IMO stay Long. and Reflect on the piliars of the Buddha. Most likely the Roche guys will not want the Eisai guys to have the only VEGF/MET inhibitor on the market.
EXEL needs some real clinicians in their meetings to help them construct effective clinical trials. They really have too many professorial types who really don't take care of patients. They miss the innuendo of what really happens in everyday patient care. They miss the potential homeruns..
Stocklooking: That's always a possibility, I've been wrong before (and also right before). However, I still think that the 260th PFS event must have occurred in Sept/Oct 2014 timeframe. At this time here on April 23, 2015. they must have the results and could be timing the release of the results so as to attain maximal publiciity from these results---say like in the week before the opening of ASCO..
This is an important study for everyone. So it could potentially take six plus months to collect all the data, to analyze it and then to recheck it. However, it would not be surprising to me that results will be released just in time for ASCO.
From my crude back of an envelope calculation, I think the data set for the first 260 PFS events must have been completed in or about Sept/Oct 2014.
At this time, 04/22/2015, the 2015 ASCO abstract board lists no abstracts for the search entity "cabozantinib AND renal cell carcinoma". Will it be a late breaking abstract for the plenary session or will it not show at all?
Thank you. I didn't know this.
Was the first patient actually enrolled in June 2013 or was there still paperwork going on at that time preparing to get the sites ready for the first patient who might have been enrolled at a later date?
You are quite incorrect. Off label use is very seldom used in clinical oncology by oncologists. The first reason is that these oncology drugs are very expensive. Insurance companies only grudgingly pay for these drugs even when the drug being used is labeled as being effective for the patients condition that is being treated. Insurance companies will clearly not pay for them when the use for which they are prescribed is not on the label....unless the drug is listed in some sort of compendium for the off label disease that you are treating . Then the oncologist has to request from the insurance company payment for the drug that will be used in the off label condition. Whether the insurance company says yes or no depends on which insurance company you are dealing.
The second reason oncologists don't often use drugs for off label conditions is that the oncologist or the institution for which she works don't want to be held responsible when the drug doesn't work or the condition does not improve. There is little personal professional responsibility for ineffective treatment when the treatment prescribed is on label. The label never says the drug is 100% effective. But when you give a drug to a patient who has a condition for which the drug's label does not state the drug will help, then the oncologist or the oncologist's institution could be held responsible for the drug's ineffectiveness.
So I wouldn't be expecting large revenues from the off label use of cabozantinib or from the off label use of any other oncology drug.
Good PBS special on Mukherjee's The Emperor of all Maladies, finishing its first three part run tonight. Much more emotional for me than the book. Worth seeing.
In Comet 1, the PFS for cabo was 5.5 months while the PFS for prednisone was 2.8 months, almost but not quite a double.
Dangers for the stock price of EXEL would seem to include 1. cabo having a poor showing in Meteor, 2. stock dilution, 3. market risk, and 4. better results in mRCC from another approach such as from an antiPD1 monoclonal. Rewards for stock price appreciation are not infinite due to company debt and changing nature of the biotech industry.
As always, Investors' DD, risk appetite and portfolio allocation management would all seem to be important .
Just my opinion.
Acquired tumor cell resistance to Nivolumab has not yet to my knowledge ever been demonstrated. Nivolumab's target is not on the tumor cell but rather on the T lymphocyte attacking the tumor cell.