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ONYX Pharmaceuticals, AŞ Message Board

kot882001 52 posts  |  Last Activity: Aug 26, 2015 10:51 PM Member since: Sep 26, 2010
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  • kot882001 kot882001 Aug 13, 2015 5:17 PM Flag

    Just an additional quote from the same article:
    "To be sure, Celldex’s drug did meet its goals with respect to PFS in the Phase 2 trial. The results just weren’t quote as dramatic as the OS results. So instead of early approval in the patients with the most advanced form of the cancer (who now have no options), patients and investors alike are going to have to wait until results of a trial of more than 700 patients. That trial is already underway, with some results expected late this year or early next."
    So, let me say it again: as good as CLDX science side, is, as bad is the regulatory side of CLDX...
    However, the science always win! So, we've waited from $4 to now, we'll wait for few months more...

  • Reply to

    If AM resigns tomorrow.....

    by vpg1720 Aug 13, 2015 9:55 AM
    kot882001 kot882001 Aug 13, 2015 1:14 PM Flag

    MBB, while I'm really not extatic about regulatory level of understanding of CLDX management, the scientific teams seems to work much better and, there is a hope that Rintega and all others will be brought to the market after all bump in the road...

  • Reply to

    If AM resigns tomorrow.....

    by vpg1720 Aug 13, 2015 9:55 AM
    kot882001 kot882001 Aug 13, 2015 11:35 AM Flag

    It would be bad news- this will show that management is not very optimistic about CLDX future...However, I don't think it will happen, since there are a lot of positive things can happen really soon (starting with stopping ACT IV on the next DMB reading at the end of the year and ending with fantastic results of Varli combination and buyout offer from BMY), while as all bios there are certain degree of risk...

  • Reply to

    Upon Receiving Data

    by investwith6s Aug 11, 2015 1:30 PM
    kot882001 kot882001 Aug 12, 2015 8:34 PM Flag

    CLDX expects it to happen EOY '15 or beg 16

  • kot882001 kot882001 Aug 11, 2015 2:01 AM Flag

    not going to happen- there is no guarantees with Varli or Glemba and Rintega needs to be approval in order for someone put real money for CLDX buyout. However, if we assume that p3 will be similar to p2, it just means that we need to wait more (than we hoped for) time until (some) value of CLDX will be unlocked...

  • kot882001 kot882001 Aug 11, 2015 1:23 AM Flag

    What I find is surprising that nobody has asked and AM did not volunteer his thoughts regarding the probability of stopping at second interim analysis. (While regarding first one he has said :"it is pretty hard hurdle to overtake"). And it is pure statistical matter that I believe could be analyzed based upon ACT III results, in the sense that if similar point of analysis would happen at ACT III, would it produce (expected) statistical result that that trial would be stopped for efficacy?

  • kot882001 kot882001 Aug 10, 2015 10:48 PM Flag

    Whip, the next catalyst is EOY/beg 2016 with second interim update of ACT IV. I'm also sure they'll come up with some other scientific encouraging updates, but regarding regulatory advance- next reading of ACT IV is our next chance. From the previous CC and presentations, it seems that Rintega really start show difference after 6 months of taking it, so I'm "causiously optimistic" regarding stopping for efficacy on the next interim analysis.

  • Reply to

    Pretty Good Day

    by dorriswelch Aug 7, 2015 4:03 PM
    kot882001 kot882001 Aug 7, 2015 5:17 PM Flag

    Another reason for CC after hours could be that AM waiting for the FDA announcement in the morning...

  • kot882001 kot882001 Aug 3, 2015 3:02 PM Flag

    Whip, it takes toll on everyone patience, but, it is because after ASCO we've not heard any news for 2 months
    and somehow where led to believe that things will happen quickly...And it is not so...In the past we used to wait months (and were ok with it) for some meaningful news and now suddently our patience running short.
    So, IMO, we need to change our state of mind and let things happen on their timetable and don't let Dorris & Mabio to spoil it...

