If it were used in conjunction with breast cancer and lung cancer, the market would increase tremendously.
The case studies are impressive. The scans are striking.
Quoted in the patent “The primary cause of morbidity and mortality in patients with CRPC is metastasis to the bone, which occurs in about 90% of cases. Bon metastases casue local disruption of normal bone remodeling with lesions generally showing a propensity for an oseoblastic (bone-forming) phenotype on imaging. …”
Considering cabo seems to improve this along with pain and the tumors, I’m thoroughly impressed and feel better about my investment. In the random trials only 3% had increased bone metatases… 76% partial or complete resolution, 21% SD. Some were not reported but it seems it’s not working in all cancers but 76% from randomized screen is impressive. Hopefully, they’ll co-dose this with drugs with cancers across the board that make it to the bone.
Thanks for the post.
The CEO is responsible to the share holders. The CEO and board are responsible to the class A investors. They have to protect the initial investment on class A shares. They'll send the commoners to the killing fields but protect that initial investment.
I assume that is what all the infrastructure is for. They're even renting their space out that they're not using.
The original investors want their money back plus profit. The board would have to approve.
I'd say at least development costs ($900M) plus 1/3 of patent life projected income cut. $450M/2 = $225M. $225M*4 = $900M. $900M+$900M = $1.8B.
Personally, I'm not paying more than $4/share for accumulation unless I can ride the waves in a tax free/delayed account.
They are in P2 for "Randomized Discontinuation Trial (RDT) Study of cabozantinib in Adults With Advanced Malignancies"
This must be the patent preceding the trial. I'll take a look. The one for the osteoporosis was interesting but mechanistically, it seems that they need to ramp up research as soon as finances allow to find a follow up on that. Otherwise, they might miss a good chance for osteoporosis. From the looks of it, it may have competing mechanisms that have different effective strengths. Optimization could improve it.
Keep an eye out for a companies following up on that. If you see patents show up in a few years (~5) with similar structures, it might be worth investing. Otherwise, I hope they're mining their compound libraries to improve on that indication.
You cannot compare a random trial from some other company to judge the end of another.
Go to Clinical Trials dot org and look at the study. It's linked from the Exelixis website. Granted the original "Estimated Primary Completion Date" was March 2014. But final enrollment was completed Sept 2104. Thus, the "delay" if there ever was one was either issues with finding the correct candidates. Perhaps they had a money safety in there to observe the first set of enrollment to justify continuing the study. That may have been the "interim" release.
Enrollment began in June 2012 and officially had final enrollment in Sept. 2014
The endpoint goals are clearly stated:
PRIMARY GOAL: OS Through 21 months after study start .
SECONDARY GOAL: End of Week 12 bone scan. (likely to inform comet-2).
Clearly you cannot have final data until 21 months after final enrollment. i.e We’ll be updated sometime after JUNE 2015.
We will have to wait. The bone scans should be done by now; but we have some time to wait for he 21 month result.
I don't agree that EXEL is only BS but thanks for posting DNDN. I likely won't invest in it but I was curious as to the "reprogramming" of the immune cells and they got one approved (the only one); but other companies are working on it. I was wondering about the science. Hopefully they have publications.
While I’d agree with you that the risk is significant and that you’d be right solely based on a naïve comparison of the company to other companies, there are reasons that Exelixis stands above the rest. Does it guarantee success? No, but the odd are better than other companies.
While AMPE does not scream "NO" as loudly as many other biopharm. I'd write Danazol off as ZERO value. I was approved in the 70's, it has structural liabilities, and the indication they're going for can be avoided with proper care in the first place. Which leaves AMPION...
Three clinical P3 trials. One completed... Where is the submission for drug approval? It's injection, which is a long term use issue and is it better than Hyaluronan? It's a huge indication but I'm finding it hard to convince myself either way of the value.
You can count it out 100%.
The results are not delayed. We can expect the data to be locked by June 2015 as scheduled. After that, it's late. Final analysis for the secondary goal should be done in Sept, but we may not see the results until June/July.
Please quit spreading rumors that it's late.
The idea that nothing can increase survival more than prednisone in extremely poor logic.
I'm curious as to why you took the time to post this... Is this truly the logic in your head? If so, you should probably just give your extra money to your Mommy.
I had the question "is it normal to have 14 trials going for a drug (if they think it's going to fail)?"
I figured there must be some analysis out there; so, I looked (a little).
From DRUG DISCOVERY TODAY (June 2014) Quantifying the probability of clinical trial success from scientific articles; Vineet Joshi, Francesca Milletti
"We found that, up until the year when a compound enters clinical trials, the cumulative number of publications about a gene–disease relationship corresponding to the compound's mechanism of action is, at the median, 30 for approved compounds but only four for failed compounds."
Cabo would fit here. There was a drug before it that was pulled from market and many publications followed that led into Cabo's development. I'd have to look but I'd guess that Cobi fits here as well. Applying this analysis across their pipeline would be an interesting exercise which I don't have time for atm.
Also noted is CCR (march 2009) Novel Designs and End Points for Phase II Clinical Trials; Alex A. Adjei1, Michaele Christian2, and Percy Ivy2
They discuss a bit the failures of gefitnib, enzastaurin and vatalanib. It's less relevant to the analysis but popped onto my radar to read (which i still need to do) but I'd throw it out there if anyone is interested.