Deadline extension posted earlier this week:
"Regulatory information – adjustment of linguistic review timetable for opinions adopted at December CHMP meetingThe European Medicines Agency (EMA) has adjusted the post-opinion linguistic review timetable for opinions adopted at the 16-19 December 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP), to take account of the Christmas break. The adjusted deadlines are as follows:Sending of draft translations to Member States (usually 5 days after opinion at the latest): the deadline of 24 December 2013 is unchanged. However, given that the EMA will be closed from 23 December this year, companies with opinions for initial authorisation applications and line extensions will exceptionally need to send their translation packages directly to the Member State contact points for linguistic review;Provision of comments by Member States to companies (usually 19 days after opinion at the latest): the deadline has been extended to 10 January 2014;Final provision of translations by companies to the EMA (usually 25 days after opinion at the latest): the deadline has been extended to 16 January 2014, excluding referrals. For referrals, for which final translations usually need to be provided 22 days after opinion at the latest, the deadline has been extended to 14 January 2014;Final provision of translations by the EMA to the European Commission (usually 27 days after opinion at the latest): the deadline has been extended to 17 January 2014."
"How the Brain Smells..." Johns Hopkins, Jan 2011
"However, in the brain, little is known about the neurons that make up those parts. “We know what our nose is doing but not what our brain is doing,” says Potter, an assistant professor of Neuroscience. “We don’t know how the signal is turned into disgust or fear. We don’t know how information is interpreted.” Why does the scent of a rose register as a sweet aroma in our brain while rotten garbage gets recorded as, well, rotten?
"One day in his lab, Potter holds a clear plastic tube up to the light to show the recently dissected brain of a fruit fly. Barely visible, the feathery form floats in a transparent liquid. It looks as white and as delicate as a snowflake. This minute brain contains about 100,000 neurons. Potter estimates that about 5,000 of those are dedicated to the sense of smell. Ultimately, he would like to map out the role of each one."
Jonesy, I can get you real work...It'd change yer life, I swear....
Have a great holiday, Jonesy...
Goozz Frabbahh...you angry little man...
What's your take on the biology of what is taking place within the trabecular bone structure as a result of Cabo treatment? Should biopsied analysis prove it to be merely an interesting relic of chemical uptake, it may only serve to distinguish Cabo's uniqueness in perceived bone effect. But...
(and I personally believe the following to be more correct)
What if there is actually a biologic renormalization of the disease-damaged bone environment... including restoration of structure, function, and physiologic processes??..IE a return to biologically intended bone-remodeling.
Are you aware of any precedent for this consideration?
Though I can foresee some overlap in the therapeutic indications of Xofigo and Cabo, there will be a lot of doctor/patient discourse wrt the appropriate usage & sequencing of these drugs. Each treatment may display positive potential, yet each will also have downside risk considerations that will mandate consideration case-by-case.
The following is from the RA-223 label, and can not be taken lightly by users or administrators:
"For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions." This smacks of hospice-care EOL considerations to me...
Cabo also has it's toxic downside risks, though it has displayed significant impact on systemic metastasis, observable visceral mets reduction, CTC reduction, and the apparent - and as yet, undefined - BV increase within the bone micro-environment. This rebalancing of bone-remodeling is not understood, and it's value is not yet quantifiable. The coming year promises many new returns on Cabo's MOA, and we (as shareholders) are simply going to have to await these results. The fact that Cabo is clearly in consideration for earlier stages of PC treatment especially demarcates it's potential from that of Xofigo.
Till We have more info, I would regard such speculative comparisons as those of apples to oranges...
The two treatments are scarcely alike, though they may share some overlap in the treatment algorithm.
Jonesy, you really don't possess any skills at all, do you...??
The lowdown below is from the Mass General Hospital personnel website. Live & learn, Big Dog...
Your ancillary commentary might be best directed toward your own anal banality, dipschwanz...
"Alice T. Shaw, MD, PhD, is an attending physician in the Center for Thoracic Cancers at Massachusetts General Hospital, an assistant professor of medicine at Harvard Medical School, and a clinical investigator at MIT's Koch Institute for Integrative Cancer Research. In addition to caring for patients with lung cancer, Dr. Shaw also performs clinical and translational research.
