They have already submitted for EU - so the clock is ticking there. FDA is slated for a prior to year end application
Just saw where the CoBRIM study is to be published today in the New England Journal of Medicine online . I checked, nothing publish as of yet. Found article on Businesswiredotcom stating this.
Thanks guys for the breakdown, thought I'd be the first up checking the wires this morning. Your breakdown was very insightful and much appreciated.
Actually, looks to me like they are setting up to market EXEL to the highest bidder, perhaps the only bidder. I realize that the following is pretty standard language, but for whatever reason it seems to be glaring at me right now. I'm not very confident that if a deal is struck in the near term, that value in pps will be achieved.
" Change in Control and Severance Benefit Plan as described below. Vesting of the Performance Options will cease upon termination of continuous service with Exelixis for any reason. Each of the Executive Officers is a party to the Exelixis, Inc. Change in Control and Severance Benefit Plan, which provides for acceleration of vesting and extended exercisability of the Performance Options in the event of certain specified change in control events involving Exelixis."
After all the earlier exchanges, I thought it a good idea to thank the folks that contribute informative data relative to EXEL's prospects to the board. Clearly, it would have been preferable to have had at the very least, marginally better data with Comet 1, but ESMO should contribute to support of pps, The challenge forward is not only related to success clinically, but the entrenched short position. GLTL E
I'm not going to go thru the transcripts to find the reference, but when asked MM stated that the whole of the COBI program with Roche is set up the same. 50% declining to 30% and option to co-promote with any additional targets developed. Not going to have any near term implications, but it does place potential value on future developments with COBI, rather than a one trick pony, depending on expectations, I can see where not selling the Cobi asset has significant future implications to Exel.
Guys, thanks for all the insightful comments, Shame I (and any other interested parties) have to wade through all the incessant BS to find all the nuggets I find from your post.
Wilder, like the passion to continue the fight, my concern is that looking at any regulatory pathway that presents an opportunity for CABO, firstly what would be the ROI, and secondly priorities and funding to complete the regulatory process may be too great a stretch for EXEL. (certainly at this time) Any thoughts pertaining to this context?
Afraid you are wrong about that, my account at Fidelity allows Margins down to $3.00, I chose not to go that route. I imagine it depends on your Broker, possibly also experience and history with said broker. Standard with Fidelity though.
I have been under the impression that folks that were heavily margined on EXEL have 3 days to settle those margin calls, and the potential for a bump in pps exist once that plays out. Today the 4th is the settlement date, meaning Friday could see some appreciation in share price, likely still below 2.50. Then again, it may depend on how active the shorts are tomorrow. If shorts do keep a lid on the price Friday, it will likely set the stage for the long haul.
JMHO based on previous experience with inflection points such as this in the marketplace.
Thanks Oncodoc, your interpretation is as I expected. Xtandi and RA223 post prednisone, too much to overcome. The PFS data is certainly positive, however falls way short of having stat sig OS results. In light of all the bantering going on right now I appreciate your taking a moment to confirm that.
The original agreement is dated 10/22/06 and simply references "compound" I'm reviewing that document, however a lot of info is bracketed and filed separately to the SEC. Below is from Nov 22 2013
Under the terms of the co-development agreement, Exelixis is entitled to an initial equal share of U.S. profits and losses for cobimetinib, which will decrease as sales increase, and will share equally in the U.S. marketing and commercialization costs. The profit share has multiple tiers—Exelixis is entitled to 50% of profits from the first $200 million of U.S. actual sales, decreasing to 30% of profits from U.S. actual sales in excess of $400 million. Exelixis is entitled to low double-digit royalties on ex-U.S. net sales. Exelixis also has the option to co-promote in the United States. The co-promotion option would allow Exelixis to provide up to 25% of the total sales force for cobimetinib in the United States. Exelixis must exercise the co-promotion option within 12 months of receiving notification of the first patient dosed in the first phase 3 clinical trial of cobimetinib. Exelixis received notification of dosing from Genentech on January 14, 2013, which triggered the beginning of the period in which Exelixis can exercise its co-promotion option
Thanks for posting, I have been under the impression that if CoBRIM data was exceptional, (As having been selected for Presidential Symposium suggest) even with marginal readout of Comet 1, it would lift the floor on EXEL pps. Enjoy your Labor Day.
Double entrandre must have been lost with Soc....
"A delusion of grandeur is the fixed, false belief that one possesses superior qualities such as genius, fame, omnipotence, or wealth. It is most often a symptom of schizophrenia, but can also be a symptom found in psychotic or bipolar disorders, as well as dementia (such as Alzheimer’s).
People with a delusion of grandeur often have the conviction of having some great but unrecognized talent or insight. They may also believe they have made some important discovery that others don’t understand or appreciate."
Even the idea that you can direct my response is an element of Omnipotence. The remainder of the quote from psychcentral is self evident.
For your sake, lets simply hope you are a bear thinly disguised.
The antics have been a bit ridiculous. Your first two lines rank up there with all the insightful comments on CABO
I think after two nights in a row, if you believe you are better informed than the entirety of the group posting here, Not to mention the sponsors of the trial (exel), you should come back in March when you anticipate a run up to the results. Good luck with that.
Yahoo didn't seem to want to allow me to copy the entire text. go to Kimmel cancer center and search title for remainder of text if you wish. However the main info 30% present in early stages of prostate cancer and up to 80% in late stage CRPC is what caught my eye. What the implications for Comet 1 OS may be if Dr. Posadas statement pertaining to soft tissue matastatic disease are addressed with CABO.
Was considering the interview with Dr Posatas post ASCO and the prevalence of soft tissue matastatic disease in advanced CRPC ran across this from the Kimmel Cancer Center. (took 3 post to capture the text)
Elevated levels of Cyclin D1b could function as a novel biomarker of lethal metastatic disease in prostate cancer patients, according to a pre-clinical study published ahead of print on December 21 in the Journal of Clinical Investigation by researchers at the Kimmel Cancer Center at Jefferson.
The group, headed by Karen E. Knudsen, Ph.D., Professor and Hilary Koprowski Chair, Departments of Cancer Biology, Urology, and Radiation Oncology at Thomas Jefferson University and Deputy Director for Basic Science at the KCC, found that Cyclin D1b, a variant of the cell cycle regulator Cyclin D1a, functions independently of the cell cycle to promote metastasis in both early and late stage prostate cancer.
Rather, Cyclin D1b, but not Cyclin D1a, regulates a large gene network, the researchers found, which was shown to cooperate with androgen receptor (AR) signaling to fuel metastatic progression in multiple models of prostate cancer.
Studies have shown that Cyclin D1b expression is elevated in early stages of prostate cancer (in up to 30% of primary disease), and researchers have now demonstrated that this occurs more frequently in late stage castration-resistant prostate cancer: up to 80%.
Cyclin D1b expression is also highly correlated with that of the pro-metastatic gene SNAI2 (Slug), which the group identified as regulated by cooperative signaling between Cyclin D1b and AR.