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Seattle Genetics, Inc. Message Board

wilderguide 189 posts  |  Last Activity: 2 hours 44 minutes ago Member since: Jan 13, 2011
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  • Reply to

    Clinical Science Director

    by wilderguide Jul 28, 2016 6:50 PM
    wilderguide wilderguide 2 hours 44 minutes ago Flag

    $$$$
    This excerpt is from the Sept 2013 EXEL PR introducing Celestial:
    "Based on available clinical trial data, the primary endpoint assumes a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90% power to detect a 32% increase in OS (HR = 0.76). Interim analyses are planned once 50% and 75% of events have been observed, respectively."

  • Reply to

    Clinical Science Director

    by wilderguide Jul 28, 2016 6:50 PM
    wilderguide wilderguide 16 hours ago Flag

    $$$$
    "What is the anticipated timing on Celestial?"
    Despite perceptions of slow recruitment, the primary completion date remains unchanged at 10/16. Company guidance suggests top line results in 2017. Placebo challenge and PD-1 buzz may have slowed initial enrollment, but METEOR success may have produced an uptick in sign-ups due to increased confidence. I begin to suspect an interim reporting is at hand, and it shouldn't come as any surprise after 3 years - should it?

  • wilderguide by wilderguide Jul 28, 2016 6:50 PM Flag

    $$$$
    Latest EXEL job postings include shopping for a CSD proficient in interim analysis and data cleansing (excerpted below) To my knowledge, the only pending interim of any consequence is CELESTIAL. Stay ready.
    "Position Description
    Perform activities related to interim analysis and data base lock e.g. data cleaning clinical data review. Analyze and interpret study data and support preparation of reports for the FDA. Proactively provide feedback on emerging clinical and competitive trends."

  • $$$$
    "Cabozantinib in the treatment of advanced renal
    cell carcinoma: design, development, and potential place in the therapy"
    Drug Design, Development, & Therapy July 2016 Grassi et al...
    Open access @ DovePress...

  • Reply to

    rumbles are heard ...

    by godhairyballs Jul 22, 2016 1:58 PM
    wilderguide wilderguide Jul 23, 2016 1:02 PM Flag

    $$$$
    "...I see it was noted that one of the analysts following the stock has info on the scripts written thus far for Cabo..."
    That'd be Michael Schmidt of Leerink, and he cited IMS Health as his source. Google them or check out a Wikipedia review. They are held in high esteem by the Street, and widely held to be a premier source of market intelligence and prescription data. JMO, but I consider that the TRx numbers might be spot on. See Capt's earlier post...

  • $$$$
    1.) The MAA transfer of cabozantinib has taken place. In the summary of opinion, the applicant is listed as Ipsen, though - at the time application was actually filed - the applicant was Exelixis. This was anticipated, and that expectation has been met without celebration. An unacknowledged job well done...
    2.) Also based upon the succinct wording of the SoO, we can infer that a revised application was made to reflect a stat-sig survival benefit. This is good news, as it indicates that any EC decision for approval in RCC will include an OS benefit on the label. No holes in this story... Despite the seemingly long wait, all our ducks seem to be in a row here. On another note, I just did a quick preview of the IV board: there's a high probability I'll be posting over that way in the near future...once I'm comfortable shifting formats. It appears that Yahoo has lost motivation in addressing the best interests of its clientele, and the posters to this MB are amongst the best with whom I have ever shared thoughts. Some folks never do miss the sweetness of the water till the well runs dry. Adios, muchachos...

  • wilderguide by wilderguide Jul 21, 2016 10:53 AM Flag

    $$$$
    ...has gone all yackey gonkers...
    You twits need a lobotomy...
    Starting with Thrope...

  • Reply to

    "Potential mechanisms"

    by wilderguide Jul 19, 2016 9:18 AM
    wilderguide wilderguide Jul 20, 2016 5:31 PM Flag

    $$$$
    "...you may want to take a closer look at the title and content..."
    Yer wastin' yer time...
    Some folks just can't handle prosperity, even when it's handed to them.

  • Reply to

    "Potential mechanisms"

    by wilderguide Jul 19, 2016 9:18 AM
    wilderguide wilderguide Jul 20, 2016 2:09 PM Flag

    $$$$
    "I've clearly stated in numerous post that I am as well..."
    I see. Is that why you denied the presentation of new data w/o even bothering to take a moment to authenticate? That alone makes you a troublesome sort - uncomprehending, unimaginative, uncommitted to any sense of valuable due diligence. Just another clueless YMB dud...
    Are you a member of the Brain Damage Club, as well?

  • Reply to

    "Potential mechanisms"

    by wilderguide Jul 19, 2016 9:18 AM
    wilderguide wilderguide Jul 20, 2016 10:56 AM Flag

    $$$$
    "Perhaps you're nothing but a Perrin cheerleader..."
    Just a fan of the science, which is actually faring well in early scrutiny. If the pace of progress is a bit slow for you, I recommend that you invest in something a bit more fantastical - perhaps Disney is more your style.

  • wilderguide by wilderguide Jul 20, 2016 8:51 AM Flag

    $$$$
    Lots in place, particularly in RCC follow-up...
    814P, 815P, 816P, 818P. Updated QOL reporting could be a sales factor...
    Apolo studies in mUC and in Cabo combo w/ Nivo will also update...
    See also Cabo in post-doxorubicin treated HGUS...
    Looks like everybody's moving to IV...
    Guess I might as well too...