  • Reply to

    Sell or keep hoping!?

    by asj1953 Jul 31, 2015 11:27 AM
    kot882001 kot882001 Aug 2, 2015 3:16 PM Flag

    They basically have very solid trial results and progress so "fundamentals" are good. All/most bios went down in the past 2 weeks, so until we learn that something really bad goes with the trial, I'd keep it,- next tide up can bring it back to $16+

  • Reply to

    AM waiting for call from FDA,

    by kot882001 Aug 1, 2015 1:56 PM
    kot882001 kot882001 Aug 2, 2015 2:40 PM Flag

    Ray, you're referring to the process and I'm referring to the result. As much complicated as it is, at the end you get "go" or "no go" and this is what AM waiting for to bring something to CC

  • Reply to

    AM waiting for call from FDA,

    by kot882001 Aug 1, 2015 1:56 PM
    kot882001 kot882001 Aug 1, 2015 3:13 PM Flag

    Dorris, there is Russian expression that saying "every rope has its end"...So, your bashing will also end...And, probably sooner than later.
    For the last 2 weeks we've experienced mini-bear market in bios and, providing absence of any real news, CLDX went with the tide. The moment tide turn the other way or some more interesting news coming, you'll become very humble and poorer...

  • and after that cc will be scheduled, IMO

  • Reply to


    by mjacob56 Jul 24, 2015 6:40 PM
    kot882001 kot882001 Jul 25, 2015 12:09 AM Flag

    Your feelings are shared by a lot of frustrated longs...However, we should keep an eyes on the ball and remember about a big picture. I'm sure that management also would like to announce something positive, but apparently, things take time and who knows why discussions with FDA are taking that long? After all dealing with burecracy is never fast. We probably'll get some update on CC in 1-2 weeks. And, in any case there much more coming,- Glemba, Varli etc, so patience is a virtue and long time investors will be rewarded.

  • How high is probability that p3 will be stopped for efficacy on the next reading (expected year-end)?
    And, unrelated question: your opinion about KPTI?

  • kot882001 kot882001 Jul 23, 2015 10:09 AM Flag


  • kot882001 by kot882001 Jul 22, 2015 8:40 PM Flag

    It is very hard to put a price tag on bio without revenue and with a lot of drugs in development without any real idea when and if they'll be approved and what is the market potential.
    However, KPTI has very strong fundamentals, i.e. no trial failure so far, "deep bench", i.e a lot of promising candidates and looking on similar bios, I'd say that KPTI is currently undervalued and even without any additional positive news should be worth at least 1.5B. In long term, with some positive developments, it will worth much more, and if shareholders will execise some patience, they will be rewarded.

  • Reply to

    After speaking w/IR recently

    by raysfrom98 Jul 22, 2015 4:19 PM
    kot882001 kot882001 Jul 22, 2015 8:31 PM Flag

    Whip & Ray, this was the case until few quarters ago...I think last year, after hiring PR person it was decided that CC serve also as an instrument to increase awareness of CLDX and provide "moral support" to shareholders, and, therefore, now CC's are conducted regardless of presence of "real news". However, it does not mean that it will be no new news, and, on the top of it, this is an opportunity for the analysts to ask questions that are of interest to all of us....
    I, personally, hope that time frame for new expected catalyst will be announced (Glemba, Varli, trials etc, and of course Rindo), and the most interesting (and important question) if there are expectations that on the next read the DMB will stop the trial for efficacy?)

  • Reply to

    Thoughts about CLDX current trading range

    by kot882001 Jul 18, 2015 3:15 PM
    kot882001 kot882001 Jul 19, 2015 11:23 AM Flag

    1. I don't remember now info about improvement in OS compare to SOT, but these number are easily traceable from p2.
    2. Regarding 400-500m, - this one is easy: at some point AM said that they will charge on par with similar treatments, i.e. about 100k-120k a year. It is estimated that out of 43k-46k people with brain cancer about 4k-5k are the patients that can benefit from Rintega so here is how I came with 400k-500k peak sales not counting outside US.
    3. I estimate CLDX s/p at $50 based upon 5 times peak sales+the rest of pipeline.
    4. I also disagree with statement that BP will buy only when results are proven,- while lately I observe that tendency, I can give you few examples MEDX, MLNM - were purchased before getting to market. And, the latest buyout for 7.2B also good example...

  • Reply to

    Thoughts about CLDX current trading range

    by kot882001 Jul 18, 2015 3:15 PM
    kot882001 kot882001 Jul 18, 2015 9:58 PM Flag

    Myown, Glemba is one of the unknown in CLDX valuation and we can just guess is slow enrollment the only reason. However, what we do know that so far CLDX's drugs were able to produce if not spectacular, but very solid results that should be enough for approval. All of this is just matter of time and approval of Rintega will bring us to $40+