Dr. Shaw's major research interests include studying anaplastic lymphoma kinase (ALK) translocations in non-small cell lung carcinoma (NSCLS); developing targeted strategies to treat NSCLCs harboring activating KRAS mutations; discovering new targets in NSCLC using both genetic and phosphoproteomic strategies; and developing novel nanoparticle-based siRNA delivery systems to target genetically defined subsets of lung cancer. Dr Shaw has been awarded a number of research grants, including grants from the Damon Runyon Cancer Research Foundation, the Burroughs Welcome Fund, the V Foundation for Cancer Research, and the NIH/NCI."
Posted today, 12/2/13, at targetedoncdotcom...informed read on a variety of NSCLC drivers.
"In a first clinical validation of RET rearrangement as another target in NSCLC, a group in New York examined whether the multitargeted kinase inhibitor cabozantinib would have activity in patients with RET fusions.Of three patients, two had “very nice” responses, Shaw said. The third patient had stable disease. Importantly, she said, the responses had endured for longer than six months (at the time of publication of the data)."
I guess you can always rely on a little beaurocratic dysfunction to complicate the holiday season.
It would appear that word of MTC approval for Cabo in Europe will become another 2014 catalyst.
Enjoy your holidays, Clem...
I stole the following from page 13 of 37 of the current agenda, posted this morning:
• Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Status: for discussion and agreement of advice to CHMP"
At least we know we've still got a hitter in the batter's box...
From the ASCO Post...some interesting comparative toxicity data wrt Cobi & Zelboraf...
Metastatic Melanoma: Encouraging Data Keep Coming
By Caroline Helwick
December 1, 2013, Volume 4, Issue 19
Unless there are LBA's or embargoed abstracts, I see nothing at either the ASH or the SABCS. In late January, the ASCO GU currently lists two Cabo posters: A reporting on the P1 Cabo plus Docetaxel in mCRPC (Abstract 108)...and a reporting on the P2 in pts w/ refractory mUC (Abstract 307).
Unless we get lucky with a timely, strategic release of EXAM OS data, European approval in MTC, or partnering news...near term catalysts appear pretty lean. I wonder if EXEL can hold onto a billion dollar valuation in the absence of news?... Time'll tell, but I suspect we're in for yet another transient dip before any serious news appears. When it finally rains, it's gonna pour...
Given the high level of clinical interest in both Cabo & Cobi...
A 20% premium based on any figure less than $12/share...
Would be a disappointment to me...
20% from current PPS would be a joke on longs...
A really, really bad joke...
Good find, Bif. Love the title...
These sorts of articles are great for gaining insight into cancer biology, and it's very tempting to buy access to this one, especially as Docter Matt is co-author. His combined access at MGH/Dana-Farber gives him some wonderful research tools...Including the Haber lab and it's advanced CTC platform.
Enjoy your Turkey Day...
NCT01995058 scheduled to begin enrollment in December.
Large, 4-arm P2 (n~280) with Cabo dosing down to 20mg...
I'm guessing early results from the P1 remain favorable to enable this much larger P2 spinoff...
Enjoy the holiday...
Thanks for the update, Clem. I don't own BAVA, but I believe PROSTVAC has a future.
,In my book, you cannot be a serious investor in any stock unless you are willing to keep an update on the competition. In CRPC, the competition has become fierce beyond recognizability when compared to the treatment landscape that existed only two years ago.
It is in your best interest to acknowledge the impact of competition on your investments, each & every one.
Posted at OncLive11/25/13...
"So cabozantinib, I love that drug as far as its mechanism. So it actually hits MET, VEGF Receptor 2 and RET. And interestingly it’s obviously the number one targeted agent for medullary because we have all of those.
What we really saw in the EXAM trial is that patients had wonderful responses and durable responses. So it’s a very good agent, it’s an active agent. The design of that trial was different than the vandetanib trial because they were being realistic and realized that if patients who have medullary thyroid cancer are stable, there is no reason to be giving them toxicity. So they did what the other trials have done and clearly defined a high-risk group and they took the patients who had clear progression of disease with medullary thyroid cancer and randomized them. The placebo arm was really only about 4 months and the cabozantinib increased progression-free survival to over 11 months, so really an incredibly active agent. I have patients on it right now who are benefitting from it."
Posted at Onclivedotcom 11/22/13. OS has not yet been determined, but these PFS #'s will be the bar.
"The median PFS was 10.8 months with sorafenib compared to 5.8 months with placebo (hazard ratio [HR] = 0.58; 95% CI, 0.45–0.75; P