  • Reply to

    "Potential mechanisms"

    by wilderguide Jul 19, 2016 9:18 AM
    wilderguide wilderguide Jul 19, 2016 8:06 PM Flag

    $$$$
    "Thanks for posting..."
    De nada. This has become a troubled MB. The most persistent posters are also those with an agenda obviously counter to the long thesis. Cynicism, contempt, and misinformation from Thrope, biotrader, and others makes for difficulty in sharing good info. I'd like to change that...

  • Reply to

    "Potential mechanisms"

    by wilderguide Jul 19, 2016 9:18 AM
    wilderguide wilderguide Jul 19, 2016 12:30 PM Flag

    $$$$
    I believe what follows is previously unpublished, and has not yet been PR'd by anyone.
    "RESULTS: There were no NSS-related serious safety events. On screening MRI, patients typically exhibited spinal cord compression and edema. Three of 5 patients had intraspinal hemorrhage. Based on central neuroradiology review of pre- and postoperative MRI scans through 6 months, none of the patients had definite cyst formation defined by T2 and T1 changes. By 6 months, 3 of 5 patients had converted from Abbreviated Injury Scale (AIS) A to AIS B(2) or C(1). One patient gained 10 points of hip and knee function by 6 months, with additional improvement and new ankle function at 12 months (increased motor score of 8). One patient converted from AIS A to B at 6 months, a late-occurring conversion that is extremely rare.

    CONCLUSION: This study represents the first use of the intraspinal NSS in patients with complete thoracic SCI. By 6 months, the low incidence of cyst formation with preservation of some intralesion internal architecture is consistent with preclinical results in which the resorbable NSS was replaced by a matrix of axon-containing remodeled tissue. The possibility of ongoing neural regeneration may contribute to the high incidence of AIS conversion and sustained period of neurological recovery."

  • wilderguide by wilderguide Jul 19, 2016 9:18 AM Flag

    $$$$
    Published in Neurosurgery, August 2016
    "High Abbreviated Injury Scale Grade Conversion Rate Following Neuro-Spinal Scaffold Implantation in Acute Thoracic Complete Abbreviated Injury Scale A Spinal Cord Injury: Potential Mechanisms."
    Theodore N, et al...

  • wilderguide by wilderguide Jul 19, 2016 8:42 AM Flag

    $$$$
    From the CHMP agenda for this week's meeting, published earlier today:
    "3.1.1. cabozantinib - EMEA/H/C/004163
    Accelerated assessment
    treatment of advanced renal cell carcinoma (RCC) Scope: Opinion
    Action: For adoption"
    Hard to believe no announcement comes this week...
    But if no opinion is proffered, the CHMP does not meet again till Sept...

  • wilderguide by wilderguide Jul 17, 2016 7:13 AM Flag

    $$$$
    J Haemotology Awan, et al....6/13/2016
    "Of 35 efficacy-evaluable patients, four (11·4%) achieved complete response and 13 (37·1%) achieved partial response. Voxtalisib, in combination with rituximab or rituximab+bendamustine, demonstrated an acceptable safety profile and encouraging anti-tumour activity in relapsed or refractory B-cell malignancies."
    Joe: I had to split earlier than expected. Next time...

  • $$$$
    "CS-3150, a novel non-steroidal mineralocorticoid receptor antagonist, shows preventive and therapeutic effects on renal injury in DOCA/salt-induced hypertensive rats"...K Arai, et al JPET July 6, 2016
    A couple of interesting experiments reported here, clearly indicating amelioration of kidney injury independent of activity in modifying systolic blood pressure. Something very novel going on here, and I look forward to the first clinical reporting of human responses. Full free text available at PMC.

  • Reply to

    The last date EXEL reached this price

    by captainhymanshocker Jul 11, 2016 1:51 PM
    wilderguide wilderguide Jul 11, 2016 2:53 PM Flag

    $$$$
    "Muskrat candlelight", written by Willis Alan Ramsey...
    One of my earliest favorite songwriters...
    He first recorded this tune in 1971, on his only album - recorded at the age of 19. He still tours, and is definitely worth the price of a ticket. Peace, out...

  • Reply to

    Sutent vs Cabometyx

    by tevanj Jul 10, 2016 9:52 AM
    wilderguide wilderguide Jul 11, 2016 7:37 AM Flag

    $$$$
    "...will Cabometryx replace Stutent or will both continue to be used?"
    I think we'll need to wait for data presentations at ESMO. Sutent's long tenure as SOC may prove a tough nut to crack, so CABOSUN data will be closely scrutinized by the RCC community. Pfizer's S-TRAC data is also promised at this venue, and the use of a TKI in early stage post-surgical disease may actually set a new standard of prophylactic adjuvant care. To my knowledge, Cabo is untested in such early stage disease, but there is compelling rationale to date suggesting Cabo superiority to sunitinib, so a future comparison in early stage disease may be inevitable. Lots to consider moving forward, and the RCC KOLs will have a field day with ESMO data as this all shakes out. Your question will likely be revisited on this MB many times in the coming months as those thought leaders weigh in after ESMO.

  • wilderguide wilderguide Jul 10, 2016 3:23 PM Flag

    $$$$
    "Then again your 'so called posters' comment was kinda douchey...
    My apologies to all for my caustic attempt at humor, but I was mainly responding to the smart-alecky approach to posting such obviously misdirected, misinterpreted info without proper confirmation.
    Sometimes I'm a very bad boy...

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