buy-out offer......is not a material event ?"

    I realize how contrary to logic this sounds. A formal buyout offer is material. Preliminary and hypothetical discussions are not. Think about it. In most cases, buyout offers are not publicized unless one party or the other decides to "leak" the information first. BMY's purchase of MEDX was finally agreed to and publicized only after an 8 month negotiation period. The very definition of material refers to the likelihood to influence stock price. Just knowing that firms are having exploratory discussions would definitely influence stock price, but many, perhaps most, of these discussions are not acknowledged.

    "And the prohibiting of "selective release of insider information" is talking about selecting to only release information to any other individuals.............while not releasing that same information to the general public (stockholders) at the same exact time it is released to anybody."

    Absolutely correct. A company cannot legally leak material information to any individual or entity. Material information, if released, must be done publicly. It is a common misconception that a company is obligated to promptly release material information, that is not the case. As I said, the main constraints on a company regarding treatment of material news are rules governing selective release and insider trading.

  • Reply to

    legal question

    by alsodoglover Jul 21, 2014 3:32 PM
    erniewerner erniewerner Jul 21, 2014 3:49 PM Flag

    "I think that would be a material event and I'm going with yes. Just a guess though."

    Even if it were a material event (which is not generally considered to be the case), company's are not obligated to promptly report all material events. Reg FD (fair disclosure) prohibits selective release of insider information and other regulations prohibit insider trading based on nondisclosed information, but companies can, and do, sit on significant news.

  • Reply to

    Roche

    by saltydog711 Jul 20, 2014 11:59 AM
    erniewerner erniewerner Jul 21, 2014 3:07 PM Flag

    "What becomes of the short position if that short is also the aquirer of the shorted company?"

    All long holders of a stock (including those whose holding resulted from the a short position) get paid off in the event of an acquisition. Let's say ABC has issued 1 million shares and XYZ has shorted 100K shares of ABC. There are now 1.1 million shares on the market held by "longs." If XYZ now acquires ABC for $10 per share, they will pay $10 million to the holders of the treasury issued shares and another $1 million to close out their short so that the holders of the 100k shares created by their short sale get their fair payout. Buying a company is not a way to escape the liability creating by a loss on a short sale.

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