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Protalix BioTherapeutics, Inc. (PLX) Message Board

kavbrian 13 posts  |  Last Activity: Sep 22, 2014 1:59 PM Member since: Aug 17, 2008
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  • Reply to

    Will ESMO and coBrim be just another non-event?

    by enabeler Sep 22, 2014 11:00 AM
    kavbrian kavbrian Sep 22, 2014 1:59 PM Flag

    I think it applies to any cobi sales. If you google "PDL-1 cobimetinib pre clinical data" the EXEL 8-K from Nov 22, 2013 should be the first link. They describe the co-development agreement in that document.

  • Reply to

    Will ESMO and coBrim be just another non-event?

    by enabeler Sep 22, 2014 11:00 AM
    kavbrian kavbrian Sep 22, 2014 1:28 PM Flag

    Don't forget that dabrafenib and trametinib also have a Presidential Symposium presentation. Looks like ESMO is trying to highlight PD-1, dabrafenib/trametinib and vemurafenib/cobimetinib. It is interesting that both the targeted combos are both being compared to vemurafenib as mono therapy.

    For cobi to save EXEL I think the PDL-1/cobimetinib combo trials will need to produce better results than PDL-1 alone (or MEHD7945A alone). I am going to assume one of the tumor types Roche is looking at with the PDL-1/cobi combo is non small cell lung cancer. They have a pivotal trial underway with PDL-1 as a mono therapy in non small cell lung cancer. Roche will also need to release the combo results before EXEL runs out of money. Unfortunately those combo trial got underway a little less than a year ago. At least PD-1 and PDL-1 are known to work quickly whereas anti-CTLA4 works a bit more slowly.

    Who knows maybe the PDL-1/cobi combo will work. The preclinical data are apparently encouraging (some might say provocative). If you google "Abstracts of the 28th Annual Scientific Meeting of the Society for Immunotherapy of Cancer" and then go to abstract P79 you will find an abstract senior authored by Ira Mellman about PDL-1/cobimetinib. They think cobi might enhance anti tumor activity by up regulating MHC Class I expression.

  • Reply to

    ESMO Presidential Symposium II September 29, 2014

    by kavbrian Sep 12, 2014 3:41 PM
    kavbrian kavbrian Sep 12, 2014 9:19 PM Flag

    CS,
    I am not sure Cobi is going to blow the doors off at ESMO. Dabrafenib and trametinib also have a Presidential Symposium presentation. Somehow I do not think ESMO will be used as an opportunity to bash another drug combination. Unfortunately, I am expecting dabrafenib/trametinib and Vemurafenib/cobimetinib to have similar results.

  • Reply to

    ESMO Presidential Symposium II September 29, 2014

    by kavbrian Sep 12, 2014 3:41 PM
    kavbrian kavbrian Sep 12, 2014 5:37 PM Flag

    Thanks for the vote of confidence but sadly I cannot take you seriously. Anyone else?

  • There are 3 presentation for Presidential Symposium II
    1. Nivolumab v investigators choice chemotherapy
    2. A randomized, open label, Phase III study comparing the combination of dabrafenib and trametinib with vemurafenib
    3. Phase III double blind placebo controlled study of Vemurafenib v Vemurafenib + Cobimetinib.

    Anyone on this board care to guess how Nivo, dabrafenib/trametinib, and vemurafenib/cobimetinib will stack up???

  • Reply to

    conference call

    by slowit Sep 8, 2014 5:52 PM
    kavbrian kavbrian Sep 10, 2014 4:38 PM Flag

    thanks for the reply. What are the linear installments from Brazil? I do not understand that aspect of the agreement with Brazil. I also do not understand the biocell stuff.

    It amazes me that they cannot sell Elelyso. It really makes me wonder about Pfizer's commitment to selling the drug. Now they are buyout bait unless the Fabry drug works better than the drugs already on the market. Or unless they hit a home run with a anti-TNF partner.

  • Reply to

    conference call

    by slowit Sep 8, 2014 5:52 PM
    kavbrian kavbrian Sep 9, 2014 7:47 PM Flag

    What are the IMS numbers for q1 and q2? I am not registered on the IMS customer portal. I will have to listen again for the linear installments comment. I have a hard time understanding him at times.

  • Reply to

    RCC PFS Approvable Endpoint

    by duckduffer Sep 5, 2014 1:14 PM
    kavbrian kavbrian Sep 5, 2014 6:51 PM Flag

    wild,

    Can you refresh my memory? How did they arrive at 5 months PFS for the Everolimus arm?

  • Reply to

    The sep 3, 2014 conference will hopefully discuss:

    by dfkerem Aug 29, 2014 9:54 AM
    kavbrian kavbrian Aug 31, 2014 9:08 PM Flag

    I sure hope they have some good news to offer in addition to the pediatric taliglucerase approval. The tali label expansion is nice but I do not think it will change things much in the short run.

    Clinical trials.gov indicates that the study completion date for the 38 week extension study for PRX-102
    (NCT01769001) is September 2014. It would be nice if they talk about new PRX-102 clinical data instead of mentioning that the trial is ongoing and they anticipate releasing data soon.

    It is interesting that the CC is being conducted on Wednesday after the long weekend when all Wall Street traders will be back from vacation. They could have had the CC last week. It seems to me that management at PLX wants to be sure they have a good audience. Let's hope they do not disappoint...

  • Reply to

    EXEL presence at ESMO

    by wilderguide Aug 8, 2014 5:16 PM
    kavbrian kavbrian Aug 20, 2014 8:54 PM Flag

    I was also hoping for a PR prior to the LBA deadline. I sure hope they are still cleaning the data. If the data are positive why would they pass up a presentation at ESMO? I do not expect a PR to be issued the day after the LBA deadline.

    Looks like Friday morning will be another nail biter.

  • Reply to

    BCRX, NIH trial this year: CDC Q&A

    by maphere Aug 6, 2014 12:01 AM
    kavbrian kavbrian Aug 10, 2014 4:33 PM Flag

    Thanks for the reply Map!! I haven't listened to the CC yet but I will when my 3 girls give me a chance.

  • Reply to

    BCRX, NIH trial this year: CDC Q&A

    by maphere Aug 6, 2014 12:01 AM
    kavbrian kavbrian Aug 10, 2014 2:39 PM Flag

    Hi Map,

    I have a few questions for you.

    What makes you think P will be approved early in August or September instead of near the PDUFA date in December?

    Will the P manufacturing issues delay a stockpile order?

    Do they have GMP quality manufactured P available for a stockpile order?

    What makes you think BCRX will jump to a pivotal trial for BCX4161 instead of doing a PIIb as they previously indicated?

    How much would a BCX 4161 pivotal trial cost?

    Does BCRX have the cash for a BCX4161 pivotal trial?

    Does BCRX have the preclinical animal toxicology data to do a pivotal trial for 4161?

    Thanks Map

  • kavbrian kavbrian Jul 28, 2014 12:18 PM Flag

    Ernie,
    Would you care to comment on the run up of the exel share price with a large increase in volume over the last few days?

    Is this the usual run up we see approaching biotech binary events? Do you think it indicates the PIII data will be released soon?

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