Seymour said it all in one of his last posts...
"Sometimes you trade, and sometimes you get traded..."
He conveniently forgot to mention that sometimes he just trades cubicle jockey IDs...
"You are quite incorrect."
You are right, I am absolutely mistaken. Evidence-based medicine has no place in oncology, and the NCCN compendium is a wishful fairy tale device that investors keep praying someday becomes a reality.
"I guess for the field of signal transduction inhibitors the next frontier is stacking and multi inhibitors..." I agree, with the addition of maybe planned TKI "switching" therapy...which seems to disarm (for a time) the onset of treatment induced resistance. At times, chasing mechanisms of tumor escape seems a bit like hunting prey that possesses the invisibility of a cloaking device - making for difficult treatment decisions in downstream therapy. As Cabo has displayed efficacy in so very many refractory and heavily pretreated patient groups, I've always felt it might always realize demand in salvage situations where approved SOC treatment options have exhausted.
"Cometriq off label!...increased revenue?""Analysts have high regard for increased revenue..."
Salvage use will always be a hit-or-miss proposition. Unless it coincidentally finds support in an NCCN compendium listing, insurers will forever be reluctant, and special applications will slow the prescription process. Analysts' regard for increasing revenues - in my experience - is limited to consistently, reliably, predictably increasing revenues. You simply cannot predict revenues based on off label use in an evolving treatment landscape.
Re: largest purchase:
Abstract PO-1-8: good case study of successful TKI-switching strategy using Cabo as 2nd line therapy post-Sutent. Notably, I can only find this strategy of Sunitinib to Cabo to Axitinib in the European literature.
Visit the website - patientsvilledotcom. Do a site search for Cometriq:
Unfortunately - as this site is set up specifically for AE reporting - there is no spin available wrt efficacy. However, there's some good info here regarding off label prescription and dosing with examples in STS, HCC, RCC, CRPC, glioblastoma, NETs, and CRC. Co administration evidence with bevacizumab, cetuximab, and many other chemo therapeutics suggest a fair degree of late stage and salvage use in unmet need. Cabo appears to be seeing its share of off label use.
I'm not sure what to expect here. If we don't see an E1512 update at ELCC, we may not get one till ASCO. Erlotinib has gotten its share of ESMO coverage, and makes me consider the politics of disclosure - patent expirations, etc. Further review of the E1512 trial reveals bi-weekly (and sometimes daily revisions) since the beginning of the year. Someone is spending a lot of time updating. This is a bit beyond my scope of experience - not sure what to make of all the "Dotting of I's; Crossing of T's" - but feel big news in the making. Given the context of trial maturity, and last interim reporting, JMO, but I feel it can't be bad news. We'll soon see...
"They lowered the dose to 60mg. Why?"
I suspect that the P2 dose-ranging study conducted by Matt Brown of Mass General was used to inform the dosing of Meteor. In addition, there has been ongoing evidence across the spectrum of indications that dose reduction was nearly always a mandate when initiated over 100mg BID. Off-label prescription (as shown in the Kidney Cancer Chronicles) is another likely source of dosing instruction for mRCC. At any rate, the Cabo balancing act of efficacy vs tolerance has been problematic. You are spot on in questioning Meteor dosing, as - to my knowledge - there is no large scale, clinically objective trial data to insure success in that indication. It's a bit of a wild card...
Here's what we know, based on the info divulged in the 11/4/14 press release:
"In the E1512 trial, 125 patients were randomized to one of the three arms: erlotinib, cabozantinib, or the combination. During a pre-planned interim ECOG-ACRIN Data Safety Monitoring Committee analysis for futility, it was found that the trial met its primary endpoint of improving progression-free survival (PFS) with cabozantinib alone and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone, and the results were highly statistically significant. Safety data were consistent with those observed in other trials of cabozantinib. At time of analysis, the median follow-up was 5.9 months and overall survival data were immature.
The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference."
This study - sponsored by the NCI, and chaired by Doc Joel Neal of Stanford - is the P2 Cabo NSCLC trial that reported positive top-line results on 11/4/14. In that EXEL PR, presentation at future venue was suggested. A quick review of revised updates to this study reveals that the study has been updated nearly each day of this month. Color me optimistic, but if we don't get news regarding this study during tomorrow's market, I think we are in for show-stopping news come Saturday. Oughta make for an interesting Monday...hope y'all have taken advantage of this pullback.
FYI - the ELCC 2015 news site updates regularly during the conference. It's an easy Google...GL
"They should hire you to run their PR..."
I think you hit the nail on the head - twonk is EDAP PR, IR, and probly CEO...
1 post | Last Activity: 28 minutes ago
Member since: Apr 15, 2015
"...any company that is either doing similar 3D life science stuff..."
I touched on this in an earlier thread, and encourage you to check out Project Athena on the Los Alamos Nat'l Lab website. To some, it may appear to be an "apples to oranges" comparison...but you really cannot deny comparison - not without due regard for the toxicity analytics potential. It's not a 3-D process. In a nutshell, they are attempting to integrate the functionality of heart/ lungs/ liver/ kidney in a fully-synthesized, software-driven human desktop model. The project has not issued a public update for about a year - to my knowledge. I think they are due...JMO Check it out...
Published in Clinical GU Cancer 3/5/15... Kutoglu, et al. NIH Cabo PI Andrea Apolo is corresponding author:
"In the present review, we focus on targeted therapies that have yielded the most promising results alone or combined with traditional chemotherapy, including the antiangiogenesis agent bevacizumab, the human epidermal growth factor receptor 2 antibody trastuzumab, and the tyrosine kinase inhibitor cabozantinib."
UC is another sleeper indication that could produce positive results at any time...JMO
"Everybody relax! no one is short here..."
It would be a productive management strategy, especially if coupled to news regarding patient enrollment, patient updates, EAP potential, etc... Face it, there are a lot of potentials for near term binary catalysts here, and ignoring fund-raising potential puts you in denial. I would not be surprised to find some dilution in the near term. It is a Wall St/ biotech fact of life...
I would rather they chose to raise funds at 52 week highs on great news, than wait to get slammed by the macro-market...only to dilute at losses to current SP. GLTA
I figured it was just a matter of time till you showed up, sporting your multitude of "devices"... Let the threatened carpet-bombing begin - I'll be sure to have lots of Orville Redenbacher, spicy BBQ, and iced Tecate beer on hand, as you'll be supplying the entertainment.
Exelixis is not sponsoring any trials in lung cancer at this time, so I wouldn't expect a PR. We'll simply have to wait and see who's data is mature enough to present. No really big deal...it'll just be P2 stuff, but if it follows suit in alignment with prior positive results, we could see some appreciation. Any data would likely come from the NCI or City of Hope trials...