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You sure he's a practicing oncologist?
re: combo guidelines
What I'm referring to, of course, is the stock compensation plans that provide stock-basd compensation to executives and other employees. Voting for those plans and not expecting them to sell those shares at some point is a little hypocritical.
I absolutely agree with you on all counts. We spoke with lawyers who do public company securities law and they assured us the soft plans were accepted by the SEC. Makes no sense to me.
Yeah, this is BS Dew.
I'll note not all 10b5 plans are created equal. Some are hard sell plans, meaning when the date or price trigger is hit a prespecified number of shares are sold and the executive cannot cancel the sales.
At least half the plans we are seeing are "soft" plans (our word). When the trigger is hit, the insider has the OPTION to sell. In some cases, the optional part comes in the form of a range of shares they have to sell.
The SEC has apparently blessed these "soft" plans as compliant, but to me they are a violation of at least the spirit of the rule.
So when some exec tells us "don't worry about the sale, it was part of a programmed 10b-5" they are often surprised when we grill them further. Also interesting is the number of companies who won't tell you in advance whether their plans are hard or soft.
Since the Titan Pharma crookedness, we ask every company we cover about executive hedges, collars, and 10b-5 plans. Some pretty interesting conversations sometimes. For the record, only Titan and Discovery Labs admitted to the collars. With DSCO, it was actually a true collar where they couldn't profit from the downside and still had a portion of the downside risk. With Titan, they profited all the way down from $65 to $2.
Happily, most companies we speak with who did not have prohibitions against hedges and collars put them into place after we tell the story.
Still working on convincing them to convert soft 10b-5s to hard ones...
It may me a new publication of follow-up research, or even unrelated labs doing reovirus work, but the general application of reovirus to PCa has been around a long time.
These data are from Oncolytics Biotech (ONCY) REO-002 trial. Here's an except from what we wrote about this trial in June 2005 when we initiated coveraged on ONCY.
You being so smart and me being so dumb and all... Explain to us all how ipilimumab, with all its side effects, will beat Provenge in the marketplace. Make sure you do it in a way that nobody will use them in combination or sequentially, because that's the only way ipi would "crush the longterm [sic] commercial prospect [sic] for Provenge."
Interestingly, in the last 2 weeks BMY has pushed back the start date from May to June. Also interestingly, it is now going to be enrolled all overseas.
Oddly, the patient representatives do not always vote for the drugs under consideration.
Richard Hollis (Hollis Eden) He was fired for cause from his namesake company a while back. Does anyone remember reading any reports of why?
See my question posed earlier about the design of that ipi trial in AS/MS M+ CRPC in a PRovenge-approved environment. I don't think it is ethical with Provenge on the market, but who knows. The FDA approved NExavar/Sutent trials against placebo in kidney cancer even though there were approved drugs on the market...
I don't think it is coincidence BMY isn't starting it until after they know what the FDA does with Provenge.
As far as PD-1/CTLA-4 are concerned, check out the immunotherapy presentation Dr. Charles Drake made at the ASCO GU conference on Friday. You can either wait for it to be on the ASCO website for free or access the virtual meeting right away for a fee.
Dendreon refused to allow combo trials with ipi. Medarex and then BMY were (are) eager to run those trials. Once approved, BMY can do whatever it wants for combo trials provided it pays for Provenge. Only way Dendreon would be involved is if they agree to participate in the trial by providing or discounting Provenge. I somehow doubt they'll do that.
My point is whether BMY moves PD-1 or ipi into these combination trials depends a lot on the melanoma outcomes. I had someone tell me that BMY hinted strongly they had positive data from the ipi+vaccine melanoma trial (ironic, since BMY wanted MEDX to turf that study).
I don't think ipi will succeed in melanoma with the current trials. PD-1 is another checkpoint inhibitor, that looks in early trials to have a better efficacy-to-side-effect profile. It was also developed by Medarex.
And BMY staff continue to contact immunotherapy companies about the possibility of combination trials.
Here are the likely candidates:
AZN if zibotentan data fails to show stat sig in the first ENTHUSE trial. They may do it even if zibo is positive but not at good as Provenge.
Bayer as they have been sniffing around on and off for almost as long as I can remember.
DNA/Roche... People forget there was a Genentech partnership with DNDN. DNA was trying to engineer a synthetic APC out of fly DNA. DNDN wanted expertise on MABs, small molecules, and antigen engineering. I don't know how many people from that collaboration are left, but it is always worth mentioning.
Sanofi to make up for the utter failure of Tax in PCa, though the nice data from cabazitaxel in 3rd line may cool this need.
And, the dark horse, Abbott. When Takeda and Abbott broke up the TAP Pharma partnership, Abbott paid up to retain the generic Lupron franchise. That makes no sense unless Abbott has larger plans for the uro market.
I hear BMY often under the theory they want to acquire active immuno properties to salvage all the $$$ they spent on ipi. My guess is that ipi will be all but dead by the end of 2010 and the company will focus on PD-1 combinations with Provenge instead. If those initial data look good, BMY will pay up to bring them both under one house.
Several have tried. Latest is someone using SGEN's linker tech to target PSMA, something that failed with IMGN's TAP technology. I'd guess there are others.
Not give them together, because that won't work. I think some of the better immunos have just been run in crappy trials. Better trials, better patient selection, and reset the immune system before you give them and I think you'd have a better shot at efficacy.
Ipilimumab query
http://www.clinicaltrials.gov/ct2/show/NCT01057810?term=ipilimumab&rank=31
ClinicalTrials.gov has a Phase III ipilimumab trial in asymp/minimally symptmatic M+ CRPC patients queued up to start in May. The trial is ipi versus placebo.
A couple of questions for the crowd:
(1) If Provenge is approved May 1, wouldn't this trial be unethical or perhaps even invalid without Provenge in the control? The trial excludes prior immunotherapy.
(2) If the trial has to account for Provenge, do you think BMY does it ipi +/- Provenge or ipi in Provenge failures or ipi +/- taxane?
(3) If you were on an IRB, would you allow ipi to be given to a Provenge patient without some Phase 1/2 data showing that combination was safe?
TIA for your input.
It's actually one thing I never understood about either the MDV3100 or the abiraterone trials. I mean I understand that earlier stage trials are miserable because the follow-up is huge, but sometimes you have to bite the bullet and go where the science makes more sense.
It should be said also that PCa patients are highly sensitive to side effects. While they may be looking at the same label, whichever drug has the better side effect profile (assuming survival benefit is in the same zip code) will win.
And, FWIW, if Provenge is approved I'd expect Taxotere to be called second-line and Cabazitaxel and other to be called third line. Taxotere is likely to only be used in symptomatic men or those with an aggressive onc and whose time to relapse or PSA kinetics suggests very rapidlly progressing disease.
Even then, if the Petrylak retrospective data hold up in IMPACT I think those fast progressors get Provenge before chemo.
OT: OMG, DD = BO
What, do you keep a spreadsheet or calendar tickler file of this stuff!?!
Good-natured ribbing aside, nice call.
I'd tend to second rk's thoughts and add the following...
Everything on the board, some cases including "official news" from a company, is someone's personal opinion shaded by their experience and prejudice towards the subject matter. How that varies from rumors is simply a matter of degree. We all know published sources that are as full of crap as the latest "bluehorseshoe says XXX for ZZZZ @$100" rumors.
Personally, I like hearing the rumor mill of stocks I own because even the stupid rumors tell me valuable information about my fellow shareholders. Understanding how volatile a stock is in relation to stupidity is important, particularly in our little corner of the market.
I think you need to discern between what the company did and what self-named Provenge advocates did. If you want to make the argument that the advocates created a toxic environment at the FDA for Provenge approval, fine. But don't shorthand it by implying the company had a role because that is simply not accurate.
Thanks, needed the chuckle today... Secured domain rights... Wow.
PR about a money raise comes tomorrow?
The bear case for Dendreon/Provenge:
I'd be interested in hearing the Board's thoughts on the bear case for Provenge specifically, and Dendreon generally. Some folks think the price gains will be staggering and uninterrupted. Aside from the fact "uninterrupted" never happens, what do you see as the roadblocks and pitfalls?
Reading between the lines is part of what makes this so interesting. With no responses and no side effects, the companies were probably ready to move it forward into Phase II trials anyway.
HEB
In reverse chronological order (oldest at the bottom). All are Adam's except for the top one which is mine.
Reasons to give HEB's Carter a raise for 2009: Kept inflation in HEB stock price to a minimum, pleasing inflation hawks.
Reasons to give HEB's Carter a raise for 2009: He chewed with his mouth closed at the corporate picnic.
Reasons to give HEB's Carter a raise for 2009: The sun continued to set in the west.
Reasons to give HEB's Carter a raise for 2009: He replenished the non-dairy creamer in the corporate breakroom.
This might be the all-time classic -- HEB's BoD awarded a 2009 bonus to CEO Bill Carter. Congratulations, Bill. So deserving!!! LMAO!
Did you see the Twitter thread on this from Feuerstein? Very funny.
The rates are high, but the percentage of GDP paid by corporations in the US puts us firmly in the middle or low end, depending on how you measure it.
http://www.cbo.gov/ftpdocs/69xx/doc6902/11-28-CorporateTax.pdf
You're right about ENCY. I think that would be a more interesting book than DNDN. Someone at that company must have done someone at the FDA wrong... to paraphrase the old country tune.
SPPI - Sorry, Blade, I don't follow them closely enough to have any opinion.
CRXX
We terminated coverage on it a while back. Another example of poor manufacturing decisions getting in the way of clinical trial efficacy. I still believe their computational model is really valuable, but the young CEO was pushed around by investors to ram something into the clinic without proper preparation.
They also got unlucky in that a dose of steroid that no literature suggested had efficacy turned out to have efficacy. Not that anyone will pay attention because it will likely never be prominently published, but it turns out we're broadly overdosing some significant number of patients who use topical steroids.